A Measles, Mumps, and Rubella Investigational Vaccine Trial (V205C-010)(COMPLETED)

Merck Sharp & Dohme LLC1,100 enrolled

Overview

The purpose of this study is to test the safety of a measles, mumps, and rubella study vaccine made from a new measles stock seed (a component of the vaccine made in 2003) with rHA (recombinant human albumin).

The duration of treatment is 6 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

1,100

Conditions

Measles

Interventions

V205C, measles, mumps, and rubella virus vaccine liveBIOLOGICAL

Comparator: Measles, Mumps, and Rubella Virus Vaccine LiveBIOLOGICAL

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: * Previous receipt of measles, mumps, rubella and/or varicella vaccine. * Prior infection or exposure to (within last 4 weeks) measles, mumps, rubella, varicella and/or zoster. * Any medical condition that might interfere with the immune response to the given vaccines (including HIV infection and/or cancer) or has undergone immunosuppressive (weakens your body's ability to fight infection) therapy. * History of seizures (convulsions) * Allergies to any component of the vaccine, including sorbitol, gelatin, or neomycin. * A recent (within the last 3 days) illness resulting in a fever (underarm temperature greater than 99.5° F \[37.5° C\]).

Outcomes

Primary Outcomes

Antibody response rate to measles at 6 weeks postvaccination

Secondary Outcomes

Geometric mean titers to measles by ELISA at 6 weeks postvaccination

Data from ClinicalTrials.gov

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