Last updated: 11/03/2018 12:04:40

Study to evaluate GSK Biologicals’ GSK2197870A vaccine given as primary course in infants

GSK study ID
111709
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: Study in healthy children of GSK Biologicals’ DTPa-IPV/Hib-MenC-TT vaccine, GSK2197870A, co-administered with Prevenar™ as a three-dose primary vaccination course in infancy followed by a booster dose of Menitorix™ at 12 months of age
Trial description: The purpose of this Phase II study is to evaluate the feasibility of GSK Biologicals’ GSK2197870A vaccine co-administered with Wyeth-Lederle’s Prevenar™ when given in healthy infants as a three-dose primary vaccination course at 2, 3 and 4 months of age followed by a booster dose of GSK Biologicals’ Menitorix™ at 12 months of age.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Number of seroprotected subjects for anti-polyribosylribitol phosphate (anti-PRP).

Timeframe: At Month 3

Number of seropositive subjects against Neisseria meningitidis using baby rabbit complement (rSBA-MenC)

Timeframe: At Month 2 and Month 3.

Secondary outcomes:

Number of subjects with anti-PRP concentrations antibody above the cut-off.

Timeframe: At Month 3

Number of subjects with anti-polysaccharide C (anti-PSC ) antibody concentrations above the cut-offs.

Timeframe: At Month 2 and Month 3.

Number of seroprotected subjects for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies.

Timeframe: At Month 3.

Number of seropositive subjects against anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN).

Timeframe: At Month 3.

Number of seroprotected subjects for anti-poliovirus (anti-polio) types 1, 2 and 3.

Timeframe: At Month 3.

Number of seropositive subjects for anti-pneumococcal (anti-PNE) serotypes.

Timeframe: At Month 3

Concentrations for anti-PRP.

Timeframe: At Month 3.

Titers for rSBA-MenC.

Timeframe: At Month 2 and Month 3.

Concentrations for anti-PSC.

Timeframe: At Month 2 and Month 3.

Concentrations for anti-T and anti-D.

Timeframe: At Month 3.

Concentrations for anti-PT, anti-FHA and anti-PRN.

Timeframe: At Month 3.

Titers for anti-polio 1, 2 and 3.

Timeframe: At Month 3.

Concentrations for anti-PNE serotypes.

Timeframe: At Month 3.

Number of seroprotected subjects for anti-PRP.

Timeframe: At Month 10 and Month 11.

Number of seropositive subjects against rSBA-MenC.

Timeframe: At Month 10 and Month 11.

Number of subjects with anti-PSC antibody concentrations above the cut-offs.

Timeframe: At Month 10 and Month 11.

Number of seroprotive subjects for anti-D and anti-T antibodies.

Timeframe: At Month 10.

Number of seropositive subjects for anti-PT, anti-FHA and anti-PRN.

Timeframe: At Month 10.

Number of seroprotected subjects for anti-anti-polio types 1, 2 and 3.

Timeframe: At Month 10.

Concentrations for anti-PRP.

Timeframe: At Month 10 and Month 11.

Titers for rSBA-MenC.

Timeframe: At Month 10 and Month 11.

Concentrations for anti-PSC.

Timeframe: At Month 10 and Month 11.

Concentrations for anti-T and anti-D.

Timeframe: At Month 10.

Concentrations for anti-PT, anti-FHA and anti-PRN.

Timeframe: At Month 10.

Titers for anti-polio 1, 2 and 3.

Timeframe: At Month 10.

Number of subjects with a booster response to rSBA-MenC antibodies.

Timeframe: At Month 11

Number of subjects with a booster response to anti-PRP antibodies.

Timeframe: At Month 11

Number of subjects with a booster response to anti-PSC antibodies.

Timeframe: At Month 11

Number of subjects reporting any solicited local symptoms.

Timeframe: During the 8-day (Days 0-7)

Number of subjects reporting any solicited local symptoms.

Timeframe: During the 8-day (Days 0-7)

Number of subjects reporting any solicited general symptoms.

Timeframe: During the 8-day (Days 0-7)

Number of subjects reporting any solicited general symptoms.

Timeframe: During the 8-day (Days 0-7)

Number of subjects reporting any unsolicited adverse events (AEs).

Timeframe: Within the 31-day (Days 0-30) follow up period after vaccination.

Number of subjects reporting any unsolicited adverse events (AEs).

Timeframe: Within the 31-day (Days 0-30) follow up period after vaccination.

Number of subjects reporting any serious adverse events (SAEs).

Timeframe: During the entire study period (Month 0 to Month 11)

Interventions:
  • Biological/vaccine: GSK2197870A
  • Biological/vaccine: Prevenar™
  • Biological/vaccine: Menitorix™
  • Biological/vaccine: Pediacel™
  • Biological/vaccine: Menjugate™
  • Enrollment:
    284
    Primary completion date:
    2010-31-03
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Khatami A et al. (2013) Phase II study of a three-dose primary vaccination course of DTPa-IPV/Hib-MenC-TT followed by a 12-month Hib-MenC-TT booster in healthy infants. Pediatr Infect Dis J. [Epub ahead of print].
    Khatami A et al. Phase II study of a three-dose primary vaccination course of DTPa-IPV/Hib-MenC-TT followed by a 12-month Hib-MenC-TT booster in healthy infants. Abstract presented at the 7th World Congress World Society for Pediatric Infectious Diseases (WSPID). Melbourne, Australia, 16-19 November 2011.
    Medical condition
    Neisseria Meningitidis, Haemophilus influenzae type b
    Product
    GSK2197870A
    Collaborators
    Not applicable
    Study date(s)
    June 2009 to December 2010
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    6 - 12 weeks
    Accepts healthy volunteers
    Yes
    • All subjects must satisfy the following criteria at study entry:
    • A male or female infant between, and including, 6 and 12 weeks of age at the time of the first vaccination.
    • The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:
    • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    London, United Kingdom, SW17 0QT
    Status
    Study Complete
    Location
    GSK Investigational Site
    Southampton, Hampshire, United Kingdom, SO16 6YD
    Status
    Study Complete
    Location
    GSK Investigational Site
    Bristol, United Kingdom, BS2 8AE
    Status
    Study Complete
    Location
    GSK Investigational Site
    Oxford, Oxfordshire, United Kingdom, OX3 7LJ
    Status
    Study Complete
    Location
    GSK Investigational Site
    Ely, Cambridgeshire, United Kingdom, CB7 4HF
    Status
    Study Complete

    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
    2010-31-03
    Actual study completion date
    2010-09-12

    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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