Clinical Trial: Immunogenicity and Safety of DTPa-HBV-IPV/Hib Compared to DTPa-IPV/Hib and HBV Administered Concomitantly

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

Official Title: Study to Assess Immunogenicity and Reactogenicity of SB Biologicals' DTPa-HBV-IPV/Hib Vaccine Given as Three-dose Primary Vaccination Course Compared to DTPa-IPV/

Brief Summary: This study will assess the immunogenicity of GlaxoSmithKline (GSK) Biologicals' (formerly SmithKline Beecham Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared to the separate administration of DTPa-HBV-IPV (Infanrix™ penta) and Hib (Hiberix™) vaccines administered at 3 and 5 months of age.

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome: Number of subjects with antibody titers equal to or greater than 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 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 (Months 8 and 9) ]
  • Immunogenicity with respect to components of the study vaccines in terms of antibody titers [ Time Frame: One month after the 2nd dose (Month 3), before and one month after the 3rd dose of the primary vaccination course (Months 8 and 9) ]
  • Immunogenicity with respect to components of the study vaccines in terms of number of subjects with a vaccine response [ Time Frame: One month after the 3rd dose of the primary vaccination course (Month 9) ]
  • 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 AEs [ Time Frame: Throughout the entire study (approximately 9 months per subject) up to and including 30 days post-vaccination ]


Original Secondary Outcome: Same as current

Information By: GlaxoSmithKline

Dates:
Date Received: October 13, 2011
Date Started: September 1998
Date Completion:
Last Updated: May 15, 2017
Last Verified: May 2017