Completed PHASE2/PHASE3 INTERVENTIONAL 2-arm NCT04754594

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

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

Sponsor: BioNTech SE

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

Interventions BNT162b2 Placebo

Updated 17 times since 2021 Last updated: Nov 22, 2024 Started: Feb 16, 2021 Primary completion: Jul 15, 2022 Completion: Jul 15, 2022

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT04754594, this PHASE2/PHASE3 trial focuses on COVID-19 and Maternal Immunization and remains completed. Sponsored by BioNTech SE, it has been updated 17 times since 2021, reflecting substantial change activity. This study is part of the global effort to build evidence for infectious disease interventions.

Status Flow

Change History

17 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE2/PHASE3
Jan 2025 — Sep 2025 [monthly]

Completed PHASE2/PHASE3

Phase: PHASE3 → PHASE2/PHASE3
Sep 2024 — Jan 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Aug 2023 — Jul 2024 [monthly]

Completed PHASE3

Phase: PHASE2_PHASE3 → PHASE3

▶ Show 12 earlier versions

Sep 2022 — Aug 2023 [monthly]

Completed PHASE2_PHASE3

Status: Active Not Recruiting → Completed
Jun 2022 — Sep 2022 [monthly]

Active Not Recruiting PHASE2_PHASE3
Mar 2022 — Jun 2022 [monthly]

Active Not Recruiting PHASE2_PHASE3

Phase: PHASE3 → PHASE2_PHASE3
Feb 2022 — Mar 2022 [monthly]

Active Not Recruiting PHASE3

Phase: PHASE2_PHASE3 → PHASE3
Dec 2021 — Feb 2022 [monthly]

Active Not Recruiting PHASE2_PHASE3

Status: Recruiting → Active Not Recruiting · Phase: PHASE3 → PHASE2_PHASE3
Nov 2021 — Dec 2021 [monthly]

Recruiting PHASE3
Oct 2021 — Nov 2021 [monthly]

Recruiting PHASE3

Phase: PHASE2_PHASE3 → PHASE3
Sep 2021 — Oct 2021 [monthly]

Recruiting PHASE2_PHASE3
Jun 2021 — Sep 2021 [monthly]

Recruiting PHASE2_PHASE3
May 2021 — Jun 2021 [monthly]

Recruiting PHASE2_PHASE3
Apr 2021 — May 2021 [monthly]

Recruiting PHASE2_PHASE3

Status: Not Yet Recruiting → Recruiting
Mar 2021 — Apr 2021 [monthly]

Not Yet Recruiting PHASE2_PHASE3

First recorded

Feb 2021

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

BioNTech SE
Pfizer

Data source: BioNTech SE

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Ammon, United States , Anaconda, United States , Antequera, Spain , Austin, United States , Badalona, Spain , Barcelona, Spain , Bedford, United States , Belo Horizonte, Brazil , Benoni, South Africa , Birmingham, United States and 41 more locations