deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT03621670

Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants

Sponsor: GlaxoSmithKline

Conditions Infections, Meningococcal
Interventions Bexsero (GSK Biologicals' Meningococcal group-B vaccine/ rMenB+OMV NZ) Hiberix M-M-R II Pediarix Placebo (saline water) Prevnar 20 Prevnar13 Rotarix Varivax
Updated 29 times since 2018 Last updated: Feb 9, 2026 Started: Jul 27, 2018 Primary completion: Dec 27, 2024 Completion: Dec 27, 2024
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 Infections, Meningococcal, this trial is completed. The trial is conducted by GlaxoSmithKline and has accumulated 29 data snapshots since 2018. Infectious disease trials contribute critical data for public health response and treatment development.

Status Flow

~Sep 2018 – ~Oct 2018 · 30 days · monthly snapshot~Oct 2018 – ~Nov 2018 · 31 days · monthly snapshot~Nov 2018 – ~Apr 2019 · 5 months · monthly snapshot~Apr 2019 – ~May 2020 · 13 months · monthly snapshot~May 2020 – ~Jul 2020 · 2 months · 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 – ~Jan 2021 · 3 months · monthly snapshot~Jan 2021 – ~May 2021 · 4 months · monthly snapshot~May 2021 – ~Sep 2021 · 4 months · monthly snapshot~Sep 2021 – ~Nov 2021 · 2 months · monthly snapshot~Nov 2021 – ~Jan 2022 · 2 months · monthly snapshot~Jan 2022 – ~Apr 2022 · 3 months · monthly snapshot~Apr 2022 – ~Jun 2022 · 2 months · monthly snapshot~Jun 2022 – ~Jul 2022 · 30 days · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 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 – ~Aug 2023 · 6 months · monthly snapshot~Aug 2023 – ~Mar 2024 · 7 months · monthly snapshot~Mar 2024 – ~Jul 2024 · 4 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Jan 2025 · 4 months · monthly snapshot~Jan 2025 – ~Feb 2025 · 31 days · monthly snapshot~Feb 2025 – ~Sep 2025 · 7 months · monthly snapshot~Sep 2025 – ~Feb 2026 · 5 months · monthly snapshot~Feb 2026 – present · 7 months · monthly snapshot

Change History

29 versions recorded

  1. Feb 2026 — Present [monthly]

    Completed PHASE3

  2. Sep 2025 — Feb 2026 [monthly]

    Completed PHASE3

  3. Feb 2025 — Sep 2025 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  4. Jan 2025 — Feb 2025 [monthly]

    Active Not Recruiting PHASE3

  5. Sep 2024 — Jan 2025 [monthly]

    Active Not Recruiting PHASE3

▶ Show 24 earlier versions

  1. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE3

  2. Mar 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE3

  3. Aug 2023 — Mar 2024 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  4. Feb 2023 — Aug 2023 [monthly]

    Recruiting PHASE3

  5. Dec 2022 — Feb 2023 [monthly]

    Recruiting PHASE3

  6. Nov 2022 — Dec 2022 [monthly]

    Recruiting PHASE3

  7. Sep 2022 — Nov 2022 [monthly]

    Recruiting PHASE3

  8. Jul 2022 — Sep 2022 [monthly]

    Recruiting PHASE3

  9. Jun 2022 — Jul 2022 [monthly]

    Recruiting PHASE3

  10. Apr 2022 — Jun 2022 [monthly]

    Recruiting PHASE3

  11. Jan 2022 — Apr 2022 [monthly]

    Recruiting PHASE3

  12. Nov 2021 — Jan 2022 [monthly]

    Recruiting PHASE3

  13. Sep 2021 — Nov 2021 [monthly]

    Recruiting PHASE3

  14. May 2021 — Sep 2021 [monthly]

    Recruiting PHASE3

  15. Jan 2021 — May 2021 [monthly]

    Recruiting PHASE3

  16. Oct 2020 — Jan 2021 [monthly]

    Recruiting PHASE3

  17. Sep 2020 — Oct 2020 [monthly]

    Recruiting PHASE3

  18. Aug 2020 — Sep 2020 [monthly]

    Recruiting PHASE3

  19. Jul 2020 — Aug 2020 [monthly]

    Recruiting PHASE3

    Status: Suspended → Recruiting

  20. May 2020 — Jul 2020 [monthly]

    Suspended PHASE3

    Status: Recruiting → Suspended

  21. Apr 2019 — May 2020 [monthly]

    Recruiting PHASE3

  22. Nov 2018 — Apr 2019 [monthly]

    Recruiting PHASE3

  23. Oct 2018 — Nov 2018 [monthly]

    Recruiting PHASE3

  24. Sep 2018 — Oct 2018 [monthly]

    Recruiting PHASE3

    First recorded

Jul 2018

Trial started

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

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 , Baltimore, United States , Bardstown, United States , Beaumont, United States , Bingham Farms, United States , Birmingham, United States , Boone, United States , Bryan, United States , Charleston, United States , Cincinnati, United States and 40 more locations