deltatrials
Completed PHASE2 NCT00133445

Pentavalent DTaP-Hep B-IPV

Randomized, Single Blinded Study of the Safety and Immunogenicity of Pentavalent DTaP-Hep B-IPV Combination Vaccine (Pediarix™; GlaxoSmithKline (GSK) Biologicals) Administered to Healthy Neonates and Infants at Birth, 2, and 6 Months of Age Compared to a Routine Infant Schedule at 2, 4, and 6 Months of Age

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Conditions Diphtheria Hepatitis B Pertussis Poliomyelitis Tetanus
Interventions DTaP-Hep B-IPV Vaccine Monovalent Hep B Vaccine Placebo
Updated 6 times since 2017 Last updated: Nov 3, 2011 Started: Dec 31, 2005 Primary completion: Aug 31, 2006 Completion: Aug 31, 2006

Listed as NCT00133445, this PHASE2 trial focuses on Diphtheria and Hepatitis B and remains completed. Sponsored by National Institute of Allergy and Infectious Diseases (NIAID), it has been updated 6 times since 2005, reflecting limited change activity. This study is part of the global effort to build evidence for infectious disease interventions.

Change History

6 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  3. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE2

  4. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE2

  5. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE2

▶ Show 1 earlier version

  1. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE2

    First recorded

Dec 2005

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Institute of Allergy and Infectious Diseases (NIAID)
Data source: National Institute of Allergy and Infectious Diseases (NIAID)

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

Study Locations

  • • Torrance, United States