Clinical Trial: Immunogenicity and Safety Study of GSK Biologicals' Infanrix-IPV+Hib™ Vaccine

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

Official Title: Immunogenicity and Safety of GlaxoSmithKline Biologicals' DTPa-IPV/Hib (Infanrix-IPV+Hib™) in Infants

Brief Summary: The purpose of the study is to evaluate the immunogenicity and reactogenicity of Infanrix-IPV/Hib™ vaccine when administered to healthy Chinese infants at 2, 3 and 4 or 3, 4 and 5 months of age.

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome:

  • Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens [ Time Frame: One month after the third vaccine dose (Month 3 or Month 4) ]
    A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
  • Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigen [ Time Frame: One month after the third vaccine dose (Month 3 or Month 4) ]
    A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (μg/mL).
  • Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens [ Time Frame: One month after the third vaccine dose (Month 3 or Month 4) ]
    A seroprotected subject was defined as a subject with anti-poliovirus (anti-polio) types 1, 2 and 3 antibody titres ≥ the value of 8.
  • Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies [ Time Frame: One month after the third vaccine dose (Month 3 or Month 4) ]

    Vaccine response was defined as:

    For PT and FHA response, antibody concentration ≥ 20 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) at post-vaccination.

    For PRN response: for initially seronegative subjects [antibody concentration

    Original Primary Outcome: Immunogenicity to study vaccine antigens [ Time Frame: One month after the third vaccine dose ]

    Current Secondary Outcome:

    • Anti-D and Anti-T Antibody Concentrations [ Time Frame: Before the first dose (Month 0) and one month after the third dose of vaccination (Month 3 or Month 4) ]
      Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.
    • Anti-PRP Antibody Concentrations [ Time Frame: Before the first dose (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4) ]
      Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.
    • Anti-polio Types 1, 2 and 3 Antibody Titers [ Time Frame: Before the first dose (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4) ]
      Antibody titers were presented as geometric mean titers (GMTs).
    • Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations [ Time Frame: Before (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4) ]
      Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
    • Number of Subjects With Any Solicited Local Symptoms [ Time Frame: During the 4-day (Days 0-3) post-vaccination period after each vaccine dose and across doses ]
      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 after each vaccine dose and across doses ]
      Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 37.0 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to study vaccination.
    • Number of Subjects With Unsolicited Adverse Events (AEs) [ Time Frame: During the 31-day (Days 0-30) post-vaccination period after any dose ]
      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 to Month 4/5) ]
      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:

    • Immunogenicity to study vaccine antigens [ Time Frame: Before the first vaccine dose and one month after the third vaccine dose ]
    • Solicited local and general symptoms [ Time Frame: During the 4-day (Day 0-3) follow-up period following each dose of the study vaccine ]
    • Unsolicited adverse events [ Time Frame: During the 31-day (Day 0-30) follow-up period following each dose of the study vaccine ]
    • Serious adverse events [ Time Frame: From Dose 1 up to 30 days after the last vaccine dose. ]


    Information By: GlaxoSmithKline

    Dates:
    Date Received: March 11, 2010
    Date Started: March 2010
    Date Completion:
    Last Updated: February 24, 2017
    Last Verified: February 2017