deltatrials
Completed PHASE2/PHASE3 INTERVENTIONAL 20-arm NCT04368728

Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals

A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS

Sponsor: BioNTech SE

Conditions COVID-19 SARS-CoV-2 Infection
Interventions BNT162b1 BNT162b2 BNT162b2SA Placebo
Updated 28 times since 2020 Last updated: Feb 27, 2023 Started: Apr 29, 2020 Primary completion: Feb 10, 2023 Completion: Feb 10, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT04368728, this PHASE2/PHASE3 trial focuses on COVID-19 and SARS-CoV-2 Infection and remains completed. Sponsored by BioNTech SE, it has been updated 28 times since 2020, reflecting substantial change activity. This study is part of the global effort to build evidence for infectious disease interventions.

Status Flow

~May 2020 – ~Jun 2020 · 31 days · monthly snapshot~Jun 2020 – ~Jul 2020 · 30 days · monthly snapshot~Jul 2020 – ~Aug 2020 · 31 days · monthly snapshot~Aug 2020 – ~Sep 2020 · 31 days · monthly snapshot~Sep 2020 – ~Oct 2020 · 30 days · monthly snapshot~Oct 2020 – ~Nov 2020 · 31 days · monthly snapshot~Nov 2020 – ~Dec 2020 · 30 days · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Mar 2021 · 28 days · monthly snapshot~Mar 2021 – ~Apr 2021 · 31 days · monthly snapshot~Apr 2021 – ~May 2021 · 30 days · monthly snapshot~May 2021 – ~Jun 2021 · 31 days · monthly snapshot~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshot~Sep 2021 – ~Nov 2021 · 2 months · monthly snapshot~Nov 2021 – ~Jan 2022 · 2 months · monthly snapshot~Jan 2022 – ~Mar 2022 · 59 days · monthly snapshot~Mar 2022 – ~Apr 2022 · 31 days · monthly snapshot~Apr 2022 – ~Jun 2022 · 2 months · monthly snapshot~Jun 2022 – ~Sep 2022 · 3 months · monthly snapshot~Sep 2022 – ~Nov 2022 · 2 months · monthly snapshot~Nov 2022 – ~Dec 2022 · 30 days · monthly snapshot~Dec 2022 – ~Feb 2023 · 2 months · monthly snapshot~Feb 2023 – ~Mar 2023 · 28 days · monthly snapshot~Mar 2023 – ~Jul 2024 · 16 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 11 months · monthly snapshot

Change History

28 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE2/PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE2/PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2/PHASE3

    Phase: PHASE2_PHASE3 → PHASE2/PHASE3

  4. Mar 2023 — Jul 2024 [monthly]

    Completed PHASE2_PHASE3

    Status: Active Not Recruiting → Completed

  5. Feb 2023 — Mar 2023 [monthly]

    Active Not Recruiting PHASE2_PHASE3

▶ Show 23 earlier versions

  1. Dec 2022 — Feb 2023 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  2. Nov 2022 — Dec 2022 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  3. Sep 2022 — Nov 2022 [monthly]

    Active Not Recruiting PHASE2_PHASE3

    Status: Recruiting → Active Not Recruiting

  4. Jun 2022 — Sep 2022 [monthly]

    Recruiting PHASE2_PHASE3

  5. Apr 2022 — Jun 2022 [monthly]

    Recruiting PHASE2_PHASE3

  6. Mar 2022 — Apr 2022 [monthly]

    Recruiting PHASE2_PHASE3

  7. Jan 2022 — Mar 2022 [monthly]

    Recruiting PHASE2_PHASE3

    Phase: PHASE3 → PHASE2_PHASE3

  8. Nov 2021 — Jan 2022 [monthly]

    Recruiting PHASE3

    Phase: PHASE2_PHASE3 → PHASE3

  9. Sep 2021 — Nov 2021 [monthly]

    Recruiting PHASE2_PHASE3

  10. Jun 2021 — Sep 2021 [monthly]

    Recruiting PHASE2_PHASE3

  11. May 2021 — Jun 2021 [monthly]

    Recruiting PHASE2_PHASE3

    Status: Active Not Recruiting → Recruiting

  12. Apr 2021 — May 2021 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  13. Mar 2021 — Apr 2021 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  14. Feb 2021 — Mar 2021 [monthly]

    Active Not Recruiting PHASE2_PHASE3

    Status: Recruiting → Active Not Recruiting

  15. Jan 2021 — Feb 2021 [monthly]

    Recruiting PHASE2_PHASE3

  16. Dec 2020 — Jan 2021 [monthly]

    Recruiting PHASE2_PHASE3

  17. Nov 2020 — Dec 2020 [monthly]

    Recruiting PHASE2_PHASE3

  18. Oct 2020 — Nov 2020 [monthly]

    Recruiting PHASE2_PHASE3

  19. Sep 2020 — Oct 2020 [monthly]

    Recruiting PHASE2_PHASE3

  20. Aug 2020 — Sep 2020 [monthly]

    Recruiting PHASE2_PHASE3

    Phase: PHASE1_PHASE2 → PHASE2_PHASE3

  21. Jul 2020 — Aug 2020 [monthly]

    Recruiting PHASE1_PHASE2

  22. Jun 2020 — Jul 2020 [monthly]

    Recruiting PHASE1_PHASE2

    Status: Not Yet Recruiting → Recruiting

  23. May 2020 — Jun 2020 [monthly]

    Not Yet Recruiting PHASE1_PHASE2

    First recorded

Apr 2020

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

Allentown, United States , Anaheim, United States , Ankara, Turkey (Türkiye) , Annandale, United States , Athens, United States , Atlanta, United States , Aurora, United States , Austin, United States , Baltimore, United States , Bardstown, United States and 115 more locations