A Measles, Mumps, and Rubella Investigational Vaccine Trial - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00109278

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 II

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:

MedlinePlus related topics: Measles Mumps Rubella

Drug Information available for: Rubella Vaccine

U.S. FDA Resources

Further study details as provided by Merck:

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00109278

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00109278 History of Changes
Other Study ID Numbers:	2005_016, V205C-010
Study First Received:	April 26, 2005
Last Updated:	January 27, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

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 February 12, 2012