Clinical Trial: Consistency & Immunogenicity Study of 3 Lots of GSK's Hib Conjugate Vaccine Versus ActHIB & Pentacel in Healthy Infants

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

Official Title: Phase III, Partially Double-blind Study to Evaluate Consistency and Immunogenicity of 3 Lots of GSK Biologicals' Hib Conjugate Vaccine 208108 Versus ActHIB and Pentacel at 2, 4, 6 and 15-18 Months of

Brief Summary: The purpose of this study is to evaluate safety, to demonstrate lot-to-lot consistency of the vaccine, to address the relevant concomitant vaccine administrations and to provide a comparison between GSK Biologicals' Hib conjugate vaccine and the licensed monovalent Hib vaccine ActHIB as well as the licensed combination product Pentacel in infants at 2, 4, 6 and 15-18 months of age. This study is designed with a primary and a booster phase.

Detailed Summary: This protocol posting has been updated following protocol amendment 3, dated 12 April 2011. The impacted section is: Eligibility Criteria (Exclusion criteria).
Sponsor: GlaxoSmithKline

Current Primary Outcome:

• Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (≥) 0.15 Microgram Per Milliliter (µg/mL) and ≥ 1.0 µg/mL [ Time Frame: At 1 month after last dose of primary vaccination ]
• Number of Subjects With Anti-Protein-D (Anti-D) and Anti-Protein-T (Anti-T) Antibody Concentrations ≥ 0.1 International Units Per Milliliter (IU/mL) [ Time Frame: At 1 month after last dose of primary vaccination ]
• Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations [ Time Frame: At 1 month after last dose of primary vaccination ]
  Antibody concentrations were given as Geometric Mean Concentrations (GMCs) expressed in micrograms per milliliter (µg/mL).
• Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibody Concentrations [ Time Frame: At 1 month after last dose of primary vaccination ]
  Antibody concentrations were given as geometric mean concentrations (GMCs) expressed as enzyme-linked immuno-sorbent assay (ELISA) units per milliliter i.e. EL.U/mL.
• Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations [ Time Frame: At 1 month after last dose of primary vaccination ]
  Antibody concentrations against S.pneumoniae were given as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL).
• Number of Subjects With Seroresponse (95%) to Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-
  
  

  Original Primary Outcome:

  • Immunogenicity (primary read-outs) with respect to components of the study vaccines and the studied co-administered vaccines [ Time Frame: 1 month after last dose of primary vaccination ]
  • Immunogenicity (primary read-outs) with respect to components of the study vaccines [ Time Frame: 1 month after booster vaccination ]
  
  
  

  Current Secondary Outcome:

  • Anti-protein-D (Anti-D) and Anti-protein-T (Anti-T) Antibody Concentrations [ Time Frame: At 1 month after last dose of primary vaccination ]
    Antibody concentrations were given as geometric mean concentrations (GMCs) and expressed as International Units per milliliter (IU/mL).
  • Number of Subjects With Any Solicited Local Symptoms [ Time Frame: During a 4-day follow-up period (Days 0-3) following any vaccination ]
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any symptom regardless of intensity grade.
  • Number of Subjects With Any Solicited General Symptoms [ Time Frame: During a 4-day follow-up period (Days 0-3) following any vaccination ]
    Assessed solicited general symptoms were drowsiness, irritability, fever and loss of appetite. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Any fever= Rectal temperature equal to or above (≥) 38 degrees Celsius (°C).
  • Number of Subjects With Any Unsolicited Adverse Events (AEs). [ Time Frame: During the 31-day (Day 0-Day 30) follow-up period after primary vaccination ]
    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: From Day 0 until 6 months following the last primary dose ]
    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.
  • Number of Subjects With AEs of Specific Interest (AESIs) [ Time Frame: From Day 0 until 6 months following the last primary dose or the receipt of the booster vaccination, whichever comes first ]
    An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.
  • Number of Subjects With Seroresponse (90%) to Anti-PT, Anti-PRN and Anti-FHA [ Time Frame: At 1 month after last dose of primary vaccination ]
    Seroresponse (90%) was defined as the number of subjects showing a concentration above a threshold that leads to 90% seroresponse in the ActHIB group.
  • Number of Subjects With Anti-PT, Anti-PRN and Anti-FHA Antibody Concentrations ≥ 5 EL.U/mL [ Time Frame: At 1 month after last dose of primary vaccination ]
  • Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations ≥ 0.15 µg/mL and ≥ 1.0 µg/mL [ Time Frame: Prior to the booster vaccination and 1 month after the booster vaccination ]
  • Anti-Hepatitis B (Anti-HBs) Antibody Concentrations [ Time Frame: At 1 month after last dose of primary vaccination ]
    Antibody concentrations were tabulated as geometric mean concentrations (GMCs) and expressedas milli-international units per milliliter (mIU/mL).
  • Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL [ Time Frame: At 1 month after the last dose of primary vaccination ]
  • Antibody Titers for Poliovirus Types 1, 2 and 3 [ Time Frame: At 1 month after last dose of primary vaccination ]
    Antibody titers were given as geometric mean titers(GMTs).
  • Number of Subjects With Anti-HBs Antibody Concentrations Greater Than or Equal to Cut-off Values [ Time Frame: At 1 month after last dose of primary vaccination ]
    The cut-off values were defined as a concentration≥ 3.3 mIU/mL (seropositivity) and ≥ 10 mIU/mL (seroprotection).
  • Anti-PRP Geometric Mean Concentrations (GMCs) [ Time Frame: Prior to the booster vaccination and 1 month after the booster vaccination ]
  • Anti-HBs Concentrations and Concentrations ≥10.0 mIU/mL and Concentrations ≥3.3 mIU/mL [ Time Frame: Prior to the booster vaccination ]
  • Anti-poliovirus Types 1, 2, and 3 Antibody Titres and Titres ≥ 8 [ Time Frame: Prior to the booster vaccination ]
  • Anti-D and Anti-T Antibody Concentrations and Concentrations ≥ 0.1 IU/mL and ≥1.0 IU/mL [ Time Frame: Prior to the booster vaccination and 1 month after the booster vaccinatio
    
    

    Original Secondary Outcome:

    • Immunogenicity (other parameters) with respect to the components of the study vaccines and the studied co-administered vaccines [ Time Frame: 1 month after last dose of primary vaccination ]
    • Solicited local and general symptoms [ Time Frame: during a 4-day follow-up period (i.e., day of vaccination and 3 subsequent days) following each primary vaccine dose ]
    • Unsolicited adverse events [ Time Frame: within 31 days following each primary vaccine dose ]
    • Serious adverse events [ Time Frame: from Day 0 until 6 months following the last primary dose or until receipt of the booster vaccination, whichever comes first ]
    • Specific adverse events [ Time Frame: from Day 0 until 6 months following the last primary dose or until receipt of the booster vaccination, whichever comes first ]
    • Immunogenicity (other parameters) with respect to the components of the study vaccines and the studied co-administered vaccines [ Time Frame: prior to the booster vaccination and one month after the booster vaccination ]
    • Solicited local and general symptoms [ Time Frame: Within 4 days (i.e., day of vaccination and 3 subsequent days) following the booster dose ]
    • Unsolicited adverse events [ Time Frame: Within 31 days following the booster dose ]
    • Serious adverse events [ Time Frame: from booster dose until 6 months following receipt of the booster dose ]
    • Specific adverse events [ Time Frame: From booster dose until 6 months following receipt of the booster dose ]
    
    
    Information By: GlaxoSmithKline
    

    Dates:
    Date Received: October 22, 2009
    Date Started: June 2010
    Date Completion:
    Last Updated: October 30, 2014
    Last Verified: October 2014