CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,474 enrolled
Drug / intervention
Havrix® +2 morebiological
Likely dose
Havrix 2 doses intramuscularly; M-M-R II 1 dose subcutaneously; VARIVAX 1 dose subcutaneouslyAI-extracted
Key inclusion· 4
  • ✓Male or female child aged 12-13 months at enrollment
  • ✓Free of obvious health problems on medical history and physical examination
  • ✓Parents/guardians willing and able to comply with protocol requirements and contactable by telephone
  • ✓Written informed consent from parents or guardian
Key exclusion· 20
  • ✕Previous vaccination against hepatitis A
  • ✕History of hepatitis A or known exposure to hepatitis A
  • ✕Previous vaccination against measles, mumps, rubella, and/or varicella
  • ✕History of measles, mumps, rubella, and/or varicella

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

Search/NCT00197015
NCT00197015Phase 3Completed
CompareCT.gov

Immunogenicity & Safety of GSK Biologicals' Inactivated Hepatitis A Vaccine (Havrix™) Co-administered With Merck & Company, Inc. Measles-Mumps-Rubella Vaccine (M-M-RII) & Merck & Co Varicella Vaccine (VARIVAX™) to Children 15 Months of Age

GlaxoSmithKline·interventional·Posted Sep 20, 2005·Updated Jul 31, 2018

In Brief

A Phase 3 clinical trial evaluating Havrix®, M-M-R®II, and 1 other intervention for Hepatitis A. Completed, enrolled 1,474 participants across 42 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 measles/mumps/rubella vaccine and a varicella (chickenpox) vaccine in children as young as 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 StartOct 6, 2003
Primary CompletionJun 9, 2009
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 20.8 years ago

Interventions

Havrix®biological

2 doses administered intramuscularly

M-M-R®IIbiological

1 dose administered subcutaneously

VARIVAX®biological

1 dose administered subcutaneously