deltatrials
Completed PHASE3 INTERVENTIONAL 4-arm NCT03537508

Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US

A Phase III, Partially Modified Double-blind, Randomized, Parallel-group, Active-controlled, Multi-center Study to Compare the Immunogenicity and Describe the Safety of MenACYW Conjugate Vaccine and MENVEO® When Administered Concomitantly With Routine Pediatric Vaccines to Healthy Infants and Toddlers in the United States

Sponsor: Sanofi Pasteur, a Sanofi Company

Conditions Healthy Volunteers (Meningococcal Infection)
Interventions DTaP-IPV//Hib vaccine Hepatitis A vaccine Hepatitis B vaccine Measles, mumps, rubella (MMR) vaccine MenACYW conjugate vaccine MenACYW-135 conjugate vaccine Pentavalent rotavirus vaccine Pneumococcal 13-valent conjugate vaccine Varicella vaccine
Updated 32 times since 2018 Last updated: Oct 10, 2024 Started: Apr 25, 2018 Primary completion: Sep 22, 2023 Completion: Sep 22, 2023
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 Healthy Volunteers (Meningococcal Infection), this trial is completed. The trial is conducted by Sanofi Pasteur, a Sanofi Company and has accumulated 32 data snapshots since 2018. Infectious disease trials contribute critical data for public health response and treatment development.

Status Flow

~Jun 2018 – ~Aug 2018 · 2 months · monthly snapshot~Aug 2018 – ~Nov 2018 · 3 months · monthly snapshot~Nov 2018 – ~Dec 2018 · 30 days · monthly snapshot~Dec 2018 – ~Jan 2019 · 31 days · monthly snapshot~Jan 2019 – ~Mar 2019 · 59 days · monthly snapshot~Mar 2019 – ~Jun 2019 · 3 months · monthly snapshot~Jun 2019 – ~Sep 2019 · 3 months · 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 – ~Jun 2020 · 3 months · monthly snapshot~Jun 2020 – ~Oct 2020 · 4 months · monthly snapshot~Oct 2020 – ~Jan 2021 · 3 months · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Mar 2021 · 28 days · monthly snapshot~Mar 2021 – ~Sep 2021 · 6 months · monthly snapshot~Sep 2021 – ~Oct 2021 · 30 days · monthly snapshot~Oct 2021 – ~Dec 2021 · 2 months · monthly snapshot~Dec 2021 – ~Feb 2022 · 2 months · monthly snapshot~Feb 2022 – ~Mar 2022 · 28 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 – ~Feb 2023 · 5 months · monthly snapshot~Feb 2023 – ~Jan 2024 · 11 months · monthly snapshot~Jan 2024 – ~Jul 2024 · 6 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Nov 2024 · 2 months · monthly snapshot~Nov 2024 – present · 21 months · monthly snapshot

Change History

32 versions recorded

  1. Nov 2024 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Nov 2024 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Jan 2024 — Jul 2024 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  5. Feb 2023 — Jan 2024 [monthly]

    Active Not Recruiting PHASE3

▶ Show 27 earlier versions

  1. Sep 2022 — Feb 2023 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  2. Jun 2022 — Sep 2022 [monthly]

    Recruiting PHASE3

  3. Apr 2022 — Jun 2022 [monthly]

    Recruiting PHASE3

  4. Mar 2022 — Apr 2022 [monthly]

    Recruiting PHASE3

  5. Feb 2022 — Mar 2022 [monthly]

    Recruiting PHASE3

  6. Dec 2021 — Feb 2022 [monthly]

    Recruiting PHASE3

  7. Oct 2021 — Dec 2021 [monthly]

    Recruiting PHASE3

  8. Sep 2021 — Oct 2021 [monthly]

    Recruiting PHASE3

  9. Mar 2021 — Sep 2021 [monthly]

    Recruiting PHASE3

  10. Feb 2021 — Mar 2021 [monthly]

    Recruiting PHASE3

  11. Jan 2021 — Feb 2021 [monthly]

    Recruiting PHASE3

  12. Oct 2020 — Jan 2021 [monthly]

    Recruiting PHASE3

  13. Jun 2020 — Oct 2020 [monthly]

    Recruiting PHASE3

  14. Mar 2020 — Jun 2020 [monthly]

    Recruiting PHASE3

  15. Feb 2020 — Mar 2020 [monthly]

    Recruiting PHASE3

  16. Jan 2020 — Feb 2020 [monthly]

    Recruiting PHASE3

  17. Dec 2019 — Jan 2020 [monthly]

    Recruiting PHASE3

  18. Nov 2019 — Dec 2019 [monthly]

    Recruiting PHASE3

  19. Oct 2019 — Nov 2019 [monthly]

    Recruiting PHASE3

  20. Sep 2019 — Oct 2019 [monthly]

    Recruiting PHASE3

  21. Jun 2019 — Sep 2019 [monthly]

    Recruiting PHASE3

  22. Mar 2019 — Jun 2019 [monthly]

    Recruiting PHASE3

  23. Jan 2019 — Mar 2019 [monthly]

    Recruiting PHASE3

  24. Dec 2018 — Jan 2019 [monthly]

    Recruiting PHASE3

  25. Nov 2018 — Dec 2018 [monthly]

    Recruiting PHASE3

  26. Aug 2018 — Nov 2018 [monthly]

    Recruiting PHASE3

  27. Jun 2018 — Aug 2018 [monthly]

    Recruiting PHASE3

    First recorded

Apr 2018

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Sanofi Pasteur, a Sanofi Company
Data source: Sanofi

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

Study Locations

Anaheim, United States , Austin, United States , Biloxi, United States , Birmingham, United States , Boone, United States , Bridgeton, United States , Brooksville, United States , Caguas, Puerto Rico , Chamblee, United States , Charleston, United States and 50 more locations