Clinical Trial: Immunogenicity and Safety of GSK Biologicals' Infanrix/Hib in Children

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Immunogenicity and Reactogenicity Study of GlaxoSmithKline Biologicals' Infanrix™/Hib Vaccine Administered as a Booster Dose to 18-24 Months Old Children

Brief Summary: 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 = NCT00412854). This Phase IIIB study will compare GSK Biologicals' DTPa/Hib vaccine to separately administered DTPa and Hib vaccines in Chinese children 18 to 24 months of age, in terms of safety and immunogenicity.

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome:

  • Anti-polyribosyl-ribitol-phosphate (PRP) Antibody Concentrations [ Time Frame: One month after booster vaccination ]
    Geometric mean concentrations are given in microgram per milliliter (μg/mL).
  • Anti-diphtheria Toxoid Antibody Concentrations [ Time Frame: One month after booster vaccination ]
    Geometric mean concentrations are given in international Unit per milliliter (IU/mL).
  • Anti-tetanus Toxoid Antibody Concentrations [ Time Frame: One month after booster vaccination ]
    Geometric mean concentrations are given in IU/mL.
  • Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations [ Time Frame: One month after booster vaccination ]
    Geometric mean concentrations are given in Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).
  • The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies [ Time Frame: One month after booster vaccination ]
    Assay cut-offs indicating seroprotection or seropositivity for the different antigens were the following: anti-PRP antibody concentrations ≥ 0.15 µg/mL, anti-diphtheria and anti-tetanus antibody concentrations ≥ 0.1 IU/mL, anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 20 EL.U/mL.


Original Primary Outcome:

  • Anti-polyribosyl-ribitol-phosphate (PRP) Antibody Concentrations [ Time Frame: One month after booster vaccination ]
  • Anti-diphtheria Toxoid Antibody Concentrations [ Time Frame: One month after booster vaccination ]
  • Anti-tetanus Toxoid Antibody Concentrations [ Time Frame: One month after booster vaccination ]
  • Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations [ Time Frame: One month after booster vaccination ]
  • Anti-PRP, anti-diphtheria, anti-tetanus, anti-PT, anti-FHA, and anti-PRN antibody concentrations [ Time Frame: One month after booster vaccination ]


Current Secondary Outcome:

  • Anti-PRP Antibody Concentrations [ Time Frame: Before booster vaccination ]
    Geometric mean concentrations are given in μg/mL.
  • Anti-diphtheria Toxoid Antibody Concentrations [ Time Frame: Before booster vaccination ]
    Geometric mean concentrations are given in IU/mL.
  • Anti-tetanus Toxoid Antibody Concentrations [ Time Frame: Before booster vaccination ]
    Geometric mean concentrations are given in IU/mL.
  • Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations [ Time Frame: Before booster vaccination ]
    Geometric mean concentrations are given in EL.U/mL.
  • The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies [ Time Frame: Before booster vaccination ]
    Assay cut-offs indicating seroprotection or seropositivity for the different antigens were the following: anti-PRP antibody concentrations ≥ 0.15 µg/mL, anti-diphtheria and anti-tetanus antibody concentrations ≥ 0.1 IU/mL, anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 20 EL.U/mL.
  • Number of Subjects Reporting Solicited Local and General Symptoms [ Time Frame: During the 4-day follow-up period after booster vaccination ]
    Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability, and loss of appetite.
  • Number of Subjects Reporting Unsolicited Adverse Events (AE) [ Time Frame: During the 31-day follow-up period after booster vaccination ]
    An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
  • Number of Subjects Reporting Serious Adverse Events (SAE) [ Time Frame: During the 31-day follow-up period after booster vaccination ]
    An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in isability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.


Original Secondary Outcome:

  • Anti-PRP Antibody Concentrations [ Time Frame: Before booster vaccination ]
  • Anti-diphtheria Toxoid Antibody Concentrations [ Time Frame: Before booster vaccination ]
  • Anti-tetanus Toxoid Antibody Concentrations [ Time Frame: Before booster vaccination ]
  • Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations [ Time Frame: Before booster vaccination ]
  • Anti-PRP, anti-diphtheria, anti-tetanus, anti-PT, anti-FHA and anti-PRN antibody concentrations [ Time Frame: Before booster vaccination ]
  • Occurrence of solicited local and general symptoms [ Time Frame: During the 4-day follow-up period after booster vaccination ]
  • Occurrence of unsolicited symptoms [ Time Frame: During the 31-day follow-up period after booster vaccination ]
  • Occurrence of serious adverse events (SAEs) [ Time Frame: Following booster vaccination ]


Information By: GlaxoSmithKline

Dates:
Date Received: June 5, 2008
Date Started: June 2008
Date Completion:
Last Updated: October 26, 2016
Last Verified: October 2016