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

Phase 2

Completed

• Conditions: Rubella; Measles; Varicella; Mumps

• Registration Number: NCT00092404
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

The duration of treatment is 6 weeks.

Study Timeline

• Study Start: 2001-12
• Study First Submitted: 2004-09-22
• Study First Submitted QC: 2004-09-24
• Study First Posted: 2004-09-27
• Primary Completion: 2005-06
• Study Completion: 2005-06
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-14
• Last Update Posted: 2017-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1210

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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