CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 598 enrolled
Drug / intervention
Varicella Virus Vaccine Live (2007 Process) (Oka/Merck) +2 morebiological
Likely dose
Varicella Virus Vaccine Live (2007 Process) (Oka/Merck) 0.5 mLfrom 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/NCT00822237
NCT00822237Phase 3Completed

Safety, Tolerability, and Immunogenicity of VARIVAX (2007 Commercial VZV Bulk Process) Administered Concomitantly With M-M-R II in Healthy Children 12-to-23 Months of Age

Merck Sharp & Dohme LLC·interventional·Posted Jan 14, 2009·Updated Apr 12, 2017

In Brief

A Phase 3 clinical trial evaluating Varicella Virus Vaccine Live (2007 Process) (Oka/Merck), Comparator: Varicella Virus Vaccine Live (1999 Process) (Oka/Merck), and 1 other intervention for Varicella. Completed, enrolled 598 participants.

Detailed Summary

This study will test the safety, tolerability, and immunogenicity of VARIVAX manufactured with the 2007 commercial Varicella-Zoster Virus (VZV) bulk process when concomitantly administered with M-M-R II in healthy children.

Study Details

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

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 14, 2009
Enrollment StartJan 1, 2009
Primary CompletionOct 1, 2009
Study CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 17.5 years ago

Interventions

Varicella Virus Vaccine Live (2007 Process) (Oka/Merck)biological

VARIVAX (2007 process) in two 0.5 mL doses by injection \~6 weeks apart

Comparator: Varicella Virus Vaccine Live (1999 Process) (Oka/Merck)biological

VARIVAX (1999 process) in two 0.5 mL doses by injection \~6 weeks apart

Measles, Mumps, and Rubella Virus Vaccine Live (MMR)biological

M-M-R II in two 0.5 mL doses by injection \~6 weeks apart