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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 (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00388440
First received: October 13, 2006
Last updated: September 15, 2016
Last verified: September 2016
  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
Rubella
Mumps
Measles
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: 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.

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

Enrollment: 150
Study Start Date: November 2000
Study Completion Date: April 2001
Primary Completion Date: April 2001 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   12 Months to 18 Months   (Child)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 209762/147
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 209762/147
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 209762/147
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 209762/147
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 209762/147
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00388440     History of Changes
Other Study ID Numbers: 209762/147 
Study First Received: October 13, 2006
Last Updated: September 15, 2016
Health Authority: Singapore: Health Sciences Authority
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
Mumps
Singapore
Rubella
Measles

Additional relevant MeSH terms:
Measles
Rubella
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Rubivirus Infections
Togaviridae Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 09, 2016