Clinical Trial: Immunogenicity and Safety Study of Booster Dose of GSK Biologicals' IPV (Poliorix™) and DTPa/Hib (Infanrix+Hib™) Vaccine

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

Official Title: Immunogenicity and Safety of a Booster Dose of GlaxoSmithKline Biologicals' IPV (Poliorix™) and DTPa/Hib (Infanrix+Hib™) in Healthy Chinese Toddlers

Brief Summary:

The purpose of this booster study is to evaluate the immune persistence in healthy Chinese subjects primed in study NCT01086423 with GSK Biologicals' Infanrix-IPV+Hib™ (DTPa-IPV/Hib) vaccine. The study will also evaluate the safety and immune response of these subjects to a booster dose of Infanrix-Hib™ (DTPa/Hib) and Poliorix™ (IPV) vaccine.

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 = NCT01086423).


Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome:

  • Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids [ Time Frame: Before the booster vaccination (At Day 0) ]
    A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
  • Anti-D and Anti-T Antibody Concentrations [ Time Frame: Before the booster vaccination (At Day 0) ]
    Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥0.1 IU/mL.
  • Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (Anti-PRP) [ Time Frame: Before the booster vaccination (At Day 0) ]
    A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).
  • Anti-PRP Antibody Concentrations [ Time Frame: Before the booster vaccination (At Day 0) ]
    Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 µg/mL.
  • Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 [ Time Frame: Before the booster vaccination (At Day 0) ]
    A seroprotected subject was defined as a vaccinated subject with anti-polio type 1, 2 and 3 antibody concentrations ≥ the cut-off value of 8 Estimated Dose 50% (ED50). ED50 is the estimated serum dilution reducing the signal generated by vir

    Original Primary Outcome:

    • Persistence with respect to components of the study vaccines in terms of number of seroprotected/seropositive subjects [ Time Frame: Before the booster vaccination (Day 0) ]
    • Persistence with respect to components of the study vaccines in terms of antibody concentrations/titers [ Time Frame: Before the booster vaccination (Day 0) ]
    • Immunogenicity with respect to components of the study vaccines in terms of number of seroprotected/seropositive subjects [ Time Frame: One month after the booster vaccination (Month 1) ]
    • Immunogenicity with respect to components of the study vaccines in terms of antibody concentrations/titers [ Time Frame: One month after the booster vaccination (Month 1) ]
    • Immunogenicity with respect to components of the study vaccines in terms of vaccine response to the pertussis antigens [ Time Frame: One month after the booster vaccination (Month 1) ]


    Current Secondary Outcome:

    • Number of Subjects With Any Solicited Local Symptoms [ Time Frame: During the 4-day (Days 0-3) post-vaccination period ]
      Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
    • Number of Subjects With Any Solicited General Symptoms [ Time Frame: During the 4-day (Days 0-3) post-vaccination period ]
      Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 37.1 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade and relationship to vaccination.
    • Number of Subjects With Any Unsolicited Adverse Events (AEs) [ Time Frame: During the 31-day (Days 0-30) post-vaccination period ]
      An unsolicited AE covers 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 and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
    • Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: During the entire study period (from Month 0 up to Month 1) ]
      Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.


    Original Secondary Outcome:

    • Occurrence of solicited local and general symptoms [ Time Frame: During the 4-day (Day 0-3) follow-up period following the booster dose of the study vaccine ]
    • Occurrence of unsolicited adverse events [ Time Frame: During the 31-day (Day 0-30) follow-up period following the booster dose of the study vaccine ]
    • Occurrence of serious adverse events [ Time Frame: From Dose 1 (Day 0) up to study end (Month 1) ]


    Information By: GlaxoSmithKline

    Dates:
    Date Received: October 6, 2011
    Date Started: October 1, 2011
    Date Completion:
    Last Updated: April 13, 2017
    Last Verified: April 2017