Assess if Immune Response of GSK Biologicals' Tritanrix™-HepB/Hib-MenAC Given Without or With Hepatitis B Vaccine at Birth is at Least as Good as Tritanrix™-HepB/Hiberix™ Without Hepatitis B Vaccine at Birth, When Given to Healthy Infants
Study to Show Non-inferiority of Tritanrix™-HepB/Hib-MenAC (+/- Hepatitis B Vaccine at Birth) Versus Tritanrix™-HepB/Hiberix™ Without Hepatitis B Vacc. at Birth for Antibody Response to All Vaccine Antigens Given in Healthy Infants
Sponsor: GlaxoSmithKline
Listed as NCT00290303, this PHASE3 trial focuses on Diphtheria and Haemophilus Influenzae Type b and remains completed. Sponsored by GlaxoSmithKline, it has been updated 6 times since 2004, reflecting limited change activity. This study is part of the global effort to build evidence for infectious disease interventions.
Status Flow
Change History
6 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE3
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Sep 2024 — Sep 2025 [monthly]
Completed PHASE3
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE3
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Jun 2018 — Jan 2021 [monthly]
Completed PHASE3
▶ Show 1 earlier version
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Jan 2017 — Jun 2018 [monthly]
Completed PHASE3
First recorded
May 2004
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- GlaxoSmithKline
For direct contact, visit the study record on ClinicalTrials.gov .