Skip to main content
MedPathMedPath Home
Clinical Trials/NCT00388440
NCT00388440
Completed
Phase 4

Phase IV Open Study to Assess the Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Live Attenuated Measles-Mumps-Rubella (MMR) Vaccine When Given to Healthy Children at the Age of 12 to 18 Months in Singapore.

GlaxoSmithKline0 sites150 target enrollmentNovember 2000
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsRubellaMumpsMeasles

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Rubella
Sponsor
GlaxoSmithKline
Enrollment
150
Primary Endpoint
Solicited symptoms (Day 0-3); unsolicited AEs (Day 0-42); SAEs (full study)
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

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).

Registry
clinicaltrials.gov
Start Date
November 2000
End Date
April 2001
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

Solicited symptoms (Day 0-3); unsolicited AEs (Day 0-42); SAEs (full study)

Secondary Outcomes

  • Antibody concentration to all vaccine antigens after vaccination

Similar Trials

Completed
Phase 3
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Subjects Four to Six Years of AgeMeasles-Mumps-Rubella
NCT01621802GlaxoSmithKline4,011
Completed
Phase 3
Immunogenicity and Safety of GSK Biologicals' Combined Measles-mumps-rubella Vaccine in Volunteers, Seven Years of Age and OlderRubellaMumpsMeasles
NCT02058563GlaxoSmithKline996
Withdrawn
Not Applicable
Safety Study of Measles-Mumps-Rubella-Varicella (MMRV) Vaccine, Priorix-Tetra™ in Children Living in the PhilippinesMumpsRubellaMeaslesVaricella
NCT01738841GlaxoSmithKline
Completed
Not Applicable
Post-marketing Safety Study of GSK Biological's Pediarix™ VaccineHepatitis BPoliomyelitisDiphtheriaTetanusAcellular Pertussis
NCT00146835GlaxoSmithKline120,794
Completed
Phase 3
Immunogenicity and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Split Virion Influenza Vaccine Fluarix Tetra (2015 Season Southern Hemisphere) in Adults 18 Years of Age and AboveInfluenza
NCT02369341GlaxoSmithKline121