Assess GSK Biologicals' MMR Vaccine (Priorix) When Given to Healthy Children at the Age of 12 to 18 Months in Singapore.
Phase 4
Completed
- Conditions
- MumpsRubellaMeasles
- Registration Number
- NCT00388440
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
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.
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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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Solicited symptoms (Day 0-3); unsolicited AEs (Day 0-42); SAEs (full study)
- Secondary Outcome Measures
Name Time Method Antibody concentration to all vaccine antigens after vaccination