CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 468 enrolled
Drug / intervention
Havrix™ +2 morebiological
Likely dose
Havrix: 2 intramuscular injections, 6 months apart; Infanrix: 1 intramuscular injection; ActHIB: 1 intramuscular injectionAI-extracted
Key inclusion· 5
  • ✓Child 12–13 months old at enrollment (will be 15 months at vaccination)
  • ✓Prior completion of exactly three doses each of DTaP (Infanrix or Pediarix) and Hib (ActHIB, HibTITER, or OmniHIB) vaccines during first year of life
  • ✓At least 6 months elapsed since third dose of Infanrix or Pediarix at time of study vaccination (15 months of age)
  • ✓Free of obvious health problems on medical history and physical examination
Key exclusion· 11
  • ✕Prior hepatitis A vaccination or known exposure to hepatitis A virus
  • ✕Any immunosuppressive or immunodeficient condition, including HIV infection
  • ✕Family history of congenital, hereditary, or infectious immunodeficiency; parental risk factors for HIV
  • ✕History of diphtheria, tetanus, pertussis, or Haemophilus influenzae type b disease, or exposure within 31 days prior to study start

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00197236
NCT00197236Phase 3Completed
CompareCT.gov

Immunogenicity and Safety of GSK Biologicals' Inactivated Hepatitis A Vaccine (Havrix™) Co-administered With GSK Biologicals' DTaP Vaccine (Infanrix™) and Aventis Pasteur's Haemophilus b Conjugate Vaccine (ActHIB) in Healthy Children 15 Months of Age

GlaxoSmithKline·interventional·Posted Sep 20, 2005·Updated Aug 20, 2018

In Brief

A Phase 3 clinical trial evaluating Havrix™, Infanrix™, and 1 other intervention for Hepatitis A. Completed, enrolled 468 participants across 22 sites.

Detailed Summary

This is a study to evaluate the immune response and safety of GSK Biologicals 2-dose inactivated hepatitis A vaccine when administered with a diphtheria, tetanus and pertussis combination (DTaP) vaccine and a Haemophilus influenza type B (Hib) vaccine in children 15 months of age. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis A
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 20, 2005
Enrollment StartNov 11, 2003
Primary CompletionDec 3, 2007
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 20.8 years ago

Interventions

Havrix™biological

2 intramuscular injections, 6 months apart

Infanrix™biological

1 intramuscular injection

ActHIB™biological

1 intramuscular injection