A Study of An Approved Vaccine at Mumps Expiry Potency in Healthy Children 12 to 18 Months of Age (V205C-007)(COMPLETED)

Merck Sharp & Dohme LLC1,997 enrolled

Overview

The purpose of this study is to determine the mumps virus strength at the end of shelf-life (expiration date) of an approved vaccine.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

1,997

Conditions

Measles Mumps Rubella Varicella

Interventions

Comparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine liveBIOLOGICAL

0.5 mL subcutaneous injection of one of three sub-lots on Day 0

Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck)BIOLOGICAL

0.5 mL subcutaneous injection on Day 0

Eligibility

Sex: ALLMin age: 12 MonthsMax age: 18 MonthsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy children 12 to 18 months of age Exclusion Criteria: * History or prior exposure to measles, mumps, rubella or varicella * History of anaphylactoid reactions or hypersensitivity to any component of the vaccine, including gelatin and neomycin

Outcomes

Primary Outcomes

Neutralizing antibodies to mumps at 6 weeks postvaccination

Time frame: 6 weeks postvaccination

Secondary Outcomes

Geometric mean titers to mumps by ELISA at 6 weeks and at 1 year postvaccination

Time frame: 6 weeks and 1 year postvaccination

Data from ClinicalTrials.gov

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