CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,274 enrolled
Drug / intervention
Comparator: VAQTA™ +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00289913
NCT00289913Phase 4Completed
CompareCT.gov

An Open, Randomized, Multicenter Study of the Safety, Tolerability, and Immunogenicity of VAQTA™ Given Concomitantly With PedvaxHIB™ and Infanrix™ in Healthy Children 15 Months of Age

Merck Sharp & Dohme LLC·interventional·Posted Feb 10, 2006·Updated Apr 13, 2017

In Brief

A Phase 4 clinical trial evaluating Comparator: VAQTA™, Comparator: Infanrix™, and 1 other intervention for Hepatitis A Virus. Completed, enrolled 1,274 participants.

Detailed Summary

This two-stage study evaluates the immunogenicity, safety, and tolerability of the administration of VAQTA™ (Hepatitis A Vaccine, Inactivated) concomitantly with PedvaxHIB™ (Haemophilus B Conjugate Vaccine \[Meningococcal Protein Conjugate\]) and Infanrix™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, GlaxoSmithKline) versus the administration of VAQTA™ in healthy children 15 months of age at study entry.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis A Virus
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 10, 2006
Enrollment StartApr 1, 2006
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 20.4 years ago

Interventions

Comparator: VAQTA™biological

VAQTA™ (Hepatitis A Vaccine, Inactivated). Two intramuscular 0.5-mL doses of VAQTA™ were administered 24 weeks apart, with the second dose being administered prior to 24 months of age.

Comparator: Infanrix™biological

Infanrix™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, GlaxoSmithKline). One intramuscular 0.5-mL injection of Infanrix™ was administered at the first study visit.

Comparator: PedvaxHIB™biological

PedvaxHIB™ (Haemophilus B Conjugate Vaccine \[Meningococcal Protein Conjugate\]). One intramuscular 0.5-mL injection of PedvaxHIB™ was administered at the first study visit.