Clinical Trial: Immunogenicity, Safety & Reactogenicity of GSK Vaccine Tritanrix™-HepB/Hib2.5 Compared to GSK Vaccine Tritanrix™-HepB/Hiberix™

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

Official Title: A Phase II, Double-blind, Randomized Study to Compare the Immunogenicity, Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Tritanrix™-HepB/Hib2.5 to GSK Biologicals' TritanrixT

Brief Summary:

In order to reduce the amount of thiomersal in its vaccines, GSK Biologicals has developed a DTPw-HBV vaccine with low thiomersal content (Tritanrix™- HepB low thio). This vaccine is to be used in combination with a Hib low dose vaccine containing 2.5µg of PRP antigen (Hib 2.5). The purpose of this study is to generate clinical data with Tritanrix™-HepB low thio vaccine when extemporaneously mixed with Hib 2.5 vaccine. The control group will receive Tritanrix™-HepB/Hiberix™.

Subjects received primary vaccination in study 208108/091 (double blind). Of these subjects 50% were randomised to participate in the PRP challenge study (208108/092) (open), and all subjects will be invited to participate in a booster study DTPWHBV=HIB2.5-093 (101477).


Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome: anti-PRP antibody concentration above a protocol defined cut-off value. [ Time Frame: One month after the third dose of the primary vaccination course. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • anti-HBs antibody concentration [ Time Frame: One month after the third dose of the primary vaccination course ]
  • anti-PRP antibody concentration [ Time Frame: One month after the third dose of the primary vaccination course ]
  • anti-tetanus antibody concentration [ Time Frame: One month after the third dose of the primary vaccination course ]
  • anti-diphtheria antibody concentration [ Time Frame: One month after the third dose of the primary vaccination course ]
  • anti-Bordetella pertussis (BPT) antibody concentration [ Time Frame: One month after the third dose of the primary vaccination course ]
  • Vaccine response to Bordetella pertussis antigen. [ Time Frame: One month after the third dose of the primary vaccination course ]
  • Seropositivity/seroprotection rates and GMCs for antibodies against all vaccine antigens [ Time Frame: Before the first dose of the primary vaccination course ]
  • anti-PRP antibody concentration [ Time Frame: Before and one month after the plain PRP challenge dose. ]
  • Occurrence of solicited symptoms [ Time Frame: During the 4-day follow-up period after each dose ]
  • Occurrence of unsolicited symptoms [ Time Frame: During the 31-day follow-up period after each dose ]
  • Occurrence of serious adverse events [ Time Frame: Over the full course of the study ]


Original Secondary Outcome: Same as current

Information By: GlaxoSmithKline

Dates:
Date Received: February 2, 2010
Date Started: August 2003
Date Completion:
Last Updated: September 8, 2016
Last Verified: September 2016