History of Changes for Study: NCT04754594

To Evaluate the Safety, Tolerability, and Immunogenicity of BNT162b2 Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older

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Study Record Versions

Version	Submitted Date	Changes
1	February 11, 2021	None (earliest Version on record)
2	March 5, 2021	Recruitment Status, Study Status, Eligibility, Contacts/Locations and Oversight
3	March 30, 2021	Contacts/Locations and Study Status
4	April 9, 2021	Contacts/Locations, Study Status, Eligibility and Outcome Measures
5	May 17, 2021	Study Status and Contacts/Locations
6	May 27, 2021	Contacts/Locations, Study Status and Study Design
7	June 16, 2021	Contacts/Locations, Outcome Measures, Study Description, Study Status and Study Design
8	July 19, 2021	Contacts/Locations, Study Status and Study Design
9	August 16, 2021	Contacts/Locations and Study Status
10	September 13, 2021	Contacts/Locations, Study Status and Study Design
11	September 29, 2021	Contacts/Locations and Study Status
12	October 27, 2021	Contacts/Locations and Study Status
13	November 16, 2021	Recruitment Status, Contacts/Locations, Study Status and Study Design
14	December 17, 2021	Contacts/Locations, Study Status and Study Design
15	January 31, 2022	Contacts/Locations, Study Status and Study Design
16	February 17, 2022	IPDSharing and Study Status
17	May 15, 2022	Contacts/Locations, Study Status, Outcome Measures, Study Design and Study Description
18	August 3, 2022	Study Status, Contacts/Locations, Outcome Measures, Conditions and Study Identification
19	August 22, 2022	Recruitment Status, Study Status, Contacts/Locations and Study Design
20	July 12, 2023	Eligibility, Contacts/Locations, Study Design, Study Status and Study Description
21	July 14, 2023	Quality Control Review has not concluded Returned: August 4, 2023 Outcome Measures, Contacts/Locations, Study Status, Study Design, Document Section
22	August 30, 2023	Quality Control Review has not concluded Returned: September 22, 2023 Adverse Events, Outcome Measures, Study Status, Participant Flow and Study Design
23	October 25, 2023	Quality Control Review has not concluded Returned: November 13, 2023 Study Status, Participant Flow and Study Design

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	C4591015
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
Secondary IDs:	2020-005444-35 [EudraCT Number]

Study Status


Record Verification:	July 2023
Overall Status:	Completed
Study Start:	February 16, 2021
Primary Completion:	July 15, 2022 [Actual]
Study Completion:	July 15, 2022 [Actual]

First Submitted:	February 9, 2021
First Submitted that Met QC Criteria:	February 11, 2021
First Posted:	February 15, 2021 [Actual]

Last Update Submitted that Met QC Criteria:
Last Update Posted:	August 7, 2023 [Actual]

Sponsor/Collaborators


Sponsor:	BioNTech SE
Responsible Party:	Sponsor
Collaborators:	Pfizer

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

Study Description

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


Conditions:	SARS-CoV-2 Infection COVID-19 Maternal Immunization
Keywords:	SARS-CoV-2 Infection COVID-19 Maternal Immunization

Study Design


Study Type:	Interventional
Primary Purpose:	Prevention
Study Phase:	Phase 2/Phase 3
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	Triple (Participant, Care Provider, Investigator)
Allocation:	Randomized
Enrollment:	726 [Actual]

Arms and Interventions

Arms	Assigned Interventions
Experimental: BNT162b2 2 doses	Biological: BNT162b2 Intramuscular Injection
Placebo Comparator: Placebo 2 doses	Placebo Intramuscular Injection

Outcome Measures

[See Results Section.]


Primary Outcome Measures:
1.	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1 [ Time Frame: From Day 1 to Day 7 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.
2.	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2 [ Time Frame: From Day 1 to Day 7 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.
3.	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1 [ Time Frame: From Day 1 to Day 7 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.
4.	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2 [ Time Frame: From Day 1 to Day 7 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.
5.	Percentage of Maternal Participants With Adverse Events (AEs) From Dose 1 Through 1 Month After Dose 2 - Blinded Follow-up Period [ Time Frame: From dose 1 on Day 1 through 1 month after dose 2 (approximately 2 months) ] 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.
6.	Percentage of Maternal Participants Reporting Serious Adverse Events (SAEs) From Dose 1 Through 1 Month After Delivery - Blinded Follow-up Period [ Time Frame: From dose 1 on Day 1 through 1 month after delivery ] 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.
Quality Control Review Comment provided by the National Library of Medicine: There does not appear to be sufficient information to understand the Time Frame.
7.	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 Maternal Participants Without Evidence of Prior SARS-CoV-2 Infection [ Time Frame: 1 Month after Dose 2 ] 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 maternal participants without evidence of prior SARS-CoV-2 infection will be reported in this outcome measure. Results for this outcome measure will be posted by July 2024.
Quality Control Review Comment provided by the National Library of Medicine: Required information appears to be missing.
8.	GMR of SARS-CoV-2 Neutralizing Titers in Pregnant Women to Those in Nonpregnant Women From Study C4591001 (NCT04368728) for Evaluable Maternal Participants With and Without Evidence of Prior SARS-CoV-2 Infection [ Time Frame: 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 maternal participants with and without evidence of prior SARS-CoV-2 infection will be reported in this outcome measure. Results for this outcome measure will be posted by July 2024.
Quality Control Review Comment provided by the National Library of Medicine: Required information appears to be missing.
Secondary Outcome Measures:
1.	COVID-19 Incidence Per 1000 Person-Years of Blinded Follow-Up in Evaluable Maternal Participants Without Evidence of Prior SARS-CoV-2 Infection [ Time Frame: From 7 days after Dose 2 up to 1 month after delivery ] 100 x (1-illness rate ratio [IRR]) (ratio of confirmed COVID-19 illness from 7 days after Dose 2 through 1 month after delivery per 1000 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]) for BNT162b2 to the placebo group will be reported in this outcome measure. Results for this outcome measure will be posted by July 2024.
2.	COVID-19 Incidence Per 1000 Person-Years of Blinded Follow-Up in Evaluable Maternal Participants With or Without Evidence of Prior SARS-CoV-2 Infection [ Time Frame: From 7 days after Dose 2 up to 1 month after delivery ] 100 x (1-illness rate ratio [IRR]) (ratio of confirmed COVID-19 illness from 7 days after Dose 2 through 1 month after delivery per 1000 person-years of blinded follow-up in evaluable maternal participants with or without evidence of prior SARS-CoV-2 infection [prior to 7 days after receipt of Dose 2]) for BNT162b2 to the placebo group will be reported in this outcome measure. Results for this outcome measure will be posted by July 2024.
3.	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 [ Time Frame: Up to 1 month after delivery ] 100 × (1 - IRR) [ratio of incidence of asymptomatic infection per 1000 person-years of follow-up in the active vaccine group to the corresponding infection rate in the placebo group through 1 month after delivery in evaluable maternal participants without evidence of prior SARS-CoV-2 infection for BNT162b2 to the placebo group will be reported in this outcome measure. Results for this outcome measure will be posted by July 2024.
4.	Geometric Mean Concentration (GMCs) of Full-Length S-Binding Immunoglobulin G (IgG) Levels in Evaluable Maternal Participants [ Time Frame: Baseline (before Dose 1), 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery ] 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 will be reported in this outcome measure. Results for this outcome measure will be posted by July 2024.
5.	Geometric Mean Titer (GMTs) of SARS-CoV-2 Neutralizing Titers in Evaluable Maternal Participants [ Time Frame: Baseline (before Dose 1), 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery ] 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 will be reported in this outcome measure. Results for this outcome measure will be posted by July 2024.
6.	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 [ Time Frame: Baseline (before Dose 1), 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery ] 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 will be reported in this outcome measure. Results for this outcome measure will be posted by July 2024.
7.	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 [ Time Frame: Baseline (before Dose 1), 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery ] 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 will be reported in this outcome measure. Results for this outcome measure will be posted by July 2024.
8.	Percentage of Infant Participants Reporting Specific Birth Outcomes [ Time Frame: At birth ] Percentage of infant participants reporting specific birth outcomes (normal, congenital malformation/anomaly, other neonatal problems) were reported in this outcome measure.
9.	Percentage of Infant Participants Reporting Adverse Events From Birth Through 1 Month of Age [ Time Frame: 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.
10.	Percentage of Infant Participants Reporting Serious Adverse Events (SAE) From Birth Through 6 Months of Age [ Time Frame: 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.
11.	Percentage of Infant Participants Reporting Adverse Event of Special Interest (AESI) From Birth Through 6 Months of Age [ Time Frame: 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.
12.	GMCs of Full-Length S-Binding IgG Levels at Birth and 6 Months of Age in Infant Participants Born to Evaluable Maternal Participants [ Time Frame: At birth and 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 will be reported in this outcome measure. Results for this outcome measure will be posted by July 2024.
13.	GMFR of Full-Length S-Binding IgG Levels From Birth to 6 Months of Age in Infant Participants Born to Evaluable Maternal Participants [ Time Frame: From birth to 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 will be reported in this outcome measure. Results for this outcome measure will be posted by July 2024.

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	Female
Gender Based:	Yes
Accepts Healthy Volunteers:	Yes
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.

Contacts/Locations


Study Officials:	Pfizer CT.gov Call Center Study Director Pfizer
Locations:	United States, Alabama
	Children's of Alabama Birmingham, Alabama, United States, 35233
	University of Alabama at Birmingham Women & Infant Center Birmingham, Alabama, United States, 35233
	University of Alabama at Birmingham/Center for Women's Reproductive Health Birmingham, Alabama, United States, 35233
	Velocity Clinical Research, Gulfport Mobile, Alabama, United States, 36608
	United States, Arizona
	Arrowhead Hospital Glendale, Arizona, United States, 85308
	Abrazo West Campus Hospital Goodyear, Arizona, United States, 85395
	St. Joseph Hospital Phoenix, Arizona, United States, 85013
	MedPharmics, LLC Phoenix, Arizona, United States, 85015
	United States, California
	Matrix Clinical Research. Huntington Park, California, United States, 90255
	Matrix Clinical Research Huntington Park, California, United States, 90255
	Chemidox Clinical Trials Inc. Lancaster, California, United States, 93534
	East LA Doctors Hospital Los Angeles, California, United States, 90023
	Matrix Clinical Research Los Angeles, California, United States, 90057
	United States, Florida
	Axcess Medical Research Loxahatchee Groves, Florida, United States, 33470
	United States, Idaho
	Idaho Falls Pediatrics Ammon, Idaho, United States, 83406
	Bingham Memorial Hospital Blackfoot, Idaho, United States, 83221
	Idaho Falls Pediatrics Idaho Falls, Idaho, United States, 83402
	Clinical Research Prime Idaho Falls, Idaho, United States, 83404
	Eastern Idaho Regional Medical Center Idaho Falls, Idaho, United States, 83404
	Mountain View Hospital Idaho Falls, Idaho, United States, 83404
	United States, Michigan
	Covenant Healthcare Saginaw, Michigan, United States, 48604
	Saginaw Valley Medical Research Group, LLC Saginaw, Michigan, United States, 48604
	United States, Montana
	Community Hospital of Anaconda Anaconda, Montana, United States, 59711
	Boeson Research (BUT) Butte, Montana, United States, 59701
	SCL St. James Healthcare Hospital Butte, Montana, United States, 59701
	Marcus Daly Memorial Hospital Hamilton, Montana, United States, 59840
	Providence St. Patrick Hospital Missoula, Montana, United States, 59802
	The Birth Center Missoula, Montana, United States, 59803
	Boeson Research Missoula, Montana, United States, 59804
	Community Medical Center Missoula, Montana, United States, 59804
	Community Physicians Group-Maternal Fetal Medicine Missoula, Montana, United States, 59804
	St. Luke Community Healthcare Hospital Ronan, Montana, United States, 59864
	United States, Nebraska
	Meridian Clinical Research, LLC Hastings, Nebraska, United States, 68901
	Meridian Clinical Research, LLC Norfolk, Nebraska, United States, 68701
	United States, Pennsylvania
	Allegheny Health and Wellness Pavilion Erie, Pennsylvania, United States, 16506
	OBGYN Associates of Erie Erie, Pennsylvania, United States, 16507
	Central Erie Primary Care Erie, Pennsylvania, United States, 16508
	Liberty Family Practice Erie, Pennsylvania, United States, 16508
	Saint Vincent Hospital Erie, Pennsylvania, United States, 16544
	United States, Texas
	St. David's Medical Center Austin, Texas, United States, 78705
	Tekton Research, Inc. Austin, Texas, United States, 78705
	Tekton Research, Inc. Austin, Texas, United States, 78745
	Texas Health Harris Methodist Hospital Hurst-Euless-Bedford Bedford, Texas, United States, 76022
	Ventavia Research Group LLC Dallas, Texas, United States, 75231
	DHR Health Institute for Research and Development Edinburg, Texas, United States, 78539
	8th Avenue Obstetrics & Gynecology Fort Worth, Texas, United States, 76104
	Baylor Scott & White All Saints Medical Center Fort Worth, Texas, United States, 76104
	Ventavia Research Group, LLC Fort Worth, Texas, United States, 76104
	Dr. Ruben Aleman & Associates McAllen, Texas, United States, 78504
	Ventavia Research Group, LLC Plano, Texas, United States, 75093
	Ventavia Research Group, LLC Weatherford, Texas, United States, 76086
	Weatherford OBGYN Weatherford, Texas, United States, 76086
	United States, Utah
	University of Utah Hospital Salt Lake City, Utah, United States, 84132
	University of Utah Salt Lake City, Utah, United States, 84132
	United States, Virginia
	The Group for Women- MAWC Norfolk, Virginia, United States, 23502
	Tidewater Physicians for Women- MAWC Norfolk, Virginia, United States, 23502
	Brazil, Minas Gerais
	Faculdade de Medicina da Universidade Federal de Minas Gerais Belo Horizonte, Minas Gerais, Brazil, 30.130-100
	Hospital das Clínicas da Universidade Federal de Minas Gerais Belo Horizonte, Minas Gerais, Brazil, 30130-100
	Brazil, SAO Paulo
	Hospital Santa Casa de Misericordia de Sorocaba Sorocaba, SAO Paulo, Brazil, 18013-000
	Unimed Sorocaba-Hospital Dr. Miguel Soeiro (HMS) Sorocaba, SAO Paulo, Brazil, 18052-210
	Brazil, SP
	Clinica de Alergia Martti Antila S/S Ltda./ CMPC - Consultoria Medica e Pesquisa Clinica Sorocaba, SP, Brazil, 18040-425
	Brazil, SÃO Paulo
	HMU SBC - Hospital Municipal Universitário de São Bernardo São Bernardo do Campo, SÃO Paulo, Brazil, 09624-000
	CEMEC - Centro Multidisciplinar de Estudos Clínicos São Bernardo do Campo, SÃO Paulo, Brazil, 09715 - 090
	South Africa, Gauteng
	WorthWhile Clinical Trials Benoni, Gauteng, South Africa, 1500
	Wits Reproductive Health and HIV Institute (Wits RHI) Shandukani Research Centre Johannesburg, Gauteng, South Africa, 2001
	Botho Ke Bontle Health Services Pretoria, Gauteng, South Africa, 0122
	Vaccines and Infectious Diseases Analytics (VIDA) Soweto, Gauteng, South Africa, 2013
	South Africa, Western CAPE
	Dr Tobias de Villiers Cape Town, Western CAPE, South Africa, 7500
	Tiervlei Trial Centre CC Cape Town, Western CAPE, South Africa, 7530
	Spain
	Hospital Universitari Vall d'Hebron Barcelona, Spain, 08035
	Hospital de la Santa Creu i Sant Pau Barcelona, Spain, 08041
	Clinica Diagonal Barcelona, Spain, 08950
	Hospital Madrid Puerta del Sur Mostoles Mostoles, Spain, 28938
	Instituto Hispalense de Pediatria- IHP1 Sevilla, Spain, 41012
	Hospital Materno-Infantil Quirón Sevilla, Spain, 41013
	Servicio de Ginecología del Hospital Quirón Salud Sagrado Corazón Sevilla, Spain, 41013
	Spain, Madrid
	Hospital Universitario HM Monteprincipe Boadilla del Monte, Madrid, Spain, 28660
	Spain, Malaga
	Hospital de Antequera Antequera, Malaga, Spain, 29200
	United Kingdom
	Leeds Teaching Hospitals NHS Trust Leeds, United Kingdom, LS9 7TF
	University College London Hospitals London, United Kingdom, NW1 2PG
	University College London Hospitals London, United Kingdom, W1T 7HA
	University College London Hospitals London, United Kingdom, WC1E 6EB
	Royal Victoria Infirmary Newcastle upon Tyne, United Kingdom, NE1 4LP
	John Radcliffe Hospital Oxford, United Kingdom, OX3 9DU
	United Kingdom, Hampshire
	Hampshire Research Hub, Royal South Hants Hospital Southampton, Hampshire, United Kingdom, SO14 0YG
	University Hospital Southampton NHS Foundation Trust Southampton, Hampshire, United Kingdom, SO16 6YD
	United Kingdom, Kent
	Medway NHS Foundation Trust Gillingham, Kent, United Kingdom, ME7 5NY

IPDSharing


Plan to Share IPD:	No

References


Links:	URL: https://pmiform.com/clinical-trial-info-request?StudyID=C4591015 Description: To obtain contact information for a study center near you, click here.
Available IPD/Information:

Document Section


	Study Protocol Document Date: March 8, 2022 Uploaded: 07/14/2023 09:06 File Name: Prot_000.pdf
	Statistical Analysis Plan Document Date: March 31, 2022 Uploaded: 07/14/2023 09:06 File Name: SAP_001.pdf

Participant Flow

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).

Pre-assignment Details

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.

Arm/Group Title

Maternal Participants: BNT162b2 30 mcg

Maternal Participants: Placebo Then BNT162b2 30 mcg

Infant Participants: BNT162b2 30 mcg

Infant Participants: Placebo

Arm/Group Description

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.

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.

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.

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.

Period Title: Blinded Period

Started

174

Vaccination 1

173

Vaccination 2

170

Completed

161

159

Not Completed

Reason Not Completed

Withdrawal by Subject

Protocol Violation

Lost to Follow-up

Unblinded before 1-month postdelivery visit

Period Title: Unblinded Period

Started

167^[1]

162^[2]

Vaccination 3

152

Vaccination 4

148

Completed

151

147

Not Completed

Reason Not Completed

Withdrawal by Subject

Lost to Follow-up

Protocol Violation

Other

[1]	6 participants unblinded before 1-month post delivery are also included.
[2]	3 participants unblinded before 1-month post delivery are also included.

Period Title: Infant Participants

Started

167

168

Completed

152

139

Not Completed

Reason Not Completed

Withdrawal by Subject

Lost to Follow-up

Death

Other

Baseline Characteristics


Arm/Group Title		Maternal Participants: BNT162b2 30 mcg	Maternal Participants: Placebo Then BNT162b2 30 mcg	Infant Participants: BNT162b2 30 mcg	Infant Participants: Placebo	Total
Arm/Group Description		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.	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.	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.	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.	Total of all reporting groups
Overall Number of Baseline Participants		173	173	167	168	681
Baseline Analysis Population Description
Age, Customized Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	173 Participants	173 Participants	167 Participants	168 Participants	681 Participants
	Less than (<) 18 years	0 0%	0 0%	167 100%	168 100%	335 49.19%
	Greater than or equal to (>=) 18 and <= 45 years	173 100%	173 100%	0 0%	0 0%	346 50.81%
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	173 Participants	173 Participants	167 Participants	168 Participants	681 Participants
	Female	173 100%	173 100%	85 50.9%	73 43.45%	504 74.01%
	Male	0 0%	0 0%	82 49.1%	95 56.55%	177 25.99%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	173 Participants	173 Participants	167 Participants	168 Participants	681 Participants
	Hispanic or Latino	70 40.46%	63 36.42%	65 38.92%	60 35.71%	258 37.89%
	Not Hispanic or Latino	103 59.54%	110 63.58%	98 58.68%	104 61.9%	415 60.94%
	Unknown or Not Reported	0 0%	0 0%	4 2.4%	4 2.38%	8 1.17%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	173 Participants	173 Participants	167 Participants	168 Participants	681 Participants
	American Indian or Alaska Native	1 0.58%	1 0.58%	1 0.6%	2 1.19%	5 0.73%
	Asian	5 2.89%	9 5.2%	3 1.8%	7 4.17%	24 3.52%
	Native Hawaiian or Other Pacific Islander	0 0%	1 0.58%	0 0%	0 0%	1 0.15%
	Black or African American	47 27.17%	43 24.86%	40 23.95%	40 23.81%	170 24.96%
	White	117 67.63%	118 68.21%	115 68.86%	104 61.9%	454 66.67%
	More than one race	1 0.58%	0 0%	0 0%	6 3.57%	7 1.03%
	Unknown or Not Reported	2 1.16%	1 0.58%	8 4.79%	9 5.36%	20 2.94%

Outcome Measures

1. Primary Outcome:

Title

Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1

Description

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.

Time Frame

From Day 1 to Day 7 after dose 1

Outcome Measure Data

Analysis Population Description

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. Human immunodeficiency virus (HIV) positive participants were excluded from analysis as pre-specified in the statistical analysis plan (SAP).


Arm/Group Title	Maternal Participants: BNT162b2 30 mcg	Maternal Participants: Placebo
Arm/Group Description	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.	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.
Overall Number of Participants Analyzed	161	163
Number (95% Confidence Interval) Unit of Measure: Percentage of participants
Redness: Mild	2.5(0.7 to 6.2)	0.6(0.0 to 3.4)
Redness: Moderate	0.6(0.0 to 3.4)	0(0.0 to 2.2)
Redness: Severe	0(0.0 to 2.3)	0(0.0 to 2.2)
Redness: Grade 4	0(0.0 to 2.3)	0(0.0 to 2.2)
Swelling: Mild	4.3(1.8 to 8.8)	0(0.0 to 2.2)
Swelling: Moderate	0.6(0.0 to 3.4)	0(0.0 to 2.2)
Swelling: Severe	0.6(0.0 to 3.4)	0(0.0 to 2.2)
Swelling: Grade 4	0(0.0 to 2.3)	0(0.0 to 2.2)
Pain at the injection site: Mild	59.0(51.0 to 66.7)	9.8(5.7 to 15.5)
Pain at the injection site: Moderate	23.6(17.3 to 30.9)	0(0.0 to 2.2)
Pain at the injection site: Severe	0(0.0 to 2.3)	0(0.0 to 2.2)
Pain at the injection site: Grade 4	0(0.0 to 2.3)	0(0.0 to 2.2)

2. Primary Outcome:

Title

Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2

Description

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.

Time Frame

From Day 1 to Day 7 after dose 2

Outcome Measure Data

Analysis Population Description

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.


Arm/Group Title	Maternal Participants: BNT162b2 30 mcg	Maternal Participants: Placebo
Arm/Group Description	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.	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.
Overall Number of Participants Analyzed	148	146
Number (95% Confidence Interval) Unit of Measure: Percentage of participants
Redness: Mild	3.4(1.1 to 7.7)	0(0.0 to 2.5)
Redness: Moderate	2.0(0.4 to 5.8)	0(0.0 to 2.5)
Redness: Severe	0(0.0 to 2.5)	0(0.0 to 2.5)
Redness: Grade 4	0(0.0 to 2.5)	0(0.0 to 2.5)
Swelling: Mild	4.1(1.5 to 8.6)	0.7(0.0 to 3.8)
Swelling: Moderate	2.7(0.7 to 6.8)	0(0.0 to 2.5)
Swelling: Severe	0(0.0 to 2.5)	0(0.0 to 2.5)
Swelling: Grade 4	0(0.0 to 2.5)	0(0.0 to 2.5)
Pain at the injection site: Mild	54.7(46.3 to 62.9)	12.3(7.5 to 18.8)
Pain at the injection site: Moderate	19.6(13.5 to 26.9)	4.1(1.5 to 8.7)
Pain at the injection site: Severe	0.7(0.0 to 3.7)	0(0.0 to 2.5)
Pain at the injection site: Grade 4	0(0.0 to 2.5)	0(0.0 to 2.5)

3. Primary Outcome:

Title

Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1

Description

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.

Time Frame

From Day 1 to Day 7 after dose 1

Outcome Measure Data

Analysis Population Description

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.


Arm/Group Title	Maternal Participants: BNT162b2 30 mcg	Maternal Participants: Placebo
Arm/Group Description	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.	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.
Overall Number of Participants Analyzed	161	163
Number (95% Confidence Interval) Unit of Measure: Percentage of participants
Fever: >=38.0 to 38.4 deg C (100.4 to 101.1 deg Fahrenheit [F])	0.6(0.0 to 3.4)	1.2(0.1 to 4.4)
Fever: >38.4 to 38.9 deg C (101.2 to 102.0 deg F)	0(0.0 to 2.3)	0(0.0 to 2.2)
Fever: >38.9 to 40.0 deg C (102.1 to 104.0 deg F)	0.6(0.0 to 3.4)	0.6(0.0 to 3.4)
Fever: >40 deg C (>104.0 deg F)	0(0.0 to 2.3)	0(0.0 to 2.2)
Fatigue/tiredness: Mild	26.1(19.5 to 33.6)	20.9(14.9 to 27.9)
Fatigue/tiredness: Moderate	23.0(16.7 to 30.3)	21.5(15.4 to 28.6)
Fatigue/tiredness: Severe	0.6(0.0 to 3.4)	0.6(0.0 to 3.4)
Fatigue/tiredness: Grade 4	0(0.0 to 2.3)	0(0.0 to 2.2)
Headache: Mild	20.5(14.5 to 27.6)	22.1(16.0 to 29.2)
Headache: Moderate	11.8(7.3 to 17.8)	12.9(8.2 to 19.0)
Headache: Severe	1.9(0.4 to 5.3)	0.6(0.0 to 3.4)
Headache: Grade 4	0(0.0 to 2.3)	0(0.0 to 2.2)
Chills: Mild	5.0(2.2 to 9.6)	5.5(2.6 to 10.2)
Chills: Moderate	1.9(0.4 to 5.3)	0(0.0 to 2.2)
Chills: Severe	0(0.0 to 2.3)	0(0.0 to 2.2)
Chills: Grade 4	0(0.0 to 2.3)	0(0.0 to 2.2)
Vomiting: Mild	5.0(2.2 to 9.6)	6.1(3.0 to 11.0)
Vomiting: Moderate	0(0.0 to 2.3)	3.1(1.0 to 7.0)
Vomiting: Severe	0(0.0 to 2.3)	0(0.0 to 2.2)
Vomiting: Grade 4	0(0.0 to 2.3)	0(0.0 to 2.2)
Diarrhea: Mild	11.2(6.8 to 17.1)	7.4(3.9 to 12.5)
Diarrhea: Moderate	0.6(0.0 to 3.4)	1.2(0.1 to 4.4)
Diarrhea: Severe	0(0.0 to 2.3)	0(0.0 to 2.2)
Diarrhea: Grade 4	0(0.0 to 2.3)	0(0.0 to 2.2)
New or worsened muscle pain: Mild	6.8(3.5 to 11.9)	6.1(3.0 to 11.0)
New or worsened muscle pain: Moderate	5.6(2.6 to 10.3)	5.5(2.6 to 10.2)
New or worsened muscle pain: Severe	0(0.0 to 2.3)	0(0.0 to 2.2)
New or worsened muscle pain: Grade 4	0(0.0 to 2.3)	0(0.0 to 2.2)
New or worsened joint pain: Mild	1.2(0.2 to 4.4)	2.5(0.7 to 6.2)
New or worsened joint pain: Moderate	1.9(0.4 to 5.3)	2.5(0.7 to 6.2)
New or worsened joint pain: Severe	0(0.0 to 2.3)	0(0.0 to 2.2)
New or worsened joint pain: Grade 4	0(0.0 to 2.3)	0(0.0 to 2.2)

4. Primary Outcome:

Title

Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2

Description

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.

Time Frame

From Day 1 to Day 7 after dose 2

Outcome Measure Data

Analysis Population Description

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.


Arm/Group Title	Maternal Participants: BNT162b2 30 mcg	Maternal Participants: Placebo
Arm/Group Description	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.	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.
Overall Number of Participants Analyzed	148	146
Number (95% Confidence Interval) Unit of Measure: Percentage of participants
Fever: >=38.0 to 38.4 deg C (100.4 to 101.1 deg F)	1.4(0.2 to 4.8)	0.7(0.0 to 3.8)
Fever: >38.4 to 38.9 deg C (101.2 to 102.0 deg F)	0.7(0.0 to 3.7)	0(0.0 to 2.5)
Fever: >38.9 to 40.0 deg C (102.1 to 104.0 deg F)	0(0.0 to 2.5)	0(0.0 to 2.5)
Fever: >40 deg C (>104.0 deg F)	0(0.0 to 2.5)	0(0.0 to 2.5)
Fatigue/tiredness: Mild	15.5(10.1 to 22.4)	15.8(10.3 to 22.7)
Fatigue/tiredness: Moderate	32.4(25.0 to 40.6)	18.5(12.6 to 25.8)
Fatigue/tiredness: Severe	2.0(0.4 to 5.8)	0(0.0 to 2.5)
Fatigue/tiredness: Grade 4	0(0.0 to 2.5)	0(0.0 to 2.5)
Headache: Mild	25.0(18.3 to 32.8)	13.7(8.6 to 20.4)
Headache: Moderate	14.9(9.6 to 21.6)	10.3(5.9 to 16.4)
Headache: Severe	1.4(0.2 to 4.8)	0(0.0 to 2.5)
Headache: Grade 4	0(0.0 to 2.5)	0(0.0 to 2.5)
Chills: Mild	4.7(1.9 to 9.5)	0.7(0.0 to 3.8)
Chills: Moderate	7.4(3.8 to 12.9)	0(0.0 to 2.5)
Chills: Severe	0.7(0.0 to 3.7)	0(0.0 to 2.5)
Chills: Grade 4	0(0.0 to 2.5)	0(0.0 to 2.5)
Vomiting: Mild	8.8(4.8 to 14.6)	2.1(0.4 to 5.9)
Vomiting: Moderate	0(0.0 to 2.5)	1.4(0.2 to 4.9)
Vomiting: Severe	0(0.0 to 2.5)	0(0.0 to 2.5)
Vomiting: Grade 4	0(0.0 to 2.5)	0(0.0 to 2.5)
Diarrhea: Mild	6.1(2.8 to 11.2)	4.1(1.5 to 8.7)
Diarrhea: Moderate	0(0.0 to 2.5)	1.4(0.2 to 4.9)
Diarrhea: Severe	0(0.0 to 2.5)	0(0.0 to 2.5)
Diarrhea: Grade 4	0(0.0 to 2.5)	0(0.0 to 2.5)
New or worsened muscle pain: Mild	13.5(8.5 to 20.1)	4.8(1.9 to 9.6)
New or worsened muscle pain: Moderate	12.8(7.9 to 19.3)	2.1(0.4 to 5.9)
New or worsened muscle pain: Severe	0.7(0.0 to 3.7)	0(0.0 to 2.5)
New or worsened muscle pain: Grade 4	0(0.0 to 2.5)	0(0.0 to 2.5)
New or worsened joint pain: Mild	7.4(3.8 to 12.9)	4.8(1.9 to 9.6)
New or worsened joint pain: Moderate	6.1(2.8 to 11.2)	1.4(0.2 to 4.9)
New or worsened joint pain: Severe	0(0.0 to 2.5)	0(0.0 to 2.5)
New or worsened joint pain: Grade 4	0(0.0 to 2.5)	0(0.0 to 2.5)

5. Primary Outcome:

Title

Percentage of Maternal Participants With Adverse Events (AEs) From Dose 1 Through 1 Month After Dose 2 - Blinded Follow-up Period

Description

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.

Time Frame

From dose 1 on Day 1 through 1 month after dose 2 (approximately 2 months)

Outcome Measure Data

Analysis Population Description

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.


Arm/Group Title	Maternal Participants: BNT162b2 30 mcg	Maternal Participants: Placebo
Arm/Group Description	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.	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.
Overall Number of Participants Analyzed	161	163
Number (95% Confidence Interval) Unit of Measure: Percentage of participants	23.6(17.3 to 30.9)	22.7(16.5 to 29.9)

6. Primary Outcome:

Title

Percentage of Maternal Participants Reporting Serious Adverse Events (SAEs) From Dose 1 Through 1 Month After Delivery - Blinded Follow-up Period

Description

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.

Time Frame

From dose 1 on Day 1 through 1 month after delivery

Quality Control Review Comment provided by the National Library of Medicine:

There does not appear to be sufficient information to understand the Time Frame.

Outcome Measure Data

Analysis Population Description

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.


Arm/Group Title	Maternal Participants: BNT162b2 30 mcg	Maternal Participants: Placebo
Arm/Group Description	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.	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.
Overall Number of Participants Analyzed	161	163
Number (95% Confidence Interval) Unit of Measure: Percentage of participants	13.0(8.3 to 19.2)	14.1(9.2 to 20.4)

7. Primary Outcome:


Title	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 Maternal Participants Without Evidence of Prior SARS-CoV-2 Infection
Description	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 maternal participants without evidence of prior SARS-CoV-2 infection will be reported in this outcome measure. Results for this outcome measure will be posted by July 2024.
Time Frame	1 Month after Dose 2
Anticipated Reporting Date	July 2024
Quality Control Review Comment provided by the National Library of Medicine: Required information appears to be missing.
Outcome Measure Data Not Reported

8. Primary Outcome:


Title	GMR of SARS-CoV-2 Neutralizing Titers in Pregnant Women to Those in Nonpregnant Women From Study C4591001 (NCT04368728) for Evaluable Maternal Participants With and Without Evidence of Prior SARS-CoV-2 Infection
Description	GMR of SARS-CoV-2 neutralizing titers in pregnant women to those in nonpregnant women from study C4591001 (NCT04368728) for evaluable maternal participants with and without evidence of prior SARS-CoV-2 infection will be reported in this outcome measure. Results for this outcome measure will be posted by July 2024.
Time Frame	1 Month after Dose 2
Anticipated Reporting Date	July 2024
Quality Control Review Comment provided by the National Library of Medicine: Required information appears to be missing.
Outcome Measure Data Not Reported

9. Secondary Outcome:


Title	COVID-19 Incidence Per 1000 Person-Years of Blinded Follow-Up in Evaluable Maternal Participants Without Evidence of Prior SARS-CoV-2 Infection
Description	100 x (1-illness rate ratio [IRR]) (ratio of confirmed COVID-19 illness from 7 days after Dose 2 through 1 month after delivery per 1000 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]) for BNT162b2 to the placebo group will be reported in this outcome measure. Results for this outcome measure will be posted by July 2024.
Time Frame	From 7 days after Dose 2 up to 1 month after delivery
Anticipated Reporting Date	July 2024
Outcome Measure Data Not Reported

10. Secondary Outcome:


Title	COVID-19 Incidence Per 1000 Person-Years of Blinded Follow-Up in Evaluable Maternal Participants With or Without Evidence of Prior SARS-CoV-2 Infection
Description	100 x (1-illness rate ratio [IRR]) (ratio of confirmed COVID-19 illness from 7 days after Dose 2 through 1 month after delivery per 1000 person-years of blinded follow-up in evaluable maternal participants with or without evidence of prior SARS-CoV-2 infection [prior to 7 days after receipt of Dose 2]) for BNT162b2 to the placebo group will be reported in this outcome measure. Results for this outcome measure will be posted by July 2024.
Time Frame	From 7 days after Dose 2 up to 1 month after delivery
Anticipated Reporting Date	July 2024
Outcome Measure Data Not Reported

11. Secondary Outcome:


Title	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
Description	100 × (1 - IRR) [ratio of incidence of asymptomatic infection per 1000 person-years of follow-up in the active vaccine group to the corresponding infection rate in the placebo group through 1 month after delivery in evaluable maternal participants without evidence of prior SARS-CoV-2 infection for BNT162b2 to the placebo group will be reported in this outcome measure. Results for this outcome measure will be posted by July 2024.
Time Frame	Up to 1 month after delivery
Anticipated Reporting Date	July 2024
Outcome Measure Data Not Reported

12. Secondary Outcome:


Title	Geometric Mean Concentration (GMCs) of Full-Length S-Binding Immunoglobulin G (IgG) Levels in Evaluable Maternal Participants
Description	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 will be reported in this outcome measure. Results for this outcome measure will be posted by July 2024.
Time Frame	Baseline (before Dose 1), 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery
Anticipated Reporting Date	July 2024
Outcome Measure Data Not Reported

13. Secondary Outcome:


Title	Geometric Mean Titer (GMTs) of SARS-CoV-2 Neutralizing Titers in Evaluable Maternal Participants
Description	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 will be reported in this outcome measure. Results for this outcome measure will be posted by July 2024.
Time Frame	Baseline (before Dose 1), 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery
Anticipated Reporting Date	July 2024
Outcome Measure Data Not Reported

14. Secondary Outcome:


Title	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
Description	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 will be reported in this outcome measure. Results for this outcome measure will be posted by July 2024.
Time Frame	Baseline (before Dose 1), 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery
Anticipated Reporting Date	July 2024
Outcome Measure Data Not Reported

15. Secondary Outcome:


Title	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
Description	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 will be reported in this outcome measure. Results for this outcome measure will be posted by July 2024.
Time Frame	Baseline (before Dose 1), 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery
Anticipated Reporting Date	July 2024
Outcome Measure Data Not Reported

16. Secondary Outcome:

Title

Percentage of Infant Participants Reporting Specific Birth Outcomes

Description

Percentage of infant participants reporting specific birth outcomes (normal, congenital malformation/anomaly, other neonatal problems) were reported in this outcome measure.

Time Frame

At birth

Outcome Measure Data

Analysis Population Description

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.


Arm/Group Title	Infant Participants: BNT162b2 30 mcg	Infant Participants: Placebo
Arm/Group Description	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.	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.
Overall Number of Participants Analyzed	167	168
Number (95% Confidence Interval) Unit of Measure: Percentage of participants
Normal	91.6(86.3 to 95.3)	89.3(83.6 to 93.5)
Congenital malformation/anomaly	6.0(2.9 to 10.7)	3.6(1.3 to 7.6)
Other neonatal problem	1.8(0.4 to 5.2)	6.5(3.3 to 11.4)

17. Secondary Outcome:

Title

Percentage of Infant Participants Reporting Adverse Events From Birth Through 1 Month of Age

Description

Time Frame

From birth through 1 month of age

Outcome Measure Data

Analysis Population Description

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.


Arm/Group Title	Infant Participants: BNT162b2 30 mcg	Infant Participants: Placebo
Arm/Group Description	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.	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.
Overall Number of Participants Analyzed	156	159
Number (95% Confidence Interval) Unit of Measure: Percentage of participants	35.3(27.8 to 43.3)	37.1(29.6 to 45.1)

18. Secondary Outcome:

Title

Percentage of Infant Participants Reporting Serious Adverse Events (SAE) From Birth Through 6 Months of Age

Description

Time Frame

From birth through 6 months of age

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Infant Participants: BNT162b2 30 mcg	Infant Participants: Placebo
Arm/Group Description	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.	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.
Overall Number of Participants Analyzed	156	159
Number (95% Confidence Interval) Unit of Measure: Percentage of participants	13.5(8.5 to 19.8)	15.1(9.9 to 21.6)

19. Secondary Outcome:

Title

Percentage of Infant Participants Reporting Adverse Event of Special Interest (AESI) From Birth Through 6 Months of Age

Description

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.

Time Frame

From birth through 6 months of age

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Infant Participants: BNT162b2 30 mcg	Infant Participants: Placebo
Arm/Group Description	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.	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.
Overall Number of Participants Analyzed	156	159
Number (95% Confidence Interval) Unit of Measure: Percentage of participants	5.1(2.2 to 9.9)	1.3(0.2 to 4.5)

20. Secondary Outcome:


Title	GMCs of Full-Length S-Binding IgG Levels at Birth and 6 Months of Age in Infant Participants Born to Evaluable Maternal Participants
Description	GMCs of full-length S-binding IgG levels at birth and 6 months of age in infant participants born to evaluable maternal participants will be reported in this outcome measure. Results for this outcome measure will be posted by July 2024.
Time Frame	At birth and 6 months of age
Anticipated Reporting Date	July 2024
Outcome Measure Data Not Reported

21. Secondary Outcome:


Title	GMFR of Full-Length S-Binding IgG Levels From Birth to 6 Months of Age in Infant Participants Born to Evaluable Maternal Participants
Description	GMFR of full-length S-binding IgG levels from birth to 6 months of age in infant participants born to evaluable maternal participants will be reported in this outcome measure. Results for this outcome measure will be posted by July 2024.
Time Frame	From birth to 6 months of age
Anticipated Reporting Date	July 2024
Outcome Measure Data Not Reported

Adverse Events


Time Frame	Maternal participants-Local reactions/systemic events: From Day 1 to 7 after dose 1 and 2; SAEs: from dose 1 on Day 1 up to 6 months after delivery (BNT162b2 30 mcg)and up to 1 month after delivery (placebo); placebo then BNT162b2: from Dose 3 up to 1 month after Dose 4; other AEs: from dose 1 up to 1 month after dose 2 (approx 2 months); (placebo then BNT162b2): from Dose 3 up to 1 month after Dose 4. For infants-SAEs: from birth up to 6 months of age; other AEs: from birth up to 1 month of age
Adverse Event Reporting 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.
Quality Control Review Comment provided by the National Library of Medicine: There does not appear to be sufficient information to understand the Time Frame. The Time Frame appears inconsistent with information provided here or in other parts of the record.

Arm/Group Title	Maternal Participants: BNT162b2 30 mcg	Maternal Participants: Placebo	Maternal Participants: Placebo Then BNT162b2	Infant Participants: BNT162b2 30 mcg	Infant Participants: Placebo	HIV Positive Maternal Participants: BNT162b2 30 mcg	HIV Positive Maternal Participants: Placebo	HIV Positive Maternal Participants: Placebo Then BNT162b2	HIV Positive Infant Participants: BNT162b2 30 mcg	HIV Positive Infant Participants: Placebo
Arm/Group Description	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.
Quality Control Review Comment provided by the National Library of Medicine: The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided.
All-Cause Mortality
	Maternal Participants: BNT162b2 30 mcg	Maternal Participants: Placebo	Maternal Participants: Placebo Then BNT162b2	Infant Participants: BNT162b2 30 mcg	Infant Participants: Placebo	HIV Positive Maternal Participants: BNT162b2 30 mcg	HIV Positive Maternal Participants: Placebo	HIV Positive Maternal Participants: Placebo Then BNT162b2	HIV Positive Infant Participants: BNT162b2 30 mcg	HIV Positive Infant Participants: Placebo
	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)
Total	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	1 / 159 (0.63%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	1 / 11 (9.09%)	0 / 9 (0%)
Serious Adverse Events
	Maternal Participants: BNT162b2 30 mcg	Maternal Participants: Placebo	Maternal Participants: Placebo Then BNT162b2	Infant Participants: BNT162b2 30 mcg	Infant Participants: Placebo	HIV Positive Maternal Participants: BNT162b2 30 mcg	HIV Positive Maternal Participants: Placebo	HIV Positive Maternal Participants: Placebo Then BNT162b2	HIV Positive Infant Participants: BNT162b2 30 mcg	HIV Positive Infant Participants: Placebo
	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)
Total	21 / 161 (13.04%)	23 / 163 (14.11%)	0 / 144 (0%)	21 / 156 (13.46%)	24 / 159 (15.09%)	2 / 12 (16.67%)	4 / 10 (40%)	0 / 8 (0%)	1 / 11 (9.09%)	2 / 9 (22.22%)
Blood and lymphatic system disorders
Anemia ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	1 / 12 (8.33%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Coagulopathy ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	1 / 159 (0.63%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Thrombocytopenia ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	1 / 159 (0.63%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Cardiac disorders
Bradycardia fetal ^{∗ A}	1 / 161 (0.62%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Non reassuring fetal heart rate pattern ^{∗ A}	0 / 161 (0%)	2 / 163 (1.23%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Congenital, familial and genetic disorders
Ankyloglossia congenital ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	2 / 159 (1.26%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Atrial septal defect ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	3 / 156 (1.92%)	1 / 159 (0.63%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Congenital rubella syndrome ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	1 / 156 (0.64%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Congenital skin dimples ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	1 / 159 (0.63%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
DiGeorge's syndrome ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	1 / 156 (0.64%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Microcephaly ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	1 / 156 (0.64%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Mucopolysaccharidosis ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	1 / 156 (0.64%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Patent ductus arteriosus ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	1 / 159 (0.63%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Polydactyly ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	1 / 156 (0.64%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Syndactyly ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	1 / 156 (0.64%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Trisomy 21 ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	1 / 156 (0.64%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Ventricular septal defect ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	1 / 159 (0.63%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Gastrointestinal disorders
Abdominal wall haematoma ^{∗ A}	1 / 161 (0.62%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Allergic colitis ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	1 / 156 (0.64%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Allergic gastroenteritis ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	1 / 156 (0.64%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Dysphagia ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	1 / 159 (0.63%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Intestinal perforation ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	1 / 159 (0.63%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Meconium plug syndrome ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	1 / 159 (0.63%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Pneumoperitoneum ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	1 / 159 (0.63%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Hepatobiliary disorders
Cholelithiasis ^{∗ A}	0 / 161 (0%)	1 / 163 (0.61%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Hyperbilirubinaemia neonatal ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	1 / 159 (0.63%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Infections and infestations
Bronchiolitis ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	2 / 156 (1.28%)	1 / 159 (0.63%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Endometritis ^{∗ A}	1 / 161 (0.62%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Gastroenteritis ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	1 / 9 (11.11%)
Lower respiratory tract infection ^{∗ A}	1 / 161 (0.62%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Neonatal pneumonia ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	1 / 156 (0.64%)	1 / 159 (0.63%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	1 / 9 (11.11%)
Pneumonia ^{∗ A}	0 / 161 (0%)	1 / 163 (0.61%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	1 / 11 (9.09%)	0 / 9 (0%)
Pneumonia respiratory syncytial viral ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	1 / 159 (0.63%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Pyelonephritis ^{∗ A}	1 / 161 (0.62%)	0 / 163 (0%)	0 / 144 (0%)	1 / 156 (0.64%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Pyelonephritis acute ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	1 / 156 (0.64%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Sepsis ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	1 / 159 (0.63%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Sepsis neonatal ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	2 / 159 (1.26%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Urinary tract infection ^{∗ A}	0 / 161 (0%)	1 / 163 (0.61%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	1 / 9 (11.11%)
Injury, poisoning and procedural complications
Injury to brachial plexus due to birth trauma ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	1 / 159 (0.63%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Traumatic intracranial hemorrhage ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	1 / 159 (0.63%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Urinary tract procedural complication ^{∗ A}	0 / 161 (0%)	1 / 163 (0.61%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Investigations
Cardiac murmur ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	1 / 156 (0.64%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Fetal heart rate abnormal ^{∗ A}	0 / 161 (0%)	1 / 163 (0.61%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Ultrasound fetal abnormal ^{∗ A}	0 / 161 (0%)	1 / 163 (0.61%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Metabolism and nutrition disorders
Dehydration ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	1 / 9 (11.11%)
Hypoglycemia neonatal ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	1 / 159 (0.63%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Metabolic acidosis ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	1 / 159 (0.63%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Musculoskeletal and connective tissue disorders
Osteoarthritis ^{∗ A}	1 / 161 (0.62%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Nervous system disorders
Coma ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	1 / 159 (0.63%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Encephalopathy neonatal ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	1 / 159 (0.63%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Hypoxic-ischemic encephalopathy ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	1 / 159 (0.63%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Nervous system disorder ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	1 / 156 (0.64%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Seizure ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	1 / 159 (0.63%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Superior sagittal sinus thrombosis ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	1 / 9 (11.11%)
Pregnancy, puerperium and perinatal conditions
Arrested labor ^{∗ A}	0 / 161 (0%)	1 / 163 (0.61%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Breech presentation ^{∗ A}	1 / 161 (0.62%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Caput succedaneum ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	1 / 159 (0.63%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Cephalo-pelvic disproportion ^{∗ A}	1 / 161 (0.62%)	3 / 163 (1.84%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	1 / 10 (10%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Failed induction of labor ^{∗ A}	1 / 161 (0.62%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Failed trial of labor ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	1 / 10 (10%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Fetal death ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	1 / 12 (8.33%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Fetal distress syndrome ^{∗ A}	3 / 161 (1.86%)	2 / 163 (1.23%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	1 / 12 (8.33%)	1 / 10 (10%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Fetal growth restriction ^{∗ A}	1 / 161 (0.62%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Fetal hypokinesia ^{∗ A}	1 / 161 (0.62%)	1 / 163 (0.61%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	1 / 10 (10%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Gestational hypertension ^{∗ A}	1 / 161 (0.62%)	1 / 163 (0.61%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Hemorrhage in pregnancy ^{∗ A}	1 / 161 (0.62%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Jaundice neonatal ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	7 / 156 (4.49%)	4 / 159 (2.52%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Low birth weight baby ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	1 / 156 (0.64%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Meconium in amniotic fluid ^{∗ A}	0 / 161 (0%)	1 / 163 (0.61%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Meconium stain ^{∗ A}	1 / 161 (0.62%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Omphalorrhexis ^{∗ A}	0 / 161 (0%)	1 / 163 (0.61%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Placental insufficiency ^{∗ A}	0 / 161 (0%)	1 / 163 (0.61%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Postpartum hemorrhage ^{∗ A}	0 / 161 (0%)	2 / 163 (1.23%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	1 / 12 (8.33%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Pre-eclampsia ^{∗ A}	4 / 161 (2.48%)	2 / 163 (1.23%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Premature baby ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	1 / 159 (0.63%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Premature separation of placenta ^{∗ A}	0 / 161 (0%)	3 / 163 (1.84%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	1 / 12 (8.33%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Preterm premature rupture of membranes ^{∗ A}	0 / 161 (0%)	1 / 163 (0.61%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Prolonged rupture of membranes ^{∗ A}	0 / 161 (0%)	1 / 163 (0.61%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Retained placenta or membranes ^{∗ A}	1 / 161 (0.62%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Small for dates baby ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	1 / 156 (0.64%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Weight decrease neonatal ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	1 / 159 (0.63%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Renal and urinary disorders
Renal tubular necrosis ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	1 / 159 (0.63%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Vesicoureteric reflux ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	1 / 156 (0.64%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Reproductive system and breast disorders
Uterine disorder ^{∗ A}	2 / 161 (1.24%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Respiratory, thoracic and mediastinal disorders
Hypoxia ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	1 / 159 (0.63%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Meconium aspiration syndrome ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	2 / 156 (1.28%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Neonatal pneumothorax ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	1 / 159 (0.63%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Neonatal respiratory distress ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	2 / 159 (1.26%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Neonatal respiratory distress syndrome ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	1 / 159 (0.63%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Neonatal respiratory failure ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	1 / 159 (0.63%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Pulmonary hypertension ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	1 / 159 (0.63%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Respiratory distress ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	1 / 159 (0.63%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Respiratory failure ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	1 / 159 (0.63%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Tachypnoea ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	1 / 159 (0.63%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Skin and subcutaneous tissue disorders
Pruritus ^{∗ A}	1 / 161 (0.62%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Vascular disorders
Deep vein thrombosis ^{∗ A}	1 / 161 (0.62%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Hypoperfusion ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	1 / 159 (0.63%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Hypotension ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	1 / 159 (0.63%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Shock ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	1 / 159 (0.63%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Subgaleal hemorrhage ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	1 / 159 (0.63%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
∗Indicates events were collected by non-systematic methods. ATerm from vocabulary, MedDRA v25.1
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	1%
	Maternal Participants: BNT162b2 30 mcg	Maternal Participants: Placebo	Maternal Participants: Placebo Then BNT162b2	Infant Participants: BNT162b2 30 mcg	Infant Participants: Placebo	HIV Positive Maternal Participants: BNT162b2 30 mcg	HIV Positive Maternal Participants: Placebo	HIV Positive Maternal Participants: Placebo Then BNT162b2	HIV Positive Infant Participants: BNT162b2 30 mcg	HIV Positive Infant Participants: Placebo
	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)	Affected / At Risk (%)
Total	143 / 161 (88.82%)	119 / 163 (73.01%)	21 / 144 (14.58%)	29 / 156 (18.59%)	33 / 159 (20.75%)	12 / 12 (100%)	10 / 10 (100%)	1 / 8 (12.5%)	1 / 11 (9.09%)	3 / 9 (33.33%)
Blood and lymphatic system disorders
Anemia ^{∗ A}	4 / 161 (2.48%)	2 / 163 (1.23%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	1 / 10 (10%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Cardiac disorders
Tachycardia ^{∗ A}	2 / 161 (1.24%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Congenital, familial and genetic disorders
Ankyloglossia congenital ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	1 / 156 (0.64%)	2 / 159 (1.26%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Congenital naevus ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	3 / 156 (1.92%)	1 / 159 (0.63%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Hydrocele ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	2 / 156 (1.28%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Polydactyly ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	1 / 9 (11.11%)
Gastrointestinal disorders
Abdominal pain ^{∗ A}	3 / 161 (1.86%)	3 / 163 (1.84%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Constipation ^{∗ A}	0 / 161 (0%)	2 / 163 (1.23%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Diarrhea (DIARRHEA) ^{† A}	24 / 161 (14.91%)	21 / 163 (12.88%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	3 / 12 (25%)	3 / 10 (30%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Dyspepsia ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	1 / 10 (10%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Gastroesophageal reflux disease ^{∗ A}	1 / 161 (0.62%)	2 / 163 (1.23%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Hemorrhoids ^{∗ A}	1 / 161 (0.62%)	2 / 163 (1.23%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Vomiting (VOMITING) ^{† A}	18 / 161 (11.18%)	16 / 163 (9.82%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	3 / 12 (25%)	1 / 10 (10%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
General disorders
Chills (CHILLS) ^{† A}	28 / 161 (17.39%)	10 / 163 (6.13%)	2 / 144 (1.39%)	0 / 156 (0%)	0 / 159 (0%)	1 / 12 (8.33%)	1 / 10 (10%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Erythema (REDNESS) ^{† A}	11 / 161 (6.83%)	1 / 163 (0.61%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Fatigue ^{∗ A}	0 / 161 (0%)	2 / 163 (1.23%)	3 / 144 (2.08%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Fatigue (FATIGUE) ^{† A}	101 / 161 (62.73%)	82 / 163 (50.31%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	8 / 12 (66.67%)	8 / 10 (80%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Hypothermia ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	1 / 156 (0.64%)	2 / 159 (1.26%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Injection site erythema ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	3 / 144 (2.08%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Injection site pain (PAIN AT INJECTION SITE) ^{† A}	138 / 161 (85.71%)	30 / 163 (18.4%)	13 / 144 (9.03%)	0 / 156 (0%)	0 / 159 (0%)	12 / 12 (100%)	4 / 10 (40%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Pain ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	3 / 144 (2.08%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Pyrexia ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	5 / 144 (3.47%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Pyrexia (FEVER) ^{† A}	6 / 161 (3.73%)	4 / 163 (2.45%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	1 / 10 (10%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Swelling (SWELLING) ^{† A}	17 / 161 (10.56%)	1 / 163 (0.61%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	1 / 12 (8.33%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Hepatobiliary disorders
Hyperbilirubinemia neonatal ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	1 / 156 (0.64%)	4 / 159 (2.52%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Infections and infestations
Amniotic cavity infection ^{∗ A}	0 / 161 (0%)	2 / 163 (1.23%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Body tinea ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	1 / 10 (10%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
COVID-19 ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	2 / 144 (1.39%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Urinary tract infection ^{∗ A}	4 / 161 (2.48%)	1 / 163 (0.61%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	1 / 12 (8.33%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Injury, poisoning and procedural complications
Exposure to communicable disease ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	1 / 9 (11.11%)
Skin laceration ^{∗ A}	2 / 161 (1.24%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Investigations
Apgar score low ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	4 / 156 (2.56%)	2 / 159 (1.26%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Cardiac murmur ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	2 / 156 (1.28%)	2 / 159 (1.26%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Streptococcus test positive ^{∗ A}	0 / 161 (0%)	2 / 163 (1.23%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Metabolism and nutrition disorders
Hypoglycemia neonatal ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	2 / 159 (1.26%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	2 / 144 (1.39%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Arthralgia (NEW OR WORSENED JOINT PAIN) ^{† A}	22 / 161 (13.66%)	13 / 163 (7.98%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	1 / 12 (8.33%)	5 / 10 (50%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Back pain ^{∗ A}	2 / 161 (1.24%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Myalgia ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	4 / 144 (2.78%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Myalgia (NEW OR WORSENED MUSCLE PAIN) ^{† A}	53 / 161 (32.92%)	26 / 163 (15.95%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	5 / 12 (41.67%)	3 / 10 (30%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Nervous system disorders
Headache ^{∗ A}	2 / 161 (1.24%)	2 / 163 (1.23%)	7 / 144 (4.86%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	1 / 8 (12.5%)	0 / 11 (0%)	0 / 9 (0%)
Headache (HEADACHE) ^{† A}	85 / 161 (52.8%)	72 / 163 (44.17%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	7 / 12 (58.33%)	7 / 10 (70%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Hypotonia ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	2 / 156 (1.28%)	1 / 159 (0.63%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Pregnancy, puerperium and perinatal conditions
Abnormal labor ^{∗ A}	0 / 161 (0%)	2 / 163 (1.23%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Caput succedaneum ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	3 / 156 (1.92%)	3 / 159 (1.89%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Fetal hypokinesia ^{∗ A}	1 / 161 (0.62%)	2 / 163 (1.23%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Gestational diabetes ^{∗ A}	1 / 161 (0.62%)	2 / 163 (1.23%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Gestational hypertension ^{∗ A}	2 / 161 (1.24%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Jaundice neonatal ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	12 / 156 (7.69%)	13 / 159 (8.18%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	1 / 9 (11.11%)
Large for dates baby ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	2 / 156 (1.28%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Low birth weight baby ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	2 / 156 (1.28%)	1 / 159 (0.63%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Oligohydramnios ^{∗ A}	1 / 161 (0.62%)	2 / 163 (1.23%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Pre-eclampsia ^{∗ A}	2 / 161 (1.24%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Premature delivery ^{∗ A}	0 / 161 (0%)	2 / 163 (1.23%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Small for dates baby ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	1 / 156 (0.64%)	4 / 159 (2.52%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	1 / 11 (9.09%)	0 / 9 (0%)
Umbilical cord around neck ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	5 / 159 (3.14%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Uterine contractions during pregnancy ^{∗ A}	2 / 161 (1.24%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Renal and urinary disorders
Leukocyturia ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	1 / 10 (10%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Reproductive system and breast disorders
Vaginal discharge ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	1 / 12 (8.33%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Vaginal hemorrhage ^{∗ A}	1 / 161 (0.62%)	2 / 163 (1.23%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Respiratory, thoracic and mediastinal disorders
Cough ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	1 / 8 (12.5%)	0 / 11 (0%)	0 / 9 (0%)
Rhinorrhoea ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	1 / 8 (12.5%)	0 / 11 (0%)	0 / 9 (0%)
Skin and subcutaneous tissue disorders
Dermatitis allergic ^{∗ A}	0 / 161 (0%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	1 / 10 (10%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
Surgical and medical procedures
Episiotomy ^{∗ A}	3 / 161 (1.86%)	0 / 163 (0%)	0 / 144 (0%)	0 / 156 (0%)	0 / 159 (0%)	0 / 12 (0%)	0 / 10 (0%)	0 / 8 (0%)	0 / 11 (0%)	0 / 9 (0%)
†Indicates events were collected by systematic assessment. ∗Indicates events were collected by non-systematic methods. ATerm from vocabulary, MedDRA v25.1

Limitations and Caveats


The evolving nature of the pandemic has required serology work to be focused on newly emerging strains as a matter of urgent priority, which has delayed serology work on earlier trials. Hence data is not yet available for all serology outcome measures.

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Certain Agreements:
Principal Investigators are NOT employed by the organization sponsoring the study. There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact:
Name/Official Title:	Pfizer ClinicalTrials.gov Call Center
Organization:	Pfizer Inc.
Phone:	1-800-718-1021
Email:	ClinicalTrials.gov_Inquiries@pfizer.com