Study to Evaluate Frozen Versus Refrigerated MMRV (Combined Measles, Mumps, Rubella, and Varicella) Investigational Vaccine (V221-016)

Merck Sharp & Dohme LLC1,200 enrolled

Overview

The purpose of this study is to demonstrate that an investigational refrigerated vaccine with measles, mumps, rubella, and varicella is well tolerated and has similar immune response when compared to a frozen vaccine with measles, mumps, rubella, and varicella.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

1,200

Conditions

Measles Mumps Rubella Varicella

Interventions

V221, measles, mumps, rubella and varicella (Oka/Merck) virus vaccine live / Duration of Treatment: 12 weeksBIOLOGICAL

Eligibility

Sex: ALLMin age: 12 MonthsMax age: 23 MonthsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy children 12-23 months of age Exclusion Criteria: * Previously had measles, mumps, rubella, or varicella * Compromised immune system

Outcomes

Primary Outcomes

Percent of patients demonstrating adequate antibody titers 6 weeks following administration

Secondary Outcomes

Geometric mean titers (GMT) 6 weeks post vaccination

Data from ClinicalTrials.gov

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