Trial To Evaluate The Safety, Tolerability, And Immunogen... | NCT03765073 | Trialant
NCT03765073
Sponsor
Pfizer
Status
Completed
Last Update Posted
Aug 5, 2025Actual
Enrollment
1,208Actual
Phase
Phase 2
Conditions
Group B Streptococcus Infections
Interventions
Multivalent Group B streptococcus vaccine
Placebo
Countries
United States
South Africa
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03765073
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
C1091002
Secondary IDs
ID
Type
Description
Link
2020-005074-96
EudraCT Number
Brief Title
Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Group B Streptococcus Vaccine In Healthy Nonpregnant Women And Pregnant Women And Their Infants
Official Title
A PHASE 1/2, RANDOMIZED, PLACEBO-CONTROLLED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT GROUP B STREPTOCOCCUS VACCINE IN HEALTHY NONPREGNANT WOMEN AND PREGNANT WOMEN 18 TO 40 YEARS OF AGE AND THEIR INFANTS
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Jun 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jan 14, 2019Actual
Primary Completion Date
Mar 4, 2024Actual
Completion Date
Mar 4, 2024Actual
First Submitted Date
Dec 4, 2018
First Submission Date that Met QC Criteria
Dec 4, 2018
First Posted Date
Dec 5, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Mar 4, 2025
Results First Submitted that Met QC Criteria
Jul 16, 2025
Results First Posted Date
Aug 5, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 16, 2025
Last Update Posted Date
Aug 5, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Phase 1/2, randomized, placebo-controlled, observer-blinded study will evaluate the safety, tolerability and immunogenicity of the investigational multivalent group B streptococcus vaccine administered at one dose level (various formulations) in healthy nonpregnant women (various formulations at one dose level), and then in healthy pregnant women (various formulations at three dose levels), and finally in healthy pregnant women at a selected dose level/formulation.
Detailed Description
Not provided
Conditions Module
Conditions
Group B Streptococcus Infections
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,208Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Stage 1 - Highest dose formulation a
Experimental
Multivalent group B streptococcus vaccine - Stage 1 Nonpregnant women
Biological: Multivalent Group B streptococcus vaccine
Stage 1 - Highest dose formulation b
Experimental
Multivalent group B streptococcus vaccine - Stage 1 Nonpregnant women
Biological: Multivalent Group B streptococcus vaccine
Stage 2 - Lowest dose formulation a
Experimental
Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
Biological: Multivalent Group B streptococcus vaccine
Stage 2 - Lowest dose formulation b
Experimental
Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
Biological: Multivalent Group B streptococcus vaccine
Stage 2 - Middle dose formulation a
Experimental
Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
Biological: Multivalent Group B streptococcus vaccine
Stage 2 - Middle dose formulation b
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Multivalent Group B streptococcus vaccine
Biological
Various formulations at three dose levels
Stage 1 - Highest dose formulation a
Stage 1 - Highest dose formulation b
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1
Local reactions (redness, swelling, and pain at the injection site of the left arm) were recorded by participants in e-diary. Erythema/Redness and induration/swelling were measured and recorded in measuring device units (1 measuring device unit=0.5 centimeter [cm]). Grading: Grade 1/mild (greater than [>] 2.5 to 5.0 cm), Grade 2/moderate (>5.0 to 10.0 cm), Grade 3/severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as Grade 1/mild (did not interfere with activity), Grade2/moderate (interfered with activity), Grade 3/severe (prevented daily activity) and Grade 4 (emergency room [ER] visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person.
Day 1 (day of vaccination) to Day 7 after Primary Dose
Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1
Local reactions (redness, swelling, and pain at the injection site of the left arm) were recorded by participants in e-diary. Erythema/Redness and induration/swelling were measured and recorded in measuring device units (1 measuring device unit=0.5 centimeter [cm]). Grading: Grade 1/mild (greater than [>] 2.5 to 5.0 cm), Grade 2/moderate (>5.0 to 10.0 cm), Grade 3/severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as Grade 1/mild (did not interfere with activity), Grade2/moderate (interfered with activity), Grade 3/severe (prevented daily activity) and Grade 4 (emergency room [ER] visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person.
Day 1 (day of vaccination) to Day 7 after booster dose
Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1
Systemic events were recorded in e-diary. Fever: oral temperature greater than or equal to (>=) 38.0 degree Celsius (deg C) and categorized as >=38.0-38.4 deg C, >38.4-38.9 deg C, >38.9-40.0 deg C and >40.0 deg C. Nausea/vomiting was graded as: Grade 1/mild (1-2 times in 24 hours [h]), Grade 2/moderate: (>2 times in 24h), Grade 3/severe (required intravenous hydration) and Grade 4 (ER visit/hospitalization for hypotensive shock). Diarrhea was graded as: Grade 1/mild (2-3 loose stools in 24h), Grade 2/moderate (4-5 loose stools in 24h), Grade 3/severe (6 or more loose stools in 24h) and Grade 4 (ER visit/hospitalization for severe diarrhea). Fatigue/tiredness, headache, muscle pain and joint pain were graded as: Grade 1/mild (did not interfere with activity), Grade 2/moderate (some interference with activity), Grade 3/severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Grade 4 were classified by investigator or medically qualified person.
Secondary Outcomes
Measure
Description
Time Frame
Geometric Mean Concentration (GMCs) of Group B Streptococcus (GBS) Serotype-Specific Immunoglobulin G (IgG) at 1 Month After Primary Dose: Non-Pregnant Women Stage 1
Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.
At 1 Month After primary Dose
GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria Stage 1 Nonpregnant Women:
Healthy nonpregnant females 18 to 40 years of age at enrollment who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
Negative urine pregnancy test at Visit 1 (prior to vaccination).
Documented negative HIV, hepatitis C virus (HCV), and acute or chronic hepatitis B virus (HBV) infection at screening.
Inclusion Criteria Stage 1 Booster Vaccination:
Participant must have received investigational product at Visit 1.
Healthy nonpregnant female determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for booster vaccination and received investigational product at Visit 1.
Negative urine pregnancy test at Visit 6 (prior to vaccination).
Documented negative HIV, hepatitis C virus (HCV), and acute or chronic hepatitis B virus (HBV) infection at screening.
Inclusion Criteria Stage 2 and 3 Maternal Participants:
Healthy females >=18 and <=40 years of age who are >=27 0/7 (Stage 2) or >=24 0/7 (Stage 3) to <=35 6/7 weeks' gestation on the day of planned vaccination, with an uncomplicated, singleton pregnancy, and at no increased risk for complications and no significant fetal abnormalities observed on ultrasound performed at any time prior to study entry and/or at the screening visit.
Documented negative HIV antibody, HBV surface antigen, HCV antibody, and syphilis tests at screening.
Inclusion Criteria Stage 2 and 3 Infant Participants:
Evidence of a signed and dated ICD signed by the parent(s). Parent(s) willing and able to comply with scheduled visits, investigational plan, laboratory tests, and other study procedures.
Exclusion Criteria Stage 1 Nonpregnant Women:
Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the investigational product or any diphtheria toxoid-containing or CRM197 containing vaccine.
History of microbiologically proven invasive disease caused by GBS (S agalactiae).
Previous vaccination with any licensed or investigational GBS vaccine (other than GBS6 received as a primary vaccination at Visit 1), or planned receipt during the participant's participation in the study (through the last blood draw).
Exclusion criteria Stage 2 and 3 Maternal Participants:
Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the investigational product or any diphtheria toxoid-containing or CRM197 containing vaccine.
History of microbiologically proven invasive disease caused by GBS (S agalactiae).
Previous vaccination with any licensed or investigational group B streptococcus vaccine, or planned receipt during the participant's participation in the study (through the last blood draw).
Prepregnancy body mass index (BMI) of ≥40 kg/m2. If prepregnancy BMI is not available, the BMI at the time of the first obstetric visit during the current pregnancy may be used.
A prior history of or current pregnancy complications or abnormalities that will increase the risk associated with the participant's participation.
Major illness of the mother or conditions of the fetus that, in the investigator's judgment, will substantially increase the risk associated with the participant's participation in, and completion of, the study or could preclude the evaluation of the participant's response.
Exclusion criteria Stage 2 and 3 Infant Participants:
Infant who is a direct descendant (eg, child or grandchild) of the study personnel.
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
A total of 66 nonpregnant women and 576 maternal participants and their 566 infants were enrolled in this study. Infants were not randomized and vaccinated in this study but summarized according to the vaccine group their mothers were randomized to. Vaccination was administered preferably to the nondominant arm of the participants.
Recruitment Details
Healthy non-pregnant participants, pregnant maternal participants between 18 to 40 years of age and infants who were born to these maternal participants were enrolled in this study. This study conducted in three stages and participants were enrolled to Stage 1, 2 and 3 separately.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant)
Nonpregnant participants were randomized to receive a single dose of 20 microgram of Group B Streptococcus 6-valent (GBS6) vaccine with aluminium phosphate, intramuscularly, preferably in nondominant arm on Day 1.
FG001
Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant)
Periods
Title
Milestones
Reasons Not Completed
Stage 1
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Mar 28, 2023
Mar 3, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
This is an observer-blinded study. Study staff dispensing and administering the vaccine will be unblinded, but all other study personnel, including the principal investigator, and the participant, will be blinded.
Who Masked
ParticipantInvestigator
Experimental
Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
Biological: Multivalent Group B streptococcus vaccine
Stage 2 - Highest dose formulation a
Experimental
Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
Biological: Multivalent Group B streptococcus vaccine
Stage 2 - Highest dose formulation b
Experimental
Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
Biological: Multivalent Group B streptococcus vaccine
Stage 3 - Selected dose and formulation
Experimental
Multivalent group B streptococcus vaccine - Stage 3 Pregnant women
Biological: Multivalent Group B streptococcus vaccine
Stage 1 Placebo
Placebo Comparator
Saline control
Biological: Placebo
Stage 2 Placebo
Placebo Comparator
Saline control
Biological: Placebo
Stage 3 Placebo
Placebo Comparator
Saline control
Biological: Placebo
Stage 2 - Highest dose formulation a
Stage 2 - Highest dose formulation b
Stage 2 - Lowest dose formulation a
Stage 2 - Lowest dose formulation b
Stage 2 - Middle dose formulation a
Stage 2 - Middle dose formulation b
Stage 3 - Selected dose and formulation
Placebo
Biological
Saline control
Stage 1 Placebo
Stage 2 Placebo
Stage 3 Placebo
Day 1 (day of vaccination) to Day 7 after primary dose
Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1
Systemic events were recorded in e-diary. Fever: oral temperature greater than or equal to (>=) 38.0 degree Celsius (deg C) and categorized as >=38.0-38.4 deg C, >38.4-38.9 deg C, >38.9-40.0 deg C and >40.0 deg C. Nausea/vomiting was graded as: Grade 1/mild (1-2 times in 24 hours [h]), Grade 2/moderate: (>2 times in 24h), Grade 3/severe (required intravenous hydration) and Grade 4 (ER visit/hospitalization for hypotensive shock). Diarrhea was graded as: Grade 1/mild (2-3 loose stools in 24h), Grade 2/moderate (4-5 loose stools in 24h), Grade 3/severe (6 or more loose stools in 24h) and Grade 4 (ER visit/hospitalization for severe diarrhea). Fatigue/tiredness, headache, muscle pain and joint pain were graded as: Grade 1/mild (did not interfere with activity), Grade 2/moderate (some interference with activity), Grade 3/severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Grade 4 were classified by investigator or medically qualified person.
Day 1 (day of vaccination) to Day 7 after booster dose
Percentage of Participants Reporting Adverse Events (AEs) Through 1 Month After Primary Dose: Non-Pregnant Participants Stage 1
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency.
Day 1 (day of vaccination) through 1 Month post primary dose
Percentage of Participants Reporting AEs Through 1 Month After Booster Dose: Non-Pregnant Participants Stage 1
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency.
Day 1 (day of vaccination) through 1 Month post booster dose
Percentage of Participants Reporting Medically Attended Adverse Events (MAEs) Through 6 Months After Primary Dose: Non-Pregnant Participants Stage 1
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Day 1 (day of vaccination) through 6 Months post primary dose
Percentage of Participants Reporting Serious Adverse Events (SAEs) Through 6 Months After Primary Dose: Non-Pregnant Participants Stage 1
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.
Day 1 (day of vaccination) through 6 Months post primary dose
Percentage of Participants Reporting MAEs Approximately 7 to 12 Months After Booster Dose: Non-Pregnant Participants Stage 1
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Day 1 (day of vaccination) through approximately 7 to 12 months post booster dose
Percentage of Participants Reporting SAEs Approximately 7 to 12 Months After Booster Dose: Non-Pregnant Participants Stage 1
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.
Day 1 (day of vaccination) through approximately 7 to 12 months post booster dose
Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2
Hemoglobin: Grade 1, Platelets High: Grade 2, White blood cells decreased: Grade 1, Neutrophils (Absolute): Grade 1, Basophils (Absolute): Grade 2, Lymphocytes Low (Absolute): Grade1, Blood urea nitrogen (bun): Grade 1, Aspartate aminotransferase (AST): Grade 2, Alanine aminotransferase (ALT): Grade 1 and 3 and Alkaline phosphate: Grade 1. Grades were considered as 1: mild, 2: moderate, 3: severe. Only categories with non-zero values were reported for this outcome measure.
2 weeks after vaccination in Stage 2
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2
Local reactions (redness, swelling, and pain at the injection site of the left arm) were recorded by participants in e-diary. Erythema/Redness and induration/swelling were measured and recorded in measuring device units (1 measuring device unit=0.5 cm). Grading: Grade 1/mild (> 2.5 to 5.0 cm), Grade 2/moderate (>5.0 to 10.0 cm), Grade 3/severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as Grade 1/mild (did not interfere with activity), Grade2/moderate (interfered with activity), Grade 3/severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person.
Day 1 (day of vaccination) to Day 7 after Vaccination
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3
Local reactions (redness, swelling, and pain at the injection site of the left arm) were recorded by participants in e-diary. Erythema/Redness and induration/swelling were measured and recorded in measuring device units (1 measuring device unit=0.5 cm). Grading: Grade 1/mild (> 2.5 to 5.0 cm), Grade 2/moderate (>5.0 to 10.0 cm), Grade 3/severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as Grade 1/mild (did not interfere with activity), Grade2/moderate (interfered with activity), Grade 3/severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person.
Day 1 (day of vaccination) to Day 7 after Vaccination
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2
Systemic events were recorded in e-diary. Fever: oral temperature >=38.0 deg C and categorized as >=38.0-38.4 deg C, >38.4-38.9 deg C, >38.9-40.0 deg C and >40.0 deg C. Nausea/vomiting was graded as: Grade 1/mild (1-2 times in 24 h), Grade 2/moderate: (>2 times in 24h), Grade 3/severe (required intravenous hydration) and Grade 4 (ER visit/hospitalization for hypotensive shock). Diarrhea was graded as: Grade 1/mild (2-3 loose stools in 24h), Grade 2/moderate (4-5 loose stools in 24h), Grade 3/severe (6 or more loose stools in 24h) and Grade 4 (ER visit/hospitalization for severe diarrhea). Fatigue/tiredness, headache, muscle pain and joint pain were graded as: Grade 1/mild (did not interfere with activity), Grade 2/moderate (some interference with activity), Grade 3/severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Grade 4 were classified by investigator or medically qualified person.
Day 1 (day of vaccination) to Day 7 after Vaccination
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3
Systemic events were recorded in e-diary. Fever: oral temperature >=38.0 deg C and categorized as >=38.0-38.4 deg C, >38.4-38.9 deg C, >38.9-40.0 deg C and >40.0 deg C. Nausea/vomiting was graded as: Grade 1/mild (1-2 times in 24 h), Grade 2/moderate: (>2 times in 24h), Grade 3/severe (required intravenous hydration) and Grade 4 (ER visit/hospitalization for hypotensive shock). Diarrhea was graded as: Grade 1/mild (2-3 loose stools in 24h), Grade 2/moderate (4-5 loose stools in 24h), Grade 3/severe (6 or more loose stools in 24h) and Grade 4 (ER visit/hospitalization for severe diarrhea). Fatigue/tiredness, headache, muscle pain and joint pain were graded as: Grade 1/mild (did not interfere with activity), Grade 2/moderate (some interference with activity), Grade 3/severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Grade 4 were classified by investigator or medically qualified person.
Day 1 (day of vaccination) to Day 7 after Vaccination
Percentage of Participants Reporting AEs Through 1 Month After Administration of Investigational Product: Maternal Participants Stage 2
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency.
Day 1 (day of vaccination) through 1 Month post vaccination
Percentage of Participants Reporting AEs Through 1 Month After Administration of Investigational Product: Maternal Participants Stage 3
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency.
Day 1 (day of vaccination) through 1 Month post vaccination
Percentage of Participants With SAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 2
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.
Day 1 (day of vaccination) through 12 Month post delivery
Percentage of Participants With SAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 3
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.
Day 1 (day of vaccination) through 12 Month post delivery
Percentage of Participants With MAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 2
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Day 1 (day of vaccination) through 12 Month post delivery
Percentage of Participants With MAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 3
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Day 1 (day of vaccination) through 12 Month post delivery
Percentage of Participants With Obstetric Complications From Visit 1 Through 12 Months Post-delivery: Maternal Participants Stage 2
Obstetric complications such as: prepartum period, intrapartum period and postpartum period were reported in this outcome measure.
Day 1 (day of vaccination) through 12 Month post delivery
Percentage of Participants With Obstetric Complications From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 3
Obstetric complications such as: prepartum period, intrapartum period and postpartum period were reported in this outcome measure.
Day 1 (day of vaccination) through 12 Month post delivery
Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2
Delivery Outcome included full term live delivery, premature live delivery, Stillbirth, induced/elective abortion and unknown. Mode of delivery included: vaginal delivery, Cesarean section: elective, semi-elective and emergency were reported in this outcome measure.
At delivery
Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 3
Delivery Outcome included full term live delivery, premature live delivery, Stillbirth, induced/elective abortion and unknown. Mode of delivery included: vaginal delivery, Cesarean section: elective, semi-elective and emergency were reported in this outcome measure.
At delivery
Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2
Gestational age of participants at birth in weeks included: greater than or equal to (>=)24 weeks to less than (<) 28 weeks, >=28 weeks to <34 weeks, >=34 weeks to <37 weeks, >=37 weeks to <42 weeks, >=42 weeks.
At Birth
Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 Minute: Infant Participants Stage 2
APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low. APGAR score at 1 minute were reported in this outcome measure.
At 1 minute of Birth
Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 5 Minutes: Infant Participants Stage 2
APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low. APGAR score at 5 minute were reported in this outcome measure.
At 5 minutes of Birth
Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 2
The Ballard score is a commonly used technique of gestational age assessment. It assists healthcare providers in determining if an infant is premature, on time, or post-term based on physical traits. This scoring allows for the estimation of age in the range of 26 weeks to 44 weeks Participants according to age determined by Ballard score: at <37 weeks 0 days, >=37 weeks to <42 weeks, >=42 weeks were reported in this outcome measure. Ballard score was not conducted routinely/mandatory.
At Birth
Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 2
Participants with newborn assessment at birth included: normal, congenital malformation/anomaly, other neonatal problem were reported in this outcome measure.
At Birth
Number of Participants With Vital Status: Infant Participants Stage 2
Participants according to vital status as: live or neonatal death were reported in this outcome measure.
At Birth
Number of Participants With Gestational Age of Participants at Birth: Infant Participants Stage 3
Gestational age of participants at birth in weeks included: greater than or equal to (>=)24 weeks to less than (<) 28 weeks, >=28 weeks to <34 weeks, >=34 weeks to <37 weeks, >=37 weeks to <42 weeks, >=42 weeks.
At 1 minute of Birth
Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 Minute: Infant Participants Stage 3
APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low. Appearance, pulse, grimace, activity, and respiration (APGAR) score at 1 minute were reported in this outcome measure.
At 1 minute of Birth
APGAR Score at 5 Minutes: Infant Participants Stage 3
APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low. Appearance, pulse, grimace, activity, and respiration (APGAR) score at 5 minute were reported in this outcome measure.
At 5 minutes of Birth
Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 3
The Ballard score is a commonly used technique of gestational age assessment. It assists healthcare providers in determining if an infant is premature, on time, or post-term based on physical traits. This scoring allows for the estimation of age in the range of 26 weeks to 44 weeks Participants according to age determined by Ballard score: at <37 weeks 0 days, >=37 weeks to <42 weeks, >=42 weeks were reported in this outcome measure. Ballard score was not conducted routinely/mandatory.
At Birth
Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 3
Participants with newborn assessment at birth included: normal, congenital malformation/anomaly, other neonatal problem were reported in this outcome measure.
At 5 minutes of Birth
Number of Participants With Vital Status: Infant Participants Stage 3
Participants according to vital status as: live or neonatal death were reported in this outcome measure.
At Birth
Number of Participants With AEs From Birth to 6 Weeks of Age: Infant Participants Stage 2
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage.
From Birth to 6 Weeks
Numberof Participants With AEs From Birth to 6 Weeks of Age: Infant Participants Stage 3
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage.
From Birth to 6 Weeks
Number of Participants With SAEs From Birth to 12 Months of Age: Infant Participants Stage 2
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.
From Birth to 12 Months
Number of Participants With SAEs From Birth to 12 Months of Age: Infant Participants Stage 3
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.
From Birth to 12 Months
Number of Participants With MAEs From Birth to 12 Months of Age: Infant Participants Stage 2
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
From Birth to 12 Months
Number of Participants With MAEs From Birth to 12 Months of Age: Infant Participants Stage 3
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
From Birth to 12 Months
Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 2
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. AEs of special interest included: major congenital anomalies, developmental delay and suspected or confirmed GBS infection.
From Birth to 12 Months
Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 3
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. AEs of special interest included: major congenital anomalies, developmental delay and suspected or confirmed GBS infection.
From Birth to 12 Months
Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.
Before (immediately before booster vaccination) and at 1, 3 and 6 Months After vaccination as Booster Dose
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2
Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.
At 2 Weeks after Vaccination, 1 Month After Vaccination and at Delivery
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3
Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.
At 2 Weeks after Vaccination, 1 Month After Vaccination and at Delivery
GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2
OPA for the 6 serotypes (Ia, Ib, II, III, IV, V) were determined in all participants for each blood sample.
At 1 Month After Vaccination and at Delivery
GBS6 Serotype-Specific OPA Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3
OPA for the 6 serotypes (Ia, Ib, II, III, IV, V) were determined in all participants for each blood sample.
At 1 Month After Vaccination and at Delivery
GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2
Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.
At Birth
GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 3
Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.
Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.
At Birth
Phoenix
Arizona
85006
United States
Chemidox Clinical Trials Inc.
Lancaster
California
93534
United States
Chemidox Clinical Trials Inc
Lancaster
California
93534
United States
Emerson Clinical Research Institute
Washington D.C.
District of Columbia
20009
United States
Clinical Research Prime
Idaho Falls
Idaho
83404
United States
Clinical Research Prime Rexburg
Rexburg
Idaho
83440
United States
Lakeview Regional Medical Center
Covington
Louisiana
70433
United States
MedPharmics
Covington
Louisiana
70433
United States
St. Tammany Parish Hospital
Covington
Louisiana
70433
United States
North Oaks Medical Center
Hammond
Louisiana
70403
United States
North Oaks Obstetrics & Gynecology
Hammond
Louisiana
70403
United States
Velocity Clinical Research
Slidell
Louisiana
70458
United States
Boeson Research
Missoula
Montana
59804
United States
Community Hospital
Missoula
Montana
59804
United States
The Birth Center
Missoula
Montana
59804
United States
Meridian Clinical Research
Hastings
Nebraska
68901
United States
Frontier Pediatric Care (Follow-Up Visits for Infant Participants)
Lincoln
Nebraska
68506
United States
Bryan Women's Care Physicians (Maternal Visits & Obstetric Exams)
Lincoln
Nebraska
68510
United States
Be Well Clinical Studies
Lincoln
Nebraska
68516
United States
Lowcountry Women's Specialists
Summerville
South Carolina
29485
United States
Summerville Medical Center
Summerville
South Carolina
29485
United States
Coastal Pediatric Research
Summerville
South Carolina
29486
United States
Sentara Leigh Hospital
Norfolk
Virginia
23502
United States
The Group for Women
Norfolk
Virginia
23502
United States
Tidewater Physicians for Women
Norfolk
Virginia
23502
United States
Wits Reproductive Health and HIV Institute
Johannesburg
Gauteng
2001
South Africa
Respiratory and Meningeal Pathogens Research Unit (RMPRU)
Soweto
Gauteng
1862
South Africa
Charlotte Maxeke Johannesburg Academic Hospital
Parktown
Johannesburg, Gauteng
2196
South Africa
Empilweni Services and Research Unit (ESRU)
Coronationville
Johannesburg
2093
South Africa
Khayelitsha District Hospital (KDH)
Khayelitsha
Western Cape
7784
South Africa
Michael Mapongwana Community Health Centre
Khayelitsha
Western Cape
7784
South Africa
Site B
Khayelitsha
Western Cape
7784
South Africa
FAMCRU
Parow Valley
Western Cape
7505
South Africa
St George's University Hospitals NHS Foundation Trust
London
Tooting
SW17 0QT
United Kingdom
Madhi SA, Anderson AS, Absalon J, Radley D, Simon R, Jongihlati B, Strehlau R, van Niekerk AM, Izu A, Naidoo N, Kwatra G, Ramsamy Y, Said M, Jones S, Jose L, Fairlie L, Barnabas SL, Newton R, Munson S, Jefferies Z, Pavliakova D, Silmon de Monerri NC, Gomme E, Perez JL, Scott DA, Gruber WC, Jansen KU. Potential for Maternally Administered Vaccine for Infant Group B Streptococcus. N Engl J Med. 2023 Jul 20;389(3):215-227. doi: 10.1056/NEJMoa2116045.
Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly, preferably in nondominant arm on Day 1.
FG002
Stage 1: Placebo (Nonpregnant)
Non pregnant participants were randomized to receive placebo (saline control) intramuscularly, preferably in nondominant arm on Day 1.
FG003
Stage 2: GBS6 5 mcg With AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 5 μg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
FG004
Stage 2: GBS6 5 mcg Without AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 5 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
FG005
Stage 2: GBS6 10 mcg With AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
FG006
Stage 2: GBS6 10 mcg Without AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
FG007
Stage 2: GBS6 20 mcg With AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
FG008
Stage 2: GBS6 20 mcg Without AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
FG009
Stage 2: Placebo (Maternal)
Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
FG010
Stage 2: GBS6 5 mcg With AlPO4 (Infant)
Infant participants born to the maternal participants randomized to receive a single dose of 5 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
FG011
Stage 2: GBS6 5 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants randomized to receive a single dose of 5 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
FG012
Stage 2: GBS6 10 mcg With AlPO4 (Infant)
Infant participants born to the maternal participants randomized to receive a single dose of 10 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
FG013
Stage 2: GBS6 10 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
FG014
Stage 2: GBS6 20 mcg With AlPO4 (Infant)
Infant participants born to the maternal participants randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
FG015
Stage 2: GBS6 20 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
FG016
Stage 2: Placebo (Infant)
Infant participants born to the maternal participants randomized to receive placebo (saline control) intramuscularly on Day 1.
FG017
Stage 3: GBS6 20 mcg Without AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AIPO4, intramuscularly on Day 1.
FG018
Stage 3: Placebo (Maternal)
Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
FG019
Stage 3: GBS6 20 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
FG020
Stage 3: Placebo (Infant)
Infant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
FG00022 subjects
FG00122 subjects
FG00222 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
Booster Vaccination
FG00011 subjects
FG0017 subjects
FG0028 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
COMPLETED
FG00021 subjects
FG00121 subjects
FG00222 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
NOT COMPLETED
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
Withdrawal by participant
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Stage 2
Type
Comment
Milestone Data
STARTED
FG0000 subjectsParticipants did not enter Stage 2 of the study.
FG0010 subjectsParticipants did not enter Stage 2 of the study.
FG0020 subjectsParticipants did not enter Stage 2 of the study.
FG00340 subjectsParticipants who were randomized to Stage 2 of the study.
FG00440 subjectsParticipants who were randomized to Stage 2 of the study.
FG00540 subjectsParticipants who were randomized to Stage 2 of the study.
FG00640 subjectsParticipants who were randomized to Stage 2 of the study.
FG00740 subjectsParticipants who were randomized to Stage 2 of the study.
FG00840 subjectsParticipants who were randomized to Stage 2 of the study.
FG009120 subjectsParticipants who were randomized to Stage 2 of the study.
FG01040 subjectsParticipants who were randomized to Stage 2 of the study.
FG01139 subjectsParticipants who were randomized to Stage 2 of the study.
FG01240 subjectsParticipants who were randomized to Stage 2 of the study.
FG01340 subjectsParticipants who were randomized to Stage 2 of the study.
FG01440 subjectsParticipants who were randomized to Stage 2 of the study.
FG01540 subjectsParticipants who were randomized to Stage 2 of the study.
FG016118 subjectsParticipants who were randomized to Stage 2 of the study.
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00332 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0038 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Stage 3
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjectsParticipants did not enter Stage 3 of the study.
FG0040 subjectsParticipants did not enter Stage 3 of the study.
FG0050 subjectsParticipants did not enter Stage 3 of the study.
FG0060 subjectsParticipants did not enter Stage 3 of the study.
FG0070 subjectsParticipants did not enter Stage 3 of the study.
FG0080 subjectsParticipants did not enter Stage 3 of the study.
FG0090 subjectsParticipants did not enter Stage 3 of the study.
FG0100 subjectsParticipants did not enter Stage 3 of the study.
FG0110 subjectsParticipants did not enter Stage 3 of the study.
FG0120 subjectsParticipants did not enter Stage 3 of the study.
FG0130 subjectsParticipants did not enter Stage 3 of the study.
FG0140 subjectsParticipants did not enter Stage 3 of the study.
FG0150 subjectsParticipants did not enter Stage 3 of the study.
FG0160 subjectsParticipants did not enter Stage 3 of the study.
FG017108 subjectsParticipants who were randomized to Stage 3 of the study.
FG018108 subjectsParticipants who were randomized to Stage 3 of the study.
FG019104 subjectsParticipants who were randomized to Stage 3 of the study.
FG020105 subjectsParticipants who were randomized to Stage 3 of the study.
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Safety analysis set included all participants who received a primary or booster dose of GBS6 vaccine or placebo.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant)
Nonpregnant participants were randomized to receive a single dose of 20 microgram of Group B Streptococcus 6-valent (GBS6) vaccine with aluminium phosphate, intramuscularly on Day 1.
BG001
Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant)
Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
BG002
Stage 1: Placebo (Nonpregnant)
Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
BG003
Stage 2: GBS6 5 mcg With AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 5 μg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
BG004
Stage 2: GBS6 5 mcg Without AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 5 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
BG005
Stage 2: GBS6 10 mcg With AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
BG006
Stage 2: GBS6 10 mcg Without AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
BG007
Stage 2: GBS6 20 mcg With AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
BG008
Stage 2: GBS6 20 mcg Without AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
BG009
Stage 2: Placebo (Maternal)
Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
BG010
Stage 2: GBS6 5 mcg With AlPO4 (Infant)
Infant participants born to the maternal participants randomized to receive a single dose of 5 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
BG011
Stage 2: GBS6 5 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants randomized to receive a single dose of 5 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
BG012
Stage 2: GBS6 10 mcg With AlPO4 (Infant)
Infant participants born to the maternal participants randomized to receive a single dose of 10 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
BG013
Stage 2: GBS6 10 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
BG014
Stage 2: GBS6 20 mcg With AlPO4 (Infant)
Infant participants born to the maternal participants randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
BG015
Stage 2: GBS6 20 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
BG016
Stage 2: Placebo (Infant)
Infant participants born to the maternal participants randomized to receive placebo (saline control) intramuscularly on Day 1.
BG017
Stage 3: GBS6 20 mcg Without AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AIPO4, intramuscularly on Day 1.
BG018
Stage 3: Placebo (Maternal)
Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
BG019
Stage 3: GBS6 20 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
BG020
Stage 3: Placebo (Infant)
Infant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
BG021
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00022
BG00122
BG00222
BG00340
BG00440
BG00540
BG00640
BG00740
BG00840
BG009120
BG01040
BG01139
BG01240
BG01340
BG01440
BG01540
BG016118
BG017108
BG018108
BG019104
BG020105
BG0211208
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Full term newborn infants (Gestational age >= 37 weeks)
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00022
BG00122
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Race
Title
Measurements
Black or African American
BG00022
BG00122
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Ethnicity
Title
Measurements
Non-Hispanic/non-Latino
BG00022
BG00122
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1
Local reactions (redness, swelling, and pain at the injection site of the left arm) were recorded by participants in e-diary. Erythema/Redness and induration/swelling were measured and recorded in measuring device units (1 measuring device unit=0.5 centimeter [cm]). Grading: Grade 1/mild (greater than [>] 2.5 to 5.0 cm), Grade 2/moderate (>5.0 to 10.0 cm), Grade 3/severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as Grade 1/mild (did not interfere with activity), Grade2/moderate (interfered with activity), Grade 3/severe (prevented daily activity) and Grade 4 (emergency room [ER] visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person.
Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Posted
Number
95% Confidence Interval
Percentage of Participants
Day 1 (day of vaccination) to Day 7 after Primary Dose
ID
Title
Description
OG000
Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant)
Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG001
Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant)
Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG002
Stage 1: Placebo (Nonpregnant)
Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Units
Counts
Participants
OG00022
OG00122
OG00222
Title
Denominators
Categories
Pain at injection site (Any)
Title
Measurements
OG00027.3(10.7 to 50.2)
OG00127.3(10.7 to 50.2)
OG00213.6(2.9 to 34.9)
Pain at injection site (Mild)
Primary
Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1
Local reactions (redness, swelling, and pain at the injection site of the left arm) were recorded by participants in e-diary. Erythema/Redness and induration/swelling were measured and recorded in measuring device units (1 measuring device unit=0.5 centimeter [cm]). Grading: Grade 1/mild (greater than [>] 2.5 to 5.0 cm), Grade 2/moderate (>5.0 to 10.0 cm), Grade 3/severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as Grade 1/mild (did not interfere with activity), Grade2/moderate (interfered with activity), Grade 3/severe (prevented daily activity) and Grade 4 (emergency room [ER] visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person.
Safety analysis set included all participants who received a booster dose of GBS6 vaccine or placebo.
Posted
Number
95% Confidence Interval
Percentage of Participants
Day 1 (day of vaccination) to Day 7 after booster dose
ID
Title
Description
OG000
Stage 1 Booster: GBS6 20 mcg With AlPO4 (Nonpregnant)
Non pregnant participants were randomized to receive a booster dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly at least 2 years after Vaccination 1 on Day 1. Participants were categorized based on their primary dose of GBS6 vaccine with AlPO4.
OG001
Stage 1 Booster: GBS6 20 mcg Without AlPO4 (Nonpregnant)
Primary
Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1
Systemic events were recorded in e-diary. Fever: oral temperature greater than or equal to (>=) 38.0 degree Celsius (deg C) and categorized as >=38.0-38.4 deg C, >38.4-38.9 deg C, >38.9-40.0 deg C and >40.0 deg C. Nausea/vomiting was graded as: Grade 1/mild (1-2 times in 24 hours [h]), Grade 2/moderate: (>2 times in 24h), Grade 3/severe (required intravenous hydration) and Grade 4 (ER visit/hospitalization for hypotensive shock). Diarrhea was graded as: Grade 1/mild (2-3 loose stools in 24h), Grade 2/moderate (4-5 loose stools in 24h), Grade 3/severe (6 or more loose stools in 24h) and Grade 4 (ER visit/hospitalization for severe diarrhea). Fatigue/tiredness, headache, muscle pain and joint pain were graded as: Grade 1/mild (did not interfere with activity), Grade 2/moderate (some interference with activity), Grade 3/severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Grade 4 were classified by investigator or medically qualified person.
Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Posted
Number
95% Confidence Interval
Percentage of Participants
Day 1 (day of vaccination) to Day 7 after primary dose
ID
Title
Description
OG000
Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant)
Nonpregnant participants were randomized to receive a primary of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG001
Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant)
Primary
Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1
Systemic events were recorded in e-diary. Fever: oral temperature greater than or equal to (>=) 38.0 degree Celsius (deg C) and categorized as >=38.0-38.4 deg C, >38.4-38.9 deg C, >38.9-40.0 deg C and >40.0 deg C. Nausea/vomiting was graded as: Grade 1/mild (1-2 times in 24 hours [h]), Grade 2/moderate: (>2 times in 24h), Grade 3/severe (required intravenous hydration) and Grade 4 (ER visit/hospitalization for hypotensive shock). Diarrhea was graded as: Grade 1/mild (2-3 loose stools in 24h), Grade 2/moderate (4-5 loose stools in 24h), Grade 3/severe (6 or more loose stools in 24h) and Grade 4 (ER visit/hospitalization for severe diarrhea). Fatigue/tiredness, headache, muscle pain and joint pain were graded as: Grade 1/mild (did not interfere with activity), Grade 2/moderate (some interference with activity), Grade 3/severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Grade 4 were classified by investigator or medically qualified person.
Safety analysis set included all participants who received a booster dose of GBS6 vaccine or placebo.
Posted
Number
95% Confidence Interval
Percentage of Participants
Day 1 (day of vaccination) to Day 7 after booster dose
ID
Title
Description
OG000
Stage 1 Booster: GBS6 20 mcg With AlPO4 (Nonpregnant)
Non pregnant participants were randomized to receive a booster dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly at least 2 years after Vaccination 1 on Day 1. Participants were categorized based on their primary dose of GBS6 vaccine with AlPO4.
Primary
Percentage of Participants Reporting Adverse Events (AEs) Through 1 Month After Primary Dose: Non-Pregnant Participants Stage 1
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency.
Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Posted
Number
95% Confidence Interval
Percentage of Participants
Day 1 (day of vaccination) through 1 Month post primary dose
ID
Title
Description
OG000
Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant)
Non pregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG001
Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant)
Non pregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG002
Stage 1: Placebo (Nonpregnant)
Primary
Percentage of Participants Reporting AEs Through 1 Month After Booster Dose: Non-Pregnant Participants Stage 1
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency.
Safety analysis set included all participants who received a booster dose of GBS6 vaccine or placebo.
Posted
Number
95% Confidence Interval
Percentage of Participants
Day 1 (day of vaccination) through 1 Month post booster dose
ID
Title
Description
OG000
Stage 1 Booster: GBS6 20 mcg With AlPO4 (Nonpregnant)
Non pregnant participants were randomized to receive a booster dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly at least 2 years after Vaccination 1 on Day 1. Participants were categorized based on their primary dose of GBS6 vaccine with AlPO4.
OG001
Stage 1 Booster: GBS6 20 mcg Without AlPO4 (Nonpregnant)
Non pregnant participants were randomized to receive a booster dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly at least 2 years after Vaccination 1 on Day 1. Participants were categorized based on their primary dose of GBS6 vaccine without AlPO4.
Primary
Percentage of Participants Reporting Medically Attended Adverse Events (MAEs) Through 6 Months After Primary Dose: Non-Pregnant Participants Stage 1
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Posted
Number
95% Confidence Interval
Percentage of Participants
Day 1 (day of vaccination) through 6 Months post primary dose
ID
Title
Description
OG000
Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant)
Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG001
Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant)
Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG002
Primary
Percentage of Participants Reporting Serious Adverse Events (SAEs) Through 6 Months After Primary Dose: Non-Pregnant Participants Stage 1
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.
Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
Posted
Number
95% Confidence Interval
Percentage of Participants
Day 1 (day of vaccination) through 6 Months post primary dose
ID
Title
Description
OG000
Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant)
Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG001
Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant)
Primary
Percentage of Participants Reporting MAEs Approximately 7 to 12 Months After Booster Dose: Non-Pregnant Participants Stage 1
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Safety analysis set included all participants who received a booster dose of GBS6 vaccine or placebo.
Posted
Number
95% Confidence Interval
Percentage of Participants
Day 1 (day of vaccination) through approximately 7 to 12 months post booster dose
ID
Title
Description
OG000
Stage 1 Booster: GBS6 20 mcg With AlPO4 (Nonpregnant)
Non pregnant participants were randomized to receive a booster dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly at least 2 years after Vaccination 1 on Day 1. Participants were categorized based on their primary dose of GBS6 vaccine with AlPO4.
OG001
Stage 1 Booster: GBS6 20 mcg Without AlPO4 (Nonpregnant)
Non pregnant participants were randomized to receive a booster dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly at least 2 years after Vaccination 1 on Day 1. Participants were categorized based on their primary dose of GBS6 vaccine without AlPO4.
Primary
Percentage of Participants Reporting SAEs Approximately 7 to 12 Months After Booster Dose: Non-Pregnant Participants Stage 1
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.
Safety analysis set included all participants who received a booster dose of GBS6 vaccine or placebo.
Posted
Number
95% Confidence Interval
Percentage of Participants
Day 1 (day of vaccination) through approximately 7 to 12 months post booster dose
ID
Title
Description
OG000
Stage 1 Booster: GBS6 20 mcg With AlPO4 (Nonpregnant)
Non pregnant participants were randomized to receive a booster dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly at least 2 years after Vaccination 1 on Day 1. Participants were categorized based on their primary dose of GBS6 vaccine with AlPO4.
Primary
Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2
Hemoglobin: Grade 1, Platelets High: Grade 2, White blood cells decreased: Grade 1, Neutrophils (Absolute): Grade 1, Basophils (Absolute): Grade 2, Lymphocytes Low (Absolute): Grade1, Blood urea nitrogen (bun): Grade 1, Aspartate aminotransferase (AST): Grade 2, Alanine aminotransferase (ALT): Grade 1 and 3 and Alkaline phosphate: Grade 1. Grades were considered as 1: mild, 2: moderate, 3: severe. Only categories with non-zero values were reported for this outcome measure.
Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo. Here , number of participants analyzed signifies number of participants in the sentinel cohort (subset of Stage 2 maternal participants) evaluable for this outcome measure.
Posted
Number
Percentage of Participants
2 weeks after vaccination in Stage 2
ID
Title
Description
OG000
Stage 2: GBS6 5 mcg With AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 5 μg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG001
Stage 2: GBS6 5 mcg Without AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 5 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG002
Primary
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2
Local reactions (redness, swelling, and pain at the injection site of the left arm) were recorded by participants in e-diary. Erythema/Redness and induration/swelling were measured and recorded in measuring device units (1 measuring device unit=0.5 cm). Grading: Grade 1/mild (> 2.5 to 5.0 cm), Grade 2/moderate (>5.0 to 10.0 cm), Grade 3/severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as Grade 1/mild (did not interfere with activity), Grade2/moderate (interfered with activity), Grade 3/severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person.
Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo. Here, number analyzed signifies participants who were evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of Participants
Day 1 (day of vaccination) to Day 7 after Vaccination
ID
Title
Description
OG000
Stage 2: GBS6 5 mcg With AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 5 μg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG001
Stage 2: GBS6 5 mcg Without AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 5 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
Primary
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3
Local reactions (redness, swelling, and pain at the injection site of the left arm) were recorded by participants in e-diary. Erythema/Redness and induration/swelling were measured and recorded in measuring device units (1 measuring device unit=0.5 cm). Grading: Grade 1/mild (> 2.5 to 5.0 cm), Grade 2/moderate (>5.0 to 10.0 cm), Grade 3/severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as Grade 1/mild (did not interfere with activity), Grade2/moderate (interfered with activity), Grade 3/severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person.
Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo. Here, number analyzed signifies participants who were evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of Participants
Day 1 (day of vaccination) to Day 7 after Vaccination
ID
Title
Description
OG000
Stage 3: GBS6 20 mcg Without AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG001
Stage 3: Placebo (Maternal)
Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Primary
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2
Systemic events were recorded in e-diary. Fever: oral temperature >=38.0 deg C and categorized as >=38.0-38.4 deg C, >38.4-38.9 deg C, >38.9-40.0 deg C and >40.0 deg C. Nausea/vomiting was graded as: Grade 1/mild (1-2 times in 24 h), Grade 2/moderate: (>2 times in 24h), Grade 3/severe (required intravenous hydration) and Grade 4 (ER visit/hospitalization for hypotensive shock). Diarrhea was graded as: Grade 1/mild (2-3 loose stools in 24h), Grade 2/moderate (4-5 loose stools in 24h), Grade 3/severe (6 or more loose stools in 24h) and Grade 4 (ER visit/hospitalization for severe diarrhea). Fatigue/tiredness, headache, muscle pain and joint pain were graded as: Grade 1/mild (did not interfere with activity), Grade 2/moderate (some interference with activity), Grade 3/severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Grade 4 were classified by investigator or medically qualified person.
Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo. Here, number analyzed signifies participants who were evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of Participants
Day 1 (day of vaccination) to Day 7 after Vaccination
ID
Title
Description
OG000
Stage 2: GBS6 5 mcg With AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 5 μg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG001
Primary
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3
Systemic events were recorded in e-diary. Fever: oral temperature >=38.0 deg C and categorized as >=38.0-38.4 deg C, >38.4-38.9 deg C, >38.9-40.0 deg C and >40.0 deg C. Nausea/vomiting was graded as: Grade 1/mild (1-2 times in 24 h), Grade 2/moderate: (>2 times in 24h), Grade 3/severe (required intravenous hydration) and Grade 4 (ER visit/hospitalization for hypotensive shock). Diarrhea was graded as: Grade 1/mild (2-3 loose stools in 24h), Grade 2/moderate (4-5 loose stools in 24h), Grade 3/severe (6 or more loose stools in 24h) and Grade 4 (ER visit/hospitalization for severe diarrhea). Fatigue/tiredness, headache, muscle pain and joint pain were graded as: Grade 1/mild (did not interfere with activity), Grade 2/moderate (some interference with activity), Grade 3/severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Grade 4 were classified by investigator or medically qualified person.
Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo. Here, number analyzed signifies participants who were evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of Participants
Day 1 (day of vaccination) to Day 7 after Vaccination
ID
Title
Description
OG000
Stage 3: GBS6 20 mcg Without AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG001
Primary
Percentage of Participants Reporting AEs Through 1 Month After Administration of Investigational Product: Maternal Participants Stage 2
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency.
Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo.
Posted
Number
95% Confidence Interval
Percentage of Participants
Day 1 (day of vaccination) through 1 Month post vaccination
ID
Title
Description
OG000
Stage 2: GBS6 5 mcg With AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 5 μg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG001
Stage 2: GBS6 5 mcg Without AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 5 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG002
Stage 2: GBS6 10 mcg With AlPO4 (Maternal)
Primary
Percentage of Participants Reporting AEs Through 1 Month After Administration of Investigational Product: Maternal Participants Stage 3
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency.
Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo.
Posted
Number
95% Confidence Interval
Percentage of Participants
Day 1 (day of vaccination) through 1 Month post vaccination
ID
Title
Description
OG000
Stage 3: GBS6 20 mcg Without AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG001
Stage 3: Placebo (Maternal)
Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Units
Counts
Primary
Percentage of Participants With SAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 2
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.
Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo.
Posted
Number
95% Confidence Interval
Percentage of Participants
Day 1 (day of vaccination) through 12 Month post delivery
ID
Title
Description
OG000
Stage 2: GBS6 5 mcg With AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 5 μg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG001
Stage 2: GBS6 5 mcg Without AlPO4 (Maternal)
Primary
Percentage of Participants With SAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 3
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.
Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo.
Posted
Number
95% Confidence Interval
Percentage of Participants
Day 1 (day of vaccination) through 12 Month post delivery
ID
Title
Description
OG000
Stage 3: GBS6 20 mcg Without AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG001
Stage 3: Placebo (Maternal)
Primary
Percentage of Participants With MAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 2
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo.
Posted
Number
95% Confidence Interval
Percentage of Participants
Day 1 (day of vaccination) through 12 Month post delivery
ID
Title
Description
OG000
Stage 2: GBS6 5 mcg With AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 5 μg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG001
Stage 2: GBS6 5 mcg Without AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 5 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG002
Stage 2: GBS6 10 mcg With AlPO4 (Maternal)
Primary
Percentage of Participants With MAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 3
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo.
Posted
Number
95% Confidence Interval
Percentage of Participants
Day 1 (day of vaccination) through 12 Month post delivery
ID
Title
Description
OG000
Stage 3: GBS6 20 mcg Without AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG001
Stage 3: Placebo (Maternal)
Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Primary
Percentage of Participants With Obstetric Complications From Visit 1 Through 12 Months Post-delivery: Maternal Participants Stage 2
Obstetric complications such as: prepartum period, intrapartum period and postpartum period were reported in this outcome measure.
Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo.
Posted
Number
95% Confidence Interval
Percentage of Participants
Day 1 (day of vaccination) through 12 Month post delivery
ID
Title
Description
OG000
Stage 2: GBS6 5 mcg With AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 5 μg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG001
Stage 2: GBS6 5 mcg Without AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 5 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG002
Stage 2: GBS6 10 mcg With AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG003
Stage 2: GBS6 10 mcg Without AlPO4 (Maternal)
Primary
Percentage of Participants With Obstetric Complications From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 3
Obstetric complications such as: prepartum period, intrapartum period and postpartum period were reported in this outcome measure.
Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo.
Posted
Number
95% Confidence Interval
Percentage of Participants
Day 1 (day of vaccination) through 12 Month post delivery
ID
Title
Description
OG000
Stage 3: GBS6 20 mcg Without AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG001
Stage 3: Placebo (Maternal)
Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Units
Counts
Participants
OG000
Primary
Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2
Delivery Outcome included full term live delivery, premature live delivery, Stillbirth, induced/elective abortion and unknown. Mode of delivery included: vaginal delivery, Cesarean section: elective, semi-elective and emergency were reported in this outcome measure.
Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo.
Posted
Number
Percentage of Participants
At delivery
ID
Title
Description
OG000
Stage 2: GBS6 5 mcg With AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 5 μg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG001
Stage 2: GBS6 5 mcg Without AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 5 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG002
Stage 2: GBS6 10 mcg With AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG003
Primary
Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 3
Delivery Outcome included full term live delivery, premature live delivery, Stillbirth, induced/elective abortion and unknown. Mode of delivery included: vaginal delivery, Cesarean section: elective, semi-elective and emergency were reported in this outcome measure.
Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo.
Posted
Number
Percentage of Participants
At delivery
ID
Title
Description
OG000
Stage 3: GBS6 20 mcg Without AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG001
Stage 3: Placebo (Maternal)
Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Units
Counts
Participants
OG000
Primary
Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2
Gestational age of participants at birth in weeks included: greater than or equal to (>=)24 weeks to less than (<) 28 weeks, >=28 weeks to <34 weeks, >=34 weeks to <37 weeks, >=37 weeks to <42 weeks, >=42 weeks.
Safety analysis set included all participants whose mother received a dose of GBS6 vaccine or placebo.
Posted
Number
Percentage of Participants
At Birth
ID
Title
Description
OG000
Stage 2: GBS6 5 mcg With AlPO4 (Infant)
Infant participants born to the maternal participants randomized to receive a single dose of 5 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG001
Stage 2: GBS6 5 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants randomized to receive a single dose of 5 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG002
Stage 2: GBS6 10 mcg With AlPO4 (Infant)
Infant participants born to the maternal participants randomized to receive a single dose of 10 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG003
Primary
Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 Minute: Infant Participants Stage 2
APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low. APGAR score at 1 minute were reported in this outcome measure.
Safety analysis set included all participants whose mother received a dose of GBS6 vaccine or placebo. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Posted
Median
Full Range
Unit on a scale
At 1 minute of Birth
ID
Title
Description
OG000
Stage 2: GBS6 5 mcg With AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 5 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG001
Stage 2: GBS6 5 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 5 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG002
Stage 2: GBS6 10 mcg With AlPO4 (Infant)
Primary
Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 5 Minutes: Infant Participants Stage 2
APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low. APGAR score at 5 minute were reported in this outcome measure.
Safety analysis set included all participants whose mother received a dose of GBS6 vaccine or placebo.
Posted
Median
Full Range
Unit on a scale
At 5 minutes of Birth
ID
Title
Description
OG000
Stage 2: GBS6 5 mcg With AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 5 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG001
Stage 2: GBS6 5 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 5 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG002
Stage 2: GBS6 10 mcg With AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
Primary
Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 2
The Ballard score is a commonly used technique of gestational age assessment. It assists healthcare providers in determining if an infant is premature, on time, or post-term based on physical traits. This scoring allows for the estimation of age in the range of 26 weeks to 44 weeks Participants according to age determined by Ballard score: at <37 weeks 0 days, >=37 weeks to <42 weeks, >=42 weeks were reported in this outcome measure. Ballard score was not conducted routinely/mandatory.
Safety analysis set included all participants whose mother received a dose of GBS6 vaccine or placebo.
Posted
Count of Participants
Participants
At Birth
ID
Title
Description
OG000
Stage 2: GBS6 5 mcg With AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 5 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG001
Stage 2: GBS6 5 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 5 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG002
Stage 2: GBS6 10 mcg With AlPO4 (Infant)
Primary
Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 2
Participants with newborn assessment at birth included: normal, congenital malformation/anomaly, other neonatal problem were reported in this outcome measure.
Safety analysis set included all participants whose mother received a dose of GBS6 vaccine or placebo.
Posted
Count of Participants
Participants
At Birth
ID
Title
Description
OG000
Stage 2: GBS6 5 mcg With AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 5 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG001
Stage 2: GBS6 5 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 5 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG002
Stage 2: GBS6 10 mcg With AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG003
Primary
Number of Participants With Vital Status: Infant Participants Stage 2
Participants according to vital status as: live or neonatal death were reported in this outcome measure.
Safety analysis set included all participants whose mother received a dose of GBS6 vaccine or placebo.
Posted
Count of Participants
Participants
At Birth
ID
Title
Description
OG000
Stage 2: GBS6 5 mcg With AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 5 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG001
Stage 2: GBS6 5 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 5 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG002
Stage 2: GBS6 10 mcg With AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG003
Stage 2: GBS6 10 mcg Without AlPO4 (Infant)
Primary
Number of Participants With Gestational Age of Participants at Birth: Infant Participants Stage 3
Gestational age of participants at birth in weeks included: greater than or equal to (>=)24 weeks to less than (<) 28 weeks, >=28 weeks to <34 weeks, >=34 weeks to <37 weeks, >=37 weeks to <42 weeks, >=42 weeks.
Safety analysis set included all participants whose mother received a dose of GBS6 vaccine or placebo.
Posted
Count of Participants
Participants
At 1 minute of Birth
ID
Title
Description
OG000
Stage 3: GBS6 20 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG001
Stage 3: Placebo (Infant)
Infant participants born to the maternal participants randomized to receive placebo (saline control) intramuscularly on Day 1.
Units
Counts
Participants
OG000
Primary
Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 Minute: Infant Participants Stage 3
APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low. Appearance, pulse, grimace, activity, and respiration (APGAR) score at 1 minute were reported in this outcome measure.
Safety analysis set included all participants whose mother received a dose of GBS6 vaccine or placebo.
Posted
Median
Full Range
Unit on a scale
At 1 minute of Birth
ID
Title
Description
OG000
Stage 3: GBS6 20 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG001
Stage 3: Placebo (Infant)
Infant participants born to the maternal participants randomized to receive placebo (saline control) intramuscularly on Day 1.
Units
Counts
Primary
APGAR Score at 5 Minutes: Infant Participants Stage 3
APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low. Appearance, pulse, grimace, activity, and respiration (APGAR) score at 5 minute were reported in this outcome measure.
Safety analysis set included all participants whose mother received a dose of GBS6 vaccine or placebo.
Posted
Median
Full Range
Unit on a scale
At 5 minutes of Birth
ID
Title
Description
OG000
Stage 3: GBS6 20 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG001
Stage 3: Placebo (Infant)
Infant participants born to the maternal participants randomized to receive placebo (saline control) intramuscularly on Day 1.
Units
Counts
Participants
Primary
Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 3
The Ballard score is a commonly used technique of gestational age assessment. It assists healthcare providers in determining if an infant is premature, on time, or post-term based on physical traits. This scoring allows for the estimation of age in the range of 26 weeks to 44 weeks Participants according to age determined by Ballard score: at <37 weeks 0 days, >=37 weeks to <42 weeks, >=42 weeks were reported in this outcome measure. Ballard score was not conducted routinely/mandatory.
Safety analysis set included all participants whose mother received a dose of GBS6 vaccine or placebo.
Posted
Count of Participants
Participants
At Birth
ID
Title
Description
OG000
Stage 3: GBS6 20 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG001
Stage 3: Placebo (Infant)
Infant participants born to the maternal participants randomized to receive placebo (saline control) intramuscularly on Day 1.
Units
Counts
Primary
Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 3
Participants with newborn assessment at birth included: normal, congenital malformation/anomaly, other neonatal problem were reported in this outcome measure.
Safety analysis set included all participants whose mother received a dose of GBS6 vaccine or placebo.
Posted
Count of Participants
Participants
At 5 minutes of Birth
ID
Title
Description
OG000
Stage 3: GBS6 20 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG001
Stage 3: Placebo (Infant)
Infant participants born to the maternal participants randomized to receive placebo (saline control) intramuscularly on Day 1.
Units
Counts
Participants
OG000
Primary
Number of Participants With Vital Status: Infant Participants Stage 3
Participants according to vital status as: live or neonatal death were reported in this outcome measure.
Safety analysis set included all participants whose mother received a dose of GBS6 vaccine or placebo.
Posted
Count of Participants
Participants
At Birth
ID
Title
Description
OG000
Stage 3: GBS6 20 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG001
Stage 3: Placebo (Infant)
Infant participants born to the maternal participants randomized to receive placebo (saline control) intramuscularly on Day 1.
Units
Counts
Participants
OG000
Primary
Number of Participants With AEs From Birth to 6 Weeks of Age: Infant Participants Stage 2
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage.
Safety analysis set included all participants whose mother received a dose of GBS6 vaccine or placebo.
Posted
Count of Participants
Participants
From Birth to 6 Weeks
ID
Title
Description
OG000
Stage 2: GBS6 5 mcg With AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 5 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG001
Stage 2: GBS6 5 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 5 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG002
Stage 2: GBS6 10 mcg With AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
Primary
Numberof Participants With AEs From Birth to 6 Weeks of Age: Infant Participants Stage 3
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage.
Safety analysis set included all participants whose mother received a dose of GBS6 vaccine or placebo.
Posted
Count of Participants
Participants
From Birth to 6 Weeks
ID
Title
Description
OG000
Stage 3: GBS6 20 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG001
Stage 3: Placebo (Infant)
Infant participants born to the maternal participants randomized to receive placebo (saline control) intramuscularly on Day 1.
Units
Counts
Participants
OG000
Primary
Number of Participants With SAEs From Birth to 12 Months of Age: Infant Participants Stage 2
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.
Safety analysis set included all participants whose mothers received a dose of GBS6 vaccine or placebo.
Posted
Count of Participants
Participants
From Birth to 12 Months
ID
Title
Description
OG000
Stage 2: GBS6 5 mcg With AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 5 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG001
Stage 2: GBS6 5 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 5 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
Primary
Number of Participants With SAEs From Birth to 12 Months of Age: Infant Participants Stage 3
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.
Safety analysis set included all participants whose mothers received a dose of GBS6 vaccine or placebo.
Posted
Count of Participants
Participants
From Birth to 12 Months
ID
Title
Description
OG000
Stage 3: GBS6 20 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG001
Stage 3: Placebo (Infant)
Infant participants born to the maternal participants randomized to receive placebo (saline control) intramuscularly on Day 1.
Primary
Number of Participants With MAEs From Birth to 12 Months of Age: Infant Participants Stage 2
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Safety analysis set included all participants whose mothers received a dose of GBS6 vaccine or placebo.
Posted
Count of Participants
Participants
From Birth to 12 Months
ID
Title
Description
OG000
Stage 2: GBS6 5 mcg With AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 5 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG001
Stage 2: GBS6 5 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 5 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG002
Stage 2: GBS6 10 mcg With AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
Primary
Number of Participants With MAEs From Birth to 12 Months of Age: Infant Participants Stage 3
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo.
Posted
Count of Participants
Participants
From Birth to 12 Months
ID
Title
Description
OG000
Stage 3: GBS6 20 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG001
Stage 3: Placebo (Infant)
Infant participants born to the maternal participants randomized to receive placebo (saline control) intramuscularly on Day 1.
Units
Counts
Participants
Primary
Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 2
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. AEs of special interest included: major congenital anomalies, developmental delay and suspected or confirmed GBS infection.
Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo.
Posted
Number
95% Confidence Interval
Participants of Participants
From Birth to 12 Months
ID
Title
Description
OG000
Stage 2: GBS6 5 mcg With AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 5 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG001
Stage 2: GBS6 5 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 5 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG002
Stage 2: GBS6 10 mcg With AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
Primary
Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 3
An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. AEs of special interest included: major congenital anomalies, developmental delay and suspected or confirmed GBS infection.
Safety analysis set included all participants who received a dose of GBS6 vaccine or placebo.
Posted
Number
95% Confidence Interval
Percentage of Participants
From Birth to 12 Months
ID
Title
Description
OG000
Stage 3: GBS6 20 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG001
Stage 3: Placebo (Infant)
Infant participants born to the maternal participants randomized to receive placebo (saline control) intramuscularly on Day 1.
Units
Counts
Participants
Secondary
Geometric Mean Concentration (GMCs) of Group B Streptococcus (GBS) Serotype-Specific Immunoglobulin G (IgG) at 1 Month After Primary Dose: Non-Pregnant Women Stage 1
Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.
Evaluable immunogenicity population.
Posted
Geometric Mean
95% Confidence Interval
microgram per milliliter
At 1 Month After primary Dose
ID
Title
Description
OG000
Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant)
Nonpregnant participants were randomized to receive a primary dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG001
Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant)
Nonpregnant participants were randomized to receive a primary dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG002
Stage 1: Placebo (Non Pregnant)
Infant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Units
Counts
Secondary
GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1
Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.
Evaluable immunogenicity population. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Geometric Mean
95% Confidence Interval
microgram per milliliter
Before (immediately before booster vaccination) and at 1, 3 and 6 Months After vaccination as Booster Dose
ID
Title
Description
OG000
Stage 1 Booster: GBS6 20 mcg With AlPO4 (Nonpregnant)
Non pregnant participants were randomized to receive a booster dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly at least 2 years after Vaccination 1 on Day 1. Participants were categorized based on their primary dose of GBS6 vaccine with AlPO4.
OG001
Stage 1 Booster: GBS6 20 mcg Without AlPO4 (Nonpregnant)
Non pregnant participants were randomized to receive a booster dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly at least 2 years after Vaccination 1 on Day 1. Participants were categorized based on their primary dose of GBS6 vaccine without AlPO4.
OG002
Stage 1 Booster: Placebo (Nonpregnant)
Secondary
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2
Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.
Evaluable immunogenicity population. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
microgram per milliliter
At 2 Weeks after Vaccination, 1 Month After Vaccination and at Delivery
ID
Title
Description
OG000
Stage 2: GBS6 5 mcg With AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 5 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG001
Stage 2: GBS6 5 mcg Without AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 5 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG002
Stage 2: GBS6 10 mcg With AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG003
Stage 2: GBS6 10 mcg Without AlPO4 (Maternal)
Secondary
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3
Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.
Evaluable immunogenicity population. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Geometric Mean
95% Confidence Interval
microgram per milliliter
At 2 Weeks after Vaccination, 1 Month After Vaccination and at Delivery
ID
Title
Description
OG000
Stage 3: GBS6 20 mcg Without AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG001
Stage 3: Placebo (Maternal)
Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Units
Counts
Participants
OG000
Secondary
GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2
OPA for the 6 serotypes (Ia, Ib, II, III, IV, V) were determined in all participants for each blood sample.
Evaluable immunogenicity population. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Geometric Mean
95% Confidence Interval
Titer
At 1 Month After Vaccination and at Delivery
ID
Title
Description
OG000
Stage 2: GBS6 5 mcg With AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 5 μg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG001
Stage 2: GBS6 5 mcg Without AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 5 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG002
Stage 2: GBS6 10 mcg With AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG003
Secondary
GBS6 Serotype-Specific OPA Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3
OPA for the 6 serotypes (Ia, Ib, II, III, IV, V) were determined in all participants for each blood sample.
Evaluable immunogenicity population. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Geometric Mean
95% Confidence Interval
Titer
At 1 Month After Vaccination and at Delivery
ID
Title
Description
OG000
Stage 3: GBS6 20 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG001
Stage 3: Placebo (Infant)
Infant participants born to the maternal participants randomized to receive placebo (saline control) intramuscularly on Day 1.
Units
Counts
Participants
OG000
Secondary
GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2
Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.
Evaluable immunogenicity population. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Geometric Mean
95% Confidence Interval
Microgram per milliliter
At Birth
ID
Title
Description
OG000
Stage 2: GBS6 5 mcg With AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 5 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG001
Stage 2: GBS6 5 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 5 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG002
Stage 2: GBS6 10 mcg With AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG003
Stage 2: GBS6 10 mcg Without AlPO4 (Infant)
Secondary
GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 3
Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.
Evaluable immunogenicity population. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Geometric Mean
95% Confidence Interval
Microgram per milliliter
At Birth
ID
Title
Description
OG000
Stage 3: GBS6 20 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG001
Stage 3: Placebo (Infant)
Infant participants born to the maternal participants randomized to receive placebo (saline control) intramuscularly on Day 1.
Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.
Evaluable immunogenicity population.Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Geometric Mean
95% Confidence Interval
Titer
At Birth
ID
Title
Description
OG000
Stage 2: GBS6 5 mcg With AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 5 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG001
Stage 2: GBS6 5 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 5 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG002
Stage 2: GBS6 10 mcg With AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.
Evaluable immunogenicity population. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Posted
Geometric Mean
95% Confidence Interval
Titer
At Birth
ID
Title
Description
OG000
Stage 3: GBS6 20 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG001
Stage 3: Placebo (Infant)
Infant participants born to the maternal participants randomized to receive placebo (saline control) intramuscularly on Day 1.
Units
Counts
Participants
OG000
Time Frame
For Stage 1: From Day 1 up to 3.5 years post vaccination, For Stage 2 and 3: maximum up to 12 months post-delivery
Description
Same event may appear as non-SAE & SAE but are distinct events. Event may be serious in one participant & non-serious in another or one participant may have experienced both serious & non-serious events. Safety analysis set included all participants who received a primary dose of GBS6 vaccine or placebo.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Stage 1: GBS6 20 mcg With AlPO4 (Nonpregnant)
Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
0
22
0
22
17
22
EG001
Stage 1: GBS6 20 mcg Without AlPO4 (Nonpregnant)
Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
0
22
0
22
17
22
EG002
Stage 1: Placebo (Nonpregnant)
Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
0
22
0
22
18
22
EG003
Stage 1 Booster: GBS6 20 mcg With AlPO4 (Nonpregnant)
Non pregnant participants were randomized to receive a booster dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly at least 2 years after Vaccination 1 on Day 1. Participants were categorized based on their primary dose of GBS6 vaccine with AlPO4.
0
11
0
11
9
11
EG004
Stage 1 Booster: GBS6 20 mcg Without AlPO4 (Nonpregnant)
Non pregnant participants were randomized to receive a booster dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly at least 2 years after Vaccination 1 on Day 1. Participants were categorized based on their primary dose of GBS6 vaccine without AlPO4.
0
7
0
7
7
7
EG005
Stage 1 Booster: Placebo (Nonpregnant)
Non pregnant participants were randomized to receive a booster dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly at least 2 years after Vaccination 1 on Day 1. Participants were categorized based on their primary dose of Placebo.
0
8
0
8
8
8
EG006
Stage 2: GBS6 5 mcg With AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 5 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
0
40
7
40
30
40
EG007
Stage 2: GBS6 5 mcg Without AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 5 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
0
40
18
40
36
40
EG008
Stage 2: GBS6 10 mcg With AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 10 μg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
0
40
9
40
31
40
EG009
Stage 2: GBS6 10 mcg Without AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
0
40
11
40
27
40
EG010
Stage 2: GBS6 20 mcg With AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
0
40
8
40
34
40
EG011
Stage 2: GBS6 20 mcg Without AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
0
40
14
40
36
40
EG012
Stage 2: Placebo (Maternal)
Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
1
120
30
120
98
120
EG013
Stage 2: GBS6 5 mcg With AlPO4 (Infant)
Infant participants born to the maternal participants randomized to receive a single dose of 5 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
0
40
17
40
27
40
EG014
Stage 2: GBS6 5 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants randomized to receive a single dose of 5 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
1
39
19
39
19
39
EG015
Stage 2: GBS6 10 mcg With AlPO4 (Infant)
Infant participants born to the maternal participants randomized to receive a single dose of 10 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
0
40
15
40
22
40
EG016
Stage 2: GBS6 10 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
0
40
12
40
26
40
EG017
Stage 2: GBS6 20 mcg With AlPO4 (Infant)
Infant participants born to the maternal participants randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
0
40
19
40
20
40
EG018
Stage 2: GBS6 20 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
0
40
14
40
21
40
EG019
Stage 2: Placebo (Infant)
Infant participants born to the maternal participants randomized to receive placebo (saline control) intramuscularly on Day 1.
2
118
60
118
66
118
EG020
Stage 3: GBS6 20 mcg Without AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
0
108
21
108
91
108
EG021
Stage 3: Placebo (Maternal)
Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1
0
108
23
108
90
108
EG022
Stage 3: GBS6 20 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
3
104
45
104
78
104
EG023
Stage 3: Placebo (Infant)
Infant participants born to the maternal participants randomized to receive placebo (saline control) intramuscularly on Day 1.
2
105
46
105
81
105
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anemia
Blood and lymphatic system disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG0030 affected11 at risk
EG0040 affected7 at risk
EG0050 affected8 at risk
EG0060 affected40 at risk
EG0071 affected40 at risk
EG0080 affected40 at risk
EG0090 affected40 at risk
EG0100 affected40 at risk
EG0110 affected40 at risk
EG0120 affected120 at risk
EG01310 affected40 at risk
EG0140 affected39 at risk
EG0150 affected40 at risk
EG0160 affected40 at risk
EG0170 affected40 at risk
EG0180 affected40 at risk
EG0190 affected118 at risk
EG0200 affected108 at risk
EG0210 affected108 at risk
EG0221 affected104 at risk
EG0230 affected105 at risk
Tachycardia
Cardiac disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Biliary colic
Hepatobiliary disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Amniotic cavity infection
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Appendicitis
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Bartholin's abscess
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Klebsiella urinary tract infection
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Postpartum sepsis
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Wound infection
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Wound sepsis
General disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Injury
Injury, poisoning and procedural complications
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Arrested labour
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Breech delivery
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Cephalo-pelvic disproportion
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Failed induction of labour
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Foetal distress syndrome
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Foetal growth restriction
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Foetal malpresentation
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Gestational hypertension
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
HELLP syndrome
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Haemorrhage in pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Meconium stain
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Placenta praevia
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Postpartum haemorrhage
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Pre-eclampsia
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Premature delivery
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Premature rupture of membranes
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Preterm premature rupture of membranes
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Prolonged labour
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Prolonged pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Prolonged rupture of membranes
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Retained products of conception
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Stillbirth
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Poor feeding infant
Metabolism and nutrition disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Depression suicidal
Psychiatric disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Generalised anxiety disorder
Psychiatric disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Pelvic haematoma
Reproductive system and breast disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Accessory auricle
Congenital, familial and genetic disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Birth mark
Congenital, familial and genetic disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Cardiac malposition
Congenital, familial and genetic disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Cerebral palsy
Congenital, familial and genetic disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Congenital cyst
Congenital, familial and genetic disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Congenital hiatus hernia
Congenital, familial and genetic disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Congenital inguinal hernia
Congenital, familial and genetic disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Congenital naevus
Congenital, familial and genetic disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Congenital umbilical hernia
Congenital, familial and genetic disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Gastrointestinal disorder congenital
Congenital, familial and genetic disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Haemangioma congenital
Congenital, familial and genetic disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Heart disease congenital
Congenital, familial and genetic disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Hypoplastic left heart syndrome
Congenital, familial and genetic disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Polydactyly
Congenital, familial and genetic disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Talipes
Congenital, familial and genetic disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Tooth development disorder
Gastrointestinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Developmental delay
General disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Bronchiolitis
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Pneumonia cytomegaloviral
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Pneumonia respiratory syncytial viral
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Pulmonary tuberculosis
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Sepsis
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Sepsis neonatal
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Staphylococcal sepsis
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Urinary tract infection neonatal
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Feeding intolerance
Metabolism and nutrition disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Hypoglycaemia neonatal
Metabolism and nutrition disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Poor feeding infant
Metabolism and nutrition disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Knee deformity
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Rickets
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Haemangioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Encephalopathy neonatal
Nervous system disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Generalised tonic-clonic seizure
Nervous system disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Hypoxic-ischaemic encephalopathy
Nervous system disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Seizure
Nervous system disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Subarachnoid haemorrhage
Nervous system disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Jaundice neonatal
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Low birth weight baby
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Premature baby
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Infantile apnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Meconium aspiration syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Neonatal respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Neonatal respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Pulmonary hypertension
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Cafe au lait spots
Skin and subcutaneous tissue disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Tachycardia foetal
Cardiac disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Anaemia postoperative
Injury, poisoning and procedural complications
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Uterine rupture
Injury, poisoning and procedural complications
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Foetal death
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Foetal hypokinesia
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Premature labour
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Perinatal depression
Psychiatric disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Bladder pain
Renal and urinary disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Cryptorchism
Congenital, familial and genetic disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Developmental hip dysplasia
Congenital, familial and genetic disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Eyelid ptosis congenital
Congenital, familial and genetic disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Factor VIII deficiency
Congenital, familial and genetic disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Preauricular cyst
Congenital, familial and genetic disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Intussusception
Gastrointestinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Necrotising colitis
Gastrointestinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Neonatal gastrointestinal disorder
Gastrointestinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Peripheral swelling
General disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Sudden infant death syndrome
General disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Hyperbilirubinaemia neonatal
Hepatobiliary disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Adenoviral conjunctivitis
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Adenoviral upper respiratory infection
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Escherichia bacteraemia
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Gastroenteritis adenovirus
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Gastroenteritis salmonella
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Infection
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Lower respiratory tract infection viral
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Meningitis viral
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Neonatal bacterial pneumonia
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Neonatal infection
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Neonatal pneumonia
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Pneumonia streptococcal
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Pneumonia viral
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Respiratory syncytial virus bronchiolitis
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Sepsis neonatal
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Hypoxic-ischaemic encephalopathy
Nervous system disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Unresponsive to stimuli
Nervous system disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Ear pain
Ear and labyrinth disorders
MedDRA v27.0
Non-systematic Assessment
EG0001 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG0031 affected11 at risk
EG0040 affected7 at risk
EG0050 affected8 at risk
EG0060 affected40 at risk
EG0070 affected40 at risk
EG0080 affected40 at risk
EG0090 affected40 at risk
EG0100 affected40 at risk
EG0110 affected40 at risk
EG0120 affected120 at risk
EG0130 affected40 at risk
EG0140 affected39 at risk
EG0151 affected40 at risk
EG0161 affected40 at risk
EG0170 affected40 at risk
EG0180 affected40 at risk
EG0190 affected118 at risk
EG0200 affected108 at risk
EG0210 affected108 at risk
EG0220 affected104 at risk
EG0230 affected105 at risk
Abdominal pain lower
Gastrointestinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0001 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0001 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Diarrhoea (DIARRHEA)
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0004 affected22 at risk
EG0012 affected22 at risk
EG0024 affected22 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0001 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0021 affected22 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0021 affected22 at risk
EG003
Vomiting (NAUSEA/VOMITING)
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0002 affected22 at risk
EG0013 affected22 at risk
EG0027 affected22 at risk
EG003
Fatigue (FATIGUE)
General disorders
MedDRA v27.0
Systematic Assessment
EG0008 affected22 at risk
EG0017 affected22 at risk
EG00210 affected22 at risk
EG003
Injection site discolouration
General disorders
MedDRA v27.0
Non-systematic Assessment
EG0001 affected22 at risk
EG0011 affected22 at risk
EG0020 affected22 at risk
EG003
Injection site erythema (REDNESS)
General disorders
MedDRA v27.0
Systematic Assessment
EG0004 affected22 at risk
EG0011 affected22 at risk
EG0021 affected22 at risk
EG003
Injection site pain (PAIN)
General disorders
MedDRA v27.0
Systematic Assessment
EG0009 affected22 at risk
EG0018 affected22 at risk
EG0027 affected22 at risk
EG003
Injection site pruritus
General disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0011 affected22 at risk
EG0020 affected22 at risk
EG003
Injection site swelling (SWELLING)
General disorders
MedDRA v27.0
Systematic Assessment
EG0003 affected22 at risk
EG0012 affected22 at risk
EG0020 affected22 at risk
EG003
Oedema peripheral
General disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0011 affected22 at risk
EG0020 affected22 at risk
EG003
Pyrexia (FEVER)
General disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected22 at risk
EG0011 affected22 at risk
EG0020 affected22 at risk
EG003
Swelling
General disorders
MedDRA v27.0
Non-systematic Assessment
EG0001 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Abscess bacterial
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0001 affected22 at risk
EG0011 affected22 at risk
EG0021 affected22 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0001 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Sinusitis
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0001 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0021 affected22 at risk
EG003
Tonsillitis bacterial
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0021 affected22 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0004 affected22 at risk
EG0011 affected22 at risk
EG0022 affected22 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0011 affected22 at risk
EG0022 affected22 at risk
EG003
Vaginal infection
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0001 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Viral rhinitis
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0002 affected22 at risk
EG0010 affected22 at risk
EG0021 affected22 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0001 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Vulval abscess
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0011 affected22 at risk
EG0020 affected22 at risk
EG003
Exposure during pregnancy
Injury, poisoning and procedural complications
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0011 affected22 at risk
EG0021 affected22 at risk
EG003
Myalgia (MUSCLE PAIN)
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0002 affected22 at risk
EG0015 affected22 at risk
EG0026 affected22 at risk
EG003
Headache
Nervous system disorders
MedDRA v27.0
Non-systematic Assessment
EG0001 affected22 at risk
EG0015 affected22 at risk
EG0021 affected22 at risk
EG003
Headache (HEADACHE)
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG0009 affected22 at risk
EG0019 affected22 at risk
EG00212 affected22 at risk
EG003
Depression
Psychiatric disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0011 affected22 at risk
EG0020 affected22 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0011 affected22 at risk
EG0020 affected22 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0021 affected22 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0011 affected22 at risk
EG0020 affected22 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0021 affected22 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0021 affected22 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0001 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0011 affected22 at risk
EG0020 affected22 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0021 affected22 at risk
EG003
Hypertension
Vascular disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0011 affected22 at risk
EG0020 affected22 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Vision blurred
Eye disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Visual impairment
Eye disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Influenza like illness
General disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Oedema
General disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Pyrexia
General disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Abscess limb
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Bartholin's abscess
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Breast abscess
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Gingivitis
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Mastitis
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Sexually transmitted disease
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Vulvovaginitis
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Wound sepsis
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Exposure to communicable disease
Injury, poisoning and procedural complications
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Incision site pain
Injury, poisoning and procedural complications
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Incision site rash
Injury, poisoning and procedural complications
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Perineal injury
Injury, poisoning and procedural complications
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Vulvovaginal injury
Injury, poisoning and procedural complications
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Amniotic fluid index decreased
Investigations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
White blood cell count increased
Investigations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Arthralgia (JOINT PAIN)
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0003 affected22 at risk
EG0015 affected22 at risk
EG0022 affected22 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Non-systematic Assessment
EG0001 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Myalgia (MUSCLE PAIN)
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Tenosynovitis stenosans
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Anogenital warts
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Sciatica
Nervous system disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Breech delivery
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Failed induction of labour
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
False labour
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Foetal growth restriction
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Gestational hypertension
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Hyperemesis gravidarum
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Morning sickness
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Postpartum haemorrhage
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Premature delivery
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Premature labour
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Retained placenta or membranes
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Perinatal depression
Psychiatric disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Stress
Psychiatric disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Glycosuria
Renal and urinary disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Leukocyturia
Renal and urinary disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Breast engorgement
Reproductive system and breast disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Uterine prolapse
Reproductive system and breast disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Vaginal discharge
Reproductive system and breast disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Vaginal disorder
Reproductive system and breast disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Vaginal haematoma
Reproductive system and breast disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Hidradenitis
Skin and subcutaneous tissue disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Suture insertion
Surgical and medical procedures
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Hypotension
Vascular disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Inferior vena cava syndrome
Vascular disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Microcytic anaemia
Blood and lymphatic system disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Otorrhoea
Ear and labyrinth disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Strabismus
Eye disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Anal fissure
Gastrointestinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Ill-defined disorder
General disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Macrosomia
General disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Vaccination site erythema
General disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Vaccination site induration
General disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Foetal growth restriction
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Gestational diabetes
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Gestational hypertension
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Haemorrhage in pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Hyperemesis gravidarum
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Jaundice neonatal
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Low birth weight baby
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Meconium stain
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Pelvic haematoma obstetric
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Postpartum haemorrhage
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Premature baby
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Premature labour
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Premature rupture of membranes
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Prolonged labour
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Prolonged pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Prolonged rupture of membranes
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Shoulder dystocia
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Abscess
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Candida nappy rash
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Conjunctivitis viral
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Folliculitis
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
HIV infection
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Impetigo
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Lower respiratory tract infection viral
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Omphalitis
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Ophthalmia neonatorum
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Otitis media
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Otitis media acute
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Pneumonia viral
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Pulmonary tuberculosis
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Rash pustular
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Rhinitis
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Skin candida
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Tinea infection
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Vaccination site abscess
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Varicella
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Varicella zoster virus infection
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Brachial plexus injury
Injury, poisoning and procedural complications
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Bone swelling
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Febrile convulsion
Nervous system disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Caput succedaneum
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Low birth weight baby
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Small for dates baby
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Balanoposthitis
Reproductive system and breast disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Vaginal discharge
Reproductive system and breast disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Dermatitis diaper
Skin and subcutaneous tissue disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Miliaria
Skin and subcutaneous tissue disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Perioral dermatitis
Skin and subcutaneous tissue disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Bradycardia neonatal
Cardiac disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Atrial septal defect
Congenital, familial and genetic disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Dacryostenosis congenital
Congenital, familial and genetic disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Hydrocele
Congenital, familial and genetic disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Patent ductus arteriosus
Congenital, familial and genetic disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Tethered oral tissue
Congenital, familial and genetic disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Dacryostenosis acquired
Eye disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Retinopathy of prematurity
Eye disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Infantile colic
Gastrointestinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Hyperbilirubinaemia neonatal
Hepatobiliary disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Food allergy
Immune system disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Milk allergy
Immune system disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Acarodermatitis
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Body tinea
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Bronchitis
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Bronchiolitis
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
COVID-19
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Candida infection
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Cellulitis
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Chronic sinusitis
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Conjunctivitis bacteria
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Dysentery
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Eczema infected
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Fungal infection
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Furuncle
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Ophthalmia neonatorum
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Oral herpes
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Otitis media chronic
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Parvovirus infection
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Respiratory syncytial virus bronchiolitis
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Skin candida
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Cardiac murmur
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Weight decreased
Investigations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Feeding disorder
Metabolism and nutrition disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Metabolic acidosis
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Obesity
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Weight gain poor
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Acquired plagiocephaly
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Newborn head moulding
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Pain in extremity
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Cephalhaematoma
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Jaundice neonatal
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Low birth weight baby
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Meconium stain
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Premature baby
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Shoulder dystocia
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Balanoposthitis
Reproductive system and breast disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Penile adhesion
Reproductive system and breast disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Adenoidal hypertrophy
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Neonatal respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Transient tachypnoea of the newborn
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Eczema infantile
Skin and subcutaneous tissue disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Macule
Skin and subcutaneous tissue disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Milia
Skin and subcutaneous tissue disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Miliaria
Skin and subcutaneous tissue disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Seborrhoeic dermatitis
Skin and subcutaneous tissue disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Transient neonatal pustular melanosis
Skin and subcutaneous tissue disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Anaemia of pregnancy
Blood and lymphatic system disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Blood loss anaemia
Blood and lymphatic system disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Palpitations
Cardiac disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Tachycardia foetal
Cardiac disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Conjunctivitis allergic
Eye disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Haemorrhoids thrombosed
Gastrointestinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Intra-abdominal fluid collection
Gastrointestinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Bacterial vaginosis
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
COVID-19
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Chlamydial infection
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Cystitis
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Eczema impetiginous
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Endometritis
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Fungal infection
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Hand-foot-and-mouth disease
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Influenza
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Norovirus infection
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Otitis externa
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Otitis media
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Viral pharyngitis
Infections and infestations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Perineal injury
Injury, poisoning and procedural complications
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
SARS-CoV-2 test positive
Investigations
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Ligament pain
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Carpal tunnel syndrome
Nervous system disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Dizziness
Nervous system disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Tension headache
Nervous system disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Cephalo-pelvic disproportion
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Gestational hypertension
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Morning sickness
Pregnancy, puerperium and perinatal conditions
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Neurodevelopmental delay
Nervous system disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Genital labial adhesions
Reproductive system and breast disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Episiotomy
Surgical and medical procedures
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Phlebitis
Vascular disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Raynaud's phenomenon
Vascular disorders
MedDRA v27.0
Non-systematic Assessment
EG0000 affected22 at risk
EG0010 affected22 at risk
EG0020 affected22 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Preterm newborn infants (Gestational age <37 weeks)
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0103
BG0113
BG0121
BG0130
BG0141
BG0151
BG0162
BG0170
BG0180
BG0198
BG0206
BG02125
Unknown
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
BG0180
BG0191
BG0201
BG0212
18-40 Years
BG00022
BG00122
BG00222
BG00340
BG00440
BG00540
BG00640
BG00740
BG00840
BG009120
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG017108
BG018108
BG0190
BG0200
BG021642
22
BG00340
BG00440
BG00540
BG00640
BG00740
BG00840
BG009120
BG01017
BG01120
BG01219
BG01320
BG01426
BG01521
BG01655
BG017108
BG018108
BG01960
BG02054
BG021934
Male
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG01023
BG01119
BG01221
BG01320
BG01414
BG01519
BG01663
BG0170
BG0180
BG01944
BG02051
BG021274
22
BG00340
BG00440
BG00540
BG00640
BG00740
BG00840
BG009120
BG01040
BG01139
BG01240
BG01340
BG01440
BG01540
BG016118
BG01782
BG01880
BG01978
BG02078
BG0211101
Asian
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0171
BG0181
BG0191
BG0201
BG0214
White
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG01723
BG01824
BG01923
BG02022
BG02192
Multiracial
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
BG0183
BG0190
BG0203
BG0216
Not reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0172
BG0180
BG0192
BG0201
BG0215
22
BG00340
BG00440
BG00540
BG00640
BG00740
BG00840
BG009120
BG01040
BG01139
BG01240
BG01340
BG01440
BG01540
BG016118
BG017100
BG018102
BG01996
BG02099
BG0211180
Hispanic or Latino
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0178
BG0186
BG0198
BG0206
BG02128
Title
Measurements
OG00022.7(7.8 to 45.4)
OG00113.6(2.9 to 34.9)
OG0029.1(1.1 to 29.2)
Pain at injection site (Moderate)
Title
Measurements
OG0004.5(0.1 to 22.8)
OG00113.6(2.9 to 34.9)
OG0024.5(0.1 to 22.8)
Pain at injection site (Severe)
Title
Measurements
OG0000(0.0 to 15.4)
OG0010(0.0 to 15.4)
OG0020(0.0 to 15.4)
Pain at injection site (Grade 4)
Title
Measurements
OG0000(0.0 to 15.4)
OG0010(0.0 to 15.4)
OG0020(0.0 to 15.4)
Erythema/redness (Any)
Title
Measurements
OG0004.5(0.1 to 22.8)
OG0014.5(0.1 to 22.8)
OG0024.5(0.1 to 22.8)
Erythema/redness (Mild)
Title
Measurements
OG0004.5(0.1 to 22.8)
OG0010(0.0 to 15.4)
OG0024.5(0.1 to 22.8)
Erythema/redness (Moderate)
Title
Measurements
OG0000(0.0 to 15.4)
OG0014.5(0.1 to 22.8)
OG0020(0.0 to 15.4)
Erythema/redness (Severe)
Title
Measurements
OG0000(0.0 to 15.4)
OG0010(0.0 to 15.4)
OG0020(0.0 to 15.4)
Erythema/redness (Grade 4)
Title
Measurements
OG0000(0.0 to 15.4)
OG0010(0.0 to 15.4)
OG0020(0.0 to 15.4)
Induration/swelling (Any)
Title
Measurements
OG0009.1(1.1 to 29.2)
OG0019.1(1.1 to 29.2)
OG0020(0.0 to 15.4)
Induration/swelling (Mild)
Title
Measurements
OG0009.1(1.1 to 29.2)
OG0014.5(0.1 to 22.8)
OG0020(0.0 to 15.4)
Induration/swelling (Moderate)
Title
Measurements
OG0000(0.0 to 15.4)
OG0014.5(0.1 to 22.8)
OG0020(0.0 to 15.4)
Induration/swelling (Severe)
Title
Measurements
OG0000(0.0 to 15.4)
OG0010(0.0 to 15.4)
OG0020(0.0 to 15.4)
Induration/swelling (Grade 4)
Title
Measurements
OG0000(0.0 to 15.4)
OG0010(0.0 to 15.4)
OG0020(0.0 to 15.4)
Non pregnant participants were randomized to receive a booster dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly at least 2 years after Vaccination 1 on Day 1. Participants were categorized based on their primary dose of GBS6 vaccine without AlPO4.
OG002
Stage 1 Booster: Placebo (Nonpregnant)
Non pregnant participants were randomized to receive a booster dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly at least 2 years after Vaccination 1 on Day 1. Participants were categorized based on their primary dose of Placebo.
Units
Counts
Participants
OG00011
OG0017
OG0028
Title
Denominators
Categories
Pain at injection site (Any)
Title
Measurements
OG00072.7(39.0 to 94.0)
OG00128.6(3.7 to 71.0)
OG00250.0(15.7 to 84.3)
Pain at injection site (Mild)
Title
Measurements
OG00045.5(16.7 to 76.6)
OG00128.6(3.7 to 71.0)
OG00237.5(8.5 to 75.5)
Pain at injection site (Moderate)
Title
Measurements
OG00027.3(6.0 to 61.0)
OG0010(0.0 to 41.0)
OG00212.5(0.3 to 52.7)
Pain at injection site (Severe)
Title
Measurements
OG0000(0.0 to 28.5)
OG0010(0.0 to 41.0)
OG0020(0.0 to 36.9)
Pain at injection site (Grade 4)
Title
Measurements
OG0000(0.0 to 28.5)
OG0010(0.0 to 41.0)
OG0020(0.0 to 36.9)
Erythema/redness (Any)
Title
Measurements
OG0009.1(0.2 to 41.3)
OG0010(0.0 to 41.0)
OG0020(0.0 to 36.9)
Erythema/redness (Mild)
Title
Measurements
OG0009.1(0.2 to 41.3)
OG0010(0.0 to 41.0)
OG0020(0.0 to 36.9)
Erythema/redness (Moderate)
Title
Measurements
OG0000(0.0 to 28.5)
OG0010(0.0 to 41.0)
OG0020(0.0 to 36.9)
Erythema/redness (Severe)
Title
Measurements
OG0000(0.0 to 28.5)
OG0010(0.0 to 41.0)
OG0020(0.0 to 36.9)
Erythema/redness (Grade 4)
Title
Measurements
OG0000(0.0 to 28.5)
OG0010(0.0 to 41.0)
OG0020(0.0 to 36.9)
Induration/swelling (Any)
Title
Measurements
OG0009.1(0.2 to 41.3)
OG0010(0.0 to 41.0)
OG0020(0.0 to 36.9)
Induration/swelling (Mild)
Title
Measurements
OG0000(0.0 to 28.5)
OG0010(0.0 to 41.0)
OG0020(0.0 to 36.9)
Induration/swelling (Moderate)
Title
Measurements
OG0009.1(0.2 to 41.3)
OG0010(0.0 to 41.0)
OG0020(0.0 to 36.9)
Induration/swelling (Severe)
Title
Measurements
OG0000(0.0 to 28.5)
OG0010(0.0 to 41.0)
OG0020(0.0 to 36.9)
Induration/swelling (Grade 4)
Title
Measurements
OG0000(0.0 to 28.5)
OG0010(0.0 to 41.0)
OG0020(0.0 to 36.9)
Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG002
Stage 1: Placebo (Nonpregnant)
Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Units
Counts
Participants
OG00022
OG00122
OG00222
Title
Denominators
Categories
Fever (>=38.0 deg C)
Title
Measurements
OG0000(0.0 to 15.4)
OG0014.5(0.1 to 22.8)
OG0020(0.0 to 15.4)
Fever (38.0 to 38.4 deg C)
Title
Measurements
OG0000(0.0 to 15.4)
OG0010(0.0 to 15.4)
OG0020(0.0 to 15.4)
Fever (38.5 to 38.9 deg C)
Title
Measurements
OG0000(0.0 to 15.4)
OG0014.5(0.1 to 22.8)
OG0020(0.0 to 15.4)
Fever (39.0 to 40.0 deg C)
Title
Measurements
OG0000(0.0 to 15.4)
OG0010(0.0 to 15.4)
OG0020(0.0 to 15.4)
Fever (>40.0 deg C)
Title
Measurements
OG0000(0.0 to 15.4)
OG0010(0.0 to 15.4)
OG0020(0.0 to 15.4)
Nausea/vomiting (Any)
Title
Measurements
OG0004.5(0.1 to 22.8)
OG0019.1(1.1 to 29.2)
OG00227.3(10.7 to 50.2)
Nausea/vomiting (Mild)
Title
Measurements
OG0000(0.0 to 15.4)
OG0014.5(0.1 to 22.8)
OG0029.1(1.1 to 29.2)
Nausea/vomiting (Moderate)
Title
Measurements
OG0004.5(0.1 to 22.8)
OG0014.5(0.1 to 22.8)
OG00218.2(5.2 to 40.3)
Nausea/vomiting (Severe)
Title
Measurements
OG0000(0.0 to 15.4)
OG0010(0.0 to 15.4)
OG0020(0.0 to 15.4)
Nausea/vomiting (Grade 4)
Title
Measurements
OG0000(0.0 to 15.4)
OG0010(0.0 to 15.4)
OG0020(0.0 to 15.4)
Diarrhea (Any)
Title
Measurements
OG0009.1(1.1 to 29.2)
OG0019.1(1.1 to 29.2)
OG00218.2(5.2 to 40.3)
Diarrhea (Mild)
Title
Measurements
OG0009.1(1.1 to 29.2)
OG0019.1(1.1 to 29.2)
OG00213.6(2.9 to 34.9)
Diarrhea (Moderate)
Title
Measurements
OG0000(0.0 to 15.4)
OG0010(0.0 to 15.4)
OG0024.5(0.1 to 22.8)
Diarrhea (Severe)
Title
Measurements
OG0000(0.0 to 15.4)
OG0010(0.0 to 15.4)
OG0020(0.0 to 15.4)
Diarrhea (Grade 4)
Title
Measurements
OG0000(0.0 to 15.4)
OG0010(0.0 to 15.4)
OG0020(0.0 to 15.4)
Headache (Any)
Title
Measurements
OG00036.4(17.2 to 59.3)
OG00140.9(20.7 to 63.6)
OG00250.0(28.2 to 71.8)
Headache (Mild)
Title
Measurements
OG00031.8(13.9 to 54.9)
OG00118.2(5.2 to 40.3)
OG00231.8(13.9 to 54.9)
Headache (Moderate)
Title
Measurements
OG0004.5(0.1 to 22.8)
OG00122.7(7.8 to 45.4)
OG00213.6(2.9 to 34.9)
Headache (Severe)
Title
Measurements
OG0000(0.0 to 15.4)
OG0010(0.0 to 15.4)
OG0020(0.0 to 15.4)
Headache (Grade 4)
Title
Measurements
OG0000(0.0 to 15.4)
OG0010(0.0 to 15.4)
OG0020(0.0 to 15.4)
Fatigue/tiredness (Any)
Title
Measurements
OG00031.8(13.9 to 54.9)
OG00131.8(13.9 to 54.9)
OG00240.9(20.7 to 63.6)
Fatigue/tiredness (Mild)
Title
Measurements
OG00018.2(5.2 to 40.3)
OG00122.7(7.8 to 45.4)
OG00231.8(13.9 to 54.9)
Fatigue/tiredness (Moderate)
Title
Measurements
OG00013.6(2.9 to 34.9)
OG0019.1(1.1 to 29.2)
OG0029.1(1.1 to 29.2)
Fatigue/tiredness (Severe)
Title
Measurements
OG0000(0.0 to 15.4)
OG0010(0.0 to 15.4)
OG0020(00 to 15.4)
Fatigue/tiredness (Grade 4)
Title
Measurements
OG0000(0.0 to 15.4)
OG0010(0.0 to 15.4)
OG0020(0.0 to 15.4)
Muscle pain (Any)
Title
Measurements
OG0004.5(0.1 to 22.8)
OG00122.7(7.8 to 45.4)
OG00222.7(7.8 to 45.4)
Muscle pain (Mild)
Title
Measurements
OG0004.5(0.1 to 22.8)
OG00113.6(2.9 to 34.9)
OG00218.2(5.2 to 40.3)
Muscle pain (Moderate)
Title
Measurements
OG0000(0.0 to 15.4)
OG0019.1(1.1 to 29.2)
OG0024.5(0.1 to 22.8)
Muscle pain (Severe)
Title
Measurements
OG0000(0.0 to 15.4)
OG0010(0.0 to 15.4)
OG0020(0.0 to 15.4)
Muscle pain (Grade 4)
Title
Measurements
OG0000(0.0 to 15.4)
OG0010(0.0 to 15.4)
OG0020(0.0 to 15.4)
Joint Pain (Any)
Title
Measurements
OG0009.1(1.1 to 29.2)
OG00118.2(5.2 to 40.3)
OG0024.5(0.1 to 22.8)
Joint Pain (Mild)
Title
Measurements
OG0009.1(1.1 to 29.2)
OG00113.6(2.9 to 34.9)
OG0024.5(0.1 to 22.8)
Joint Pain (Moderate)
Title
Measurements
OG0000(00 to 15.4)
OG0014.5(0.1 to 22.8)
OG0020(0.0 to 15.4)
Joint Pain (Severe)
Title
Measurements
OG0000(0.0 to 15.4)
OG0010(0.0 to 15.4)
OG0020(0.0 to 15.4)
Joint Pain (Grade 4)
Title
Measurements
OG0000(0.0 to 15.4)
OG0010(0.0 to 15.4)
OG0020(0.0 to 15.4)
OG001
Stage 1 Booster: GBS6 20 mcg Without AlPO4 (Nonpregnant)
Non pregnant participants were randomized to receive a booster dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly at least 2 years after Vaccination 1 on Day 1. Participants were categorized based on their primary dose of GBS6 vaccine without AlPO4.
OG002
Stage 1 Booster: Placebo (Nonpregnant)
Non pregnant participants were randomized to receive a booster dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly at least 2 years after Vaccination 1 on Day 1. Participants were categorized based on their primary dose of Placebo.
Units
Counts
Participants
OG00011
OG0017
OG0028
Title
Denominators
Categories
Fever (38.0 deg C)
Title
Measurements
OG0000(0.0 to 28.5)
OG0010(0.0 to 41.0)
OG0020(0.0 to 36.9)
Fever (38.0 to 38.4 deg C)
Title
Measurements
OG0000(0.0 to 28.5)
OG0010(0.0 to 41.0)
OG0020(0.0 to 36.9)
Fever (38.5 to 38.9 deg C)
Title
Measurements
OG0000(0.0 to 28.5)
OG0010(0.0 to 41.0)
OG0020(0.0 to 36.9)
Fever (39.0 to 40.0 deg C)
Title
Measurements
OG0000(0.0 to 28.5)
OG0010(0.0 to 41.0)
OG0020(0.0 to 36.9)
Fever (>40.0 deg C)
Title
Measurements
OG0000(0.0 to 28.5)
OG0010(0.0 to 41.0)
OG0020(0.0 to 36.9)
Nausea/vomiting (Any)
Title
Measurements
OG0009.1(0.2 to 41.3)
OG00114.3(0.4 to 57.9)
OG00225.0(3.2 to 65.1)
Nausea/vomiting (Mild)
Title
Measurements
OG0000(0.0 to 28.5)
OG00114.3(0.4 to 57.9)
OG00225.0(3.2 to 65.1)
Nausea/vomiting (Moderate)
Title
Measurements
OG0009.1(0.2 to 41.3)
OG0010(0.0 to 41.0)
OG0020(0.0 to 36.9)
Nausea/vomiting (Severe)
Title
Measurements
OG0000(0.0 to 28.5)
OG0010(0.0 to 41.0)
OG0020(0.0 to 36.9)
Nausea/vomiting (Grade 4)
Title
Measurements
OG0000(0.0 to 28.5)
OG0010(0.0 to 41.0)
OG0020(0.0 to 36.9)
Diarrhea (Any)
Title
Measurements
OG00018.2(2.3 to 51.8)
OG0010(0.0 to 41.0)
OG00212.5(0.3 to 52.7)
Diarrhea (Mild)
Title
Measurements
OG00018.2(2.3 to 51.8)
OG0010(0.0 to 41.0)
OG0020(0.0 to 36.9)
Diarrhea (Moderate)
Title
Measurements
OG0000(0.0 to 28.5)
OG0010(0.0 to 41.0)
OG00212.5(0.3 to 52.7)
Diarrhea (Severe)
Title
Measurements
OG0000(0.0 to 28.5)
OG0010(0.0 to 41.0)
OG0020(0.0 to 36.9)
Diarrhea (Grade 4)
Title
Measurements
OG0000(0.0 to 28.5)
OG0010(0.0 to 41.0)
OG0020(0.0 to 36.9)
Headache (Any)
Title
Measurements
OG00027.3(6.0 to 61.0)
OG00114.3(0.4 to 57.9)
OG00262.5(24.5 to 91.5)
Headache (Mild)
Title
Measurements
OG0000(0.0 to 28.5)
OG00114.3(0.4 to 57.9)
OG00225.0(3.2 to 65.1)
Headache (Moderate)
Title
Measurements
OG00027.3(6.0 to 61.0)
OG0010(0.0 to 41.0)
OG00237.5(8.5 to 75.5)
Headache (Severe)
Title
Measurements
OG0000(0.0 to 28.5)
OG0010(0.0 to 41.0)
OG0020(0.0 to 36.9)
Headache (Grade 4)
Title
Measurements
OG0000(0.0 to 28.5)
OG0010(0.0 to 41.0)
OG0020(0.0 to 36.9)
Fatigue/tiredness (Any)
Title
Measurements
OG00027.3(6.0 to 61.0)
OG0010(0.0 to 41.0)
OG00237.5(8.5 to 75.5)
Fatigue/tiredness (Mild)
Title
Measurements
OG0009.1(0.2 to 41.3)
OG0010(0.0 to 41.0)
OG0020(0.0 to 36.9)
Fatigue/tiredness (Moderate)
Title
Measurements
OG00018.2(2.3 to 51.8)
OG0010(0.0 to 41.0)
OG00237.5(8.5 to 75.5)
Fatigue/tiredness (Severe)
Title
Measurements
OG0000(0.0 to 28.5)
OG0010(0.0 to 41.0)
OG0020(0.0 to 36.9)
Fatigue/tiredness (Grade 4)
Title
Measurements
OG0000(0.0 to 28.5)
OG0010(0.0 to 41.0)
OG0020(0.0 to 36.9)
Muscle pain (Any)
Title
Measurements
OG0009.1(0.2 to 41.3)
OG0010(0.0 to 41.0)
OG00237.5(8.5 to 75.5)
Muscle pain (Mild)
Title
Measurements
OG0000(0.0 to 28.5)
OG0010(0.0 to 41.0)
OG00225.0(3.2 to 65.1)
Muscle pain (Moderate)
Title
Measurements
OG0009.1(0.2 to 41.3)
OG0010(0.0 to 41.0)
OG00212.5(0.3 to 52.7)
Muscle pain (Severe)
Title
Measurements
OG0000(0.0 to 28.5)
OG0010(0.0 to 41.0)
OG0020(0.0 to 36.9)
Muscle pain (Grade 4)
Title
Measurements
OG0000(0.0 to 28.5)
OG0010(0.0 to 41.0)
OG0020(0.0 to 36.9)
Joint Pain (Any)
Title
Measurements
OG00018.2(2.3 to 51.8)
OG00114.3(0.4 to 57.9)
OG00212.5(0.3 to 52.7)
Joint Pain (Mild)
Title
Measurements
OG0000(0.0 to 28.5)
OG00114.3(0.4 to 57.9)
OG0020(0.0 to 36.9)
Joint Pain (Moderate)
Title
Measurements
OG00018.2(2.3 to 51.8)
OG0010(0.0 to 41.0)
OG00212.5(0.3 to 52.7)
Joint Pain (Severe)
Title
Measurements
OG0000(0.0 to 28.5)
OG0010(0.0 to 41.0)
OG0020(0.0 to 36.9)
Joint Pain (Grade 4)
Title
Measurements
OG0000(0.0 to 28.5)
OG0010(0.0 to 41.0)
OG0020(0.0 to 36.9)
Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Units
Counts
Participants
OG00022
OG00122
OG00222
Title
Denominators
Categories
Title
Measurements
OG00054.5(32.2 to 75.6)
OG00145.5(24.4 to 67.8)
OG00236.4(17.2 to 59.3)
OG002
Stage 1 Booster: Placebo (Nonpregnant)
Non pregnant participants were randomized to receive a booster dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly at least 2 years after Vaccination 1 on Day 1. Participants were categorized based on their primary dose of Placebo.
Units
Counts
Participants
OG00011
OG0017
OG0028
Title
Denominators
Categories
Title
Measurements
OG00018.2(2.3 to 51.8)
OG0010(0.0 to 41.0)
OG00212.5(0.3 to 52.7)
Stage 1: Placebo (Nonpregnant)
Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Units
Counts
Participants
OG00022
OG00122
OG00222
Title
Denominators
Categories
Title
Measurements
OG00045.5(24.4 to 67.8)
OG00140.9(20.7 to 63.6)
OG00240.9(20.7 to 63.6)
Nonpregnant participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG002
Stage 1: Placebo (Nonpregnant)
Non pregnant participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Units
Counts
Participants
OG00022
OG00122
OG00222
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 15.4)
OG0010(00 to 15.4)
OG0020(0.0 to 15.4)
OG002
Stage 1 Booster: Placebo (Nonpregnant)
Non pregnant participants were randomized to receive a booster dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly at least 2 years after Vaccination 1 on Day 1. Participants were categorized based on their primary dose of Placebo.
Units
Counts
Participants
OG00011
OG0017
OG0028
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 28.5)
OG00114.3(0.4 to 57.9)
OG00225.0(3.2 to 65.1)
OG001
Stage 1 Booster: GBS6 20 mcg Without AlPO4 (Nonpregnant)
Non pregnant participants were randomized to receive a booster dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly at least 2 years after Vaccination 1 on Day 1. Participants were categorized based on their primary dose of GBS6 vaccine without AlPO4.
OG002
Stage 1 Booster: Placebo (Nonpregnant)
Non pregnant participants were randomized to receive a booster dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly at least 2 years after Vaccination 1 on Day 1. Participants were categorized based on their primary dose of Placebo.
Units
Counts
Participants
OG00011
OG0017
OG0028
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 28.5)
OG0010(0.0 to 41.0)
OG0020(0.0 to 36.9)
Stage 2: GBS6 10 mcg With AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG003
Stage 2: GBS6 10 mcg Without AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG004
Stage 2: GBS6 20 mcg With AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG005
Stage 2: GBS6 20 mcg Without AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG006
Stage 2: Placebo (Maternal)
Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Units
Counts
Participants
OG00013
OG00114
OG00214
OG00314
OG00414
OG00512
OG00642
Title
Denominators
Categories
Hemoglobin Grade 1
Title
Measurements
OG0000
OG0017.1
OG0020
OG0037.1
OG0040
OG0050
OG0062.4
Platelets High Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
White blood cells decreased Grade 1
Title
Measurements
OG00015.4
OG00121.4
OG0027.1
OG003
Neutrophils (Absolute) Grade 1
Title
Measurements
OG0007.7
OG00135.7
OG0027.1
OG003
Basophils (Absolute) Grade 2
Title
Measurements
OG0000
OG0010
OG00214.3
OG003
Lymphocytes Low (Absolute) Grade 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Blood urea nitrogen Grade 1
Title
Measurements
OG0001
OG0017.1
OG0020
OG003
Aspartate aminotransferase Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Alanine aminotransferase Grade 1
Title
Measurements
OG0000
OG0017.1
OG0020
OG003
Alanine aminotransferase Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Alkaline phosphate Grade 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG002
Stage 2: GBS6 10 mcg With AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG003
Stage 2: GBS6 10 mcg Without AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG004
Stage 2: GBS6 20 mcg With AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG005
Stage 2: GBS6 20 mcg Without AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG006
Stage 2: Placebo (Maternal)
Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Units
Counts
Participants
OG00040
OG00140
OG00240
OG00339
OG00440
OG00540
OG006120
Title
Denominators
Categories
Pain at injection site (Any)
Title
Measurements
OG00037.5(22.7 to 54.2)
OG00115.0(5.7 to 29.8)
OG00240.0(24.9 to 56.7)
OG00315.4(5.9 to 30.5)
OG00447.5(31.5 to 63.9)
OG00535.0(20.6 to 51.7)
OG00615.8(9.8 to 23.6)
Pain at injection site (Mild)
Title
Measurements
OG00032.5(18.6 to 49.1)
OG00112.5(4.2 to 26.8)
OG00235.0(20.6 to 51.7)
OG003
Pain at injection site (Moderate)
Title
Measurements
OG0005.0(0.6 to 16.9)
OG0012.5(0.1 to 13.2)
OG0025.0(0.6 to 16.9)
OG003
Pain at injection site (Severe)
Title
Measurements
OG0000(0.0 to 8.8)
OG0010(0.0 to 8.8)
OG0020(0.0 to 8.8)
OG003
Pain at injection site (Grade 4)
Title
Measurements
OG0000(0.0 to 8.8)
OG0010(0.0 to 8.8)
OG0020(0.0 to 8.8)
OG003
Erythema/redness (Any)
Title
Measurements
OG0000(0.0 to 8.8)
OG0010(0.0 to 8.8)
OG0022.5(0.01 to 13.2)
OG003
Erythema/redness (Mild)
Title
Measurements
OG0000(0.0 to 8.8)
OG0010(0.0 to 8.8)
OG0020(0.0 to 8.8)
OG003
Erythema/redness (Moderate)
Title
Measurements
OG0000(0.0 to 8.8)
OG0010(0.0 to 8.8)
OG0020(0.0 to 8.8)
OG003
Erythema/redness (Severe)
Title
Measurements
OG0000(0.0 to 8.8)
OG0010(0.0 to 8.8)
OG0022.5(0.1 to 13.2)
OG003
Erythema/redness (Grade 4)
Title
Measurements
OG0000(0.0 to 8.8)
OG0010(0.0 to 8.8)
OG0020(0.0 to 8.8)
OG003
Induration/swelling (Any)
Title
Measurements
OG0000(0.0 to 8.8)
OG0012.5(0.1 to 13.2)
OG0022.5(0.1 to 13.2)
OG003
Induration/swelling (Mild)
Title
Measurements
OG0000(0.0 to 8.8)
OG0012.5(0.1 to 13.2)
OG0020(0.0 to 8.8)
OG003
Induration/swelling (Moderate)
Title
Measurements
OG0000(0.0 to 8.8)
OG0010(0.0 to 8.8)
OG0020(0.0 to 8.8)
OG003
Induration/swelling (Severe)
Title
Measurements
OG0000(0.0 to 8.8)
OG0010(0.0 to 8.8)
OG0022.5(0.1 to 13.2)
OG003
Induration/swelling (Grade 4)
Title
Measurements
OG0000(0.0 to 8.8)
OG0010(0.0 to 8.8)
OG0020(0.0 to 8.8)
OG003
Units
Counts
Participants
OG000106
OG001103
Title
Denominators
Categories
Pain at injection site (Any)
Title
Measurements
OG00030.2(21.7 to 39.9)
OG00118.4(11.5 to 27.3)
Pain at injection site (Mild)
Title
Measurements
OG00025.5(17.5 to 34.9)
OG00113.6(7.6 to 21.8)
Pain at injection site (Moderate)
Title
Measurements
OG0004.7(1.5 to 10.7)
OG0014.9(1.6 to 11.0)
Pain at injection site (Severe)
Title
Measurements
OG0000(0.0 to 3.4)
OG0010(0.0 to 3.5)
Pain at injection site (Grade 4)
Title
Measurements
OG0000(0.0 to 3.4)
OG0010(0.0 to 3.5)
Erythema/redness (Any)
Title
Measurements
OG0000(0.0 to 3.4)
OG0010(0.0 to 3.5)
Erythema/redness (Mild)
Title
Measurements
OG0000(0.0 to 3.4)
OG0010(0.0 to 3.5)
Erythema/redness (Moderate)
Title
Measurements
OG0000(0.0 to 3.4)
OG0010(0.0 to 3.5)
Erythema/redness (Severe)
Title
Measurements
OG0000(0.0 to 3.4)
OG0010(0.0 to 3.5)
Erythema/redness (Grade 4)
Title
Measurements
OG0000(0.0 to 3.4)
OG0010(0.0 to 3.5)
Induration/swelling (Any)
Title
Measurements
OG0000(0.0 to 3.4)
OG0010(0.0 to 3.5)
Induration/swelling (Mild)
Title
Measurements
OG0000(0.0 to 3.4)
OG0010(0.0 to 3.5)
Induration/swelling (Moderate)
Title
Measurements
OG0000(0.0 to 3.4)
OG0010(0.0 to 3.5)
Induration/swelling (Severe)
Title
Measurements
OG0000(0.0 to 3.4)
OG0010(0.0 to 3.5)
Induration/swelling (Grade 4)
Title
Measurements
OG0000(0.0 to 3.4)
OG0010(0.0 to 3.5)
Stage 2: GBS6 5 mcg Without AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 5 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG002
Stage 2: GBS6 10 mcg With AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG003
Stage 2: GBS6 10 mcg Without AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG004
Stage 2: GBS6 20 mcg With AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG005
Stage 2: GBS6 20 mcg Without AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG006
Stage 2: Placebo (Maternal)
Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Units
Counts
Participants
OG00040
OG00140
OG00240
OG00339
OG00440
OG00540
OG006120
Title
Denominators
Categories
Fever (>=38.0 deg C)
Title
Measurements
OG0002.5(0.1 to 13.2)
OG0015.0(0.6 to 16.9)
OG0022.5(0.1 to 13.2)
OG0037.7(1.6 to 20.9)
OG0042.5(0.1 to 13.2)
OG0055.0(0.6 to 16.9)
OG0065.0(1.9 to 10.6)
Fever (38.0 to 38.4 deg C)
Title
Measurements
OG0002.5(0.1 to 13.2)
OG0010(0.0 to 8.8)
OG0022.5(0.1 to 13.2)
OG003
Fever (38.5 to 38.9 deg C)
Title
Measurements
OG0000(0.0 to 8.8)
OG0015.0(0.6 to 16.9)
OG0020(0.0 to 8.8)
OG003
Fever (39.0 to 40.0 deg C)
Title
Measurements
OG0000(0.0 to 8.8)
OG0010(0.0 to 8.8)
OG0020(0.0 to 8.8)
OG003
Fever (>40.0 deg C)
Title
Measurements
OG0000(0.0 to 8.8)
OG0010(0.0 to 8.8)
OG0020(0.0 to 8.8)
OG003
Nausea/vomiting (Any)
Title
Measurements
OG00015.0(5.7 to 29.8)
OG0017.5(1.6 to 20.4)
OG00220.0(9.1 to 35.6)
OG003
Nausea/vomiting (Mild)
Title
Measurements
OG00010.0(2.8 to 23.7)
OG0015.0(0.6 to 16.9)
OG00217.5(7.3 to 32.8)
OG003
Nausea/vomiting (Moderate)
Title
Measurements
OG0005.0(0.6 to 16.9)
OG0012.5(0.1 to 13.2)
OG0022.5(0.1 to 13.2)
OG003
Nausea/vomiting (Severe)
Title
Measurements
OG0000(0.0 to 8.8)
OG0010(0.0 to 8.8)
OG0020(0.0 to 8.8)
OG003
Nausea/vomiting (Grade 4)
Title
Measurements
OG0000(0.0 to 8.8)
OG0010(0.0 to 8.8)
OG0020(00 to 8.8)
OG003
Diarrhea (Any)
Title
Measurements
OG0005.0(0.6 to 16.9)
OG00117.5(7.3 to 32.8)
OG00210.0(2.8 to 23.7)
OG003
Diarrhea (Mild)
Title
Measurements
OG0005.0(0.6 to 16.9)
OG00112.5(4.2 to 26.8)
OG0027.5(1.6 to 20.4)
OG003
Diarrhea (Moderate)
Title
Measurements
OG0000(0.0 to 8.8)
OG0015.0(0.6 to 16.9)
OG0022.5(0.1 to 13.2)
OG003
Diarrhea (Severe)
Title
Measurements
OG0000(0.0 to 8.8)
OG0010(0.0 to 8.8)
OG0020(0.0 to 8.8)
OG003
Diarrhea (Grade 4)
Title
Measurements
OG0000(0.0 to 8.8)
OG0010(0.0 to 8.8)
OG0020(0.0 to 8.8)
OG003
Headache (Any)
Title
Measurements
OG00030.0(16.6 to 46.5)
OG00147.5(31.5 to 63.9)
OG00230.0(16.6 to 46.5)
OG003
Headache (Mild)
Title
Measurements
OG00022.5(10.8 to 38.5)
OG00137.5(22.7 to 54.2)
OG00215.0(5.7 to 29.8)
OG003
Headache (Moderate)
Title
Measurements
OG0007.5(1.6 to 20.4)
OG00110.0(2.8 to 23.7)
OG00215.0(5.7 to 29.8)
OG003
Headache (Severe)
Title
Measurements
OG0000(0.0 to 8.8)
OG0010(0.0 to 8.8)
OG0020(0.0 to 8.8)
OG003
Headache (Grade 4)
Title
Measurements
OG0000(0.0 to 8.8)
OG0010(0.0 to 8.8)
OG0020(0.0 to 8.8)
OG003
Fatigue/tiredness (Any)
Title
Measurements
OG00037.5(22.7 to 54.2)
OG00145.0(29.3 to 61.5)
OG00237.5(22.7 to 54.2)
OG003
Fatigue/tiredness (Mild)
Title
Measurements
OG00027.5(14.6 to 43.9)
OG00122.5(10.8 to 38.5)
OG00225.0(12.7 to 41.2)
OG003
Fatigue/tiredness (Moderate)
Title
Measurements
OG00010.0(2.8 to 23.7)
OG00122.5(10.8 to 38.5)
OG00212.5(4.2 to 26.8)
OG003
Fatigue/tiredness (Severe)
Title
Measurements
OG0000(0.0 to 8.8)
OG0010(0.0 to 8.8)
OG0020(0.0 to 8.8)
OG003
Fatigue/tiredness (Grade 4)
Title
Measurements
OG0000(0.0 to 8.8)
OG0010(0.0 to 8.8)
OG0020(0.0 to 8.8)
OG003
Muscle pain (Any)
Title
Measurements
OG00012.5(4.2 to 26.8)
OG00125.0(12.7 to 41.2)
OG00217.5(7.3 to 32.8)
OG003
Muscle pain (Mild)
Title
Measurements
OG0007.5(1.6 to 20.4)
OG00112.5(4.2 to 26.8)
OG00215.0(5.7 to 29.8)
OG003
Muscle pain (Moderate)
Title
Measurements
OG0005.0(0.6 to 16.9)
OG00112.5(4.2 to 26.8)
OG0022.5(0.1 to 13.2)
OG003
Muscle pain (Severe)
Title
Measurements
OG0000(0.0 to 8.8)
OG0010(0.0 to 8.8)
OG0020(0.0 to 8.8)
OG003
Muscle pain (Grade 4)
Title
Measurements
OG0000(0.0 to 8.8)
OG0010(0.0 to 8.8)
OG0020(0.0 to 8.8)
OG003
Joint pain (Any)
Title
Measurements
OG00010.0(2.8 to 23.7)
OG00110.0(2.8 to 23.7)
OG0022.5(0.1 to 13.2)
OG003
Joint pain (Mild)
Title
Measurements
OG0007.5(1.6 to 20.4)
OG0012.5(0.1 to 13.2)
OG0022.5(0.1 to 13.2)
OG003
Joint pain (Moderate)
Title
Measurements
OG0002.5(0.1 to 13.2)
OG0017.5(1.6 to 20.4)
OG0020(0.0 to 8.8)
OG003
Joint pain (Severe)
Title
Measurements
OG0000(0.0 to 8.8)
OG0010(0.0 to 8.8)
OG0020(0.0 to 8.8)
OG003
Joint pain (Grade 4)
Title
Measurements
OG0000(0.0 to 8.8)
OG0010(0.0 to 8.8)
OG0020(0.0 to 8.8)
OG003
Stage 3: Placebo (Maternal)
Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Units
Counts
Participants
OG000106
OG001103
Title
Denominators
Categories
Fever (>=38.0 deg C)
Title
Measurements
OG0002.8(0.6 to 8.0)
OG0014.9(1.6 to 11.0)
Fever (38.0 to 38.4 deg C)
Title
Measurements
OG0002.8(0.6 to 8.0)
OG0012.9(0.6 to 8.3)
Fever (38.5 to 38.9 deg C)
Title
Measurements
OG0000(0.0 to 3.4)
OG0011.9(0.2 to 6.8)
Fever (39.0 to 40.0 deg C)
Title
Measurements
OG0000(0.0 to 3.4)
OG0010(0.0 to 3.5)
Fever (>40.0 deg C)
Title
Measurements
OG0000(0.0 to 3.4)
OG0010(0.0 to 3.5)
Nausea/vomiting (Any)
Title
Measurements
OG00021.7(14.3 to 30.8)
OG00129.1(20.6 to 38.9)
Nausea/vomiting (Mild)
Title
Measurements
OG00018.9(11.9 to 27.6)
OG00122.3(14.7 to 31.6)
Nausea/vomiting (Moderate)
Title
Measurements
OG0002.8(0.6 to 8.0)
OG0016.8(2.8 to 13.5)
Nausea/vomiting (Severe)
Title
Measurements
OG0000(0.0 to 3.4)
OG0010(0.0 to 3.5)
Nausea/vomiting (Grade 4)
Title
Measurements
OG0000(0.0 to 3.4)
OG0010(0.0 to 3.5)
Diarrhea (Any)
Title
Measurements
OG00012.3(6.7 to 20.1)
OG00111.7(6.2 to 19.5)
Diarrhea (Mild)
Title
Measurements
OG00012.3(6.7 to 20.1)
OG0018.7(4.1 to 15.9)
Diarrhea (Moderate)
Title
Measurements
OG0000(0.0 to 3.4)
OG0012.9(0.6 to 8.3)
Diarrhea (Severe)
Title
Measurements
OG0000(0.0 to 3.4)
OG0010(0.0 to 3.5)
Diarrhea (Grade 4)
Title
Measurements
OG0000(0.0 to 3.4)
OG0010(0.0 to 3.5)
Headache (Any)
Title
Measurements
OG00036.8(27.6 to 46.7)
OG00137.9(28.5 to 48.0)
Headache (Mild)
Title
Measurements
OG00019.8(12.7 to 28.7)
OG00130.1(21.5 to 39.9)
Headache (Moderate)
Title
Measurements
OG00017.0(10.4 to 25.5)
OG0017.8(3.4 to 14.7)
Headache (Severe)
Title
Measurements
OG0000(0.0 to 3.4)
OG0010(0.0 to 3.5)
Headache (Grade 4)
Title
Measurements
OG0000(0.0 to 3.4)
OG0010(0.0 to 3.5)
Fatigue/tiredness (Any)
Title
Measurements
OG00042.5(32.9 to 52.4)
OG00142.7(33.0 to 52.8)
Fatigue/tiredness (Mild)
Title
Measurements
OG00024.5(16.7 to 33.8)
OG00124.3(16.4 to 33.7)
Fatigue/tiredness (Moderate)
Title
Measurements
OG00017.9(11.2 to 26.6)
OG00115.5(9.1 to 24.0)
Fatigue/tiredness (Severe)
Title
Measurements
OG0000(0.0 to 3.4)
OG0012.9(0.6 to 8.3)
Fatigue/tiredness (Grade 4)
Title
Measurements
OG0000(0.0 to 3.4)
OG0010(0.0 to 3.5)
Muscle pain (Any)
Title
Measurements
OG00018.9(11.9 to 27.6)
OG00114.6(8.4 to 22.9)
Muscle pain (Mild)
Title
Measurements
OG00013.2(7.4 to 21.2)
OG0015.8(2.2 to 12.2)
Muscle pain (Moderate)
Title
Measurements
OG0005.7(2.1 to 11.9)
OG0018.7(4.1 to 15.9)
Muscle pain (Severe)
Title
Measurements
OG0000(0.0 to 3.4)
OG0010(0.0 to 3.5)
Muscle pain (Grade 4)
Title
Measurements
OG0000(0.0 to 3.4)
OG0010(0.0 to 3.5)
Joint pain (Any)
Title
Measurements
OG00015.1(8.9 to 23.4)
OG00113.6(7.6 to 21.8)
Joint pain (Mild)
Title
Measurements
OG0009.4(4.6 to 16.7)
OG0018.7(4.1 to 15.9)
Joint pain (Moderate)
Title
Measurements
OG0005.7(2.1 to 11.9)
OG0013.9(1.1 to 9.6)
Joint pain (Severe)
Title
Measurements
OG0000(0.0 to 3.4)
OG0011.0(0.0 to 5.3)
Joint pain (Grade 4)
Title
Measurements
OG0000(0.0 to 3.4)
OG0010(0.0 to 3.5)
Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG003
Stage 2: GBS6 10 mcg Without AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG004
Stage 2: GBS6 20 mcg With AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG005
Stage 2: GBS6 20 mcg Without AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG006
Stage 2: Placebo (Maternal)
Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Units
Counts
Participants
OG00040
OG00140
OG00240
OG00340
OG00440
OG00540
OG006120
Title
Denominators
Categories
Title
Measurements
OG00027.5(14.6 to 43.9)
OG00140.0(24.9 to 56.7)
OG00222.5(10.8 to 38.5)
OG00322.5(10.8 to 38.5)
OG00430.0(16.6 to 46.5)
OG00530.0(16.6 to 46.7)
OG00627.5(19.7 to 36.7)
Participants
OG000108
OG001108
Title
Denominators
Categories
Title
Measurements
OG00036.1(27.1 to 45.9)
OG00132.4(23.7 to 42.1)
Maternal participants were randomized to receive a single dose of 5 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG002
Stage 2: GBS6 10 mcg With AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG003
Stage 2: GBS6 10 mcg Without AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG004
Stage 2: GBS6 20 mcg With AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG005
Stage 2: GBS6 20 mcg Without AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG006
Stage 2: Placebo (Maternal)
Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Units
Counts
Participants
OG00040
OG00140
OG00240
OG00340
OG00440
OG00540
OG006120
Title
Denominators
Categories
Title
Measurements
OG00017.5(7.3 to 32.8)
OG00145.0(29.3 to 61.5)
OG00222.5(0.8 to 38.5)
OG00327.5(14.6 to 43.9)
OG00420.0(9.1 to 35.6)
OG00535.0(20.6 to 51.7)
OG00625.0(17.5 to 33.7)
Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Units
Counts
Participants
OG000108
OG001108
Title
Denominators
Categories
Title
Measurements
OG00019.4(12.5 to 28.2)
OG00121.3(14.0 to 30.2)
Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG003
Stage 2: GBS6 10 mcg Without AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG004
Stage 2: GBS6 20 mcg With AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG005
Stage 2: GBS6 20 mcg Without AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG006
Stage 2: Placebo (Maternal)
Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Units
Counts
Participants
OG00040
OG00140
OG00240
OG00340
OG00440
OG00540
OG006120
Title
Denominators
Categories
Title
Measurements
OG00030.0(16.6 to 46.5)
OG00145.0(29.3 to 61.5)
OG00230.0(16.6 to 46.5)
OG00327.5(14.6 to 43.9)
OG00425.0(12.7 to 41.2)
OG00532.5(18.6 to 49.1)
OG00642.5(33.5 to 51.9)
Units
Counts
Participants
OG000108
OG001108
Title
Denominators
Categories
Title
Measurements
OG00051.9(42.0 to 61.6)
OG00142.6(33.1 to 52.5)
Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG004
Stage 2: GBS6 20 mcg With AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG005
Stage 2: GBS6 20 mcg Without AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG006
Stage 2: Placebo (Maternal)
Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Units
Counts
Participants
OG00040
OG00140
OG00240
OG00340
OG00440
OG00540
OG006120
Title
Denominators
Categories
Prepartum Period
Title
Measurements
OG0005.0(0.6 to 16.9)
OG00112.5(4.2 to 26.8)
OG0025.0(0.6 to 16.9)
OG00310.0(2.8 to 23.7)
OG0045.0(0.6 to 16.9)
OG00510.0(2.8 to 23.7)
OG00611.7(6.5 to 18.8)
Intrapartum Period
Title
Measurements
OG00010.0(2.8 to 23.7)
OG00130.0(16.6 to 46.5)
OG00210.0(2.8 to 23.7)
OG003
Postpartum Period
Title
Measurements
OG0000(0.0 to 8.8)
OG0012.5(0.1 to 13.2)
OG0022.5(0.1 to 13.2)
OG003
108
OG001108
Title
Denominators
Categories
Prepartum Period
Title
Measurements
OG0009.3(4.5 to 16.4)
OG00113.0(7.3 to 20.8)
Intrapartum Period
Title
Measurements
OG00013.9(8.0 to 21.9)
OG00113.0(7.3 to 20.8)
Postpartum Period
Title
Measurements
OG0002.8(0.6 to 7.9)
OG0011.9(0.2 to 6.5)
Stage 2: GBS6 10 mcg Without AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG004
Stage 2: GBS6 20 mcg With AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG005
Stage 2: GBS6 20 mcg Without AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG006
Stage 2: Placebo (Maternal)
Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Units
Counts
Participants
OG00040
OG00140
OG00240
OG00340
OG00440
OG00540
OG006120
Title
Denominators
Categories
Full term live delivery
Title
Measurements
OG00092.5
OG00190.0
OG00297.5
OG003100.0
OG00497.5
OG00597.5
OG00695.8
Premature live delivery
Title
Measurements
OG0007.5
OG0017.5
OG0022.5
OG003
Stillbirth
Title
Measurements
OG0000
OG0012.5
OG0020
OG003
Induced/elective abortion
Title
Measurements
OG0000
OG0010
OG0020
OG003
Delivery outcome-Unknown
Title
Measurements
OG0000
OG0010
OG0020
OG003
Vaginal delivery
Title
Measurements
OG00085.0
OG00160.0
OG00282.5
OG003
Cesarean section: elective
Title
Measurements
OG0005.0
OG00112.5
OG0027.5
OG003
Cesarean section: semi-elective
Title
Measurements
OG0000
OG0010
OG0020
OG003
Cesarean section: emergency
Title
Measurements
OG00010.0
OG00127.5
OG00210.0
OG003
Delivery mode-Unknown
Title
Measurements
OG0000
OG0010
OG0020
OG003
108
OG001108
Title
Denominators
Categories
Full term live delivery
Title
Measurements
OG00088.0
OG00191.7
Premature live delivery
Title
Measurements
OG0007.4
OG0015.6
Stillbirth
Title
Measurements
OG0000.9
OG0010
Induced/elective abortion
Title
Measurements
OG0000
OG0010
Delivery outcome-Unknown
Title
Measurements
OG0003.7
OG0012.7
Vaginal delivery
Title
Measurements
OG00072.2
OG00175.9
Cesarean section: elective
Title
Measurements
OG00012.0
OG0019.3
Cesarean section: semi-elective
Title
Measurements
OG0001.9
OG0010
Cesarean section: emergency
Title
Measurements
OG00010.2
OG00112.0
Delivery mode-Unknown
Title
Measurements
OG0003.7
OG0012.8
Stage 2: GBS6 10 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG004
Stage 2: GBS6 20 mcg With AlPO4 (Infant)
Infant participants born to the maternal participants randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG005
Stage 2: GBS6 20 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG006
Stage 2: Placebo (Infant)
Infant participants born to the maternal participants randomized to receive placebo (saline control) intramuscularly on Day 1.
Units
Counts
Participants
OG00040
OG00139
OG00240
OG00340
OG00440
OG00540
OG006118
Title
Denominators
Categories
>=24 weeks to <28 weeks
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
>=28 weeks to <34 weeks
Title
Measurements
OG0002.5
OG0012.6
OG0020
OG003
>=34 weeks to <37 weeks
Title
Measurements
OG0005.0
OG0015.1
OG0022.5
OG003
>=37 weeks to <42 weeks
Title
Measurements
OG00087.5
OG00184.6
OG00297.5
OG003
>=42 weeks
Title
Measurements
OG0005.0
OG0017.7
OG0020
OG003
Infant participants born to the maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG003
Stage 2: GBS6 10 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG004
Stage 2: GBS6 20 mcg With AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG005
Stage 2: GBS6 20 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG006
Stage 2: Placebo (Infant)
Infant participants born to the maternal participants randomized to receive placebo (saline control) intramuscularly on Day 1.
Units
Counts
Participants
OG00040
OG00138
OG00240
OG00340
OG00440
OG00540
OG006113
Title
Denominators
Categories
Title
Measurements
OG0009.0(8 to 9)
OG0019.0(6 to 9)
OG0029.0(8 to 9)
OG0039.0(7 to 9)
OG0049.0(3 to 9)
OG0059.0(5 to 9)
OG0069.0(1 to 9)
OG003
Stage 2: GBS6 10 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG004
Stage 2: GBS6 20 mcg With AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG005
Stage 2: GBS6 20 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG006
Stage 2: Placebo (Infant)
Infant participants born to the maternal participants randomized to receive placebo (saline control) intramuscularly on Day 1.
Units
Counts
Participants
OG00040
OG00139
OG00240
OG00340
OG00440
OG00540
OG006118
Title
Denominators
Categories
Title
Measurements
OG00010.0(8 to 10)
OG00110.0(8 to 10)
OG00210.0(9 to 10)
OG00310.0(9 to 10)
OG00410.0(7 to 10)
OG00510.0(5 to 10)
OG00610.0(4 to 10)
Infant participants born to the maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG003
Stage 2: GBS6 10 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG004
Stage 2: GBS6 20 mcg With AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG005
Stage 2: GBS6 20 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG006
Stage 2: Placebo (Infant)
Infant participants born to the maternal participants randomized to receive placebo (saline control) intramuscularly on Day 1.
Units
Counts
Participants
OG00040
OG00139
OG00240
OG00340
OG00440
OG00540
OG006118
Title
Denominators
Categories
<37 weeks 0 days
Title
Measurements
OG0001(8 to 10)
OG0012(8 to 10)
OG0021(9 to 10)
OG0031(9 to 10)
OG0042(7 to 10)
OG0052(5 to 10)
OG0064(4 to 10)
>=37 weeks to <42 weeks
Title
Measurements
OG0006
OG0013
OG0027
OG003
>=42 weeks
Title
Measurements
OG0001
OG0011
OG0021
OG003
Not reported
Title
Measurements
OG00032
OG00133
OG00231
OG003
Stage 2: GBS6 10 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG004
Stage 2: GBS6 20 mcg With AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG005
Stage 2: GBS6 20 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG006
Stage 2: Placebo (Infant)
Infant participants born to the maternal participants randomized to receive placebo (saline control) intramuscularly on Day 1.
Units
Counts
Participants
OG00040
OG00139
OG00240
OG00340
OG00440
OG00540
OG006118
Title
Denominators
Categories
Normal
Title
Measurements
OG00034(8 to 10)
OG00130(8 to 10)
OG00238(9 to 10)
OG00338(9 to 10)
OG00434(7 to 10)
OG00535(5 to 10)
OG00689(4 to 10)
Congenital malformation/anomaly
Title
Measurements
OG0007
OG0018
OG0022
OG003
Other neonatal problem
Title
Measurements
OG0003
OG0014
OG0022
OG003
Infant participants born to the maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG004
Stage 2: GBS6 20 mcg With AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG005
Stage 2: GBS6 20 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG006
Stage 2: Placebo (Infant)
Infant participants born to the maternal participants randomized to receive placebo (saline control) intramuscularly on Day 1.
Units
Counts
Participants
OG00040
OG00139
OG00240
OG00340
OG00440
OG00540
OG006118
Title
Denominators
Categories
Live
Title
Measurements
OG00040(8 to 10)
OG00138(8 to 10)
OG00240(9 to 10)
OG00340(9 to 10)
OG00440(7 to 10)
OG00540(5 to 10)
OG006117(4 to 10)
Neonatal death
Title
Measurements
OG0000
OG0011
OG0020
OG003
104
OG001105
Title
Denominators
Categories
>=24 weeks to <28 weeks
Title
Measurements
OG0000
OG0010
>=28 weeks to <34 weeks
Title
Measurements
OG0001
OG0012
>=34 weeks to <37 weeks
Title
Measurements
OG0007
OG0014
>=37 weeks to <42 weeks
Title
Measurements
OG00094
OG00194
>=42 weeks
Title
Measurements
OG0001
OG0014
Unknown
Title
Measurements
OG0001
OG0011
Participants
OG000104
OG001105
Title
Denominators
Categories
Title
Measurements
OG0009.0(2 to 10)
OG0019.0(1 to 9)
OG000104
OG001105
Title
Denominators
Categories
Title
Measurements
OG00010.0(7 to 10)
OG00110.0(4 to 10)
Participants
OG000104
OG001105
Title
Denominators
Categories
<37 weeks 0 days
Title
Measurements
OG0004
OG0014
>=37 weeks to <42 weeks
Title
Measurements
OG00030
OG00137
>=42 weeks
Title
Measurements
OG0005
OG0014
Not reported
Title
Measurements
OG00065
OG00160
104
OG001105
Title
Denominators
Categories
Normal
Title
Measurements
OG00082
OG00179
Congenital malformation/anomaly
Title
Measurements
OG00015
OG00116
Other neonatal problem
Title
Measurements
OG00012
OG00115
104
OG001105
Title
Denominators
Categories
Live
Title
Measurements
OG000103
OG001104
Neonatal death
Title
Measurements
OG0001
OG0011
OG003
Stage 2: GBS6 10 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG004
Stage 2: GBS6 20 mcg With AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG005
Stage 2: GBS6 20 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG006
Stage 2: Placebo (Infant)
Infant participants born to the maternal participants randomized to receive placebo (saline control) intramuscularly on Day 1.
Units
Counts
Participants
OG00040
OG00139
OG00240
OG00340
OG00440
OG00540
OG006118
Title
Denominators
Categories
Title
Measurements
OG00026(8 to 10)
OG00121(8 to 10)
OG00225(9 to 10)
OG00321(9 to 10)
OG00419(7 to 10)
OG00518(5 to 10)
OG00668(4 to 10)
104
OG001105
Title
Denominators
Categories
Title
Measurements
OG00065
OG00164
OG002
Stage 2: GBS6 10 mcg With AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG003
Stage 2: GBS6 10 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG004
Stage 2: GBS6 20 mcg With AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG005
Stage 2: GBS6 20 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG006
Stage 2: Placebo (Infant)
Infant participants born to the maternal participants randomized to receive placebo (saline control) intramuscularly on Day 1.
Units
Counts
Participants
OG00040
OG00139
OG00240
OG00340
OG00440
OG00540
OG006118
Title
Denominators
Categories
Title
Measurements
OG00017(8 to 10)
OG00119(8 to 10)
OG00215(9 to 10)
OG00312(9 to 10)
OG00419(7 to 10)
OG00514(5 to 10)
OG00660(4 to 10)
Units
Counts
Participants
OG000104
OG001105
Title
Denominators
Categories
Title
Measurements
OG00045
OG00146
OG003
Stage 2: GBS6 10 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG004
Stage 2: GBS6 20 mcg With AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG005
Stage 2: GBS6 20 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG006
Stage 2: Placebo (Infant)
Infant participants born to the maternal participants randomized to receive placebo (saline control) intramuscularly on Day 1.
Units
Counts
Participants
OG00040
OG00139
OG00240
OG00340
OG00440
OG00540
OG006118
Title
Denominators
Categories
Title
Measurements
OG00022(8 to 10)
OG00114(8 to 10)
OG00219(9 to 10)
OG00321(9 to 10)
OG00418(7 to 10)
OG00518(5 to 10)
OG00658(4 to 10)
OG000104
OG001105
Title
Denominators
Categories
Title
Measurements
OG00065
OG00166
OG003
Stage 2: GBS6 10 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG004
Stage 2: GBS6 20 mcg With AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG005
Stage 2: GBS6 20 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG006
Stage 2: Placebo (Infant)
Infant participants born to the maternal participants randomized to receive placebo (saline control) intramuscularly on Day 1.
Units
Counts
Participants
OG00040
OG00139
OG00240
OG00340
OG00440
OG00540
OG006118
Title
Denominators
Categories
Major congenital anomalies
Title
Measurements
OG0000(0.0 to 8.8)
OG0012.6(0.1 to 13.5)
OG0022.5(0.1 to 13.2)
OG0030(0.0 to 8.8)
OG0040(0.0 to 8.8)
OG0050(0.0 to 8.8)
OG0061.7(0.2 to 6.0)
Developmental delay
Title
Measurements
OG0000(0.0 to 8.8)
OG0012.6(0.1 to 13.5)
OG0020(0.0 to 8.8)
OG003
Suspected or confirmed GBS infection
Title
Measurements
OG0000(0.0 to 8.8)
OG0010(0.0 to 9.0)
OG0020(0.0 to 8.8)
OG003
OG000104
OG001105
Title
Denominators
Categories
Major congenital anomalies
Title
Measurements
OG0000(0.0 to 3.5)
OG0010(0.0 to 3.5)
Developmental delay
Title
Measurements
OG0001.0(0.0 to 5.2)
OG0010(0.0 to 3.5)
Suspected or confirmed GBS infection
Title
Measurements
OG0000(0.0 to 3.5)
OG0010(0.0 to 3.5)
Participants
OG00022
OG00122
OG00222
Title
Denominators
Categories
Ia
Title
Measurements
OG00064.729(19.893 to 210.612)
OG00125.781(8.040 to 82.661)
OG0020.152(0.029 to 0.807)
Ib
Title
Measurements
OG0004.986(1.639 to 15.165)
OG0015.546(1.497 to 20.549)
OG0020.019(0.009 to 0.039)
II
Title
Measurements
OG00023.359(10.941 to 49.870)
OG00137.920(14.374 to 100.033)
OG0020.179(0.087 to 0.365)
III
Title
Measurements
OG00022.622(8.569 to 59.725)
OG00119.065(8.430 to 43.116)
OG0020.068(0.022 to 0.213)
IV
Title
Measurements
OG0005.748(2.784 to 11.864)
OG0012.564(1.292 to 5.091)
OG0020.041(0.016 to 0.104)
V
Title
Measurements
OG0000.599(0.220 to 1.631)
OG0010.420(0.105 to 1.676)
OG0020.058(0.020 to 0.168)
Non pregnant participants were randomized to receive a booster dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly at least 2 years after Vaccination 1 on Day 1. Participants were categorized based on their primary dose of Placebo.
Units
Counts
Participants
OG00011
OG0017
OG0027
Title
Denominators
Categories
Ia (Before)
Title
Measurements
OG00021.088(5.663 to 78.520)
OG0013.230(0.164 to 63.426)
OG0020.812(0.026 to 25.244)
Ia (Month 1)
Title
Measurements
OG00086.661(47.789 to 157.153)
OG00148.241(15.580 to 149.375)
OG00268.222(3.526 to 1319.87)
Ia (Month 3)
Title
Measurements
OG00060.200(28.513 to 127.102)
OG00127.000(6.370 to 114.442)
OG00249.958(3.463 to 720.799)
Ia (Month 6)
Title
Measurements
OG00051.631(21.557 to 123.660)
OG00118.936(4.154 to 86.321)
OG00223.140(2.552 to 209.826)
Ib (Before)
Title
Measurements
OG0001.643(0.457 to 5.914)
OG0010.215(0.012 to 3.749)
OG0020.057(0.014 to 0.222)
Ib (Month 1)
Title
Measurements
OG00029.416(17.765 to 48.706)
OG00111.171(2.526 to 49.402)
OG0026.176(0.928 to 41.110)
Ib (Month 3)
Title
Measurements
OG00016.062(8.198 to 31.470)
OG0016.134(1.183 to 31.813)
OG0023.479(0.666 to 18.173)
Ib (Month 6)
Title
Measurements
OG00011.053(4.697 to 26.010)
OG0014.033(0.753 to 21.588)
OG0022.304(0.446 to 11.896)
II (Before)
Title
Measurements
OG0004.041(1.542 to 10.593)
OG00110.338(1.123 to 95.149)
OG0020.185(0.053 to 0.646)
II (Month 1)
Title
Measurements
OG000113.187(57.027 to 224.653)
OG00192.478(17.542 to 487.530)
OG00248.523(10.696 to 220.122)
II (Month 3)
Title
Measurements
OG00064.110(31.261 to 131.479)
OG00162.160(9.893 to 390.578)
OG00232.569(6.968 to 152.225)
II (Month 6)
Title
Measurements
OG00038.482(17.354 to 85.334)
OG00148.827(7.872 to 302.837)
OG00224.262(5.239 to 112.349)
III (Before)
Title
Measurements
OG0006.765(1.919 to 23.847)
OG0013.058(0.343 to 27.231)
OG0020.084(0.017 to 0.403)
III (Month 1)
Title
Measurements
OG00036.579(17.516 to 76.390)
OG00130.831(11.300 to 84.117)
OG00214.092(4.614 to 43.045)
III (Month 3)
Title
Measurements
OG00025.006(11.011 to 56.790)
OG00118.206(4.216 to 78.614)
OG0027.729(2.486 to 24.024)
III (Month 6)
Title
Measurements
OG00021.808(9.021 to 52.717)
OG00112.540(2.433 to 64.642)
OG0024.941(2.015 to 12.117)
IV (Before)
Title
Measurements
OG0000.949(0.388 to 2.324)
OG0010.351(0.080 to 1.545)
OG0020.031(0.006 to 0.151)
IV (Month 1)
Title
Measurements
OG00033.784(18.478 to 61.771)
OG00114.228(5.724 to 35.368)
OG00214.942(5.920 to 37.717)
IV (Month 3)
Title
Measurements
OG00014.744(7.275 to 29.882)
OG0015.820(2.005 to 16.893)
OG0027.524(2.629 to 21.536)
IV (Month 6)
Title
Measurements
OG0009.750(4.014 to 23.681)
OG0013.325(1.082 to 10.218)
OG0024.918(1.606 to 15.057)
V (Before)
Title
Measurements
OG0000.245(0.056 to 1.076)
OG0010.261(0.026 to 2.596)
OG0020.080(0.012 to 0.532)
V (Month 1)
Title
Measurements
OG0008.208(2.328 to 28.936)
OG0017.177(0.841 to 61.232)
OG0026.511(0.665 to 63.696)
V (Month 3)
Title
Measurements
OG0004.454(1.177 to 16.857)
OG0013.782(0.448 to 31.946)
OG0025.400(0.710 to 41.094)
V (Month 6)
Title
Measurements
OG0003.086(0.767 to 12.417)
OG0012.594(0.314 to 21.411)
OG0024.666(0.601 to 36.239)
Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG004
Stage 2: GBS6 20 mcg With AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG005
Stage 2: GBS6 20 mcg Without AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG006
Stage 2: Placebo (Maternal)
Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Units
Counts
Participants
OG00039
OG00139
OG00228
OG00326
OG00439
OG00540
OG006103
Title
Denominators
Categories
Ia (Week 2)
Title
Measurements
OG0008.399(3.031 to 23.274)
OG00116.089(7.267 to 35.623)
OG00211.073(3.974 to 30.852)
OG00310.782(2.432 to 47.800)
OG00413.813(4.502 to 42.381)
OG00541.201(20.997 to 80.843)
OG0060.099(0.055 to 0.178)
Ia (Month 1)
Title
Measurements
OG0008.850(3.119 to 25.116)
OG00114.987(6.881 to 32.640)
OG00214.356(4.650 to 44.324)
OG003
Ia (At Delivery)
Title
Measurements
OG00011.940(5.566 to 25.613)
OG00113.901(5.547 to 34.833)
OG00214.492(5.244 to 40.045)
OG003
Ib (Week 2)
Title
Measurements
OG0000.270(0.090 to 0.811)
OG0010.306(0.106 to 0.878)
OG0020.315(0.077 to 1.282)
OG003
Ib (Month 1)
Title
Measurements
OG0000.275(0.082 to 0.922)
OG0010.382(0.131 to 1.119)
OG0020.350(0.098 to 1.248)
OG003
Ib (At Delivery)
Title
Measurements
OG0000.453(0.155 to 1.329)
OG0010.293(0.101 to 0.847)
OG0020.625(0.179 to 2.181)
OG003
II (Week 2)
Title
Measurements
OG0008.153(4.325 to 15.368)
OG0015.294(2.942 to 9.525)
OG0028.232(3.838 to 17.654)
OG003
II (Month 1)
Title
Measurements
OG0007.784(3.533 to 17.153)
OG0014.555(2.277 to 9.112)
OG00210.449(4.742 to 23.026)
OG003
II (At Delivery)
Title
Measurements
OG0008.676(4.463 to 16.866)
OG0013.220(1.509 to 6.872)
OG0029.676(4.528 to 20.679)
OG003
III (Week 2)
Title
Measurements
OG0001.518(0.534 to 4.312)
OG0012.165(0.829 to 5.658)
OG0024.164(1.236 to 14.033)
OG003
III (Month 1)
Title
Measurements
OG0001.294(0.432 to 3.878)
OG0011.638(0.658 to 4.077)
OG0027.260(2.394 to 22.014)
OG003
III (At Delivery)
Title
Measurements
OG0002.518(0.994 to 6.382)
OG0011.657(0.602 to 4.561)
OG0026.152(2.063 to 18.348)
OG003
IV (Week 2)
Title
Measurements
OG0001.219(0.577 to 2.573)
OG0010.831(0.408 to 1.693)
OG0021.783(0.883 to 3.599)
OG003
IV (Month 1)
Title
Measurements
OG0001.198(0.534 to 2.687)
OG0010.783(0.369 to 1.661)
OG0021.563(0.706 to 3.460)
OG003
IV (At Delivery)
Title
Measurements
OG0001.690(0.915 to 3.121)
OG0010.556(0.250 to 1.235)
OG0021.624(0.776 to 3.399)
OG003
V (Week 2)
Title
Measurements
OG0000.114(0.052 to 0.248)
OG0010.217(0.080 to 0.587)
OG0020.522(0.193 to 1.411)
OG003
V (Month 1)
Title
Measurements
OG0000.115(0.051 to 0.260)
OG0010.222(0.074 to 0.663)
OG0020.610(0.213 to 1.743)
OG003
V (At Delivery)
Title
Measurements
OG0000.188(0.098 to 0.360)
OG0010.252(0.087 to 0.732)
OG0020.919(0.344 to 2.458)
OG003
102
OG001100
Title
Denominators
Categories
Ia (Week 2)
Title
Measurements
OG0009.233(4.648 to 18.343)
OG0010.051(0.027 to 0.096)
Ia (Month 1)
Title
Measurements
OG0009.631(5.178 to 17.914)
OG0010.054(0.028 to 0.103)
Ia (At Delivery)
Title
Measurements
OG0008.817(4.969 to 15.643)
OG0010.052(0.028 to 0.100)
Ib (Week 2)
Title
Measurements
OG0000.815(0.458 to 1.450)
OG0010.009(0.006 to 0.013)
Ib (Month 1)
Title
Measurements
OG0000.832(0.465 to 1.488)
OG0010.011(0.007 to 0.016)
Ib (At Delivery)
Title
Measurements
OG0000.645(0.377 to 1.103)
OG0010.011(0.007 to 0.016)
II (Week 2)
Title
Measurements
OG00040.234(27.437 to 58.999)
OG0010.149(0.103 to 0.216)
II (Month 1)
Title
Measurements
OG00032.831(21.455 to 50.240)
OG0010.140(0.096 to 0.204)
II (At Delivery)
Title
Measurements
OG00022.460(14.817 to 34.043)
OG0010.146(0.099 to 0.215)
III (Week 2)
Title
Measurements
OG0006.422(3.475 to 11.869)
OG0010.034(0.023 to 0.050)
III (Month 1)
Title
Measurements
OG0007.158(4.141 to 12.375)
OG0010.034(0.022 to 0.051)
III (At Delivery)
Title
Measurements
OG0005.641(3.486 to 9.129)
OG0010.031(0.021 to 0.046)
IV (Week 2)
Title
Measurements
OG0005.719(3.952 to 8.275)
OG0010.014(0.009 to 0.020)
IV (Month 1)
Title
Measurements
OG0004.598(3.229 to 6.549)
OG0010.014(0.009 to 0.020)
IV (At Delivery)
Title
Measurements
OG0002.708(1.920 to 3.821)
OG0010.012(0.009 to 0.018)
V (Week 2)
Title
Measurements
OG0000.760(0.427 to 1.352)
OG0010.013(0.009 to 0.017)
V (Month 1)
Title
Measurements
OG0000.732(0.410 to 1.306)
OG0010.014(0.010 to 0.020)
V (At Delivery)
Title
Measurements
OG0000.452(0.266 to 0.768)
OG0010.012(0.009 to 0.017)
Stage 2: GBS6 10 mcg Without AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG004
Stage 2: GBS6 20 mcg With AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG005
Stage 2: GBS6 20 mcg Without AlPO4 (Maternal)
Maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG006
Stage 2: Placebo (Maternal)
Maternal participants were randomized to receive placebo (saline control) intramuscularly on Day 1.
Units
Counts
Participants
OG00039
OG00139
OG00228
OG00326
OG00439
OG00540
OG006103
Title
Denominators
Categories
Ia (Month 1)
Title
Measurements
OG00013012.1(8833.7 to 19166.7)
OG0017765.3(4510.1 to 13369.8)
OG00214408.2(8688.7 to 23892.6)
OG0039722.0(5042.9 to 18742.6)
OG0048133.8(3884.6 to 17031.1)
OG00523271.2(16886.0 to 32070.9)
OG006200.2(148.1 to 270.6)
Ia (At delivery)
Title
Measurements
OG00010500.3(5750.8 to 19172.5)
OG0017160.6(4139.7 to 12386.1)
OG0027560.6(4145.9 to 13788.0)
OG003
Ib (Month 1)
Title
Measurements
OG00011534.8(6127.3 to 21714.3)
OG00110639.1(5992.3 to 18889.3)
OG0029835.4(4446.4 to 21755.7)
OG003
Ib (At delivery)
Title
Measurements
OG00014876.0(6608.3 to 33487.9)
OG00112259.3(6958.6 to 21597.9)
OG00214665.8(6990.4 to 30768.4)
OG003
II (Month 1)
Title
Measurements
OG0009908.6(6649.3 to 14765.6)
OG0015486.1(3655.7 to 8232.9)
OG00216560.9(9736.9 to 28167.2)
OG003
II (At delivery)
Title
Measurements
OG0009573.5(5948.3 to 15408.0)
OG0016521.0(3963.2 to 10729.7)
OG00218640.8(13002.6 to 26723.8)
OG003
III (Month 1)
Title
Measurements
OG0004026.7(2234.9 to 7255.0)
OG0013285.5(1802.0 to 5990.4)
OG00211207.9(5496.5 to 22854.0)
OG003
III (At delivery)
Title
Measurements
OG0005105.3(2701.9 to 9646.8)
OG0013959.5(2200.6 to 7124.3)
OG0025229.1(2638.7 to 10362.5)
OG003
IV (Month 1)
Title
Measurements
OG0006591.5(4596.8 to 9451.9)
OG0016087.6(4249.5 to 8720.9)
OG0028773.7(5381.7 to 14303.7)
OG003
IV (At delivery)
Title
Measurements
OG0008074.3(5019.7 to 12987.6)
OG0016302.6(4344.3 to 9143.7)
OG0027713.8(5537.3 to 10745.9)
OG003
V (Month 1)
Title
Measurements
OG0003048.0(2012.8 to 4615.7)
OG0015568.4(3485.6 to 8896.0)
OG0027288.6(3896.5 to 13633.6)
OG003
V (At delivery)
Title
Measurements
OG0002450.4(1564.1 to 3839.0)
OG0013109.0(1777.9 to 5436.6)
OG0026309.7(3524.3 to 11296.3)
OG003
102
OG001100
Title
Denominators
Categories
Ia: at 1 month
Title
Measurements
OG00011462.9(7717.7 to 17025.6)
OG001196.1(143.3 to 268.5)
Ia: at delivery
Title
Measurements
OG0006228.2(3987.0 to 9729.2)
OG001211.4(146.0 to 306.0)
Ib: at 1 month
Title
Measurements
OG00013306.1(9230.1 to 19182.2)
OG001480.8(316.5 to 730.3)
Ib: at delivery
Title
Measurements
OG0007011.6(4414.7 to 11136.1)
OG001481.6(314.6 to 737.1)
II: at 1 month
Title
Measurements
OG00035652.7(27220.2 to 46697.5)
OG0011911.7(1381.8 to 2644.6)
II: at delivery
Title
Measurements
OG00022650.9(16845.7 to 30456.6)
OG0011998.5(1418.4 to 2816.0)
III: at 1 month
Title
Measurements
OG0009064.7(6412.0 to 12814.8)
OG001511.9(362.8 to 722.3)
III: at delivery
Title
Measurements
OG0005822.1(3929.9 to 8625.3)
OG001561.7(392.2 to 804.6)
IV: at 1 month
Title
Measurements
OG00011800.6(9297.8 to 14977.0)
OG0011152.1(854.6 to 1553.2)
IV: at delivery
Title
Measurements
OG0008242.0(6327.8 to 10735.1)
OG0011164.0(837.9 to 1617.0)
V: at 1 month
Title
Measurements
OG0009258.1(7138.7 to 12006.7)
OG001846.0(569.0 to 1257.9)
V: at delivery
Title
Measurements
OG0005501.3(3875.7 to 7808.6)
OG001837.5(530.6 to 1322.0)
Infant participants born to the maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG004
Stage 2: GBS6 20 mcg With AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG005
Stage 2: GBS6 20 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG006
Stage 2: Placebo (Infant)
Infant participants born to the maternal participants randomized to receive placebo (saline control) intramuscularly on Day 1.
Units
Counts
Participants
OG00036
OG00130
OG00231
OG00331
OG00436
OG00538
OG00699
Title
Denominators
Categories
Ia
Title
Measurements
OG0004.322(1.291 to 14.471)
OG00110.978(4.362 to 27.625)
OG0026.128(0.996 to 37.710)
OG00311.089(1.919 to 64.083)
OG0046.094(1.435 to 25.870)
OG00522.159(11.705 to 41.949)
OG0060.047(0.025 to 0.091)
Ib
Title
Measurements
OG0000.155(0.034 to 0.712)
OG0010.182(0.045 to 0.727)
OG0020.481(0.056 to 4.113)
OG003
II
Title
Measurements
OG0007.680(2.851 to 20.690)
OG0011.935(1.009 to 3.711)
OG0025.190(1.314 to 20.507)
OG003
III
Title
Measurements
OG0000.954(0.219 to 4.148)
OG0011.009(0.289 to 3.521)
OG0020.917(0.118 to 7.109)
OG003
IV
Title
Measurements
OG0000.993(0.403 to 2.447)
OG0010.448(0.165 to 1.215)
OG0020.759(0.275 to 2.098)
OG003
V
Title
Measurements
OG0000.084(0.031 to 0.226)
OG0010.090(0.025 to 0.327)
OG0020.183(0.054 to 0.618)
OG003
86
OG00188
Title
Denominators
Categories
Ia
Title
Measurements
OG0006.366(3.343 to 12.122)
OG0010.048(0.026 to 0.089)
Ib
Title
Measurements
OG0000.466(0.261 to 0.833)
OG0010.009(0.006 to 0.014)
II
Title
Measurements
OG00016.123(10.030 to 25.916)
OG0010.134(0.090 to 0.201)
III
Title
Measurements
OG0003.609(2.076 to 6.275)
OG0010.024(0.016 to 0.036)
IV
Title
Measurements
OG0002.124(1.391 to 3.243)
OG0010.013(0.009 to 0.020)
V
Title
Measurements
OG0000.278(0.160 to 0.481)
OG0010.011(0.008 to 0.015)
Infant participants born to the maternal participants were randomized to receive a single dose of 10 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG004
Stage 2: GBS6 20 mcg With AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine with AlPO4, intramuscularly on Day 1.
OG005
Stage 2: GBS6 20 mcg Without AlPO4 (Infant)
Infant participants born to the maternal participants were randomized to receive a single dose of 20 mcg of GBS6 vaccine without AlPO4, intramuscularly on Day 1.
OG006
Stage 2: Placebo (Infant)
Infant participants born to the maternal participants randomized to receive placebo (saline control) intramuscularly on Day 1.