deltatrials
Completed PHASE3 INTERVENTIONAL 3-arm NCT01444781

Study of the Booster Effect of DTaP-IPV-Hep B-PRP~T Combined Vaccine or Infanrix Hexa™ and Prevenar™ in Healthy Infants

Evaluation of Antibody Persistence Following a Primary Series at 2, 4, and 6 Months on Trial A3L24 and Booster Effect of the DTaP-IPV-Hep B-PRP~T Combined Vaccine or Infanrix Hexa™ Concomitantly Administered With Prevenar™ at 12 to 24 Months of Age in Healthy Latin American Infants

Sponsor: Sanofi Pasteur, a Sanofi Company

Conditions Diphtheria Hepatitis B Poliomyelitis Tetanus Whooping Cough
Interventions DTaP-Hep B-IPV // Hib Vaccine + Pneumococcal polysaccharide DTaP-IPV-Hep B-PRP~T + Pneumococcal polysaccharide vaccine DTaP-IPV-Hep B-PRP~T combined vaccine + Pneumococcal polysaccharide
Updated 7 times since 2017 Last updated: Jul 14, 2014 Started: Sep 30, 2011 Primary completion: Apr 30, 2013 Completion: Oct 31, 2013
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01444781, this PHASE3 trial focuses on Diphtheria and Hepatitis B and remains completed. Sponsored by Sanofi Pasteur, a Sanofi Company, it has been updated 7 times since 2011, reflecting limited change activity. This study is part of the global effort to build evidence for infectious disease interventions.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – ~Nov 2025 · 2 months · monthly snapshotCompleted~Nov 2025 – present · 8 months · monthly snapshotCompleted

Change History

7 versions recorded

  1. Nov 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2025 — Nov 2025 [monthly]

    Completed PHASE3

  3. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  5. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE3

▶ Show 2 earlier versions

  1. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE3

  2. Jan 2017 — Jun 2018 [monthly]

    Completed PHASE3

    First recorded

Sep 2011

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