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

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ClinicalTrials.gov Identifier: NCT00109278
Recruitment Status : Completed
First Posted : April 26, 2005
Last Update Posted : March 15, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment Phase
Measles Biological: V205C, measles, mumps, and rubella virus vaccine live Biological: Comparator: Measles, Mumps, and Rubella Virus Vaccine Live Phase 2

Detailed Description:
The duration of treatment is 6 weeks.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1100 participants
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 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
Study Start Date : October 2004
Actual Primary Completion Date : May 2005
Actual Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Measles Mumps Rubella




Primary Outcome Measures :
  1. Antibody response rate to measles at 6 weeks postvaccination

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


Information from the National Library of Medicine

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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:

  • 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]).

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): NCT00109278


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

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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00109278     History of Changes
Other Study ID Numbers: V205C-010
2005_016
First Posted: April 26, 2005    Key Record Dates
Last Update Posted: March 15, 2017
Last Verified: March 2017

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
Vaccines
Immunologic Factors
Physiological Effects of Drugs