Last updated: 11/07/2018 15:11:36

study to evaluate GlaxoSmithKline (GSK) Biologicals’ MenC-TT vaccine and Hib-MenC-TT vaccine in infants

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GSK study ID
711202/001
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Clinicaltrials.gov ID
NCT00135486
EudraCT ID
Not applicable
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: Evaluate immunogenicity, reactogenicity, safety of GSK Biologicals’ MenC-TT vaccine (2 formulations) given with Infanrix hexa® + GSK Biologicals’ Hib MenC-TT vaccine (2 formulations) given with Infanrix penta® to infants in mths 3,4,5 of life
Trial description: The purpose of this primary vaccination study is to evaluate the immunogenicity, safety and reactogenicity of three doses of GSK Biologicals' MenC-TT (Neisseria meningitidis group C polysaccharide-tetanus toxoid) vaccine (2 different formulations) and of three doses of GSK Biologicals' Hib-MenC-TT (Haemophilus influenzae type b-MenC-TT) vaccine (2 different formulations) when given to infants in their 3rd, 4th, and 5th months of life. Concomitant vaccines were given to all children to complete the vaccination agenda.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Evaluation of Meningococcal C serum bactericidal assay using rabbit complement (rSBA-MenC) antibody titers ≥ 1:8 & ≥ 1:128 and titers

Timeframe: Prior to vaccination, one month after the 2nd and 3rd vaccine doses

Evaluation of anti-polysaccharide C (anti-PSC) antibody concentrations ≥ 0.3 µg/mL & ≥ 2 µg/mL and concentrations

Timeframe: Prior to vaccination, one month after the 2nd and 3rd vaccine doses

Evaluation of anti-polyribosyl ribitol phosphate (anti-PRP) antibody concentrations ≥ 0.15 µg/mL & ≥ 1 µg/mL and concentrations

Timeframe: Prior to vaccination, one month after the 2nd and 3rd vaccine doses

Evaluation of anti-diphtheria antibody concentrations ≥ 0.1 IU/mL by ELISA

Timeframe: Prior to and one month after the 3rd vaccine dose

Evaluation of anti-tetanus antibody concentrations ≥ 0.1 IU/mL

Timeframe: Prior to and one month after the 3rd vaccine dose

Evaluation of anti-hepatitis B surface antigen (anti-HBs) antibody concentrations ≥ 10 mIU/mL

Timeframe: Prior to and one month after the 3rd vaccine dose

Evaluation of anti-poliovirus types 1, 2 and 3 antibody titers ≥ 8 mIU/mL

Timeframe: Prior to and one month after the 3rd vaccine dose

Vaccine response to pertussis toxoid (PT)

Timeframe: Prior to 3rd vaccine dose

Evaluation of anti-diphtheria antibody concentrations

Timeframe: Prior to 3rd vaccine dose

Anti-poliovirus types 1, 2 and 3 antibody titers

Timeframe: Prior to and one month after the 3rd vaccine dose

Occurrence of solicited local injection site symptoms

Timeframe: During the solicited follow-up period (Day 0 7) following administration of each vaccine dose

Occurrence of solicited systemic symptoms

Timeframe: During the solicited follow-up period (Day 0 7) following administration of each vaccine dose

Occurrence of unsolicited non-serious adverse events (AEs)

Timeframe: Within one month (Day 0 30) after each vaccination

Occurrence of any serious adverse events (SAEs)

Timeframe: Throughout the entire study period up to and including one month (maximum 30 days) after the last vaccine dose

Vaccine response to pertussis toxoid (PT)

Timeframe: One month after the 3rd vaccine dose

Vaccine response to filamentous haemagglutinin (FHA)

Timeframe: Prior to 3rd vaccine dose

Vaccine response to filamentous haemagglutinin (FHA)

Timeframe: One month after the 3rd vaccine dose

Vaccine response to pertactin (PRN)

Timeframe: Prior to 3rd vaccine dose

Vaccine response to pertactin (PRN)

Timeframe: One month after the 3rd vaccine dose

Evaluation of anti-diphtheria antibody concentrations

Timeframe: One month after the 3rd vaccine dose

Evaluation of anti-tetanus antibody concentrations

Timeframe: Prior to 3rd vaccine dose

Evaluation of anti-tetanus antibody concentrations

Timeframe: One month after the 3rd vaccine dose

Evaluation of anti-HBs antibody concentrations

Timeframe: Prior to 3rd vaccine dose

Evaluation of anti-HBs antibody concentrations

Timeframe: One month after the 3rd vaccine dose

Evaluation of anti-PT antibody concentrations

Timeframe: Prior to 3rd vaccine dose

Evaluation of anti-PT antibody concentrations

Timeframe: One month after the 3rd vaccine dose

Evaluation of anti-FHA antibody concentrations

Timeframe: Prior to 3rd vaccine dose

Evaluation of anti-FHA antibody concentrations

Timeframe: One month after the 3rd vaccine dose

Evaluation of anti-PRN antibody concentrations

Timeframe: Prior to 3rd vaccine dose

Evaluation of anti-PRN antibody concentrations

Timeframe: One month after the 3rd vaccine dose

Secondary outcomes:
Not applicable
Interventions:
  • Biological/vaccine: MenC-TT
  • Biological/vaccine: Hib-MenC-TT
    • Enrollment:
    500
    Primary completion date:
    2003-31-01
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Schmitt HJ et al. (2007) Immunogenicity, reactogenicity, and immune memory after primary vaccination with a novel Haemophilus influenzae-Neisseria meningitidis serogroup C conjugate vaccine. Clin Vaccine Immunol. 14(4):426–434.
    Medical condition
    Infections, Meningococcal
    Product
    Meningococcal Vaccine
    Collaborators
    Not applicable
    Study date(s)
    March 2002 to January 2003
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    8 - 16 weeks
    Accepts healthy volunteers
    Yes
    • Healthy male or female infants, 8 to 16 weeks of age at the time of the first vaccination.
    • Previous vaccination against OR history of OR exposure since birth to diphtheria, pertussis, tetanus, polio, hepatitis B, Hib and/or meningococcal disease.
    • Planned administration/administration of a vaccine not foreseen in the study since birth.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Healthy male or female infants, 8 to 16 weeks of age at the time of the first vaccination.
    Exclusion criteria:
    • Previous vaccination against OR history of OR exposure since birth to diphtheria, pertussis, tetanus, polio, hepatitis B, Hib and/or meningococcal disease.
    • Planned administration/administration of a vaccine not foreseen in the study since birth.
    • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
    • A family history of congenital or hereditary immunodeficiency.
    • History of any neurologic disorders or seizures, allergic disease or reactions likely to be exacerbated by any component of the vaccine

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

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

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

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2003-31-01
    Actual study completion date
    2003-31-01

    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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    Additional information
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    study to evaluate GlaxoSmithKline (GSK) Biologicals’ MenC-TT vaccine and Hib-MenC-TT vaccine in infants, Trial ID 711202%2F001 | GSK