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

Measles Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00109278
• Other study ID #: V205C-010
• Secondary ID: 2005_016
• Status: Completed
• Phase: Phase 2
• First received: April 26, 2005
• Last updated: March 14, 2017
• Start date: October 2004
• Est. completion date: May 2005

Study information

• Verified date: March 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

The duration of treatment is 6 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1100
• Est. completion date: May 2005
• Est. primary completion date: May 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 18 Months

Eligibility

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]).

Related Conditions & MeSH terms

• Measles

Intervention

Biological:
• V205C, measles, mumps, and rubella virus vaccine live

• Comparator: Measles, Mumps, and Rubella Virus Vaccine Live

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antibody response rate to measles at 6 weeks postvaccination
Secondary	Geometric mean titers to measles by ELISA at 6 weeks postvaccination