Trial record 6 of 111 for:    "Measles"

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00109278
First received: April 26, 2005
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

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).


Condition Intervention Phase
Measles
Biological: V205C, 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/Efficacy 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 From the 2003 Measles Stock Seed With Recombinant Human Albumin (rHA) Versus Currently Licensed V205C Manufactured From the 1967 Measles Stock Seed With 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 rate to measles at 6 weeks postvaccination

Secondary Outcome Measures:
  • Geometric mean titers to measles by ELISA at 6 weeks postvaccination

Enrollment: 1100
Study Start Date: October 2004
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
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:

  • 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]).
  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: NCT00109278

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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00109278     History of Changes
Other Study ID Numbers: V205C-010, 2005_016
Study First Received: April 26, 2005
Last Updated: October 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Prevention of Measles

Additional relevant MeSH terms:
Measles
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on August 20, 2014