Last updated: 02/17/2020 14:00:09

Response to GSK Biologicals’ Tritanrix-HepB/Hib-MenAC vacc (4th dose) at 15-24m & Mencevax ACWY at 24-30m

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GSK study ID
104727 (Booster - 15-24 mths)
See study documents
Clinicaltrials.gov ID
NCT00136604
See results summary
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: Assess immunogenicity, safety & reactogenicity of a 4th dose of GSK Biologicals’ Tritanrix-HepB/Hib-MenAC at 15-24 m & of a dose of Mencevax ACWY at 24-30 m in subjects primed with 3 doses of Tritanrix-HepB/Hib-MenAC
Trial description: The purpose of the study is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of DTPw-HBV/Hib-MenAC compared to DTPw-HBV/Hib given to healthy subjects at 15 to 24 months of age primed with 3 doses of Tritanrix-HepB/Hib-MenAC in study 100480. Antibody persistence will be evaluated at 24 to 30 months. Immunogenicity, safety and reactogenicity of a dose of Mencevax ACWY given at 24 to 30 months will also be evaluated when given to subjects not boosted with a MenA conjugate and/or MenC containing vaccine.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Single (Care Provider)
Allocation:
Randomized
Primary outcomes:

Percentage of subjects with Meningococcal C Serum Bactericidal Assay (SBA-MenC) antibody titers above the cut-off value

Timeframe: One month Post-Booster vaccination at 15-24 months of age

Percentage of subjects with SBA-MenA antibody titers above the cut-off value

Timeframe: One Month Post-Booster vaccination at 15-24 months of age

Percentage of seroprotected (SPR) subjects with Anti-Polyribosyl Ribitol Phosphate anti-(PRP) antibody concentrations above the cut-off value

Timeframe: One Month Post-Booster vaccination at 15-24 months of age

Secondary outcomes:

Percentage of SPR subjects with anti-(PRP) antibody concentrations above predefined cut-off values

Timeframe: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age

Anti-PRP antibody concentrations

Timeframe: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age

Percentage of subjects with SBA-MenC antibody titers above the cut-off values

Timeframe: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age

Anti-SBA-MenC antibody titers

Timeframe: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age

Percentage of subjects with serum bactericidal assay against meningococcal serogroup A using rabbit complement (rSBA-MenA) antibody titers above the pre-defined cut-off values

Timeframe: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age

Anti-rSBA-MenA antibody titers

Timeframe: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age

Percentage of subjects with Anti-polysaccharide C (anti-PSC) antibody concentrations above the predefined cut-off values

Timeframe: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age

Anti-PSC antibody concentrations

Timeframe: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age

Percentage of subjects with Anti-polysaccharide A (anti-PSA) antibody concentrations above the predefined cut-off values

Timeframe: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age

Anti-PSA antibody concentrations

Timeframe: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age

Percentage of seroprotected (SPR) subjects with Anti-diphtheria toxoid (anti-DT) antibody concentrations above the predefined cut-off values

Timeframe: One month after (POST) the Booster vaccination at 15-24 months of age

Anti-D antibody concentrations

Timeframe: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age

Percentage of seroprotected (SPR) subjects with Anti-tetanus toxoid (anti-TT) antibody concentrations above the predefined cut-off values

Timeframe: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age

Anti-TT antibody concentrations

Timeframe: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age

Percentage of seroprotected (SPR) subjects with Anti-Bordetella Pertussis Toxoid (anti-BPT) antibody concentrations above the predefined cut-off value

Timeframe: One month Post-Booster vaccination

Anti-BPT antibody concentrations

Timeframe: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age

Percentage of seroprotected (SPR) subjects with Anti-hepatitis B (anti-HBs) antibody concentrations above the predefined cut-off value

Timeframe: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age

Anti-HBs antibody concentrations

Timeframe: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age

Number of subjects with any and grade 3 solicited local symptoms

Timeframe: During the 4-day (Day 0 to Day 3) post-vaccination period

Number of subjects with any, grade 3 and related solicited general symptoms

Timeframe: During the 4-day (Days 0-3) post-vaccination period

Number of subjects with any unsolicited adverse events (AEs)

Timeframe: During the 31-day (Days 0-30) post-vaccination period

Number of subjects with serious adverse events (SAEs)

Timeframe: Up to one month Post-Booster vaccination

Interventions:
  • Biological/vaccine: Tritanrix-HepB/Hib-MenAC
  • Biological/vaccine: Mencevax ACWY
  • Biological/vaccine: Tritanrix-HepB/Hiberix
  • Biological/vaccine: Meningitec
    • Enrollment:
    617
    Primary completion date:
    2006-23-04
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Whole Cell Pertussis, Haemophilus influenzae type b, Hepatitis B, Diphtheria, Tetanus, Diphtheria-Tetanus-Pertussis-Hepatitis B-Haemophilus influenzae type b-Neisseria Meningitidis Vaccin
    Product
    SB759346
    Collaborators
    Not applicable
    Study date(s)
    January 2006 to April 2006
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    427 - 730 days
    Accepts healthy volunteers
    Yes
    • Inclusion criteria:
    • Healthy male or female between and including 15 and 24 months of age
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Healthy male or female between and including 15 and 24 months of age
    • Having participated in the primary vaccination study DTPW-HBV=HIB-MENAC-TT-003 (eTrack No. 100480) Exclusion criteria:
    • Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A and/or C disease not foreseen in the protocol, after the date of the study conclusion visit of the primary vaccination study DTPW-HBV=HIB-MENAC-TT-003 (eTrack No. 100480).
    • History of or known exposure to diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A or C disease.
    • Any confirmed or suspected immunosuppressive or immunodeficient condition.
    • A family history of congenital or hereditary immunodeficiency.
    • Major congenital defects or serious chronic illness.
    • History of any neurologic disorders or seizures including febrile seizures (at least two events) in infancy.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Bangkok, Thailand, 10400
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Khon Kaen, Thailand, 40002
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Songkla, Thailand, 90110
    Status
    Study Complete
    Contact us

    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

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2006-23-04
    Actual study completion date
    2006-23-04

    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
    Primary Study
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