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Study to Test the Safety and Immunogenicity of VARIVAX (2007 Process) (Study V210-057) (Completed)

NCT00822237 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 598

Last updated 2017-04-12

Study results available
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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.

Conditions

  • Varicella

Interventions

BIOLOGICAL

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

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

BIOLOGICAL

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

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

BIOLOGICAL

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

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

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
23 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-10-31
Completion
2009-12-31

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00822237 on ClinicalTrials.gov