deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT04031846

Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-025) (PNEU-PED-EU-1)

A Phase 3, Multicenter, Randomized, Double-blind, Active-comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (PNEU-PED-EU-1)

Sponsor: Merck Sharp & Dohme LLC

Conditions Pneumococcal Infections
Interventions Infanrix™ hexa Prevenar 13™ Rotarix™ V114
Updated 19 times since 2019 Last updated: Jul 20, 2023 Started: Sep 4, 2019 Primary completion: Aug 5, 2021 Completion: Aug 5, 2021
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT04031846, this PHASE3 trial focuses on Pneumococcal Infections and remains completed. Sponsored by Merck Sharp & Dohme LLC, it has been updated 19 times since 2019, reflecting substantial change activity. This study is part of the global effort to build evidence for infectious disease interventions.

Status Flow

~Aug 2019 – ~Sep 2019 · 31 days · monthly snapshot~Sep 2019 – ~Oct 2019 · 30 days · monthly snapshot~Oct 2019 – ~Nov 2019 · 31 days · monthly snapshot~Nov 2019 – ~Dec 2019 · 30 days · monthly snapshot~Dec 2019 – ~Jan 2020 · 31 days · monthly snapshot~Jan 2020 – ~Feb 2020 · 31 days · monthly snapshot~Feb 2020 – ~Mar 2020 · 29 days · monthly snapshot~Mar 2020 – ~Oct 2020 · 7 months · monthly snapshot~Oct 2020 – ~Jan 2021 · 3 months · monthly snapshot~Jan 2021 – ~Apr 2021 · 3 months · monthly snapshot~Apr 2021 – ~Sep 2021 · 5 months · monthly snapshot~Sep 2021 – ~Jan 2022 · 4 months · monthly snapshot~Jan 2022 – ~Jun 2022 · 5 months · monthly snapshot~Jun 2022 – ~Jun 2023 · 12 months · monthly snapshot~Jun 2023 – ~Aug 2023 · 2 months · monthly snapshot~Aug 2023 – ~Jul 2024 · 11 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 12 months · monthly snapshot

Change History

19 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Aug 2023 — Jul 2024 [monthly]

    Completed PHASE3

  5. Jun 2023 — Aug 2023 [monthly]

    Completed PHASE3

▶ Show 14 earlier versions

  1. Jun 2022 — Jun 2023 [monthly]

    Completed PHASE3

  2. Jan 2022 — Jun 2022 [monthly]

    Completed PHASE3

  3. Sep 2021 — Jan 2022 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  4. Apr 2021 — Sep 2021 [monthly]

    Active Not Recruiting PHASE3

  5. Jan 2021 — Apr 2021 [monthly]

    Active Not Recruiting PHASE3

  6. Oct 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE3

  7. Mar 2020 — Oct 2020 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  8. Feb 2020 — Mar 2020 [monthly]

    Recruiting PHASE3

  9. Jan 2020 — Feb 2020 [monthly]

    Recruiting PHASE3

  10. Dec 2019 — Jan 2020 [monthly]

    Recruiting PHASE3

  11. Nov 2019 — Dec 2019 [monthly]

    Recruiting PHASE3

  12. Oct 2019 — Nov 2019 [monthly]

    Recruiting PHASE3

    Status: Not Yet Recruiting → Recruiting

  13. Sep 2019 — Oct 2019 [monthly]

    Not Yet Recruiting PHASE3

  14. Aug 2019 — Sep 2019 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Merck Sharp & Dohme LLC
Data source: Merck Sharp & Dohme LLC

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

Study Locations

Aalst, Belgium , Antequera, Spain , Aschaffenburg, Germany , Athens, Greece , Badalona, Spain , Bramsche, Germany , Bruges, Belgium , Bydgoszcz, Poland , Datteln, Germany , Dębica, Poland and 41 more locations