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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Measles

Intervention: V205C, measles, mumps, and rubella virus vaccine live (Biological); Comparator: Measles, Mumps, and Rubella Virus Vaccine Live (Biological)

Phase: Phase 2

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.


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).

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Primary outcome: Antibody response rate to measles at 6 weeks postvaccination

Secondary outcome: Geometric mean titers to measles by ELISA at 6 weeks postvaccination

Detailed description: The duration of treatment is 6 weeks.


Minimum age: 12 Months. Maximum age: 18 Months. Gender(s): Both.


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]).

Locations and Contacts

Additional Information

Starting date: October 2004
Last updated: October 17, 2014

Page last updated: August 23, 2015

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