Haemophilus Influenzae Type b Clinical Trial
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' Tritanrix™-HepB/Hiberix™ When Administered as a Three-dose Primary Vaccination Course to Healthy Infants at 6, 10 and 14 Weeks of Age. A Dose of Unconjugated Hib Vaccine (Plain PRP Booster) Will be Administered at the Age of 10 Months to 50% of the Subjects
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).
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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