ProQuad™ Versus M-M-R II™ and VARIVAX™ in Healthy Children (V221-009)(COMPLETED)

NCT00975507 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2015-10-06

Study results available
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Summary

This study will compare Measles, Mumps, Rubella, and Varicella Vaccine (V221) and concomitant administration of Varivax and M-M-R II vaccines in healthy children.

Conditions

Interventions

BIOLOGICAL

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

a single 0.5 mL subcutaneous injection of V221 at Day 0 and Day 90

BIOLOGICAL

Comparator: Placebo

a single 0.5 mL subcutaneous placebo injection at Day 0

BIOLOGICAL

Comparator: Varivax

a single 0.5 mL subcutaneous injection of Varivax at Day 0

BIOLOGICAL

Comparator: M-M-R II

a single 0.5 mL subcutaneous injection of M-M-R II at Day 0

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
1998-03-31
Primary Completion
1999-01-31
Completion
1999-06-30

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Entities

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 NCT00975507 on ClinicalTrials.gov