A Phase 1/2, Randomized, Placebo-controlled, Observer-bli... | NCT03170609 | Trialant
NCT03170609
Sponsor
Pfizer
Status
Completed
Last Update Posted
Jul 2, 2019Actual
Enrollment
365Actual
Phase
Phase 2
Conditions
Group B Streptococcal Infections
Interventions
Multivalent group B streptococcus vaccine
Placebo
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT03170609
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
C1091001
Secondary IDs
Not provided
Brief 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 Adults 18 To 49 Years Of Age
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 ADULTS 18 TO 49 YEARS OF AGE
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Jun 2019
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
Jun 5, 2017Actual
Primary Completion Date
Jun 25, 2018Actual
Completion Date
Jun 25, 2018Actual
First Submitted Date
May 26, 2017
First Submission Date that Met QC Criteria
May 26, 2017
First Posted Date
May 31, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Jun 13, 2019
Results First Submitted that Met QC Criteria
Jun 13, 2019
Results First Posted Date
Jul 2, 2019Actual
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
Jun 13, 2019
Last Update Posted Date
Jul 2, 2019Actual
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
No
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is the Phase 1/2 first-in-human, randomized, placebo-controlled, observer-blinded study evaluating the investigational multivalent group B streptococcus vaccine. Healthy adults aged 18 to 49 years of age with no history of group B streptococcal vaccination will be randomized to receive either a single intramuscular dose of multivalent group B streptococcus vaccine (various formulations at 3 dose levels) or a placebo (saline control).
Detailed Description
Not provided
Conditions Module
Conditions
Group B Streptococcal 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
365Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Lowest dose formulation a
Experimental
Multivalent group B streptococcus vaccine
Biological: Multivalent group B streptococcus vaccine
Middle dose formulation a
Experimental
Multivalent group B streptococcus vaccine
Biological: Multivalent group B streptococcus vaccine
Highest dose formulation a
Experimental
Multivalent group B streptococcus vaccine
Biological: Multivalent group B streptococcus vaccine
Lowest dose formulation b
Experimental
Multivalent group B streptococcus vaccine
Biological: Multivalent group B streptococcus vaccine
Middle dose formulation b
Experimental
Multivalent group B streptococcus vaccine
Biological: Multivalent group B streptococcus vaccine
Highest dose formulation b
Experimental
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Multivalent group B streptococcus vaccine
Biological
Various formulations at three dose levels
Highest dose formulation a
Highest dose formulation b
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Clinical Laboratory Abnormalities at 1-Week After Vaccination as Measured by Food and Drug Administration (FDA) Grade
Percentage of Participants With Local Reactions by Maximum Severity Within 14 Days After Vaccination
Local reactions were collected by using an e-diary and included redness, swelling and pain at injection site. Redness and swelling were graded as: mild (2.5-5.0 centimeter [cm]), moderate (greater than [>] 5.0-10.0 cm) and severe (>10.0 cm), grade 4 for redness (necrosis or exfoliative dermatitis) and grade 4 for swelling (necrosis). Pain at injection site was graded as: mild (did not interfere with activity), moderate (repeated use of nonnarcotic pain reliever >24 hours or interfered with activity), severe (any use of narcotic pain reliever or prevented daily activity which resulted in missed days of work or school or was otherwise incapacitating, or included use of narcotics for analgesia), and grade 4 (required emergency room visit or hospitalization). The maximum severity (highest grading) of each location reaction within 14 days of vaccination was derived.
Within 14 days after vaccination
Percentage of Participants With Systemic Events by Maximum Severity Within 14 Days After Vaccination
Secondary Outcomes
Measure
Description
Time Frame
GBS6 Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination
Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.
1 month after vaccination
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Healthy adults (male and female) 18 to 49 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 for all female subjects who are of childbearing potential.
Exclusion Criteria:
Male subjects and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for at least 3 months after the last dose of investigational product.
Acute or chronic medical or psychiatric condition 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 subject inappropriate for entry into this study. Chronic medical conditions include human immunodeficiency virus, chronic hepatitis B virus (HBV) infection (HBV surface antigen positive), and/or hepatitis C virus infection.
History of severe adverse reaction and/or severe allergic reaction (eg, anaphylaxis) to any vaccine.
History of microbiologically proven invasive disease caused by group B streptococcus (Streptococcus agalactiae).
Previous vaccination with any licensed or investigational group B streptococcus vaccine, or planned receipt during the subject's participation in the study (through the last blood draw).
Absalon J, Segall N, Block SL, Center KJ, Scully IL, Giardina PC, Peterson J, Watson WJ, Gruber WC, Jansen KU, Peng Y, Munson S, Pavliakova D, Scott DA, Anderson AS. Safety and immunogenicity of a novel hexavalent group B streptococcus conjugate vaccine in healthy, non-pregnant adults: a phase 1/2, randomised, placebo-controlled, observer-blinded, dose-escalation trial. Lancet Infect Dis. 2021 Feb;21(2):263-274. doi: 10.1016/S1473-3099(20)30478-3. Epub 2020 Sep 3.
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
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.
Participants were randomized to receive a single dose of 5 microgram of Group B Streptococcus 6-valent (GBS6) vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
FG001
GBS6 5 Microgram Without Aluminum Phosphate
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
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
Aug 29, 2017
Jun 13, 2019
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
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
Not provided
Who Masked
ParticipantInvestigator
Multivalent group B streptococcus vaccine
Biological: Multivalent group B streptococcus vaccine
Placebo
Placebo Comparator
Saline control
Biological: Placebo
Lowest dose formulation a
Lowest dose formulation b
Middle dose formulation a
Middle dose formulation b
Placebo
Biological
Saline Control
Placebo
Fever:38.0-38.4 degree Celsius (C),38.5-38.9 degree C,39.0-40.0 degree C,>40.0 degree C;nausea/vomiting:mild(not interfered with activity/1-2times in 24 hours[hr]),moderate(some interference with activity/>2times in 24hr),severe(prevented daily activity;required intravenous hydration); diarrhea:mild(2-3 loose stools in 24hr),moderate(4-5 loose stools in 24hr),severe(>=6 loose stools in 24 hr); headache:mild(not interfered with activity),moderate(repeated use of non-narcotic pain reliever >24 hr/some interference with activity),severe(significant;any use of narcotic pain reliever/prevented daily activity);fatigue,muscle and joint pain:mild(not interfered with activity), moderate(some interference with activity),severe(significant;prevented daily activity).Prevented daily activity=missed days of work, school/otherwise incapacitating/use of narcotics for analgesia.Nausea/vomiting,diarrhea,headache,fatigue/tiredness,muscle and joint pain: grade 4=emergency room visit or hospitalization.
Within 14 days after vaccination
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event. AEs included both non-serious AEs and SAEs.
Within 1 month after vaccination
Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Month After Vaccination
An AE was any untoward medical occurrence in a participant in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event.
Within 6 months after vaccination
Percentage of Participants With Medically Attended Adverse Events (MAEs) Within 6 Months After Vaccination
An AE was any untoward medical occurrence in a participant in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event. An MAE was defined as a non serious AE (AE other than SAE) that resulted in an evaluation at a medical facility.
Within 6 months after vaccination
Bardstown
Kentucky
40004
United States
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City
Utah
84109
United States
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City
Utah
84121
United States
To obtain contact information for a study center near you, click here.
Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
FG002
GBS6 10 Microgram With Aluminum Phosphate
Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
FG003
GBS6 10 Microgram Without Aluminum Phosphate
Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
FG004
GBS6 20 Microgram With Aluminum Phosphate
Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
FG005
GBS6 20 Microgram Without Aluminum Phosphate
Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
FG006
Placebo
Participants were randomized to receive placebo (saline control) intramuscularly on Day 1 and were followed up to 6 months.
FG00053 subjects
FG00152 subjects
FG00252 subjects
FG00352 subjects
FG00452 subjects
FG00552 subjects
FG00652 subjects
Vaccinated
FG00052 subjects
FG00152 subjects
FG00252 subjects
FG00352 subjects
FG00452 subjects
FG00552 subjects
FG00652 subjects
COMPLETED
FG00050 subjects
FG00150 subjects
FG00246 subjects
FG00350 subjects
FG00451 subjects
FG00550 subjects
FG00651 subjects
NOT COMPLETED
FG0003 subjects
FG0012 subjects
FG0026 subjects
FG0032 subjects
FG0041 subjects
FG0052 subjects
FG0061 subjects
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Withdrawal by Subject
FG0001 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0025 subjects
FG0032 subjects
FG004
Other
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Safety population included all participants who received either GBS6 vaccine or placebo.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
GBS6 5 Microgram With Aluminum Phosphate
Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
BG001
GBS6 5 Microgram Without Aluminum Phosphate
Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
BG002
GBS6 10 Microgram With Aluminum Phosphate
Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
BG003
GBS6 10 Microgram Without Aluminum Phosphate
Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
BG004
GBS6 20 Microgram With Aluminum Phosphate
Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months
BG005
GBS6 20 Microgram Without Aluminum Phosphate
Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
BG006
Placebo
Participants were randomized to receive placebo (saline control) intramuscularly on Day 1 and were followed up to 6 months.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00052
BG00152
BG00252
BG00352
BG00452
BG00552
BG00652
BG007364
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00032.9± 8.43
BG00134.7± 9.35
BG00232.8± 8.31
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00035
BG00141
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0002
BG0014
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
White
BG00044
BG00141
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 With Clinical Laboratory Abnormalities at 1-Week After Vaccination as Measured by Food and Drug Administration (FDA) Grade
Analysis population for this outcome measure included a subset of participants who received GBS6 vaccine or placebo.
Posted
Number
percentage of participants
1 week after vaccination
ID
Title
Description
OG000
GBS6 5 Microgram With Aluminum Phosphate
Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
OG001
GBS6 5 Microgram Without Aluminum Phosphate
Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
OG002
GBS6 10 Microgram With Aluminum Phosphate
Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
OG003
GBS6 10 Microgram Without Aluminum Phosphate
Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
OG004
GBS6 20 Microgram With Aluminum Phosphate
Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months
OG005
GBS6 20 Microgram Without Aluminum Phosphate
Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
Units
Counts
Participants
OG00016
OG00116
OG00216
OG003
Title
Denominators
Categories
Hemoglobin: Grade 1
Title
Measurements
OG0000
OG0016.3
OG00212.5
OG003
Primary
Percentage of Participants With Local Reactions by Maximum Severity Within 14 Days After Vaccination
Local reactions were collected by using an e-diary and included redness, swelling and pain at injection site. Redness and swelling were graded as: mild (2.5-5.0 centimeter [cm]), moderate (greater than [>] 5.0-10.0 cm) and severe (>10.0 cm), grade 4 for redness (necrosis or exfoliative dermatitis) and grade 4 for swelling (necrosis). Pain at injection site was graded as: mild (did not interfere with activity), moderate (repeated use of nonnarcotic pain reliever >24 hours or interfered with activity), severe (any use of narcotic pain reliever or prevented daily activity which resulted in missed days of work or school or was otherwise incapacitating, or included use of narcotics for analgesia), and grade 4 (required emergency room visit or hospitalization). The maximum severity (highest grading) of each location reaction within 14 days of vaccination was derived.
Safety population included all participants who received GBS6 vaccine or placebo.
Posted
Number
95% Confidence Interval
percentage of participants
Within 14 days after vaccination
ID
Title
Description
OG000
GBS6 5 Microgram With Aluminum Phosphate
Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
OG001
GBS6 5 Microgram Without Aluminum Phosphate
Primary
Percentage of Participants With Systemic Events by Maximum Severity Within 14 Days After Vaccination
Fever:38.0-38.4 degree Celsius (C),38.5-38.9 degree C,39.0-40.0 degree C,>40.0 degree C;nausea/vomiting:mild(not interfered with activity/1-2times in 24 hours[hr]),moderate(some interference with activity/>2times in 24hr),severe(prevented daily activity;required intravenous hydration); diarrhea:mild(2-3 loose stools in 24hr),moderate(4-5 loose stools in 24hr),severe(>=6 loose stools in 24 hr); headache:mild(not interfered with activity),moderate(repeated use of non-narcotic pain reliever >24 hr/some interference with activity),severe(significant;any use of narcotic pain reliever/prevented daily activity);fatigue,muscle and joint pain:mild(not interfered with activity), moderate(some interference with activity),severe(significant;prevented daily activity).Prevented daily activity=missed days of work, school/otherwise incapacitating/use of narcotics for analgesia.Nausea/vomiting,diarrhea,headache,fatigue/tiredness,muscle and joint pain: grade 4=emergency room visit or hospitalization.
Safety population included all participants who received GBS6 vaccine or placebo.
Posted
Number
95% Confidence Interval
percentage of participants
Within 14 days after vaccination
ID
Title
Description
OG000
GBS6 5 Microgram With Aluminum Phosphate
Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
OG001
GBS6 5 Microgram Without Aluminum Phosphate
Primary
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event. AEs included both non-serious AEs and SAEs.
Safety population included all participants who received GBS6 vaccine or placebo.
Posted
Number
95% Confidence Interval
percentage of participants
Within 1 month after vaccination
ID
Title
Description
OG000
GBS6 5 Microgram With Aluminum Phosphate
Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
OG001
GBS6 5 Microgram Without Aluminum Phosphate
Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
OG002
GBS6 10 Microgram With Aluminum Phosphate
Primary
Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Month After Vaccination
An AE was any untoward medical occurrence in a participant in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event.
Safety population included all participants who received GBS6 vaccine or placebo.
Posted
Number
95% Confidence Interval
percentage of participants
Within 6 months after vaccination
ID
Title
Description
OG000
GBS6 5 Microgram With Aluminum Phosphate
Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
OG001
GBS6 5 Microgram Without Aluminum Phosphate
Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
OG002
GBS6 10 Microgram With Aluminum Phosphate
Primary
Percentage of Participants With Medically Attended Adverse Events (MAEs) Within 6 Months After Vaccination
An AE was any untoward medical occurrence in a participant in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event. An MAE was defined as a non serious AE (AE other than SAE) that resulted in an evaluation at a medical facility.
Safety population included all participants who received GBS6 vaccine or placebo.
Posted
Number
95% Confidence Interval
percentage of participants
Within 6 months after vaccination
ID
Title
Description
OG000
GBS6 5 Microgram With Aluminum Phosphate
Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
OG001
GBS6 5 Microgram Without Aluminum Phosphate
Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
Secondary
GBS6 Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination
Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.
Evaluable immunogenicity population included all eligible participants who received GBS6 vaccine or placebo, had 1 month after vaccination blood drawn for assay and had at least 1 valid determinate assay result with no major protocol violation. 'Number analyzed' = number of participants with valid, determinate assay results for specified serotype.
Posted
Geometric Mean
95% Confidence Interval
Microgram per milliliter
1 month after vaccination
ID
Title
Description
OG000
GBS6 5 Microgram With Aluminum Phosphate
Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
OG001
GBS6 5 Microgram Without Aluminum Phosphate
Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
OG002
GBS6 10 Microgram With Aluminum Phosphate
Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
Time Frame
Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1
Description
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.Safety population included all participants who received 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
GBS6 5 Microgram With Aluminum Phosphate
Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
0
52
1
52
40
52
EG001
GBS6 5 Microgram Without Aluminum Phosphate
Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
0
52
0
52
35
52
EG002
GBS6 10 Microgram With Aluminum Phosphate
Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
1
52
1
52
39
52
EG003
GBS6 10 Microgram Without Aluminum Phosphate
Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
0
52
0
52
36
52
EG004
GBS6 20 Microgram With Aluminum Phosphate
Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months
0
52
1
52
41
52
EG005
GBS6 20 Microgram Without Aluminum Phosphate
Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
0
52
0
52
36
52
EG006
Placebo
Participants were randomized to receive placebo (saline control) intramuscularly on Day 1 and were followed up to 6 months.
0
52
0
52
35
52
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA v 21.1
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected52 at risk
EG0020 affected52 at risk
EG0030 affected52 at risk
EG004
Completed suicide
Psychiatric disorders
MedDRA v 21.1
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected52 at risk
EG0021 affected52 at risk
EG003
Metrorrhagia
Reproductive system and breast disorders
MedDRA v 21.1
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected52 at risk
EG0020 affected52 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA v 21.1
Systematic Assessment
EG0007 affected52 at risk
EG00111 affected52 at risk
EG0027 affected52 at risk
EG00311 affected52 at risk
EG00411 affected52 at risk
EG0059 affected52 at risk
EG0066 affected52 at risk
Nausea/vomiting
Gastrointestinal disorders
MedDRA v 21.1
Systematic Assessment
EG0007 affected52 at risk
EG0013 affected52 at risk
EG0026 affected52 at risk
EG003
Fatigue
General disorders
MedDRA v 21.1
Systematic Assessment
EG00022 affected52 at risk
EG00117 affected52 at risk
EG00218 affected52 at risk
EG003
Influenza
Infections and infestations
MedDRA v 21.1
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected52 at risk
EG0022 affected52 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA v 21.1
Non-systematic Assessment
EG0002 affected52 at risk
EG0010 affected52 at risk
EG0022 affected52 at risk
EG003
Sinusitis
Infections and infestations
MedDRA v 21.1
Non-systematic Assessment
EG0004 affected52 at risk
EG0012 affected52 at risk
EG0022 affected52 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA v 21.1
Non-systematic Assessment
EG0001 affected52 at risk
EG0010 affected52 at risk
EG0023 affected52 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA v 21.1
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected52 at risk
EG0020 affected52 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v 21.1
Systematic Assessment
EG0007 affected52 at risk
EG0015 affected52 at risk
EG0027 affected52 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA v 21.1
Systematic Assessment
EG0009 affected52 at risk
EG00113 affected52 at risk
EG00210 affected52 at risk
EG003
Headache
Nervous system disorders
MedDRA v 21.1
Systematic Assessment
EG00021 affected52 at risk
EG00119 affected52 at risk
EG00217 affected52 at risk
EG003
Migraine
Nervous system disorders
MedDRA v 21.1
Non-systematic Assessment
EG0000 affected52 at risk
EG0010 affected52 at risk
EG0021 affected52 at risk
EG003
Injection site pain
General disorders
MedDRA v 21.1
Systematic Assessment
EG00028 affected52 at risk
EG00117 affected52 at risk
EG00225 affected52 at risk
EG003
Injection site swelling
General disorders
MedDRA v 21.1
Systematic Assessment
EG0000 affected52 at risk
EG0013 affected52 at risk
EG0021 affected52 at risk
EG003
Injection site erythema
General disorders
MedDRA v 21.1
Systematic Assessment
EG0000 affected52 at risk
EG0012 affected52 at risk
EG0021 affected52 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 publications 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.
Participants were randomized to receive placebo (saline control) intramuscularly on Day 1 and were followed up to 6 months.
16
OG00416
OG00516
OG00624
0
OG0040
OG0056.3
OG0060
Hemoglobin: Grade 2
Title
Measurements
OG0006.3
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
Platelets: Grade 1
Title
Measurements
OG0000
OG0010
OG0026.3
OG0036.7
OG0040
OG0050
OG0060
Leukocyte decrease:Grade 1
Title
Measurements
OG0006.3
OG0016.3
OG0020
OG0030
OG0040
OG0050
OG0060
Leukocyte increase: Grade 1
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0056.3
OG0060
Leukocyte increase: Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0064.2
Neutrophils decrease(Absolute): Grade 1
Title
Measurements
OG0006.3
OG00118.8
OG0020
OG0030
OG0040
OG0056.3
OG0060
Neutrophils decrease (Absolute): Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0046.3
OG0050
OG0060
Blood urea nitrogen: Grade 1
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0064.2
Blood urea nitrogen: Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0056.3
OG0060
Aspartate aminotransferase: Grade 1
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0046.3
OG0050
OG0060
Aspartate aminotransferase: Grade 3
Title
Measurements
OG0000
OG0016.3
OG0020
OG0030
OG0040
OG0050
OG0060
Alanine aminotransferase: Grade 1
Title
Measurements
OG0000
OG0016.3
OG0020
OG0030
OG00412.5
OG0050
OG0060
Bilirubin in presence of normal AST and ALT:Grade1
Title
Measurements
OG0000
OG0010
OG0026.3
OG0030
OG0040
OG0050
OG0060
Alkaline phosphate: Grade 1
Title
Measurements
OG0000
OG0010
OG0026.3
OG0030
OG0040
OG0050
OG0060
Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
OG002
GBS6 10 Microgram With Aluminum Phosphate
Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
OG003
GBS6 10 Microgram Without Aluminum Phosphate
Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
OG004
GBS6 20 Microgram With Aluminum Phosphate
Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months
OG005
GBS6 20 Microgram Without Aluminum Phosphate
Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
OG006
Placebo
Participants were randomized to receive placebo (saline control) intramuscularly on Day 1 and were followed up to 6 months.
Units
Counts
Participants
OG00052
OG00152
OG00252
OG00352
OG00452
OG00552
OG00652
Title
Denominators
Categories
Pain:Any
Title
Measurements
OG00053.8(39.5 to 67.8)
OG00132.7(20.3 to 47.1)
OG00248.1(34.0 to 62.4)
OG00338.5(25.3 to 53.0)
OG00451.9(37.6 to 66.0)
OG00525.0(14.0 to 38.9)
OG00615.4(6.9 to 28.1)
Pain:Mild
Title
Measurements
OG00051.9(37.6 to 66.0)
OG00128.8(17.1 to 43.1)
OG00244.2(30.5 to 58.7)
OG003
Pain:Moderate
Title
Measurements
OG0001.9(0.0 to 10.3)
OG0013.8(0.5 to 13.2)
OG0023.8(0.5 to 13.2)
OG003
Pain:Severe
Title
Measurements
OG0000(0.0 to 6.8)
OG0010(0.0 to 6.8)
OG0020(0.0 to 6.8)
OG003
Pain:Grade 4
Title
Measurements
OG0000(0.0 to 6.8)
OG0010(0.0 to 6.8)
OG0020(0.0 to 6.8)
OG003
Redness:Any
Title
Measurements
OG0000(0.0 to 6.8)
OG0013.8(0.5 to 13.2)
OG0021.9(0.0 to 10.3)
OG003
Redness:Mild
Title
Measurements
OG0000(0.0 to 6.8)
OG0010(0.0 to 6.8)
OG0020(0.0 to 6.8)
OG003
Redness:Moderate
Title
Measurements
OG0000(0.0 to 6.8)
OG0013.8(0.5 to 13.2)
OG0021.9(0.0 to 10.3)
OG003
Redness:Severe
Title
Measurements
OG0000(0.0 to 6.8)
OG0010(0.0 to 6.8)
OG0020(0.0 to 6.8)
OG003
Redness:Grade 4
Title
Measurements
OG0000(0.0 to 6.8)
OG0010(0.0 to 6.8)
OG0020(0.0 to 6.8)
OG003
Swelling:Any
Title
Measurements
OG0000(0.0 to 6.8)
OG0015.8(1.2 to 15.9)
OG0021.9(0.0 to 10.3)
OG003
Swelling:Mild
Title
Measurements
OG0000(0.0 to 6.8)
OG0011.9(0.0 to 10.3)
OG0021.9(0.0 to 10.3)
OG003
Swelling:Moderate
Title
Measurements
OG0000(0.0 to 6.8)
OG0013.8(0.5 to 13.2)
OG0020(0.0 to 6.8)
OG003
Swelling:Severe
Title
Measurements
OG0000(0.0 to 6.8)
OG0010(0.0 to 6.8)
OG0020(0.0 to 6.8)
OG003
Swelling:Grade 4
Title
Measurements
OG0000(0.0 to 6.8)
OG0010(0.0 to 6.8)
OG0020(0.0 to 6.8)
OG003
Participants were randomized to receive a single dose of 5 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
OG002
GBS6 10 Microgram With Aluminum Phosphate
Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
OG003
GBS6 10 Microgram Without Aluminum Phosphate
Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
OG004
GBS6 20 Microgram With Aluminum Phosphate
Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months
OG005
GBS6 20 Microgram Without Aluminum Phosphate
Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
OG006
Placebo
Participants were randomized to receive placebo (saline control) intramuscularly on Day 1 and were followed up to 6 months.
Units
Counts
Participants
OG00052
OG00152
OG00252
OG00352
OG00452
OG00552
OG00652
Title
Denominators
Categories
Fever:>=38.0 degree C
Title
Measurements
OG0000(0.0 to 6.8)
OG0010(0.0 to 6.8)
OG0021.9(0.0 to 10.3)
OG0030(0.0 to 6.8)
OG0041.9(0.0 to 10.3)
OG0051.9(0.0 to 10.3)
OG0061.9(0.0 to 10.3)
Fever:38.0 to 38.4 degree C
Title
Measurements
OG0000(0.0 to 6.8)
OG0010(0.0 to 6.8)
OG0020(0.0 to 6.8)
OG003
Fever:38.5 to 38.9 degree C
Title
Measurements
OG0000(0.0 to 6.8)
OG0010(0.0 to 6.8)
OG0020(0.0 to 6.8)
OG003
Fever:39.0 to 40.0 degree C
Title
Measurements
OG0000(0.0 to 6.8)
OG0010(0.0 to 6.8)
OG0021.9(0.0 to 10.3)
OG003
Fever:>40.0 degree C
Title
Measurements
OG0000(0.0 to 6.8)
OG0010(0.0 to 6.8)
OG0020(0 to 6.8)
OG003
Nausea/vomiting: Any
Title
Measurements
OG00013.5(5.6 to 25.8)
OG0015.8(1.2 to 15.9)
OG00211.5(4.4 to 23.4)
OG003
Nausea/vomiting: Mild
Title
Measurements
OG0009.6(3.2 to 21.0)
OG0013.8(0.5 to 13.2)
OG0029.6(3.2 to 21.0)
OG003
Nausea/vomiting: Moderate
Title
Measurements
OG0003.8(0.5 to 13.2)
OG0011.9(0.0 to 10.3)
OG0021.9(0.0 to 10.3)
OG003
Nausea/vomiting: Severe
Title
Measurements
OG0000(0.0 to 6.8)
OG0010(0.0 to 6.8)
OG0020(0.0 to 6.8)
OG003
Nausea/vomiting: Grade 4
Title
Measurements
OG0000(0.0 to 6.8)
OG0010(0.0 to 6.8)
OG0020(0.0 to 6.8)
OG003
Diarrhea:Any
Title
Measurements
OG00013.5(5.6 to 25.8)
OG00121.2(11.1 to 34.7)
OG00213.5(5.6 to 25.8)
OG003
Diarrhea:Mild
Title
Measurements
OG00011.5(4.4 to 23.4)
OG00121.2(11.1 to 34.7)
OG00211.5(4.4 to 23.4)
OG003
Diarrhea:Moderate
Title
Measurements
OG0001.9(0.0 to 10.3)
OG0010(0.0 to 6.8)
OG0021.9(0.0 to 10.3)
OG003
Diarrhea:Severe
Title
Measurements
OG0000(0.0 to 6.8)
OG0010(0.0 to 6.8)
OG0020(0.0 to 6.8)
OG003
Diarrhea:Grade 4
Title
Measurements
OG0000(0.0 to 6.8)
OG0010(0.0 to 6.8)
OG0020(0.0 to 6.8)
OG003
Headache:Any
Title
Measurements
OG00040.4(27.0 to 54.9)
OG00136.5(23.6 to 51.0)
OG00232.7(20.3 to 47.1)
OG003
Headache:Mild
Title
Measurements
OG00026.9(15.6 to 41.0)
OG00121.2(11.1 to 34.7)
OG00215.4(6.9 to 28.1)
OG003
Headache:Moderate
Title
Measurements
OG00013.5(5.6 to 25.8)
OG00113.5(5.6 to 25.8)
OG00215.4(6.9 to 28.1)
OG003
Headache:Severe
Title
Measurements
OG0000(0.0 to 6.8)
OG0011.9(0.0 to 10.3)
OG0021.9(0.0 to 10.3)
OG003
Headache:Grade 4
Title
Measurements
OG0000(0.0 to 6.8)
OG0010(0.0 to 6.8)
OG0020(0.0 to 6.8)
OG003
Fatigue/tiredness: Any
Title
Measurements
OG00042.3(28.7 to 56.8)
OG00132.7(20.3 to 47.1)
OG00234.6(22.0 to 49.1)
OG003
Fatigue/tiredness: Mild
Title
Measurements
OG00019.2(9.6 to 32.5)
OG00111.5(4.4 to 23.4)
OG0029.6(3.2 to 21.0)
OG003
Fatigue/tiredness: Moderate
Title
Measurements
OG00023.1(12.5 to 36.8)
OG00121.2(11.1 to 34.7)
OG00221.2(11.1 to 34.7)
OG003
Fatigue/tiredness: Severe
Title
Measurements
OG0000(0.0 to 6.8)
OG0010(0.0 to 6.8)
OG0023.8(0.5 to 13.2)
OG003
Fatigue/tiredness:Grade 4
Title
Measurements
OG0000(0.0 to 6.8)
OG0010(0.0 to 6.8)
OG0020(0.0 to 6.8)
OG003
Muscle pain:Any
Title
Measurements
OG00017.3(8.2 to 30.3)
OG00125.0(14.0 to 38.9)
OG00219.2(9.6 to 32.5)
OG003
Muscle pain:Mild
Title
Measurements
OG0009.6(3.2 to 21.0)
OG00117.3(8.2 to 30.3)
OG0027.7(2.1 to 18.5)
OG003
Muscle pain:Moderate
Title
Measurements
OG0007.7(2.1 to 18.5)
OG0017.7(2.1 to 18.5)
OG0029.6(3.2 to 21.0)
OG003
Muscle pain:Severe
Title
Measurements
OG0000(0.0 to 6.8)
OG0010(0.0 to 6.8)
OG0021.9(0.0 to 10.3)
OG003
Muscle pain:Grade 4
Title
Measurements
OG0000(0.0 to 6.8)
OG0010(0.0 to 6.8)
OG0020(0.0 to 6.8)
OG003
Joint pain:Any
Title
Measurements
OG00013.5(5.6 to 25.8)
OG0019.6(3.2 to 21.0)
OG00213.5(5.6 to 25.8)
OG003
Joint pain:Mild
Title
Measurements
OG0009.6(3.2 to 21.0)
OG0015.8(1.2 to 15.9)
OG0023.8(0.5 to 13.2)
OG003
Joint pain:Moderate
Title
Measurements
OG0003.8(0.5 to 13.2)
OG0013.8(0.5 to 13.2)
OG0029.6(3.2 to 21.0)
OG003
Joint pain:Severe
Title
Measurements
OG0000(0.0 to 6.8)
OG0010(0.0 to 6.8)
OG0020(0.0 to 6.8)
OG003
Joint pain:Grade 4
Title
Measurements
OG0000(0.0 to 6.8)
OG0010(0.0 to 6.8)
OG0020(0.0 to 6.8)
OG003
Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
OG003
GBS6 10 Microgram Without Aluminum Phosphate
Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
OG004
GBS6 20 Microgram With Aluminum Phosphate
Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months
OG005
GBS6 20 Microgram Without Aluminum Phosphate
Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
OG006
Placebo
Participants were randomized to receive placebo (saline control) intramuscularly on Day 1 and were followed up to 6 months.
Units
Counts
Participants
OG00052
OG00152
OG00252
OG00352
OG00452
OG00552
OG00652
Title
Denominators
Categories
Title
Measurements
OG00019.2(9.6 to 32.5)
OG0015.8(1.2 to 15.9)
OG00219.2(9.6 to 32.5)
OG00313.5(5.6 to 25.8)
OG00426.9(15.6 to 41.0)
OG00528.8(17.1 to 43.1)
OG00621.2(11.1 to 34.7)
Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
OG003
GBS6 10 Microgram Without Aluminum Phosphate
Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
OG004
GBS6 20 Microgram With Aluminum Phosphate
Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months
OG005
GBS6 20 Microgram Without Aluminum Phosphate
Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
OG006
Placebo
Participants were randomized to receive placebo (saline control) intramuscularly on Day 1 and were followed up to 6 months.
Units
Counts
Participants
OG00052
OG00152
OG00252
OG00352
OG00452
OG00552
OG00652
Title
Denominators
Categories
Title
Measurements
OG0001.9(0.0 to 10.3)
OG0010(0.0 to 6.8)
OG0021.9(0.0 to 10.3)
OG0030(0.0 to 6.8)
OG0041.9(0.0 to 10.3)
OG0050(0.0 to 6.8)
OG0060(0.0 to 6.8)
OG002
GBS6 10 Microgram With Aluminum Phosphate
Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
OG003
GBS6 10 Microgram Without Aluminum Phosphate
Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
OG004
GBS6 20 Microgram With Aluminum Phosphate
Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months
OG005
GBS6 20 Microgram Without Aluminum Phosphate
Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
OG006
Placebo
Participants were randomized to receive placebo (saline control) intramuscularly on Day 1 and were followed up to 6 months.
Units
Counts
Participants
OG00052
OG00152
OG00252
OG00352
OG00452
OG00552
OG00652
Title
Denominators
Categories
Title
Measurements
OG00021.2(11.1 to 34.7)
OG00123.1(12.5 to 36.8)
OG00228.8(17.1 to 43.1)
OG00319.2(9.6 to 32.5)
OG00434.6(22.0 to 49.1)
OG00526.9(15.6 to 41.0)
OG00634.6(22.0 to 49.1)
OG003
GBS6 10 Microgram Without Aluminum Phosphate
Participants were randomized to receive a single dose of 10 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
OG004
GBS6 20 Microgram With Aluminum Phosphate
Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine with aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months
OG005
GBS6 20 Microgram Without Aluminum Phosphate
Participants were randomized to receive a single dose of 20 microgram of GBS6 vaccine without aluminium phosphate, intramuscularly on Day 1 and were followed up to 6 months.
OG006
Placebo
Participants were randomized to receive placebo (saline control) intramuscularly on Day 1 and were followed up to 6 months.