deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT02624947

A Study to Determine the Safety and Efficacy of the RSV F Vaccine to Protect Infants Via Maternal Immunization

A Phase 3, Randomized, Observer-Blind, Placebo-Controlled, Group-Sequential Study to Determine the Immunogenicity and Safety of a Respiratory Syncytial Virus (RSV) F Nanoparticle Vaccine With Aluminum in Healthy Third-trimester Pregnant Women; and Safety and Efficacy of Maternally Transferred Antibodies in Preventing RSV Disease in Their Infants

Sponsor: Bill and Melinda Gates Foundation

Conditions Respiratory Syncytial Virus Infections
Interventions Formulation buffer RSV F vaccine with adjuvant
Updated 21 times since 2017 Last updated: Apr 17, 2025 Started: Dec 31, 2015 Primary completion: Dec 28, 2018 Completion: Jul 12, 2019
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Respiratory Syncytial Virus Infections, this trial is completed. The trial is conducted by Bill and Melinda Gates Foundation and has accumulated 21 data snapshots since 2015. Infectious disease trials contribute critical data for public health response and treatment development.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~May 2017 · 3 months · monthly snapshot~May 2017 – ~Sep 2017 · 4 months · monthly snapshot~Sep 2017 – ~Dec 2017 · 3 months · monthly snapshot~Dec 2017 – ~Jan 2018 · 31 days · monthly snapshot~Jan 2018 – ~Feb 2018 · 31 days · monthly snapshot~Feb 2018 – ~Mar 2018 · 28 days · monthly snapshot~Mar 2018 – ~Apr 2018 · 31 days · monthly snapshot~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Dec 2018 · 5 months · monthly snapshot~Dec 2018 – ~Apr 2019 · 4 months · monthly snapshot~Apr 2019 – ~Sep 2019 · 5 months · monthly snapshot~Sep 2019 – ~May 2020 · 8 months · monthly snapshot~May 2020 – ~Jan 2021 · 8 months · monthly snapshot~Jan 2021 – ~Apr 2022 · 15 months · monthly snapshot~Apr 2022 – ~Jul 2024 · 27 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Jun 2025 · 9 months · monthly snapshot~Jun 2025 – ~Sep 2025 · 3 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

21 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Jun 2025 — Sep 2025 [monthly]

    Completed PHASE3

  3. Sep 2024 — Jun 2025 [monthly]

    Completed PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  5. Apr 2022 — Jul 2024 [monthly]

    Completed PHASE3

▶ Show 16 earlier versions

  1. Jan 2021 — Apr 2022 [monthly]

    Completed PHASE3

  2. May 2020 — Jan 2021 [monthly]

    Completed PHASE3

  3. Sep 2019 — May 2020 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  4. Apr 2019 — Sep 2019 [monthly]

    Active Not Recruiting PHASE3

  5. Dec 2018 — Apr 2019 [monthly]

    Active Not Recruiting PHASE3

  6. Jul 2018 — Dec 2018 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  7. Jun 2018 — Jul 2018 [monthly]

    Recruiting PHASE3

  8. Apr 2018 — Jun 2018 [monthly]

    Recruiting PHASE3

  9. Mar 2018 — Apr 2018 [monthly]

    Recruiting PHASE3

  10. Feb 2018 — Mar 2018 [monthly]

    Recruiting PHASE3

  11. Jan 2018 — Feb 2018 [monthly]

    Recruiting PHASE3

  12. Dec 2017 — Jan 2018 [monthly]

    Recruiting PHASE3

  13. Sep 2017 — Dec 2017 [monthly]

    Recruiting PHASE3

  14. May 2017 — Sep 2017 [monthly]

    Recruiting PHASE3

  15. Feb 2017 — May 2017 [monthly]

    Recruiting PHASE3

  16. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE3

    First recorded

Dec 2015

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Bill and Melinda Gates Foundation
  • Novavax
Data source: Novavax

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

Study Locations

Adelaide, Australia , Alabang, Philippines , Alexandria, United States , Augusta, United States , Aurora, United States , Barcelona, Spain , Beaumont, United States , Bellville, South Africa , Benoni, South Africa , Biloxi, United States and 75 more locations