Phase 3
N=348
To Evaluate the Safety, Tolerability, and Immunogenicity of BNT162b2 Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older
SARS-CoV-2 Infection · COVID-19 · Maternal Immunization
Bottom Line
View on ClinicalTrials.gov: NCT04754594 ↗Enrolled (actual)
348
Serious AEs
11.8%
Results posted
Dec 2024
Primary outcome: Primary: Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1 — 2.5; 0.6; 0.6; 0 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- BNT162b2 (Biological); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- BioNTech SE
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1 |
2.5; 0.6; 0.6; 0; 0; 0 | — |
| PRIMARY Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2 |
3.4; 0; 2.0; 0; 0; 0 | — |
| PRIMARY Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1 |
0.6; 1.2; 0; 0; 0.6; 0.6 | — |
| PRIMARY Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2 |
1.4; 0.7; 0.7; 0; 0; 0 | — |
| PRIMARY Percentage of Maternal Participants With Adverse Events (AEs) From Dose 1 Through 1 Month After Dose 2 - Blinded Follow-up Period |
23.6; 22.7 | — |
| PRIMARY Percentage of Maternal Participants Reporting Serious Adverse Events (SAEs) From Dose 1 Through 1 Month After Delivery - Blinded Follow-up Period |
13.0; 14.1 | — |
| PRIMARY Geometric Mean Ratio (GMR) of the SARS-CoV-2 Neutralizing Titers in Pregnant Women to Those in Nonpregnant Women From Study C4591001 (NCT04368728) for Evaluable Immunogenicity Population Without Evidence of Prior SARS-CoV-2 Infection |
1109.2; 1663.7 | — |
| PRIMARY GMR of SARS-CoV-2 Neutralizing Titers in Pregnant Women to Those in Nonpregnant Women From Study C4591001 (NCT04368728) for Evaluable Immunogenicity Population With and Without Evidence of Prior SARS-CoV-2 Infection |
2198.7; 1732.0 | — |
| SECONDARY COVID-19 Incidence Per 100 Person-Years of Blinded Follow up in Evaluable Maternal Participants Without Evidence of Prior SARS-CoV-2 Infection |
12.903; 13.423 | — |
| SECONDARY COVID-19 Incidence Per 100 Person-Years of Blinded Follow up in Evaluable Maternal Participants With or Without Evidence of Prior SARS-CoV-2 Infection |
7.407; 11.407 | — |
| SECONDARY Incidence of Asymptomatic Infection of SARS-CoV-2 Through 1 Month After Delivery in Evaluable Maternal Participants Without Evidence of Prior SARS-CoV-2 Infection |
40.404; 68.027 | — |
| SECONDARY Geometric Mean Concentration (GMCs) of Full-Length S-Binding Immunoglobulin G (IgG) Levels in Evaluable Maternal Participants |
2.4; 2.0; 7802.0; 1.8; 4281.0; 1.8 | — |
| SECONDARY Geometric Mean Titer (GMTs) of SARS-CoV-2 Neutralizing Titers in Evaluable Maternal Participants |
47.6; 43.5; 1991.8; 45.0; 1212.6; 43.5 | — |
| SECONDARY Geometric Mean Fold Rise (GMFR) From Before Vaccination to Each Subsequent Time Point After Vaccination for Full-Length S-Binding IgG Levels in Evaluable Maternal Participants |
3618.7; 0.9; 2276.4; 0.9; 1377.6; 0.8 | — |
| SECONDARY Geometric Mean Fold Rise (GMFR) From Before Vaccination to Each Subsequent Time Point After Vaccination for SARS-CoV-2 Neutralizing Titers in Evaluable Maternal Participants |
43.7; 1.0; 25.3; 1.0; 15.6; 1.0 | — |
| SECONDARY Percentage of Infant Participants Reporting Specific Birth Outcomes |
91.6; 89.3; 6.0; 3.6; 1.8; 6.5 | — |
| SECONDARY Percentage of Infant Participants Reporting Adverse Events From Birth Through 1 Month of Age |
35.3; 37.1 | — |
| SECONDARY Percentage of Infant Participants Reporting Serious Adverse Events (SAE) From Birth Through 6 Months of Age |
13.5; 15.1 | — |
| SECONDARY Percentage of Infant Participants Reporting Adverse Event of Special Interest (AESI) From Birth Through 6 Months of Age |
5.1; 1.3 | — |
| SECONDARY GMCs of Full-Length S-Binding IgG Levels at Birth and 6 Months of Age in Infant Participants Born to Evaluable Maternal Participants |
5576.4; 19.4; 311.1; 22.0 | — |
| SECONDARY GMFR of Full-Length S-Binding IgG Levels From Birth to 6 Months of Age in Infant Participants Born to Evaluable Maternal Participants |
0.1; 0.6 | — |
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).
Eligibility Criteria
Inclusion Criteria
- Healthy women ≥18 years of age who are between 24 0/7 and 34 0/7 weeks' gestation on the day of planned vaccination, with an uncomplicated, singleton pregnancy, who are at no known increased risk for complications.
- Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Healthy participants who are determined by medical history, physical examination, and clinical judgment to be appropriate for inclusion in the study
- Documented negative HIV antibody test (Phase 2 only), syphilis test, and HBV surface antigen test during this pregnancy and prior to randomization
- Participant is willing to give informed consent for her infant to participate in the study
- Capable of giving signed informed consent
Exclusion Criteria
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID 19.
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention or any related vaccine.
- Participants with known or suspected immunodeficiency.
- Bleeding diathesis or condition associated with prolonged bleeding that would in the opinion of the investigator contraindicate intramuscular injection.
- Previous vaccination with any coronavirus vaccine.
- Receipt of medications intended to prevent COVID 19.
- Receipt of blood/plasma products or immunoglobulin, from 60 days before administration of study intervention, or planned receipt through delivery, with 1 exception, anti-D immunoglobulin (eg, RhoGAM), which can be given at any time.
- Current alcohol abuse or illicit drug use.
- Participants who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt through the postvaccination blood draw.
- Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.
- Previous participation in other studies involving study intervention containing LNPs.
- Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
- Participants whose unborn baby has been fathered by investigational site staff members directly involved in the conduct of the study or their family members, site staff members otherwise supervised by the investigator, or Pfizer employees directly involved in the conduct of the study.
Data sourced from ClinicalTrials.gov (NCT04754594). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.