Last updated: 11/04/2018 00:25:22

Immunogenicity & Safety of Hepatitis A Vaccine co-admin with a Measles/Mumps/Rubella & a Varicella Vaccine in Children

GSK study ID
208109/231
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Immunogenicity & Safety of GSK Biologicals' Inactivated Hepatitis A Vaccine (Havrix™) Co-administered With Merck & Company, Inc. Measles-Mumps-Rubella Vaccine (M-M-RII) & Merck & Co Varicella Vaccine (VARIVAX™) to Children 15 Months of Age
Trial description: This is a study to evaluate the immune response and safety of GSK Biologicals 2-dose inactivated hepatitis A vaccine when administered with a measles/mumps/rubella vaccine and a varicella (chickenpox) vaccine in children as young as 15 months of age.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Anti-hepatitis A virus (HAV) antibody concentrations in HAV and HAV+MMR+V groups.

Timeframe: 31 days following the second dose of Havrix®

Number of subjects with anti-hepatitis A virus (HAV) antibody concentration equal or above the cut-off value in HAV and HAV+MMR+V groups

Timeframe: 31 days following the second dose of Havrix®

Number of subjects seroconverted for anti-measle, anti-mumps and anti-varicella antibodies in HAV+MMR+V and MMR+V→HAV groups

Timeframe: 42 days following the administration of M-M-R®II and VARIVAX®

Number of subjects with vaccine response for anti-rubella antibodies in HAV+MMR+V and MMR+V→HAV groups

Timeframe: 42 days following administration of M-M-R®II and VARIVAX®

Secondary outcomes:

Anti-measles, anti-mumps, anti-rubella and anti-varicella antibody titers in HAV+MMR+V and MMR+V→HAV groups

Timeframe: 42 days following the administration of M-M-R®II and VARIVAX®

Anti-hepatitis A virus (HAV) antibody concentrations in HAV and HAV+MMR+V groups

Timeframe: 42 days following the first dose of Havrix®

Number of subjects with anti-hepatitis A virus (HAV) antibody concentration equal or above the cut-off value in HAV and HAV+MMR+V groups

Timeframe: 42 days following the first dose of Havrix®

Anti-hepatitis A virus (HAV) antibody concentrations in MMR+V→HAV Group

Timeframe: 31 days following the second dose of Havrix®

Number of subjects with anti-hepatitis A virus (HAV) antibody concentrations above the cut-off value in MMR+V→HAV Group

Timeframe: 31 days following the second dose of Havrix®

Number of subjects with vaccine response to Havrix®

Timeframe: 31 days following the second dose of Havrix®

Number of subjects reporting solicited local symptoms

Timeframe: During the 4-day period following each dose of vaccine

Number of subjects reporting solicited general symptoms

Timeframe: During the 4-day period following each dose of vaccine

Number of subjects reporting measles, mumps, rubella and varicella specific solicited general adverse events

Timeframe: During the 43-day period following each dose of vaccine

Number of subjects reporting unsolicited adverse events (AEs)

Timeframe: During the 31-day period following each dose of vaccine

Number of subjects reporting serious adverse events (SAEs)

Timeframe: During the Active Phase (from Day 0 up to Day 31 after the second dose) and the Extended Safety Follow-up Phase of the study (from Day 31 after the second dose up to study end)

Number of subjects reporting new chronic illnesses

Timeframe: During the Active Phase (from Day 0 up to Day 31 after the second dose) and the Extended Safety Follow-up Phase of the study (from Day 31 after the second dose up to study end)

Number of subjects reporting medically significant events

Timeframe: During the Active Phase (from Day 0 up to Day 31 after the second dose) and the Extended Safety Follow-up Phase of the study (from Day 31 after the second dose up to study end)

Interventions:
  • Biological/vaccine: Havrix®
  • Biological/vaccine: M-M-R®II
  • Biological/vaccine: VARIVAX®
  • Enrollment:
    1474
    Primary completion date:
    2009-09-06
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Rinderknecht S et al. (2011) Immunogenicity and safety of an inactivated hepatitis A vaccine when coadministered with measles-mumps-rubella and varicella vaccines in children less than 2 years of age. Pediatr Infect Dis J. 30(10):e179-185.
    Medical condition
    Hepatitis A
    Product
    SB208109
    Collaborators
    Not applicable
    Study date(s)
    October 2003 to June 2009
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    12 - 13 months
    Accepts healthy volunteers
    Yes
    • Subjects whose parents/guardians are believed by the investigator to be willing to comply with the requirements of the protocol
    • A male or female child 12 and 13 months of age at the time of entry into the Enrollment Phase
    • Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 42 days preceding the first dose of study vaccine, or planned use during the study period,
    • Chronic administration (defined as more than 14 days) of immuno-suppressant or other immune-modifying drugs within six months prior to vaccination or planned administration at any time during the study period. (For corticosteroids, this will mean prednisone, or equivalent, ≥0.5 mg/kg/day. Inhaled, nasal and topical steroids are allowed.)

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Beaver Falls, Pennsylvania, United States, 15010
    Status
    Study Complete
    Location
    GSK Investigational Site
    Rolling Hills Estates, California, United States, 90274
    Status
    Study Complete
    Location
    GSK Investigational Site
    Norfolk, Virginia, United States, 23510
    Status
    Study Complete
    Location
    GSK Investigational Site
    Baltimore, Maryland, United States, 21201
    Status
    Study Complete
    Location
    GSK Investigational Site
    Oakland, California, United States, 94609
    Status
    Study Complete
    Location
    GSK Investigational Site
    Tulsa, Oklahoma, United States, 74104
    Status
    Study Complete
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    Study documents

    Clinical study report
    Available language(s): English
    Scientific result summary
    Available language(s): English

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2009-09-06
    Actual study completion date
    2009-09-06

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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