Assess GSK Biologicals' MMR Vaccine (Priorix) When Given to Healthy Children at the Age of 12 to 18 Months in Singapore.

NCT ID: NCT00388440

Last Updated: 2016-09-20

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

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-11-30

Study Completion Date

2001-04-30

Brief Summary

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To evaluate the safety and immunogenicity of GSK Biologicals' live attenuated MMR vaccine (Priorix) in a local population in Singapore. The vaccine was administered as a single dose to healthy children (12-18 months of age) and blood samples were collected at two time points (before vaccination and after vaccination).

Detailed Description

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Conditions

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Rubella Mumps Measles

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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MMR vaccine (Priorix)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* A male or female infant between 12 and 18 months of age at the time of the vaccination
* Written informed consent obtained from the parents or guardians of the subject.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Exclusion Criteria

* Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the dose of study vaccine
* Previous vaccination against mumps and/or rubella
* History of, or intercurrent, measles, mumps, and/or rubella disease
* Known exposure to measles, mumps or rubella within 30 days prior to the start of the study
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
Minimum Eligible Age

12 Months

Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Study Documents

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Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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209762/147

Identifier Type: -

Identifier Source: org_study_id

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