Immunogenicity, Antibody Persistence and Safety of GSK Biologicals’ DTPa (INFANRIX) and dTpa (BOOSTRIX) Vaccines.

Overview

To evaluate the immunogenicity, persistence of antibodies and reactogenicity of GSK Biologicals' DTPa (INFANRIX) and dTpa (BOOSTRIX), when administered to subjects 18-20 months old, compared with not giving a booster DTP vaccine at 18-20 months. Study double blinded for the two DTP vaccines and single blinded for the control arm.

Full Title of Study: “Phase IIIb Study to Evaluate Immunogenicity, Antibody Persistency and Reactogenicity of DTPa – INFANRIX and dTpa – BOOSTRIX Vaccines Administered to Healthy Children Previously Primed With 3 Doses of DTPa Vaccine Compared to Placebo (HAVRIX┬«JUNIOR)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single

Interventions

  • Biological: INFANRIX
  • Biological: BOOSTRIX
  • Biological: HAVRIX

Clinical Trial Outcome Measures

Primary Measures

  • Anti-diphtheria and anti-tetanus antibody concentration (1M, 15-18M & 27-29M after vacc)
  • Occurrence of local injection site reactions (1M after vacc).

Secondary Measures

  • Antibody concentration to all vaccine antigens (1M, 15-18M & 27-29M after vacc),
  • Solicited (Day 0-14) & Unsolicited symptoms (Day 0-30),
  • SAEs (full study).

Participating in This Clinical Trial

Inclusion Criteria

  • Male or female children between and including 18 -20 months of age at the time of the vaccination. – Completed a primary vaccination course with DTPa (INFANRIX) vaccine at 2, 4, and 6 months. – Written informed consent obtained before study entry from the parents or guardians of the subject. – Free of obvious health problems as established by medical history and clinical examination before entering into the study. Exclusion Criteria:

  • Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the administration of the study vaccine dose, or planned use during the study period. – Evidence of previous or intercurrent diphtheria, tetanus, or pertussis disease, or of vaccination against any of these diseases since completion of the primary course of DTPa (INFANRIX) vaccine.

Gender Eligibility: All

Minimum Age: 18 Months

Maximum Age: 20 Months

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • GlaxoSmithKline
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • GSK Clinical Trials, Study Director, GlaxoSmithKline

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