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

This study has been completed.
Information provided by:
GlaxoSmithKline Identifier:
First received: October 13, 2006
Last updated: NA
Last verified: October 2006
History: No changes posted
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).

Condition Intervention Phase
Biological: MMR vaccine (Priorix)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Study to Assess the Safety and Immunogenicity of GSK Biologicals' Live Attenuated Measles-Mumps-Rubella (MMR) Vaccine (Priorix) When Given to Healthy Children at the Age of 12 to 18 Months in Singapore.

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Solicited symptoms (Day 0-3); unsolicited AEs (Day 0-42); SAEs (full study)

Secondary Outcome Measures:
  • Antibody concentration to all vaccine antigens after vaccination

Estimated Enrollment: 150
Study Start Date: November 2000

Ages Eligible for Study:   12 Months to 18 Months   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.
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Please refer to this study by its identifier: NCT00388440

GSK Clinical Trials Call Center
Singapore, Singapore, 688846
Sponsors and Collaborators
Study Director: Clinical Trials GlaxoSmithKline
  More Information Identifier: NCT00388440     History of Changes
Other Study ID Numbers: 209762/147 
Study First Received: October 13, 2006
Last Updated: October 13, 2006
Health Authority: Singapore: Health Sciences Authority

Keywords provided by GlaxoSmithKline:

Additional relevant MeSH terms:
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Rubivirus Infections
Togaviridae Infections
Immunologic Factors
Physiological Effects of Drugs processed this record on August 25, 2016