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A Study of ProQuad™ in Healthy Children in Korea (V221-023)

NCT00839917 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-04-12

Study results available
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Summary

This study will compare ProQuad™ and concomitant administration of M-M-R™ II and Varivax™ with respect to immunogenicity, safety and tolerability. The primary hypothesis to be tested is that the antibody response rates to measles, mumps, rubella, and varicella 6 weeks after vaccination with ProQuad™ will be non-inferior to the antibody response rates after vaccination with concomitant M-M-R™ II and Varivax™.

Conditions

Interventions

BIOLOGICAL

Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (ProQuad™)

Single administration of 0.5 mL subcutaneous injection

BIOLOGICAL

M-M-R™ II and Varivax™

Single administration of 0.5 mL subcutaneous injection

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2008-05-31
Completion
2008-05-31

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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 NCT00839917 on ClinicalTrials.gov