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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.

Primary Purpose

Rubella, Mumps, Measles

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
MMR vaccine (Priorix)
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rubella focused on measuring Mumps, Singapore, Rubella, Measles

Eligibility Criteria

12 Months - 18 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Outcomes

    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

    Full Information

    First Posted
    October 13, 2006
    Last Updated
    September 15, 2016
    Sponsor
    GlaxoSmithKline
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00388440
    Brief Title
    Assess GSK Biologicals' MMR Vaccine (Priorix) When Given to Healthy Children at the Age of 12 to 18 Months in Singapore.
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2000 (undefined)
    Primary Completion Date
    April 2001 (Actual)
    Study Completion Date
    April 2001 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    GlaxoSmithKline

    4. Oversight

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rubella, Mumps, Measles
    Keywords
    Mumps, Singapore, Rubella, Measles

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    150 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Biological
    Intervention Name(s)
    MMR vaccine (Priorix)
    Primary Outcome Measure Information:
    Title
    Solicited symptoms (Day 0-3); unsolicited AEs (Day 0-42); SAEs (full study)
    Secondary Outcome Measure Information:
    Title
    Antibody concentration to all vaccine antigens after vaccination

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Months
    Maximum Age & Unit of Time
    18 Months
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    GSK Clinical Trials
    Organizational Affiliation
    GlaxoSmithKline
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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.
    Links:
    URL
    https://www.clinicalstudydatarequest.com
    Description
    Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
    Available IPD and Supporting Information:
    Available IPD/Information Type
    Study Protocol
    Available IPD/Information URL
    https://www.clinicalstudydatarequest.com
    Available IPD/Information Identifier
    209762/147
    Available IPD/Information Comments
    For additional information about this study please refer to the GSK Clinical Study Register
    Available IPD/Information Type
    Informed Consent Form
    Available IPD/Information URL
    https://www.clinicalstudydatarequest.com
    Available IPD/Information Identifier
    209762/147
    Available IPD/Information Comments
    For additional information about this study please refer to the GSK Clinical Study Register
    Available IPD/Information Type
    Clinical Study Report
    Available IPD/Information URL
    https://www.clinicalstudydatarequest.com
    Available IPD/Information Identifier
    209762/147
    Available IPD/Information Comments
    For additional information about this study please refer to the GSK Clinical Study Register
    Available IPD/Information Type
    Dataset Specification
    Available IPD/Information URL
    https://www.clinicalstudydatarequest.com
    Available IPD/Information Identifier
    209762/147
    Available IPD/Information Comments
    For additional information about this study please refer to the GSK Clinical Study Register
    Available IPD/Information Type
    Individual Participant Data Set
    Available IPD/Information URL
    https://www.clinicalstudydatarequest.com
    Available IPD/Information Identifier
    209762/147
    Available IPD/Information Comments
    For additional information about this study please refer to the GSK Clinical Study Register

    Learn more about this trial

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

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