To Evaluate the Safety, Tolerability, and Immunogenicity... | NCT04754594 | Trialant
NCT04754594
Sponsor
BioNTech SE
Status
Completed
Last Update Posted
Dec 6, 2024Actual
Enrollment
726Actual
Phase
Phase 2Phase 3
Conditions
SARS-CoV-2 Infection
COVID-19
Maternal Immunization
Interventions
BNT162b2
Placebo
Countries
United States
Brazil
South Africa
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT04754594
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
C4591015
Secondary IDs
ID
Type
Description
Link
2020-005444-35
EudraCT Number
Brief Title
To Evaluate the Safety, Tolerability, and Immunogenicity of BNT162b2 Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older
Official Title
A PHASE 2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A SARS-COV-2 RNA VACCINE CANDIDATE (BNT162b2) AGAINST COVID-19 IN HEALTHY PREGNANT WOMEN 18 YEARS OF AGE AND OLDER
Acronym
Not provided
Organization
BioNTech SEINDUSTRY
Status Module
Record Verification Date
Nov 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
Not provided
Start Date
Feb 16, 2021Actual
Primary Completion Date
Jul 15, 2022Actual
Completion Date
Jul 15, 2022Actual
First Submitted Date
Feb 9, 2021
First Submission Date that Met QC Criteria
Feb 11, 2021
First Posted Date
Feb 15, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Jul 14, 2023
Results First Submitted that Met QC Criteria
Nov 22, 2024
Results First Posted Date
Dec 6, 2024Actual
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
Nov 22, 2024
Last Update Posted Date
Dec 6, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
BioNTech SEINDUSTRY
Collaborators
Name
Class
Pfizer
INDUSTRY
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
Yes
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Results will be submitted, however please note that data are not yet available for all serology outcome measures.
This will be a Phase 2/3, randomized, placebo-controlled, observer-blind study evaluating the safety, tolerability, and immunogenicity of 30 µg of BNT162b2 or placebo administered in 2 doses, 21 days apart, in approximately 350 healthy pregnant women 18 years of age or older vaccinated at 24 to 34 weeks' gestation. Participants will be randomized 1:1 to receive BNT162b2 or placebo (saline).
Detailed Description
The Phase 2 portion of the study will include approximately 200 pregnant women randomized 1:1 to receive BNT162b2 or placebo (saline) at 27 to 34 weeks' gestation. IRC review of safety data through 7 days after the second dose for all Phase 2 participants will be completed.
The Phase 3 portion of this study will assess the safety, tolerability, and immunogenicity of BNT162b2 among pregnant women enrolled at 24 to 34 weeks' gestation.
Maternal participants who originally received placebo will receive BNT162b2 at defined time points as part of the study.
Conditions Module
Conditions
SARS-CoV-2 Infection
COVID-19
Maternal Immunization
Keywords
SARS-CoV-2 Infection
COVID-19
Maternal Immunization
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 2Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
726Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
BNT162b2
Experimental
2 doses
Biological: BNT162b2
Placebo
Placebo Comparator
2 doses
Other: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
BNT162b2
Biological
Intramuscular Injection
BNT162b2
Placebo
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1
Pain at injection site, redness & swelling were recorded by participants in an electronic diary (e-diary). Redness & swelling were measured & recorded in measuring devise units (range 1 to 21) then converted to cm. 1 measuring device unit = 0.5 cm & graded as mild: > 2.0 to 5.0 cm, moderate: > 5.0 to 10.0 cm, severe: > 10.0 cm, grade 4 (potentially life threatening): necrosis or exfoliative dermatitis (redness) & necrosis (swelling). Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity & grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Reactions reported as adverse events in the case report form within 7 days after the study vaccination were also included in the analysis. Exact 2-sided 95% confidence interval (CI) was based on Clopper & Pearson method.
From Day 1 to Day 7 after dose 1
Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2
Pain at injection site, redness & swelling were recorded by participants in an e-diary. Redness & swelling were measured & recorded in measuring devise units (range 1 to 21) then converted to cm. 1 measuring device unit = 0.5 cm & graded as mild: > 2.0 to 5.0 cm, moderate: > 5.0 to 10.0 cm, severe: > 10.0 cm, grade 4 (potentially life threatening): necrosis or exfoliative dermatitis (redness) & necrosis (swelling). Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity & grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Reactions reported as adverse events (AEs) in the case report form (CRF) within 7 days after the study vaccination were also included in the analysis. Exact 2-sided 95% CI was based on the Clopper & Pearson method.
From Day 1 to Day 7 after dose 2
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1
Secondary Outcomes
Measure
Description
Time Frame
COVID-19 Incidence Per 100 Person-Years of Blinded Follow up in Evaluable Maternal Participants Without Evidence of Prior SARS-CoV-2 Infection
COVID-19 incidence per 100 person-years of blinded follow-up in evaluable maternal participants without evidence of prior SARS-CoV-2 infection prior to 7 days after receipt of Dose 2 was reported in this outcome measure.
From 7 days after Dose 2 up to 1 month after delivery (Surveillance time [100 person-year]: BNT162b2- 0.155, Placebo- 0.149)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Healthy women ≥18 years of age who are between 24 0/7 and 34 0/7 weeks' gestation on the day of planned vaccination, with an uncomplicated, singleton pregnancy, who are at no known increased risk for complications.
Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Healthy participants who are determined by medical history, physical examination, and clinical judgment to be appropriate for inclusion in the study
Documented negative HIV antibody test (Phase 2 only), syphilis test, and HBV surface antigen test during this pregnancy and prior to randomization
Participant is willing to give informed consent for her infant to participate in the study
Capable of giving signed informed consent
Exclusion Criteria:
Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID 19.
History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention or any related vaccine.
Participants with known or suspected immunodeficiency.
Bleeding diathesis or condition associated with prolonged bleeding that would in the opinion of the investigator contraindicate intramuscular injection.
Previous vaccination with any coronavirus vaccine.
Receipt of medications intended to prevent COVID 19.
Receipt of blood/plasma products or immunoglobulin, from 60 days before administration of study intervention, or planned receipt through delivery, with 1 exception, anti-D immunoglobulin (eg, RhoGAM), which can be given at any time.
Current alcohol abuse or illicit drug use.
Participants who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt through the postvaccination blood draw.
Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.
Previous participation in other studies involving study intervention containing LNPs.
Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
Participants whose unborn baby has been fathered by investigational site staff members directly involved in the conduct of the study or their family members, site staff members otherwise supervised by the investigator, or Pfizer employees directly involved in the conduct of the study.
Accepts Healthy Volunteers
Yes
Sex
Female
Sex/Gender Based
Yes
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Pfizer CT.gov Call Center
Pfizer
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Children's of Alabama
Birmingham
Alabama
35233
United States
University of Alabama at Birmingham Women & Infant Center
Nana M, Hodson K, Lucas N, Camporota L, Knight M, Nelson-Piercy C. Diagnosis and management of covid-19 in pregnancy. BMJ. 2022 Apr 26;377:e069739. doi: 10.1136/bmj-2021-069739.
Mohapatra S, Ananda P, Tripathy S. Pharmacological consideration of COVID-19 infection and vaccines in pregnancy. J Chin Med Assoc. 2022 May 1;85(5):537-542. doi: 10.1097/JCMA.0000000000000712. Epub 2022 May 2.
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
A total of 726 participants were enrolled in this study. 391 were maternal participants who signed informed consent form and were enrolled out of which 41 were screen failures and 2 participants were not randomized. Eventually 348 maternal participants were randomized to receive treatment. 335 were infants born to maternal participants.
Recruitment Details
This study was conducted in 2 periods-Blinded Period (from Day 1 to 1 month post-delivery) and Unblinded Period (1 to 6 Months Post-Delivery for those maternal participants who initially received BNT162b2 and from first dose of BNT162b2 to 1 month after second dose of BNT162b2 for those maternal participants who initially received placebo).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Maternal Participants: BNT162b2 30 mcg
Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.
FG001
Periods
Title
Milestones
Reasons Not Completed
Blinded Period
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
1
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 8, 2022
Jul 14, 2023
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
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderInvestigator
Other
Intramuscular Injection
Placebo
Systemic events were recorded by participants in an e-diary. Fever was oral temperature >= 38 degree Celsius (°C) & categorized as >=38.0 to 38.4 °C, >38.4 to 38.9 °C, >38.9 to 40.0 °C & >40.0 °C. Fatigue, headache, chills, new or worsened muscle pain & new or worsened joint pain were graded mild: did not interfere with activity, moderate: some interference with activity & severe: prevented daily routine activity. Vomiting was graded mild: 1 to 2 times in 24 hours (h), moderate: >2 times in 24h & severe: required intravenous hydration. Diarrhea was graded mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h & severe: 6 or more loose stools in 24h. For all systemic events except fever, Grade 4= emergency room visit or hospitalization. Grade 4 events were classified by the investigator/medically qualified person. Systemic events reported as AEs in the CRF within 7 days after vaccination were also included in analysis. Exact 95% CI was based on Clopper & Pearson method.
From Day 1 to Day 7 after dose 1
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2
Systemic events were recorded by participants in an e-diary. Fever was oral temperature >= 38 °C & categorized as >=38.0 to 38.4 °C, >38.4 to 38.9 °C, >38.9 to 40.0 °C & >40.0 °C. Fatigue, headache, chills, new or worsened muscle pain & new or worsened joint pain were graded mild: did not interfere with activity, moderate: some interference with activity & severe: prevented daily routine activity. Vomiting was graded mild: 1 to 2 times in 24 h, moderate: >2 times in 24 h & severe: required intravenous hydration. Diarrhea was graded mild: 2 to 3 loose stools in 24 h, moderate: 4 to 5 loose stools in 24 h & severe: 6 or more loose stools in 24 h. For all systemic events except fever, Grade 4= emergency room visit or hospitalization. Grade 4 events were classified by the investigator/medically qualified person. Systemic events reported as AEs in the CRF within 7 days after vaccination were also included in analysis. Exact 95% CI was based on Clopper & Pearson method.
From Day 1 to Day 7 after dose 2
Percentage of Maternal Participants With Adverse Events (AEs) From Dose 1 Through 1 Month After Dose 2 - Blinded Follow-up Period
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
From dose 1 on Day 1 through 1 month after dose 2 (approximately 2 months)
Percentage of Maternal Participants Reporting Serious Adverse Events (SAEs) From Dose 1 Through 1 Month After Delivery - Blinded Follow-up Period
An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
From dose 1 on Day 1 through 1 month after delivery (up to 22 weeks)
Geometric Mean Ratio (GMR) of the SARS-CoV-2 Neutralizing Titers in Pregnant Women to Those in Nonpregnant Women From Study C4591001 (NCT04368728) for Evaluable Immunogenicity Population Without Evidence of Prior SARS-CoV-2 Infection
GMR of SARS-CoV-2 neutralizing titers in pregnant women to those in nonpregnant women from study C4591001 (NCT04368728) for evaluable immunogenicity population without evidence of prior SARS-CoV-2 infection up to 1 month after Dose 2 was reported in this outcome measure. Geometric mean titer (GMT) and 2-sided 95% CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on student t distribution) and was reported in descriptive section. GMR was reported in statistical analysis section of this outcome measure. Evaluable immunogenicity population included all participants who were eligible and randomized, received 2 doses of vaccine to which they were randomized, with Dose 2 received within predefined window (19-42 days, inclusive, after Dose 1); had at least 1 valid immunogenicity result within an appropriate window 1 month after Dose 2 (28-42 days, inclusive, after Dose 2); and had no other important protocol deviations as determined by the clinician.
1 Month after Dose 2
GMR of SARS-CoV-2 Neutralizing Titers in Pregnant Women to Those in Nonpregnant Women From Study C4591001 (NCT04368728) for Evaluable Immunogenicity Population With and Without Evidence of Prior SARS-CoV-2 Infection
GMR of SARS-CoV-2 neutralizing titers in pregnant women to those in nonpregnant women from study C4591001 (NCT04368728) for evaluable immunogenicity population with and without evidence of prior SARS-CoV-2 infection was reported in this outcome measure. GMT and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the student t distribution) and was reported in the descriptive section. GMR was reported in the statistical analysis section. Evaluable immunogenicity population included all participants who were eligible and randomized, received 2 doses of the vaccine to which they were randomized, with Dose 2 received within the predefined window (19-42 days, inclusive, after Dose 1); had at least 1 valid immunogenicity result within an appropriate window 1 month after Dose 2 (28-42 days, inclusive, after Dose 2); and had no other important protocol deviations as determined by the clinician.
1 Month after Dose 2
COVID-19 Incidence Per 100 Person-Years of Blinded Follow up in Evaluable Maternal Participants With or Without Evidence of Prior SARS-CoV-2 Infection
COVID-19 incidence per 100 person-years of blinded follow-up in evaluable maternal participants with or without evidence of prior SARS-CoV-2 infection was reported in this outcome measure.
From 7 days after Dose 2 up to 1 month after delivery (Surveillance time [100 person-year]: BNT162b2- 0.270, Placebo- 0.263)
Incidence of Asymptomatic Infection of SARS-CoV-2 Through 1 Month After Delivery in Evaluable Maternal Participants Without Evidence of Prior SARS-CoV-2 Infection
Incidence of asymptomatic infection of SARS-CoV-2 through 1 month after delivery in evaluable maternal participants without evidence of prior SARS-CoV-2 infection prior to the first post-dose 2 N-binding test was reported in this outcome measure.
Up to 1 month after delivery (Surveillance time [100 person-year]: BNT162b2- 0.099, Placebo- 0.147)
Geometric Mean Concentration (GMCs) of Full-Length S-Binding Immunoglobulin G (IgG) Levels in Evaluable Maternal Participants
GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. GMCs of full-length S-binding IgG levels in evaluable maternal participants at baseline, 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery was reported in this outcome measure. Evaluable immunogenicity population included all participants who were eligible and randomized, received 2 doses of the vaccine to which they were randomized, with Dose 2 received within the predefined window (19-42 days, inclusive, after Dose 1); had at least 1 valid immunogenicity result within an appropriate window 1 month after Dose 2 (28-42 days, inclusive, after Dose 2); and had no other important protocol deviations as determined by the clinician.
Baseline (before Dose 1), 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery
Geometric Mean Titer (GMTs) of SARS-CoV-2 Neutralizing Titers in Evaluable Maternal Participants
GMTs, and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. GMTs of SARS-CoV-2 neutralizing titers in evaluable maternal participants at baseline, 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery was reported in this outcome measure. Evaluable immunogenicity population included all participants who were eligible and randomized, received 2 doses of the vaccine to which they were randomized, with Dose 2 received within the predefined window (19-42 days, inclusive, after Dose 1); had at least 1 valid immunogenicity result within an appropriate window 1 month after Dose 2 (28-42 days, inclusive, after Dose 2); and had no other important protocol deviations as determined by the clinician.
Baseline (before Dose 1), 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery
Geometric Mean Fold Rise (GMFR) From Before Vaccination to Each Subsequent Time Point After Vaccination for Full-Length S-Binding IgG Levels in Evaluable Maternal Participants
GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. GMFR from before vaccination to each subsequent time point after vaccination for full-length S-binding IgG levels in evaluable maternal participants at 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery was reported in this outcome measure. Evaluable immunogenicity population included all participants who were eligible and randomized, received 2 doses of the vaccine to which they were randomized, with Dose 2 received within the predefined window (19-42 days, inclusive, after Dose 1); had at least 1 valid immunogenicity result within an appropriate window 1 month after Dose 2 (28-42 days, inclusive, after Dose 2); and had no other important protocol deviations as determined by the clinician.
From before dose 1 up to 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery
Geometric Mean Fold Rise (GMFR) From Before Vaccination to Each Subsequent Time Point After Vaccination for SARS-CoV-2 Neutralizing Titers in Evaluable Maternal Participants
GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. GMFR from before vaccination to each subsequent time point after vaccination for SARS-CoV-2 neutralizing titers in evaluable maternal participants at 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery was reported in this outcome measure. Evaluable immunogenicity population included all participants who were eligible and randomized, received 2 doses of the vaccine to which they were randomized, with Dose 2 received within the predefined window (19-42 days, inclusive, after Dose 1); had at least 1 valid immunogenicity result within an appropriate window 1 month after Dose 2 (28-42 days, inclusive, after Dose 2); and had no other important protocol deviations as determined by the clinician.
From before dose 1 up to 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery
Percentage of Infant Participants Reporting Specific Birth Outcomes
Percentage of infant participants reporting specific birth outcomes (normal, congenital malformation/anomaly, other neonatal problems) were reported in this outcome measure.
At birth
Percentage of Infant Participants Reporting Adverse Events From Birth Through 1 Month of Age
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
From birth through 1 month of age
Percentage of Infant Participants Reporting Serious Adverse Events (SAE) From Birth Through 6 Months of Age
An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
From birth through 6 months of age
Percentage of Infant Participants Reporting Adverse Event of Special Interest (AESI) From Birth Through 6 Months of Age
Percentage of infant participants who reported AESI including major congenital anomalies and developmental delay from birth through 6 months of age were reported in this outcome measure. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
From birth through 6 months of age
GMCs of Full-Length S-Binding IgG Levels at Birth and 6 Months of Age in Infant Participants Born to Evaluable Maternal Participants
GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. GMCs of full-length S-binding IgG levels at birth and 6 months of age in infant participants born to evaluable maternal participants was reported in this outcome measure.
At birth and 6 months of age
GMFR of Full-Length S-Binding IgG Levels From Birth to 6 Months of Age in Infant Participants Born to Evaluable Maternal Participants
GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. GMFR of full-length S-binding IgG levels from birth to 6 months of age in infant participants born to evaluable maternal participants was reported in this outcome measure.
From birth to 6 months of age
Birmingham
Alabama
35233
United States
University of Alabama at Birmingham/Center for Women's Reproductive Health
Birmingham
Alabama
35233
United States
Velocity Clinical Research, Gulfport
Mobile
Alabama
36608
United States
Arrowhead Hospital
Glendale
Arizona
85308
United States
Abrazo West Campus Hospital
Goodyear
Arizona
85395
United States
St. Joseph Hospital
Phoenix
Arizona
85013
United States
MedPharmics, LLC
Phoenix
Arizona
85015
United States
Matrix Clinical Research.
Huntington Park
California
90255
United States
Matrix Clinical Research
Huntington Park
California
90255
United States
Chemidox Clinical Trials Inc.
Lancaster
California
93534
United States
East LA Doctors Hospital
Los Angeles
California
90023
United States
Matrix Clinical Research
Los Angeles
California
90057
United States
Axcess Medical Research
Loxahatchee Groves
Florida
33470
United States
Idaho Falls Pediatrics
Ammon
Idaho
83406
United States
Bingham Memorial Hospital
Blackfoot
Idaho
83221
United States
Idaho Falls Pediatrics
Idaho Falls
Idaho
83402
United States
Clinical Research Prime
Idaho Falls
Idaho
83404
United States
Eastern Idaho Regional Medical Center
Idaho Falls
Idaho
83404
United States
Mountain View Hospital
Idaho Falls
Idaho
83404
United States
Covenant Healthcare
Saginaw
Michigan
48604
United States
Saginaw Valley Medical Research Group, LLC
Saginaw
Michigan
48604
United States
Community Hospital of Anaconda
Anaconda
Montana
59711
United States
Boeson Research (BUT)
Butte
Montana
59701
United States
SCL St. James Healthcare Hospital
Butte
Montana
59701
United States
Marcus Daly Memorial Hospital
Hamilton
Montana
59840
United States
Providence St. Patrick Hospital
Missoula
Montana
59802
United States
The Birth Center
Missoula
Montana
59803
United States
Boeson Research
Missoula
Montana
59804
United States
Community Medical Center
Missoula
Montana
59804
United States
Community Physicians Group-Maternal Fetal Medicine
Missoula
Montana
59804
United States
St. Luke Community Healthcare Hospital
Ronan
Montana
59864
United States
Meridian Clinical Research, LLC
Hastings
Nebraska
68901
United States
Meridian Clinical Research, LLC
Norfolk
Nebraska
68701
United States
Allegheny Health and Wellness Pavilion
Erie
Pennsylvania
16506
United States
OBGYN Associates of Erie
Erie
Pennsylvania
16507
United States
Central Erie Primary Care
Erie
Pennsylvania
16508
United States
Liberty Family Practice
Erie
Pennsylvania
16508
United States
Saint Vincent Hospital
Erie
Pennsylvania
16544
United States
St. David's Medical Center
Austin
Texas
78705
United States
Tekton Research, Inc.
Austin
Texas
78705
United States
Tekton Research, Inc.
Austin
Texas
78745
United States
Texas Health Harris Methodist Hospital Hurst-Euless-Bedford
Bedford
Texas
76022
United States
Ventavia Research Group LLC
Dallas
Texas
75231
United States
DHR Health Institute for Research and Development
Edinburg
Texas
78539
United States
8th Avenue Obstetrics & Gynecology
Fort Worth
Texas
76104
United States
Baylor Scott & White All Saints Medical Center
Fort Worth
Texas
76104
United States
Ventavia Research Group, LLC
Fort Worth
Texas
76104
United States
Dr. Ruben Aleman & Associates
McAllen
Texas
78504
United States
Ventavia Research Group, LLC
Plano
Texas
75093
United States
Ventavia Research Group, LLC
Weatherford
Texas
76086
United States
Weatherford OBGYN
Weatherford
Texas
76086
United States
University of Utah Hospital
Salt Lake City
Utah
84132
United States
University of Utah
Salt Lake City
Utah
84132
United States
The Group for Women- MAWC
Norfolk
Virginia
23502
United States
Tidewater Physicians for Women- MAWC
Norfolk
Virginia
23502
United States
Faculdade de Medicina da Universidade Federal de Minas Gerais
Belo Horizonte
Minas Gerais
30.130-100
Brazil
Hospital das ClÃnicas da Universidade Federal de Minas Gerais
Belo Horizonte
Minas Gerais
30130-100
Brazil
HMU SBC - Hospital Municipal Universitário de São Bernardo
São Bernardo do Campo
São Paulo
09624-000
Brazil
CEMEC - Centro Multidisciplinar de Estudos ClÃnicos
São Bernardo do Campo
São Paulo
09715 - 090
Brazil
Hospital Santa Casa de Misericordia de Sorocaba
Sorocaba
São Paulo
18013-000
Brazil
Clinica de Alergia Martti Antila S/S Ltda./ CMPC - Consultoria Medica e Pesquisa Clinica
Sorocaba
São Paulo
18040-425
Brazil
Unimed Sorocaba-Hospital Dr. Miguel Soeiro (HMS)
Sorocaba
São Paulo
18052-210
Brazil
WorthWhile Clinical Trials
Benoni
Gauteng
1500
South Africa
Wits Reproductive Health and HIV Institute (Wits RHI) Shandukani Research Centre
Johannesburg
Gauteng
2001
South Africa
Botho Ke Bontle Health Services
Pretoria
Gauteng
0122
South Africa
Vaccines and Infectious Diseases Analytics (VIDA)
Soweto
Gauteng
2013
South Africa
Dr Tobias de Villiers
Cape Town
Western Cape
7500
South Africa
Tiervlei Trial Centre CC
Cape Town
Western Cape
7530
South Africa
Hospital Universitari Germans Trias i Pujol
Badalona
Barcelona
08916
Spain
Hospital Sant Joan de Deu
Esplugues de Llobregat
Barcelona
08950
Spain
Hospital Universitario HM Monteprincipe
Boadilla del Monte
Madrid
28660
Spain
Hospital de Antequera
Antequera
Malaga
29200
Spain
Hospital Quironsalud Barcelona
Barcelona
08023
Spain
Hospital Universitari Vall d'Hebron
Barcelona
08035
Spain
Hospital de la Santa Creu i Sant Pau
Barcelona
08041
Spain
Clinica Diagonal
Barcelona
08950
Spain
Hospital Madrid Puerta del Sur Mostoles
Móstoles
28938
Spain
Instituto Hispalense de Pediatria- IHP1
Seville
41012
Spain
Hospital Materno-Infantil Quirón
Seville
41013
Spain
Servicio de GinecologÃa del Hospital Quirón Salud Sagrado Corazón
Seville
41013
Spain
Hampshire Research Hub, Royal South Hants Hospital
Southampton
Hampshire
SO14 0YG
United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton
Hampshire
SO16 6YD
United Kingdom
Medway NHS Foundation Trust
Gillingham
KENT
ME7 5NY
United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds
LS9 7TF
United Kingdom
University College London Hospitals
London
NW1 2PG
United Kingdom
University College London Hospitals
London
W1T 7HA
United Kingdom
University College London Hospitals
London
WC1E 6EB
United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne
NE1 4LP
United Kingdom
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
Maternal Participants: Placebo Then BNT162b2 30 mcg
Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. After unblinding at 1 month post-delivery, participants were administered 2 doses of BNT162b2 vaccine as an intramuscular injection separated by 21 days. Participants were followed-up until 1 month after last dose of vaccination.
FG002
Infant Participants: BNT162b2 30 mcg
Infant participants who were born to maternal participants vaccinated with BNT162b2 30 mcg during pregnancy were included. Infant participants were followed up to 6 months of age.
FG003
Infant Participants: Placebo
Infant participants who were born to maternal participants vaccinated with placebo during pregnancy were included. Infant participants were followed up to 6 months of age.
FG000174 subjects
FG001174 subjects
FG0020 subjects
FG0030 subjects
Vaccination 1
FG000173 subjects
FG001173 subjects
FG0020 subjects
FG0030 subjects
Vaccination 2
FG000170 subjects
FG001170 subjects
FG0020 subjects
FG0030 subjects
COMPLETED
FG000161 subjects
FG001159 subjects
FG0020 subjects
FG0030 subjects
NOT COMPLETED
FG00013 subjects
FG00115 subjects
FG0020 subjects
FG0030 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0004 subjects
FG0019 subjects
FG0020 subjects
FG0030 subjects
Protocol Violation
FG0002 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
Lost to Follow-up
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
Unblinded before 1-month postdelivery visit
FG0006 subjects
FG0013 subjects
FG0020 subjects
FG0030 subjects
Unblinded Period
Type
Comment
Milestone Data
STARTED
FG000167 subjects6 participants unblinded before 1-month post delivery are also included.
FG001162 subjects3 participants unblinded before 1-month post delivery are also included.
FG0020 subjects
FG0030 subjects
Vaccination 3
FG0000 subjects
FG001152 subjects
FG0020 subjects
FG0030 subjects
Vaccination 4
FG0000 subjects
FG001148 subjects
FG0020 subjects
FG0030 subjects
COMPLETED
FG000151 subjects
FG001147 subjects
FG0020 subjects
FG0030 subjects
NOT COMPLETED
FG00016 subjects
FG00115 subjects
FG0020 subjects
FG0030 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0006 subjects
FG0018 subjects
FG0020 subjects
FG003
Infant Participants
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG002167 subjects
FG003168 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG002152 subjects
FG003139 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG00215 subjects
FG00329 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0029 subjects
FG003
For maternal participants, safety population included all randomized participants who received at least 1 dose of the study intervention. For infant participants, safety population included all infant participants born to maternal participants who received at least 1 dose of the study intervention.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Maternal Participants: BNT162b2 30 mcg
Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.
BG001
Maternal Participants: Placebo Then BNT162b2 30 mcg
Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. After unblinding at 1 month post-delivery, participants were administered 2 doses of BNT162b2 vaccine as an intramuscular injection separated by 21 days. Participants were followed-up until 1 month after last dose of vaccination.
BG002
Infant Participants: BNT162b2 30 mcg
Infant participants who were born to maternal participants vaccinated with BNT162b2 30 mcg during pregnancy were included. Infant participants were followed up to 6 months of age.
BG003
Infant Participants: Placebo
Infant participants who were born to maternal participants vaccinated with placebo during pregnancy were included. Infant participants were followed up to 6 months of age.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000173
BG001173
BG002167
BG003168
BG004681
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
Less than (<) 18 years
BG0000
BG0010
BG002167
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000173
BG001173
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00070
BG00163
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0001
BG0011
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 Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1
Pain at injection site, redness & swelling were recorded by participants in an electronic diary (e-diary). Redness & swelling were measured & recorded in measuring devise units (range 1 to 21) then converted to cm. 1 measuring device unit = 0.5 cm & graded as mild: > 2.0 to 5.0 cm, moderate: > 5.0 to 10.0 cm, severe: > 10.0 cm, grade 4 (potentially life threatening): necrosis or exfoliative dermatitis (redness) & necrosis (swelling). Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity & grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Reactions reported as adverse events in the case report form within 7 days after the study vaccination were also included in the analysis. Exact 2-sided 95% confidence interval (CI) was based on Clopper & Pearson method.
For maternal participants, safety population included all randomized participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" (N) signifies participants evaluable for this outcome measure. Human immunodeficiency virus (HIV) positive participants were excluded from analysis as pre-specified in the statistical analysis plan (SAP).
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 to Day 7 after dose 1
ID
Title
Description
OG000
Maternal Participants: BNT162b2 30 mcg
Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.
OG001
Maternal Participants: Placebo
Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.
Units
Counts
Participants
OG000161
OG001163
Title
Denominators
Categories
Redness: Mild
Title
Measurements
OG0002.5(0.7 to 6.2)
OG0010.6(0.0 to 3.4)
Redness: Moderate
Title
Measurements
OG000
Primary
Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2
Pain at injection site, redness & swelling were recorded by participants in an e-diary. Redness & swelling were measured & recorded in measuring devise units (range 1 to 21) then converted to cm. 1 measuring device unit = 0.5 cm & graded as mild: > 2.0 to 5.0 cm, moderate: > 5.0 to 10.0 cm, severe: > 10.0 cm, grade 4 (potentially life threatening): necrosis or exfoliative dermatitis (redness) & necrosis (swelling). Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity & grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Reactions reported as adverse events (AEs) in the case report form (CRF) within 7 days after the study vaccination were also included in the analysis. Exact 2-sided 95% CI was based on the Clopper & Pearson method.
For maternal participants, safety population included all randomized participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in the SAP.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 to Day 7 after dose 2
ID
Title
Description
OG000
Maternal Participants: BNT162b2 30 mcg
Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.
Primary
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1
Systemic events were recorded by participants in an e-diary. Fever was oral temperature >= 38 degree Celsius (°C) & categorized as >=38.0 to 38.4 °C, >38.4 to 38.9 °C, >38.9 to 40.0 °C & >40.0 °C. Fatigue, headache, chills, new or worsened muscle pain & new or worsened joint pain were graded mild: did not interfere with activity, moderate: some interference with activity & severe: prevented daily routine activity. Vomiting was graded mild: 1 to 2 times in 24 hours (h), moderate: >2 times in 24h & severe: required intravenous hydration. Diarrhea was graded mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h & severe: 6 or more loose stools in 24h. For all systemic events except fever, Grade 4= emergency room visit or hospitalization. Grade 4 events were classified by the investigator/medically qualified person. Systemic events reported as AEs in the CRF within 7 days after vaccination were also included in analysis. Exact 95% CI was based on Clopper & Pearson method.
For maternal participants, safety population included all randomized participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in the SAP.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 to Day 7 after dose 1
ID
Title
Description
OG000
Maternal Participants: BNT162b2 30 mcg
Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.
Primary
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2
Systemic events were recorded by participants in an e-diary. Fever was oral temperature >= 38 °C & categorized as >=38.0 to 38.4 °C, >38.4 to 38.9 °C, >38.9 to 40.0 °C & >40.0 °C. Fatigue, headache, chills, new or worsened muscle pain & new or worsened joint pain were graded mild: did not interfere with activity, moderate: some interference with activity & severe: prevented daily routine activity. Vomiting was graded mild: 1 to 2 times in 24 h, moderate: >2 times in 24 h & severe: required intravenous hydration. Diarrhea was graded mild: 2 to 3 loose stools in 24 h, moderate: 4 to 5 loose stools in 24 h & severe: 6 or more loose stools in 24 h. For all systemic events except fever, Grade 4= emergency room visit or hospitalization. Grade 4 events were classified by the investigator/medically qualified person. Systemic events reported as AEs in the CRF within 7 days after vaccination were also included in analysis. Exact 95% CI was based on Clopper & Pearson method.
For maternal participants, safety population included all randomized participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in the SAP.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 to Day 7 after dose 2
ID
Title
Description
OG000
Maternal Participants: BNT162b2 30 mcg
Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.
Primary
Percentage of Maternal Participants With Adverse Events (AEs) From Dose 1 Through 1 Month After Dose 2 - Blinded Follow-up Period
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
For maternal participants, safety population included all randomized participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in the SAP.
Posted
Number
95% Confidence Interval
Percentage of participants
From dose 1 on Day 1 through 1 month after dose 2 (approximately 2 months)
ID
Title
Description
OG000
Maternal Participants: BNT162b2 30 mcg
Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.
OG001
Maternal Participants: Placebo
Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.
Primary
Percentage of Maternal Participants Reporting Serious Adverse Events (SAEs) From Dose 1 Through 1 Month After Delivery - Blinded Follow-up Period
An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
For maternal participants, safety population included all randomized participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in the SAP.
Posted
Number
95% Confidence Interval
Percentage of participants
From dose 1 on Day 1 through 1 month after delivery (up to 22 weeks)
ID
Title
Description
OG000
Maternal Participants: BNT162b2 30 mcg
Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.
OG001
Maternal Participants: Placebo
Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.
Primary
Geometric Mean Ratio (GMR) of the SARS-CoV-2 Neutralizing Titers in Pregnant Women to Those in Nonpregnant Women From Study C4591001 (NCT04368728) for Evaluable Immunogenicity Population Without Evidence of Prior SARS-CoV-2 Infection
GMR of SARS-CoV-2 neutralizing titers in pregnant women to those in nonpregnant women from study C4591001 (NCT04368728) for evaluable immunogenicity population without evidence of prior SARS-CoV-2 infection up to 1 month after Dose 2 was reported in this outcome measure. Geometric mean titer (GMT) and 2-sided 95% CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on student t distribution) and was reported in descriptive section. GMR was reported in statistical analysis section of this outcome measure. Evaluable immunogenicity population included all participants who were eligible and randomized, received 2 doses of vaccine to which they were randomized, with Dose 2 received within predefined window (19-42 days, inclusive, after Dose 1); had at least 1 valid immunogenicity result within an appropriate window 1 month after Dose 2 (28-42 days, inclusive, after Dose 2); and had no other important protocol deviations as determined by the clinician.
Evaluable immunogenicity population without evidence of SARS-CoV2 infection up to 1 month after Dose 2 was analyzed. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in the SAP.
Posted
Geometric Mean
95% Confidence Interval
Titer
1 Month after Dose 2
ID
Title
Description
OG000
Maternal Participants: BNT162b2 30 mcg
Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days.
Primary
GMR of SARS-CoV-2 Neutralizing Titers in Pregnant Women to Those in Nonpregnant Women From Study C4591001 (NCT04368728) for Evaluable Immunogenicity Population With and Without Evidence of Prior SARS-CoV-2 Infection
GMR of SARS-CoV-2 neutralizing titers in pregnant women to those in nonpregnant women from study C4591001 (NCT04368728) for evaluable immunogenicity population with and without evidence of prior SARS-CoV-2 infection was reported in this outcome measure. GMT and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the student t distribution) and was reported in the descriptive section. GMR was reported in the statistical analysis section. Evaluable immunogenicity population included all participants who were eligible and randomized, received 2 doses of the vaccine to which they were randomized, with Dose 2 received within the predefined window (19-42 days, inclusive, after Dose 1); had at least 1 valid immunogenicity result within an appropriate window 1 month after Dose 2 (28-42 days, inclusive, after Dose 2); and had no other important protocol deviations as determined by the clinician.
Evaluable immunogenicity population was analyzed. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in the SAP.
Posted
Geometric Mean
95% Confidence Interval
Titer
1 Month after Dose 2
ID
Title
Description
OG000
Maternal Participants: BNT162b2 30 mcg
Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days.
Secondary
COVID-19 Incidence Per 100 Person-Years of Blinded Follow up in Evaluable Maternal Participants Without Evidence of Prior SARS-CoV-2 Infection
COVID-19 incidence per 100 person-years of blinded follow-up in evaluable maternal participants without evidence of prior SARS-CoV-2 infection prior to 7 days after receipt of Dose 2 was reported in this outcome measure.
Evaluable efficacy population included all eligible randomized participants who received all vaccinations as randomized, with Dose 2 received within predefined window (within 19-42 days after Dose 1) and had no other important protocol deviations as determined by clinician on or before 7 days after Dose 2. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in SAP.
Posted
Number
Events per 100 person-years
From 7 days after Dose 2 up to 1 month after delivery (Surveillance time [100 person-year]: BNT162b2- 0.155, Placebo- 0.149)
ID
Title
Description
OG000
Maternal Participants: BNT162b2 30 mcg
Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.
OG001
Maternal Participants: Placebo
Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.
Secondary
COVID-19 Incidence Per 100 Person-Years of Blinded Follow up in Evaluable Maternal Participants With or Without Evidence of Prior SARS-CoV-2 Infection
COVID-19 incidence per 100 person-years of blinded follow-up in evaluable maternal participants with or without evidence of prior SARS-CoV-2 infection was reported in this outcome measure.
Evaluable efficacy population included all eligible randomized participants who received all vaccinations as randomized, with Dose 2 received within predefined window (within 19-42 days after Dose 1) and had no other important protocol deviations as determined by clinician on or before 7 days after Dose 2. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in SAP.
Posted
Number
Events per 100 person-years
From 7 days after Dose 2 up to 1 month after delivery (Surveillance time [100 person-year]: BNT162b2- 0.270, Placebo- 0.263)
ID
Title
Description
OG000
Maternal Participants: BNT162b2 30 mcg
Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.
OG001
Maternal Participants: Placebo
Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.
Secondary
Incidence of Asymptomatic Infection of SARS-CoV-2 Through 1 Month After Delivery in Evaluable Maternal Participants Without Evidence of Prior SARS-CoV-2 Infection
Incidence of asymptomatic infection of SARS-CoV-2 through 1 month after delivery in evaluable maternal participants without evidence of prior SARS-CoV-2 infection prior to the first post-dose 2 N-binding test was reported in this outcome measure.
Evaluable efficacy population included all eligible randomized participants who received all vaccinations as randomized, with Dose 2 received within predefined window (within 19-42 days after Dose 1) and had no other important protocol deviations as determined by clinician on or before 7 days after Dose 2. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in SAP.
Posted
Number
Events per 100 person-years
Up to 1 month after delivery (Surveillance time [100 person-year]: BNT162b2- 0.099, Placebo- 0.147)
ID
Title
Description
OG000
Maternal Participants: BNT162b2 30 mcg
Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.
OG001
Maternal Participants: Placebo
Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.
Secondary
Geometric Mean Concentration (GMCs) of Full-Length S-Binding Immunoglobulin G (IgG) Levels in Evaluable Maternal Participants
GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. GMCs of full-length S-binding IgG levels in evaluable maternal participants at baseline, 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery was reported in this outcome measure. Evaluable immunogenicity population included all participants who were eligible and randomized, received 2 doses of the vaccine to which they were randomized, with Dose 2 received within the predefined window (19-42 days, inclusive, after Dose 1); had at least 1 valid immunogenicity result within an appropriate window 1 month after Dose 2 (28-42 days, inclusive, after Dose 2); and had no other important protocol deviations as determined by the clinician.
Evaluable immunogenicity population was analyzed. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified rows. HIV positive participants were excluded from analysis as pre-specified in the SAP.
Posted
Geometric Mean
95% Confidence Interval
Units/milliliter (U/mL)
Baseline (before Dose 1), 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery
ID
Title
Description
OG000
Maternal Participants: BNT162b2 30 mcg
Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.
Secondary
Geometric Mean Titer (GMTs) of SARS-CoV-2 Neutralizing Titers in Evaluable Maternal Participants
GMTs, and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. GMTs of SARS-CoV-2 neutralizing titers in evaluable maternal participants at baseline, 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery was reported in this outcome measure. Evaluable immunogenicity population included all participants who were eligible and randomized, received 2 doses of the vaccine to which they were randomized, with Dose 2 received within the predefined window (19-42 days, inclusive, after Dose 1); had at least 1 valid immunogenicity result within an appropriate window 1 month after Dose 2 (28-42 days, inclusive, after Dose 2); and had no other important protocol deviations as determined by the clinician.
Evaluable immunogenicity population was analyzed. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified rows. HIV positive participants were excluded from analysis as pre-specified in the SAP.
Posted
Geometric Mean
95% Confidence Interval
Titer
Baseline (before Dose 1), 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery
ID
Title
Description
OG000
Maternal Participants: BNT162b2 30 mcg
Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.
Secondary
Geometric Mean Fold Rise (GMFR) From Before Vaccination to Each Subsequent Time Point After Vaccination for Full-Length S-Binding IgG Levels in Evaluable Maternal Participants
GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. GMFR from before vaccination to each subsequent time point after vaccination for full-length S-binding IgG levels in evaluable maternal participants at 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery was reported in this outcome measure. Evaluable immunogenicity population included all participants who were eligible and randomized, received 2 doses of the vaccine to which they were randomized, with Dose 2 received within the predefined window (19-42 days, inclusive, after Dose 1); had at least 1 valid immunogenicity result within an appropriate window 1 month after Dose 2 (28-42 days, inclusive, after Dose 2); and had no other important protocol deviations as determined by the clinician.
Evaluable immunogenicity population was analyzed. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified rows. HIV positive participants were excluded from analysis as pre-specified in the SAP.
Posted
Geometric Mean
95% Confidence Interval
Fold rise
From before dose 1 up to 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery
ID
Title
Description
OG000
Maternal Participants: BNT162b2 30 mcg
Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.
Secondary
Geometric Mean Fold Rise (GMFR) From Before Vaccination to Each Subsequent Time Point After Vaccination for SARS-CoV-2 Neutralizing Titers in Evaluable Maternal Participants
GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. GMFR from before vaccination to each subsequent time point after vaccination for SARS-CoV-2 neutralizing titers in evaluable maternal participants at 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery was reported in this outcome measure. Evaluable immunogenicity population included all participants who were eligible and randomized, received 2 doses of the vaccine to which they were randomized, with Dose 2 received within the predefined window (19-42 days, inclusive, after Dose 1); had at least 1 valid immunogenicity result within an appropriate window 1 month after Dose 2 (28-42 days, inclusive, after Dose 2); and had no other important protocol deviations as determined by the clinician.
Evaluable immunogenicity population was analyzed. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified rows. HIV positive participants were excluded from analysis as pre-specified in the SAP.
Posted
Geometric Mean
95% Confidence Interval
Fold rise
From before dose 1 up to 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery
ID
Title
Description
OG000
Maternal Participants: BNT162b2 30 mcg
Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.
Secondary
Percentage of Infant Participants Reporting Specific Birth Outcomes
Percentage of infant participants reporting specific birth outcomes (normal, congenital malformation/anomaly, other neonatal problems) were reported in this outcome measure.
Safety population for infant participants included all infant participants born to maternal participants who received at least 1 dose of the study intervention. As this outcome measure was measured at birth, HIV positive infant participants were included in this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
At birth
ID
Title
Description
OG000
Infant Participants: BNT162b2 30 mcg
Infant participants who were born to maternal participants vaccinated with BNT162b2 30 mcg during pregnancy were included. Infant participants were followed up to 6 months of age.
OG001
Infant Participants: Placebo
Infant participants who were born to maternal participants vaccinated with placebo during pregnancy were included. Infant participants were followed up to 6 months of age.
Units
Counts
Participants
Secondary
Percentage of Infant Participants Reporting Adverse Events From Birth Through 1 Month of Age
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Safety population for infant participants included all infant participants born to maternal participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in the SAP.
Posted
Number
95% Confidence Interval
Percentage of participants
From birth through 1 month of age
ID
Title
Description
OG000
Infant Participants: BNT162b2 30 mcg
Infant participants who were born to maternal participants vaccinated with BNT162b2 30 mcg during pregnancy were included. Infant participants were followed up to 6 months of age.
OG001
Infant Participants: Placebo
Infant participants who were born to maternal participants vaccinated with placebo during pregnancy were included. Infant participants were followed up to 6 months of age.
Secondary
Percentage of Infant Participants Reporting Serious Adverse Events (SAE) From Birth Through 6 Months of Age
An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Safety population for infant participants included all infant participants born to maternal participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in the SAP.
Posted
Number
95% Confidence Interval
Percentage of participants
From birth through 6 months of age
ID
Title
Description
OG000
Infant Participants: BNT162b2 30 mcg
Infant participants who were born to maternal participants vaccinated with BNT162b2 30 mcg during pregnancy were included. Infant participants were followed up to 6 months of age.
OG001
Infant Participants: Placebo
Infant participants who were born to maternal participants vaccinated with placebo during pregnancy were included. Infant participants were followed up to 6 months of age.
Secondary
Percentage of Infant Participants Reporting Adverse Event of Special Interest (AESI) From Birth Through 6 Months of Age
Percentage of infant participants who reported AESI including major congenital anomalies and developmental delay from birth through 6 months of age were reported in this outcome measure. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Safety population for infant participants included all infant participants born to maternal participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in the SAP.
Posted
Number
95% Confidence Interval
Percentage of participants
From birth through 6 months of age
ID
Title
Description
OG000
Infant Participants: BNT162b2 30 mcg
Infant participants who were born to maternal participants vaccinated with BNT162b2 30 mcg during pregnancy were included. Infant participants were followed up to 6 months of age.
OG001
Infant Participants: Placebo
Infant participants who were born to maternal participants vaccinated with placebo during pregnancy were included. Infant participants were followed up to 6 months of age.
Secondary
GMCs of Full-Length S-Binding IgG Levels at Birth and 6 Months of Age in Infant Participants Born to Evaluable Maternal Participants
GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. GMCs of full-length S-binding IgG levels at birth and 6 months of age in infant participants born to evaluable maternal participants was reported in this outcome measure.
All infant participants born to evaluable immunogenicity maternal participants and had no important protocol deviations as determined by the clinician. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified rows. HIV positive participants were excluded from analysis as pre-specified in the SAP.
Posted
Geometric Mean
95% Confidence Interval
Units/milliliter (U/mL)
At birth and 6 months of age
ID
Title
Description
OG000
Infant Participants: BNT162b2 30 mcg
Infant participants who were born to maternal participants vaccinated with BNT162b2 30 mcg during pregnancy were included. Infant participants were followed up to 6 months of age.
OG001
Infant Participants: Placebo
Infant participants who were born to maternal participants vaccinated with placebo during pregnancy were included. Infant participants were followed up to 6 months of age.
Secondary
GMFR of Full-Length S-Binding IgG Levels From Birth to 6 Months of Age in Infant Participants Born to Evaluable Maternal Participants
GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. GMFR of full-length S-binding IgG levels from birth to 6 months of age in infant participants born to evaluable maternal participants was reported in this outcome measure.
All infant participants born to evaluable immunogenicity maternal participants and had no important protocol deviations as determined by the clinician. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in the SAP.
Posted
Geometric Mean
95% Confidence Interval
Fold rise
From birth to 6 months of age
ID
Title
Description
OG000
Infant Participants: BNT162b2 30 mcg
Infant participants who were born to maternal participants vaccinated with BNT162b2 30 mcg during pregnancy were included. Infant participants were followed up to 6 months of age.
OG001
Infant Participants: Placebo
Infant participants who were born to maternal participants vaccinated with placebo during pregnancy were included. Infant participants were followed up to 6 months of age.
Time Frame
Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Description
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
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
Maternal Participants: BNT162b2 30 mcg (Blinded Phase)
Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery. HIV positive maternal participants were excluded.
0
161
21
161
143
161
EG001
Maternal Participants: Placebo (Blinded Phase)
Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. HIV positive maternal participants were excluded.
0
163
23
163
119
163
EG002
Maternal Participants: Placebo Then BNT162b2 (Unblinded Phase)
Participants who originally received 2 doses of blinded placebo were administered 2 doses of 30 mcg BNT162b2 vaccine as intramuscular injection separated by 21 days after unblinding at 1 month post-delivery. Participants were followed-up until 1 month after last vaccination. HIV positive maternal participants were excluded.
0
144
0
144
21
144
EG003
Infant Participants: BNT162b2 30 mcg
Infant participants who were born to maternal participants vaccinated with BNT162b2 30 mcg during pregnancy were included. Infant participants were followed up to 6 months of age. HIV positive infant participants born to HIV positive maternal participants were excluded.
0
156
21
156
29
156
EG004
Infant Participants: Placebo
Infant participants who were born to maternal participants vaccinated with placebo during pregnancy were included. Infant participants were followed up to 6 months of age. HIV positive infant participants born to HIV positive maternal participants were excluded.
1
159
24
159
33
159
EG005
HIV Positive Maternal Participants: BNT162b2 30 mcg (Blinded Phase)
Maternal participants who were HIV positive received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.
0
12
2
12
12
12
EG006
HIV Positive Maternal Participants: Placebo (Blinded Phase)
Maternal participants who were HIV positive received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.
0
10
4
10
10
10
EG007
HIV Positive Maternal Participants: Placebo Then BNT162b2 (Unblinded Phase)
HIV positive maternal participants who originally received 2 doses of blinded placebo were administered 2 doses of 30 mcg BNT162b2 vaccine as intramuscular injection separated by 21 days after unblinding at 1 month post-delivery. Participants were followed-up until 1 month after last vaccination.
0
8
0
8
1
8
EG008
HIV Positive Infant Participants: BNT162b2 30 mcg
Infant participants who were born to HIV positive maternal participants vaccinated with BNT162b2 30 mcg during pregnancy were included. Infant participants were followed up to 6 months of age.
1
11
1
11
1
11
EG009
HIV Positive Infant Participants: Placebo
Infant participants who were born to HIV positive maternal participants vaccinated with placebo during pregnancy were included. Infant participants were followed up to 6 months of age.
0
9
2
9
3
9
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Bradycardia fetal
Cardiac disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG0030 affected156 at risk
EG0040 affected159 at risk
EG0050 affected12 at risk
EG0060 affected10 at risk
EG0070 affected8 at risk
EG0080 affected11 at risk
EG0090 affected9 at risk
Non reassuring fetal heart rate pattern
Cardiac disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0012 affected163 at risk
EG0020 affected144 at risk
EG003
Abdominal wall haematoma
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Allergic colitis
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Allergic gastroenteritis
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Meconium plug syndrome
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Pneumoperitoneum
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0020 affected144 at risk
EG003
Hyperbilirubinaemia neonatal
Hepatobiliary disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Endometritis
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0020 affected144 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0020 affected144 at risk
EG003
Bronchiolitis
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Neonatal pneumonia
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Pneumonia respiratory syncytial viral
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Sepsis
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Sepsis neonatal
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Injury to brachial plexus due to birth trauma
Injury, poisoning and procedural complications
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Traumatic intracranial hemorrhage
Injury, poisoning and procedural complications
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Urinary tract procedural complication
Injury, poisoning and procedural complications
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0020 affected144 at risk
EG003
Fetal heart rate abnormal
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0020 affected144 at risk
EG003
Cardiac murmur
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Ultrasound fetal abnormal
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0020 affected144 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Arrested labor
Pregnancy, puerperium and perinatal conditions
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0020 affected144 at risk
EG003
Breech presentation
Pregnancy, puerperium and perinatal conditions
MedDRA v25.1
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Cephalo-pelvic disproportion
Pregnancy, puerperium and perinatal conditions
MedDRA v25.1
Non-systematic Assessment
EG0001 affected161 at risk
EG0013 affected163 at risk
EG0020 affected144 at risk
EG003
Failed induction of labor
Pregnancy, puerperium and perinatal conditions
MedDRA v25.1
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Fetal distress syndrome
Pregnancy, puerperium and perinatal conditions
MedDRA v25.1
Non-systematic Assessment
EG0003 affected161 at risk
EG0012 affected163 at risk
EG0020 affected144 at risk
EG003
Fetal growth restriction
Pregnancy, puerperium and perinatal conditions
MedDRA v25.1
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Fetal hypokinesia
Pregnancy, puerperium and perinatal conditions
MedDRA v25.1
Non-systematic Assessment
EG0001 affected161 at risk
EG0011 affected163 at risk
EG0020 affected144 at risk
EG003
Gestational hypertension
Pregnancy, puerperium and perinatal conditions
MedDRA v25.1
Non-systematic Assessment
EG0001 affected161 at risk
EG0011 affected163 at risk
EG0020 affected144 at risk
EG003
Hemorrhage in pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA v25.1
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Meconium in amniotic fluid
Pregnancy, puerperium and perinatal conditions
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0020 affected144 at risk
EG003
Meconium stain
Pregnancy, puerperium and perinatal conditions
MedDRA v25.1
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Omphalorrhexis
Pregnancy, puerperium and perinatal conditions
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0020 affected144 at risk
EG003
Placental insufficiency
Pregnancy, puerperium and perinatal conditions
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0020 affected144 at risk
EG003
Postpartum hemorrhage
Pregnancy, puerperium and perinatal conditions
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0012 affected163 at risk
EG0020 affected144 at risk
EG003
Pre-eclampsia
Pregnancy, puerperium and perinatal conditions
MedDRA v25.1
Non-systematic Assessment
EG0004 affected161 at risk
EG0012 affected163 at risk
EG0020 affected144 at risk
EG003
Premature separation of placenta
Pregnancy, puerperium and perinatal conditions
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0013 affected163 at risk
EG0020 affected144 at risk
EG003
Preterm premature rupture of membranes
Pregnancy, puerperium and perinatal conditions
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0020 affected144 at risk
EG003
Prolonged rupture of membranes
Pregnancy, puerperium and perinatal conditions
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0020 affected144 at risk
EG003
Retained placenta or membranes
Pregnancy, puerperium and perinatal conditions
MedDRA v25.1
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Caput succedaneum
Pregnancy, puerperium and perinatal conditions
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Jaundice neonatal
Pregnancy, puerperium and perinatal conditions
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Low birth weight baby
Pregnancy, puerperium and perinatal conditions
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Premature baby
Pregnancy, puerperium and perinatal conditions
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Small for dates baby
Pregnancy, puerperium and perinatal conditions
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Weight decrease neonatal
Pregnancy, puerperium and perinatal conditions
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Uterine disorder
Reproductive system and breast disorders
MedDRA v25.1
Non-systematic Assessment
EG0002 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Hypoperfusion
Vascular disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Hypotension
Vascular disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Shock
Vascular disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Subgaleal hemorrhage
Vascular disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Coagulopathy
Blood and lymphatic system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Ankyloglossia congenital
Congenital, familial and genetic disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Atrial septal defect
Congenital, familial and genetic disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Congenital rubella syndrome
Congenital, familial and genetic disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Congenital skin dimples
Congenital, familial and genetic disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
DiGeorge's syndrome
Congenital, familial and genetic disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Microcephaly
Congenital, familial and genetic disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Mucopolysaccharidosis
Congenital, familial and genetic disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Patent ductus arteriosus
Congenital, familial and genetic disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Polydactyly
Congenital, familial and genetic disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Syndactyly
Congenital, familial and genetic disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Trisomy 21
Congenital, familial and genetic disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Ventricular septal defect
Congenital, familial and genetic disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Hypoglycemia neonatal
Metabolism and nutrition disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Metabolic acidosis
Metabolism and nutrition disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Coma
Nervous system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Encephalopathy neonatal
Nervous system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Hypoxic-ischemic encephalopathy
Nervous system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Nervous system disorder
Nervous system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Seizure
Nervous system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Renal tubular necrosis
Renal and urinary disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Vesicoureteric reflux
Renal and urinary disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Meconium aspiration syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Neonatal pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Neonatal respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Neonatal respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Neonatal respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Pulmonary hypertension
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Tachypnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Failed trial of labor
Pregnancy, puerperium and perinatal conditions
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Fetal death
Pregnancy, puerperium and perinatal conditions
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Anemia
Blood and lymphatic system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Superior sagittal sinus thrombosis
Nervous system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anemia
Blood and lymphatic system disorders
MedDRA v25.1
Non-systematic Assessment
EG0004 affected161 at risk
EG0012 affected163 at risk
EG0020 affected144 at risk
EG0030 affected156 at risk
EG0040 affected159 at risk
EG0050 affected12 at risk
EG0061 affected10 at risk
EG0070 affected8 at risk
EG0080 affected11 at risk
EG0090 affected9 at risk
Tachycardia
Cardiac disorders
MedDRA v25.1
Non-systematic Assessment
EG0002 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0003 affected161 at risk
EG0013 affected163 at risk
EG0020 affected144 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0012 affected163 at risk
EG0020 affected144 at risk
EG003
Diarrhea (DIARRHEA)
Gastrointestinal disorders
MedDRA v25.1
Systematic Assessment
EG00024 affected161 at risk
EG00121 affected163 at risk
EG0020 affected144 at risk
EG003
Gastroesophageal reflux disease
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected161 at risk
EG0012 affected163 at risk
EG0020 affected144 at risk
EG003
Hemorrhoids
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected161 at risk
EG0012 affected163 at risk
EG0020 affected144 at risk
EG003
Vomiting (VOMITING)
Gastrointestinal disorders
MedDRA v25.1
Systematic Assessment
EG00018 affected161 at risk
EG00116 affected163 at risk
EG0020 affected144 at risk
EG003
Chills (CHILLS)
General disorders
MedDRA v25.1
Systematic Assessment
EG00028 affected161 at risk
EG00110 affected163 at risk
EG0022 affected144 at risk
EG003
Erythema (REDNESS)
General disorders
MedDRA v25.1
Systematic Assessment
EG00011 affected161 at risk
EG0011 affected163 at risk
EG0020 affected144 at risk
EG003
Fatigue
General disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0012 affected163 at risk
EG0023 affected144 at risk
EG003
Fatigue (FATIGUE)
General disorders
MedDRA v25.1
Systematic Assessment
EG000101 affected161 at risk
EG00182 affected163 at risk
EG0020 affected144 at risk
EG003
Injection site pain (PAIN AT INJECTION SITE)
General disorders
MedDRA v25.1
Systematic Assessment
EG000138 affected161 at risk
EG00130 affected163 at risk
EG00213 affected144 at risk
EG003
Pyrexia (FEVER)
General disorders
MedDRA v25.1
Systematic Assessment
EG0006 affected161 at risk
EG0014 affected163 at risk
EG0020 affected144 at risk
EG003
Swelling (SWELLING)
General disorders
MedDRA v25.1
Systematic Assessment
EG00017 affected161 at risk
EG0011 affected163 at risk
EG0020 affected144 at risk
EG003
Amniotic cavity infection
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0012 affected163 at risk
EG0020 affected144 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0004 affected161 at risk
EG0011 affected163 at risk
EG0020 affected144 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA v25.1
Non-systematic Assessment
EG0002 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Streptococcus test positive
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0012 affected163 at risk
EG0020 affected144 at risk
EG003
Arthralgia (NEW OR WORSENED JOINT PAIN)
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Systematic Assessment
EG00022 affected161 at risk
EG00113 affected163 at risk
EG0020 affected144 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0002 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Myalgia (NEW OR WORSENED MUSCLE PAIN)
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Systematic Assessment
EG00053 affected161 at risk
EG00126 affected163 at risk
EG0020 affected144 at risk
EG003
Headache
Nervous system disorders
MedDRA v25.1
Non-systematic Assessment
EG0002 affected161 at risk
EG0012 affected163 at risk
EG0027 affected144 at risk
EG003
Headache (HEADACHE)
Nervous system disorders
MedDRA v25.1
Systematic Assessment
EG00085 affected161 at risk
EG00172 affected163 at risk
EG0020 affected144 at risk
EG003
Abnormal labor
Pregnancy, puerperium and perinatal conditions
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0012 affected163 at risk
EG0020 affected144 at risk
EG003
Fetal hypokinesia
Pregnancy, puerperium and perinatal conditions
MedDRA v25.1
Non-systematic Assessment
EG0001 affected161 at risk
EG0012 affected163 at risk
EG0020 affected144 at risk
EG003
Gestational diabetes
Pregnancy, puerperium and perinatal conditions
MedDRA v25.1
Non-systematic Assessment
EG0001 affected161 at risk
EG0012 affected163 at risk
EG0020 affected144 at risk
EG003
Gestational hypertension
Pregnancy, puerperium and perinatal conditions
MedDRA v25.1
Non-systematic Assessment
EG0002 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Oligohydramnios
Pregnancy, puerperium and perinatal conditions
MedDRA v25.1
Non-systematic Assessment
EG0001 affected161 at risk
EG0012 affected163 at risk
EG0020 affected144 at risk
EG003
Pre-eclampsia
Pregnancy, puerperium and perinatal conditions
MedDRA v25.1
Non-systematic Assessment
EG0002 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Premature delivery
Pregnancy, puerperium and perinatal conditions
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0012 affected163 at risk
EG0020 affected144 at risk
EG003
Uterine contractions during pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA v25.1
Non-systematic Assessment
EG0002 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Vaginal hemorrhage
Reproductive system and breast disorders
MedDRA v25.1
Non-systematic Assessment
EG0001 affected161 at risk
EG0012 affected163 at risk
EG0020 affected144 at risk
EG003
Episiotomy
Surgical and medical procedures
MedDRA v25.1
Non-systematic Assessment
EG0003 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Injection site erythema
General disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0023 affected144 at risk
EG003
Pain
General disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0023 affected144 at risk
EG003
Pyrexia
General disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0025 affected144 at risk
EG003
COVID-19
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0022 affected144 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0022 affected144 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0024 affected144 at risk
EG003
Ankyloglossia congenital
Congenital, familial and genetic disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Congenital naevus
Congenital, familial and genetic disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Hydrocele
Congenital, familial and genetic disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Hypothermia
General disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Hyperbilirubinemia neonatal
Hepatobiliary disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Apgar score low
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Cardiac murmur
Investigations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Hypoglycemia neonatal
Metabolism and nutrition disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Hypotonia
Nervous system disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Caput succedaneum
Pregnancy, puerperium and perinatal conditions
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Jaundice neonatal
Pregnancy, puerperium and perinatal conditions
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Large for dates baby
Pregnancy, puerperium and perinatal conditions
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Low birth weight baby
Pregnancy, puerperium and perinatal conditions
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Small for dates baby
Pregnancy, puerperium and perinatal conditions
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Umbilical cord around neck
Pregnancy, puerperium and perinatal conditions
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Body tinea
Infections and infestations
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Leukocyturia
Renal and urinary disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Vaginal discharge
Reproductive system and breast disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Polydactyly
Congenital, familial and genetic disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Exposure to communicable disease
Injury, poisoning and procedural complications
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA v25.1
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected144 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
The sponsor (or its agents) 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.
Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.
Units
Counts
Participants
OG000148
OG001146
Title
Denominators
Categories
Redness: Mild
Title
Measurements
OG0003.4(1.1 to 7.7)
OG0010(0.0 to 2.5)
Redness: Moderate
Title
Measurements
OG0002.0(0.4 to 5.8)
OG0010(0.0 to 2.5)
Redness: Severe
Title
Measurements
OG0000(0.0 to 2.5)
OG0010(0.0 to 2.5)
Redness: Grade 4
Title
Measurements
OG0000(0.0 to 2.5)
OG0010(0.0 to 2.5)
Swelling: Mild
Title
Measurements
OG0004.1(1.5 to 8.6)
OG0010.7(0.0 to 3.8)
Swelling: Moderate
Title
Measurements
OG0002.7(0.7 to 6.8)
OG0010(0.0 to 2.5)
Swelling: Severe
Title
Measurements
OG0000(0.0 to 2.5)
OG0010(0.0 to 2.5)
Swelling: Grade 4
Title
Measurements
OG0000(0.0 to 2.5)
OG0010(0.0 to 2.5)
Pain at the injection site: Mild
Title
Measurements
OG00054.7(46.3 to 62.9)
OG00112.3(7.5 to 18.8)
Pain at the injection site: Moderate
Title
Measurements
OG00019.6(13.5 to 26.9)
OG0014.1(1.5 to 8.7)
Pain at the injection site: Severe
Title
Measurements
OG0000.7(0.0 to 3.7)
OG0010(0.0 to 2.5)
Pain at the injection site: Grade 4
Title
Measurements
OG0000(0.0 to 2.5)
OG0010(0.0 to 2.5)
OG001
Maternal Participants: Placebo
Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.
Units
Counts
Participants
OG000161
OG001163
Title
Denominators
Categories
Fever: >=38.0 to 38.4 deg C (100.4 to 101.1 deg Fahrenheit [F])
Title
Measurements
OG0000.6(0.0 to 3.4)
OG0011.2(0.1 to 4.4)
Fever: >38.4 to 38.9 deg C (101.2 to 102.0 deg F)
Title
Measurements
OG0000(0.0 to 2.3)
OG0010(0.0 to 2.2)
Fever: >38.9 to 40.0 deg C (102.1 to 104.0 deg F)
Title
Measurements
OG0000.6(0.0 to 3.4)
OG0010.6(0.0 to 3.4)
Fever: >40 deg C (>104.0 deg F)
Title
Measurements
OG0000(0.0 to 2.3)
OG0010(0.0 to 2.2)
Fatigue/tiredness: Mild
Title
Measurements
OG00026.1(19.5 to 33.6)
OG00120.9(14.9 to 27.9)
Fatigue/tiredness: Moderate
Title
Measurements
OG00023.0(16.7 to 30.3)
OG00121.5(15.4 to 28.6)
Fatigue/tiredness: Severe
Title
Measurements
OG0000.6(0.0 to 3.4)
OG0010.6(0.0 to 3.4)
Fatigue/tiredness: Grade 4
Title
Measurements
OG0000(0.0 to 2.3)
OG0010(0.0 to 2.2)
Headache: Mild
Title
Measurements
OG00020.5(14.5 to 27.6)
OG00122.1(16.0 to 29.2)
Headache: Moderate
Title
Measurements
OG00011.8(7.3 to 17.8)
OG00112.9(8.2 to 19.0)
Headache: Severe
Title
Measurements
OG0001.9(0.4 to 5.3)
OG0010.6(0.0 to 3.4)
Headache: Grade 4
Title
Measurements
OG0000(0.0 to 2.3)
OG0010(0.0 to 2.2)
Chills: Mild
Title
Measurements
OG0005.0(2.2 to 9.6)
OG0015.5(2.6 to 10.2)
Chills: Moderate
Title
Measurements
OG0001.9(0.4 to 5.3)
OG0010(0.0 to 2.2)
Chills: Severe
Title
Measurements
OG0000(0.0 to 2.3)
OG0010(0.0 to 2.2)
Chills: Grade 4
Title
Measurements
OG0000(0.0 to 2.3)
OG0010(0.0 to 2.2)
Vomiting: Mild
Title
Measurements
OG0005.0(2.2 to 9.6)
OG0016.1(3.0 to 11.0)
Vomiting: Moderate
Title
Measurements
OG0000(0.0 to 2.3)
OG0013.1(1.0 to 7.0)
Vomiting: Severe
Title
Measurements
OG0000(0.0 to 2.3)
OG0010(0.0 to 2.2)
Vomiting: Grade 4
Title
Measurements
OG0000(0.0 to 2.3)
OG0010(0.0 to 2.2)
Diarrhea: Mild
Title
Measurements
OG00011.2(6.8 to 17.1)
OG0017.4(3.9 to 12.5)
Diarrhea: Moderate
Title
Measurements
OG0000.6(0.0 to 3.4)
OG0011.2(0.1 to 4.4)
Diarrhea: Severe
Title
Measurements
OG0000(0.0 to 2.3)
OG0010(0.0 to 2.2)
Diarrhea: Grade 4
Title
Measurements
OG0000(0.0 to 2.3)
OG0010(0.0 to 2.2)
New or worsened muscle pain: Mild
Title
Measurements
OG0006.8(3.5 to 11.9)
OG0016.1(3.0 to 11.0)
New or worsened muscle pain: Moderate
Title
Measurements
OG0005.6(2.6 to 10.3)
OG0015.5(2.6 to 10.2)
New or worsened muscle pain: Severe
Title
Measurements
OG0000(0.0 to 2.3)
OG0010(0.0 to 2.2)
New or worsened muscle pain: Grade 4
Title
Measurements
OG0000(0.0 to 2.3)
OG0010(0.0 to 2.2)
New or worsened joint pain: Mild
Title
Measurements
OG0001.2(0.2 to 4.4)
OG0012.5(0.7 to 6.2)
New or worsened joint pain: Moderate
Title
Measurements
OG0001.9(0.4 to 5.3)
OG0012.5(0.7 to 6.2)
New or worsened joint pain: Severe
Title
Measurements
OG0000(0.0 to 2.3)
OG0010(0.0 to 2.2)
New or worsened joint pain: Grade 4
Title
Measurements
OG0000(0.0 to 2.3)
OG0010(0.0 to 2.2)
OG001
Maternal Participants: Placebo
Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.
Units
Counts
Participants
OG000148
OG001146
Title
Denominators
Categories
Fever: >=38.0 to 38.4 deg C (100.4 to 101.1 deg F)
Title
Measurements
OG0001.4(0.2 to 4.8)
OG0010.7(0.0 to 3.8)
Fever: >38.4 to 38.9 deg C (101.2 to 102.0 deg F)
Title
Measurements
OG0000.7(0.0 to 3.7)
OG0010(0.0 to 2.5)
Fever: >38.9 to 40.0 deg C (102.1 to 104.0 deg F)
Title
Measurements
OG0000(0.0 to 2.5)
OG0010(0.0 to 2.5)
Fever: >40 deg C (>104.0 deg F)
Title
Measurements
OG0000(0.0 to 2.5)
OG0010(0.0 to 2.5)
Fatigue/tiredness: Mild
Title
Measurements
OG00015.5(10.1 to 22.4)
OG00115.8(10.3 to 22.7)
Fatigue/tiredness: Moderate
Title
Measurements
OG00032.4(25.0 to 40.6)
OG00118.5(12.6 to 25.8)
Fatigue/tiredness: Severe
Title
Measurements
OG0002.0(0.4 to 5.8)
OG0010(0.0 to 2.5)
Fatigue/tiredness: Grade 4
Title
Measurements
OG0000(0.0 to 2.5)
OG0010(0.0 to 2.5)
Headache: Mild
Title
Measurements
OG00025.0(18.3 to 32.8)
OG00113.7(8.6 to 20.4)
Headache: Moderate
Title
Measurements
OG00014.9(9.6 to 21.6)
OG00110.3(5.9 to 16.4)
Headache: Severe
Title
Measurements
OG0001.4(0.2 to 4.8)
OG0010(0.0 to 2.5)
Headache: Grade 4
Title
Measurements
OG0000(0.0 to 2.5)
OG0010(0.0 to 2.5)
Chills: Mild
Title
Measurements
OG0004.7(1.9 to 9.5)
OG0010.7(0.0 to 3.8)
Chills: Moderate
Title
Measurements
OG0007.4(3.8 to 12.9)
OG0010(0.0 to 2.5)
Chills: Severe
Title
Measurements
OG0000.7(0.0 to 3.7)
OG0010(0.0 to 2.5)
Chills: Grade 4
Title
Measurements
OG0000(0.0 to 2.5)
OG0010(0.0 to 2.5)
Vomiting: Mild
Title
Measurements
OG0008.8(4.8 to 14.6)
OG0012.1(0.4 to 5.9)
Vomiting: Moderate
Title
Measurements
OG0000(0.0 to 2.5)
OG0011.4(0.2 to 4.9)
Vomiting: Severe
Title
Measurements
OG0000(0.0 to 2.5)
OG0010(0.0 to 2.5)
Vomiting: Grade 4
Title
Measurements
OG0000(0.0 to 2.5)
OG0010(0.0 to 2.5)
Diarrhea: Mild
Title
Measurements
OG0006.1(2.8 to 11.2)
OG0014.1(1.5 to 8.7)
Diarrhea: Moderate
Title
Measurements
OG0000(0.0 to 2.5)
OG0011.4(0.2 to 4.9)
Diarrhea: Severe
Title
Measurements
OG0000(0.0 to 2.5)
OG0010(0.0 to 2.5)
Diarrhea: Grade 4
Title
Measurements
OG0000(0.0 to 2.5)
OG0010(0.0 to 2.5)
New or worsened muscle pain: Mild
Title
Measurements
OG00013.5(8.5 to 20.1)
OG0014.8(1.9 to 9.6)
New or worsened muscle pain: Moderate
Title
Measurements
OG00012.8(7.9 to 19.3)
OG0012.1(0.4 to 5.9)
New or worsened muscle pain: Severe
Title
Measurements
OG0000.7(0.0 to 3.7)
OG0010(0.0 to 2.5)
New or worsened muscle pain: Grade 4
Title
Measurements
OG0000(0.0 to 2.5)
OG0010(0.0 to 2.5)
New or worsened joint pain: Mild
Title
Measurements
OG0007.4(3.8 to 12.9)
OG0014.8(1.9 to 9.6)
New or worsened joint pain: Moderate
Title
Measurements
OG0006.1(2.8 to 11.2)
OG0011.4(0.2 to 4.9)
New or worsened joint pain: Severe
Title
Measurements
OG0000(0.0 to 2.5)
OG0010(0.0 to 2.5)
New or worsened joint pain: Grade 4
Title
Measurements
OG0000(0.0 to 2.5)
OG0010(0.0 to 2.5)
Units
Counts
Participants
OG000161
OG001163
Title
Denominators
Categories
Title
Measurements
OG00023.6(17.3 to 30.9)
OG00122.7(16.5 to 29.9)
Units
Counts
Participants
OG000161
OG001163
Title
Denominators
Categories
Title
Measurements
OG00013.0(8.3 to 19.2)
OG00114.1(9.2 to 20.4)
OG001
Non-Pregnant Participants: Study C4591001
Non-pregnant participants who received two doses of BNT162b2 30 mcg as an intramuscular injection separated by 21 days in study C4591001 (NCT04368728).
Units
Counts
Participants
OG00058
OG001107
Title
Denominators
Categories
Title
Measurements
OG0001109.2(849.2 to 1448.9)
OG0011663.7(1411.5 to 1960.8)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
GMRs and 2-sided 95% CIs was calculated by exponentiating the mean difference of the logarithms of the assay and the corresponding CIs.
Geometric mean ratio
0.67
2-Sided
95
0.50
0.90
Other
OG001
Non-Pregnant Participants: Study C4591001
Non-pregnant participants who received two doses of BNT162b2 30 mcg as an intramuscular injection separated by 21 days in study C4591001 (NCT04368728).
Units
Counts
Participants
OG000100
OG001114
Title
Denominators
Categories
Title
Measurements
OG0002198.7(1618.5 to 2987.0)
OG0011732.0(1469.4 to 2041.5)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
GMRs and 2-sided 95% CIs was calculated by exponentiating the mean difference of the logarithms of the assay and the corresponding CIs.
Geometric mean ratio
1.27
2-Sided
95
0.91
1.77
Other
OG000
OG001
GMRs and 2-sided 95% CIs was calculated by exponentiating the mean difference of the logarithms of the assay and the corresponding CIs.
Geometric mean ratio
0.95
2-Sided
95
0.69
1.30
Other
Units
Counts
Participants
OG00086
OG00189
Title
Denominators
Categories
Title
Measurements
OG00012.903
OG00113.423
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Vaccine efficacy
3.8
2-Sided
95
-1227.8
93.0
Other
Vaccine efficacy was estimated by 100*(1 - illness rate ratio [IRR]), where IRR=calculated ratio of confirmed COVID-19 illness per 1000 person-years of blinded follow-up in the active vaccine group to the corresponding illness rate in the placebo group.
Units
Counts
Participants
OG000145
OG001149
Title
Denominators
Categories
Title
Measurements
OG0007.407
OG00111.407
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Vaccine efficacy
35.1
2-Sided
95
-466.5
94.6
Other
Vaccine efficacy was estimated by 100*(1 - IRR), where IRR=calculated ratio of confirmed COVID-19 illness per 1000 person-years of blinded follow-up in the active vaccine group to the corresponding illness rate in the placebo group.
Units
Counts
Participants
OG00084
OG00189
Title
Denominators
Categories
Title
Measurements
OG00040.404
OG00168.027
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Vaccine efficacy
40.9
2-Sided
95
-104.9
86.5
Other
Vaccine efficacy was estimated by 100*(1 - IRR), where IRR=calculated ratio of confirmed COVID-19 illness per 1000 person-years of blinded follow-up in the active vaccine group to the corresponding illness rate in the placebo group.
OG001
Maternal Participants: Placebo
Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.
Units
Counts
Participants
OG00065
OG00159
Title
Denominators
Categories
Before Dose 1
ParticipantsOG00065
ParticipantsOG00159
Title
Measurements
OG0002.4(1.6 to 3.7)
OG0012.0(1.4 to 2.8)
2 weeks after Dose 2
ParticipantsOG00041
ParticipantsOG00135
Title
Measurements
OG0007802.0(6273.3 to 9703.2)
OG001
1 month after Dose 2
ParticipantsOG00036
ParticipantsOG00131
Title
Measurements
OG0004281.0(3234.7 to 5665.7)
OG001
At delivery
ParticipantsOG00039
ParticipantsOG00129
Title
Measurements
OG0002747.6(2144.7 to 3520.0)
OG001
6 months after delivery
ParticipantsOG00020
ParticipantsOG0010
Title
Measurements
OG0001639.4(780.1 to 3445.4)
OG001
Maternal Participants: Placebo
Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.
Units
Counts
Participants
OG00065
OG00159
Title
Denominators
Categories
Before Dose 1
ParticipantsOG00065
ParticipantsOG00159
Title
Measurements
OG00047.6(41.6 to 54.4)
OG00143.5(43.5 to 43.5)
2 weeks after Dose 2
ParticipantsOG00041
ParticipantsOG00135
Title
Measurements
OG0001991.8(1456.3 to 2724.1)
OG001
1 month after Dose 2
ParticipantsOG00036
ParticipantsOG00131
Title
Measurements
OG0001212.6(855.2 to 1719.4)
OG001
At delivery
ParticipantsOG00039
ParticipantsOG00129
Title
Measurements
OG000695.7(500.6 to 966.8)
OG001
6 months after delivery
ParticipantsOG00020
ParticipantsOG0010
Title
Measurements
OG000465.4(168.6 to 1284.5)
OG001
Maternal Participants: Placebo
Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.
Units
Counts
Participants
OG00058
OG00154
Title
Denominators
Categories
2 weeks after Dose 2
ParticipantsOG00058
ParticipantsOG00154
Title
Measurements
OG0003618.7(2489.1 to 5260.7)
OG0010.9(0.8 to 1.1)
1 month after Dose 2
ParticipantsOG00050
ParticipantsOG00149
Title
Measurements
OG0002276.4(1545.5 to 3352.9)
OG001
At delivery
ParticipantsOG00055
ParticipantsOG00147
Title
Measurements
OG0001377.6(948.6 to 2000.5)
OG001
6 months after delivery
ParticipantsOG00026
ParticipantsOG0010
Title
Measurements
OG000650.3(279.3 to 1514.3)
OG001
Maternal Participants: Placebo
Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.