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Completed PHASE1/PHASE2 INTERVENTIONAL 6-arm NCT02927873

A Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals' RSV Investigational Vaccine Based on Viral Proteins Encoded by Chimpanzee-derived Adenovector (ChAd155-RSV) (GSK3389245A) in RSV-seropositive Infants

A Phase 1/2, Randomized, Observer-blind, Controlled, Multi-center, Dose-escalation Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Respiratory Syncytial Virus (RSV) Investigational Vaccine Based on the RSV Viral Proteins F, N and M2-1 Encoded by Chimpanzee-derived Adenovector (ChAd155-RSV) (GSK3389245A), When Administered Intramuscularly According to a 0, 1-month Schedule to RSV-seropositive Infants Aged 12 to 23 Months

Sponsor: GlaxoSmithKline

Conditions Respiratory Syncytial Virus Infections
Interventions Placebo RSV (GSK3389245A) high dose formulation vaccine RSV (GSK3389245A) low dose formulation vaccine RSV (GSK3389245A) middle dose formulation vaccine
Updated 33 times since 2017 Last updated: Sep 28, 2021 Started: Jan 11, 2017 Primary completion: Feb 19, 2019 Completion: Nov 26, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT02927873, this PHASE1/PHASE2 trial focuses on Respiratory Syncytial Virus Infections and remains completed. Sponsored by GlaxoSmithKline, it has been updated 33 times since 2017, reflecting substantial change activity. This study is part of the global effort to build evidence for infectious disease interventions.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Mar 2017 · 28 days · monthly snapshot~Mar 2017 – ~May 2017 · 2 months · monthly snapshot~May 2017 – ~Jun 2017 · 31 days · monthly snapshot~Jun 2017 – ~Jul 2017 · 30 days · monthly snapshot~Jul 2017 – ~Oct 2017 · 3 months · monthly snapshot~Oct 2017 – ~Jan 2018 · 3 months · monthly snapshot~Jan 2018 – ~Mar 2018 · 59 days · monthly snapshot~Mar 2018 – ~Apr 2018 · 31 days · monthly snapshot~Apr 2018 – ~May 2018 · 30 days · monthly snapshot~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Aug 2018 · 31 days · monthly snapshot~Aug 2018 – ~Sep 2018 · 31 days · monthly snapshot~Sep 2018 – ~Oct 2018 · 30 days · monthly snapshot~Oct 2018 – ~Nov 2018 · 31 days · monthly snapshot~Nov 2018 – ~Mar 2019 · 4 months · monthly snapshot~Mar 2019 – ~Jun 2019 · 3 months · monthly snapshot~Jun 2019 – ~Nov 2019 · 5 months · monthly snapshot~Nov 2019 – ~Dec 2019 · 30 days · monthly snapshot~Dec 2019 – ~Jan 2020 · 31 days · monthly snapshot~Jan 2020 – ~Mar 2020 · 2 months · monthly snapshot~Mar 2020 – ~Apr 2020 · 31 days · monthly snapshot~Apr 2020 – ~Aug 2020 · 4 months · monthly snapshot~Aug 2020 – ~Oct 2020 · 2 months · monthly snapshot~Oct 2020 – ~Jan 2021 · 3 months · monthly snapshot~Jan 2021 – ~Jun 2021 · 5 months · monthly snapshot~Jun 2021 – ~Nov 2021 · 5 months · monthly snapshot~Nov 2021 – ~Jul 2024 · 32 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – ~Oct 2025 · 30 days · monthly snapshot~Oct 2025 – present · 11 months · monthly snapshot

Change History

33 versions recorded

  1. Oct 2025 — Present [monthly]

    Completed PHASE1/PHASE2

  2. Sep 2025 — Oct 2025 [monthly]

    Completed PHASE1/PHASE2

  3. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE1/PHASE2

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1/PHASE2

    Phase: PHASE1_PHASE2 → PHASE1/PHASE2

  5. Nov 2021 — Jul 2024 [monthly]

    Completed PHASE1_PHASE2

▶ Show 28 earlier versions

  1. Jun 2021 — Nov 2021 [monthly]

    Completed PHASE1_PHASE2

    Phase: PHASE2 → PHASE1_PHASE2

  2. Jan 2021 — Jun 2021 [monthly]

    Completed PHASE2

    Status: Active Not Recruiting → Completed

  3. Oct 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE2

  4. Aug 2020 — Oct 2020 [monthly]

    Active Not Recruiting PHASE2

  5. Apr 2020 — Aug 2020 [monthly]

    Active Not Recruiting PHASE2

  6. Mar 2020 — Apr 2020 [monthly]

    Active Not Recruiting PHASE2

  7. Jan 2020 — Mar 2020 [monthly]

    Active Not Recruiting PHASE2

  8. Dec 2019 — Jan 2020 [monthly]

    Active Not Recruiting PHASE2

  9. Nov 2019 — Dec 2019 [monthly]

    Active Not Recruiting PHASE2

  10. Jun 2019 — Nov 2019 [monthly]

    Active Not Recruiting PHASE2

  11. Mar 2019 — Jun 2019 [monthly]

    Active Not Recruiting PHASE2

    Status: Recruiting → Active Not Recruiting

  12. Nov 2018 — Mar 2019 [monthly]

    Recruiting PHASE2

  13. Oct 2018 — Nov 2018 [monthly]

    Recruiting PHASE2

  14. Sep 2018 — Oct 2018 [monthly]

    Recruiting PHASE2

  15. Aug 2018 — Sep 2018 [monthly]

    Recruiting PHASE2

  16. Jul 2018 — Aug 2018 [monthly]

    Recruiting PHASE2

  17. Jun 2018 — Jul 2018 [monthly]

    Recruiting PHASE2

  18. May 2018 — Jun 2018 [monthly]

    Recruiting PHASE2

  19. Apr 2018 — May 2018 [monthly]

    Recruiting PHASE2

  20. Mar 2018 — Apr 2018 [monthly]

    Recruiting PHASE2

  21. Jan 2018 — Mar 2018 [monthly]

    Recruiting PHASE2

  22. Oct 2017 — Jan 2018 [monthly]

    Recruiting PHASE2

  23. Jul 2017 — Oct 2017 [monthly]

    Recruiting PHASE2

  24. Jun 2017 — Jul 2017 [monthly]

    Recruiting PHASE2

  25. May 2017 — Jun 2017 [monthly]

    Recruiting PHASE2

  26. Mar 2017 — May 2017 [monthly]

    Recruiting PHASE2

    Status: Not Yet Recruiting → Recruiting

  27. Feb 2017 — Mar 2017 [monthly]

    Not Yet Recruiting PHASE2

  28. Jan 2017 — Feb 2017 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • GlaxoSmithKline
Data source: GlaxoSmithKline

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

Study Locations

Anaheim, United States , Aurora, United States , Burgos, Spain , David, Panama , Dębica, Poland , Frederick, United States , Halifax, Canada , Hsinchu, Taiwan , Madrid, Spain , Majadahonda (Madrid), Spain and 11 more locations