Safety, Tolerability, and Immunogenicity of an Investigational Vaccine With Recombinant Human Albumin (rHA) in Children 12 to 18 Months of Age (V205C-009)(COMPLETED)

Merck Sharp & Dohme LLC1,210 enrolled

Overview

The purpose of this trial is to study the safety and immune response to measles, mumps, and rubella in children who were vaccinated with an investigational measles-mumps-rubella live vaccine made with artificially made human protein.

The duration of treatment is 6 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

1,210

Conditions

Measles Mumps Rubella Varicella

Interventions

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: * History or prior exposure to measles, mumps, or rubella * History of allergic reactions to any component of the vaccines as evaluated by the study doctor

Outcomes

Primary Outcomes

Antibody response rates to measles, mumps, and rubella at 6 weeks postvaccination

Time frame: 6 weeks postvaccination

Secondary Outcomes

Geometric mean titers to measles, mumps, and rubella by ELISA at 6 weeks postvaccination

Time frame: 6 weeks postvaccination

Data from ClinicalTrials.gov

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