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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092404
First received: September 22, 2004
Last updated: January 21, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Measles
Mumps
Rubella
Varicella
Biological: measles, mumps, and rubella virus vaccine live
Biological: Comparator: Measles, Mumps, and Rubella Virus Vaccine Live
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Comparison of the Safety, Tolerability, and Immunogenicity of V205C Manufactured With Recombinant Human Albumin (rHA) Versus V205C Manufactured With Pooled-Donor Human Serum Albumin (HSA) in Healthy Children 12 to 18 Months of Age

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Antibody response rates to measles, mumps, and rubella at 6 weeks postvaccination [ Time Frame: 6 weeks postvaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Geometric mean titers to measles, mumps, and rubella by ELISA at 6 weeks postvaccination [ Time Frame: 6 weeks postvaccination ] [ Designated as safety issue: No ]

Enrollment: 1210
Study Start Date: December 2001
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: measles, mumps, and rubella virus vaccine live
    Other Name: V205C
    Biological: Comparator: Measles, Mumps, and Rubella Virus Vaccine Live
Detailed Description:

The duration of treatment is 6 weeks.

  Eligibility

Ages Eligible for Study:   12 Months to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00092404

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00092404     History of Changes
Other Study ID Numbers: 2004_074, V205C-009
Study First Received: September 22, 2004
Last Updated: January 21, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Albunex
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014