CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 653 enrolled
Drug / intervention
Comparator: VAQTA™ (Hepatitis A vaccine) +2 morebiological
Likely dose
VAQTA 0.5 mL, ProQuad 0.5 mL, Prevnar 0.5 mL injections administered concomitantlyAI-extracted
Key inclusion· 4
  • Age 12 to 15 months
  • No active liver disease
  • No prior hepatitis A infection
  • No prior measles, mumps, rubella, or varicella infection
Key exclusion· 5
  • Prior hepatitis A vaccination
  • Prior measles, mumps, rubella, or varicella vaccination
  • Any immune deficiency
  • Allergy to vaccine components

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

Search/NCT00312858
NCT00312858Phase 4Completed

An Open, Randomized, Multicenter Study of the Safety, Tolerability, & Immunogenicity of VAQTA™ Given Concomitantly With PROQUAD™ and PREVNAR™ in Healthy Children 12 Months of Age

Merck Sharp & Dohme LLC·interventional·Posted Apr 11, 2006·Updated Apr 13, 2017

In Brief

A Phase 4 clinical trial evaluating Comparator: VAQTA™ (Hepatitis A vaccine), Comparator: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine), and 1 other intervention for Hepatitis A Virus. Completed, enrolled 653 participants.

Detailed Summary

Hepatitis A vaccine will be given either alone or together with measles, mumps, rubella, and varicella vaccine and pneumococcal 7-valent conjugate vaccine at the first dose and together with measles, mumps, rubella, and varicella \[Oka/Merck\] virus vaccine at the second dose. Immunogenicity and safety data will be collected after each dose of vaccine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 11, 2006
Enrollment StartApr 1, 2006
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 20.2 years ago

Interventions

Comparator: VAQTA™ (Hepatitis A vaccine)biological

VAQTA™ 0.5 mL injection

Comparator: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine)biological

ProQuad™ 0.5 mL injection

Comparator: Prevnar™ (Pneumococcal 7-Valent Conjugate vaccine)biological

Prevnar™ 0.5 mL injection