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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00109278
Enrollment
1100
Registered
2005-04-26
Start date
2004-10-31
Completion date
2005-05-31
Last updated
2017-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Measles

Keywords

Prevention of Measles

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).

Detailed description

The duration of treatment is 6 weeks.

Interventions

BIOLOGICALV205C, measles, mumps, and rubella virus vaccine live

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
12 Months to 18 Months
Healthy volunteers
Yes

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 \[37.5° C\]).

Design outcomes

Primary

MeasureTime frame
Antibody response rate to measles at 6 weeks postvaccination

Secondary

MeasureTime frame
Geometric mean titers to measles by ELISA at 6 weeks postvaccination

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026