Last updated: 11/03/2018 08:40:38

Safety of Hib-MenCY-TT vaccine versus licensed Hib conjugate vaccine, given at 12 to 15 months of age.

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GSK study ID
105988
Clinicaltrials.gov ID
NCT00345683
See results summary
EudraCT ID
2005-006066-34
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: Single-blind, randomized, controlled, multinational study for the evaluation of safety of GSK Biologicals' Hib-MenCY-TT vaccine compared to monovalent Hib control vaccine in healthy infants at 2, 4, 6, and 12 to 15 months of age.
Trial description: The booster phase of the study will evaluate the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine at 12 to 15 months of age.
This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00345579).
No new recruitment will take place during this booster phase of the study.
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:
Single (Care Provider)
Allocation:
Randomized
Primary outcomes:

Number of subjects reporting Serious Adverse Events (SAEs)

Timeframe: From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)

Number of subjects reporting New Onset of Chronic illnesses (NOCIs)

Timeframe: From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)

Number of subjects reporting rash

Timeframe: From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)

Number of subjects reporting Adverse Events resulting in Emergency Room (ER) visits

Timeframe: From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)

Number of subjects with Serious Adverse Events (SAEs)

Timeframe: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)

Number of subjects with New Onset of Chronic illnesses (NOCIs)

Timeframe: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)

Number of subjects with rash

Timeframe: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)

Number of subjects with Adverse Events resulting in Emergency Room (ER) visits

Timeframe: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)

Secondary outcomes:
Not applicable
Interventions:
  • Biological/vaccine: GSK Biologicals’ Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined (792014)
  • Biological/vaccine: PedvaxHIB
  • Biological/vaccine: Prevnar
  • Biological/vaccine: M-M-R II
  • Biological/vaccine: Varivax
    • Enrollment:
    4021
    Primary completion date:
    2008-02-09
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Haemophilus influenzae type b, Neisseria Meningitidis
    Product
    SB792014
    Collaborators
    Not applicable
    Study date(s)
    July 2007 to November 2008
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    12 - 15 months
    Accepts healthy volunteers
    Yes
    • Subjects enrolled in the primary study (NCT00345579) are eligible for participating in the booster study
    • Subjects should not be administered M-M-R II and Varivax if any of these criteria apply:
    • History of measles, mumps, rubella or varicella.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Subjects enrolled in the primary study (NCT00345579) are eligible for participating in the booster study
    Exclusion criteria:
    • Subjects should not be administered M-M-R II and Varivax if any of these criteria apply:
    • History of measles, mumps, rubella or varicella.
    • Previous vaccination against measles, mumps, rubella or varicella.
    • Hypersensitivity to any component of the vaccines, including gelatin or neomycin.
    • Patients receiving immunosuppressive therapy.
    • Individuals with blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.
    • Individuals with primary and acquired immunodeficiency states.
    • Individuals with a family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
    • Individuals with active tuberculosis.
    • Acute disease at time of booster vaccination

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Ogden, Utah, United States, 84405
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Birmingham, Alabama, United States, 35205
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Pittsburgh, Pennsylvania, United States, 15241
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Layton, Utah, United States, 84041
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Wexford, Pennsylvania, United States, 15090
    Status
    Study Complete
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    Location
    GSK Investigational Site
    South Euclid, Ohio, United States, 44121
    Status
    Study Complete
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    Study documents

    No study documents available.

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2008-02-09
    Actual study completion date
    2008-12-11

    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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