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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00092404
First Posted: September 27, 2004
Last Update Posted: March 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • Geometric mean titers to measles, mumps, and rubella by ELISA at 6 weeks postvaccination [ Time Frame: 6 weeks postvaccination ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   12 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00092404


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

Publications:
Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092404     History of Changes
Other Study ID Numbers: V205C-009
2004_074
First Submitted: September 22, 2004
First Posted: September 27, 2004
Last Update Posted: March 15, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Rubella
Rubivirus Infections
Togaviridae Infections
RNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs