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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.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00388440
First received: October 13, 2006
Last updated: NA
Last verified: October 2006
History: No changes posted
  Purpose

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
Measles
Mumps
Rubella
 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:

MedlinePlus related topics: Measles Mumps Rubella
U.S. FDA Resources

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
  Eligibility

Ages Eligible for Study:   12 Months to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00388440

Locations
Singapore
GSK Clinical Trials Call Center
Singapore, Singapore, 688846
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: Clinical Trials GlaxoSmithKline
  More Information

No publications provided

ClinicalTrials.gov 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:
Measles
Mumps
Rubella
Singapore

Additional relevant MeSH terms:
Measles
Mumps
Parotitis
Rubella
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
 Rubulavirus Infections
Parotid Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Sialadenitis
Rubivirus Infections
Togaviridae Infections

ClinicalTrials.gov processed this record on June 18, 2013