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

NCT ID: NCT00109278

Last Updated: 2017-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

1100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2005-05-31

Brief Summary

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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

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The duration of treatment is 6 weeks.

Conditions

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Measles

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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V205C, measles, mumps, and rubella virus vaccine live

Intervention Type BIOLOGICAL

Comparator: Measles, Mumps, and Rubella Virus Vaccine Live

Intervention Type BIOLOGICAL

Eligibility Criteria

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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 \[37.5° C\]).
Minimum Eligible Age

12 Months

Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Study Documents

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Document Type: CSR Synopsis

View Document

Other Identifiers

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2005_016

Identifier Type: -

Identifier Source: secondary_id

V205C-010

Identifier Type: -

Identifier Source: org_study_id

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