Clinical Trial: Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib, Compared to DTPa-HBV-IPV and Hib Administered Separately

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

Official Title: Study to Assess the Immunogenicity and Reactogenicity of DTPa-HBV-IPV Vaccine Mixed With Hib Vaccine to Healthy Infants at 3, 5 and 11 Months of Age, Compared to Each Vacc

Brief Summary: This study will assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals' (formerly SB Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared with separate administration of DTPa-HBV-IPV (Infanrix penta™) and Hib (Hiberix™) vaccine administered at 3, 5 and 11 (or 12) months of age.

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome: Immunogenicity with respect to the components of the study vaccine in terms of number of subjects with antibody titres greater than or equal to cut off value [ Time Frame: One month after the 2nd dose of the primary vaccination course ( Month 3) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Immunogenicity with respect to the components of the study vaccines in terms of number of seroprotected subjects [ Time Frame: One month after the 2nd dose ( Month 3), before and one month after the 3rd dose of the primary vaccination course ( Month 8 and 9) ]
  • Immunogenicity with respect to the components of the study vaccines in terms of number of seropositive subjects [ Time Frame: One month after the 2nd dose ( Month 3), before and one month after the 3rd dose of the primary vaccination course ( Month 8 and 9) ]
  • Immunogenicity with respect to the components of the study vaccines in terms of antibody titres [ Time Frame: One month after the 2nd dose ( Month 3), before and one month after the 3rd dose of the primary vaccination course ( Month 8 and 9) ]
  • Immunogenicity with respect to the components of the study vaccines in terms of vaccine response [ Time Frame: One month after the 3rd dose ( Month 9), and one month after the 2nd dose of the primary vaccination course ( Month3) ]
  • Occurrence of solicited local symptoms [ Time Frame: Within 4 days after each vaccination and overall ]
  • Occurrence of solicited general symptoms [ Time Frame: Within 4 days after each vaccination and overall ]
  • Occurrence of unsolicited symptoms [ Time Frame: Within 30 days after each vaccination and overall ]
  • Occurrence of serious adverse events [ Time Frame: Throughout the entire study up to and including 30 days post-vaccination ( Month 0 to Month 9) ]


Original Secondary Outcome: Same as current

Information By: GlaxoSmithKline

Dates:
Date Received: October 20, 2011
Date Started: January 1999
Date Completion:
Last Updated: May 15, 2017
Last Verified: May 2017