NCT01061541

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 192 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 6 Weeks – 8 Weeks
• Healthy volunteers: Accepted

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).

Conditions

• Haemophilus Influenzae Type b

Interventions

Type	Name	Description
BIOLOGICAL	Tritanrix™-HepB low thio /	One dose as intramuscular injection at 6, 10 and 14 weeks of age.
BIOLOGICAL	Hib 2.5	One dose as intramuscular injection at 6, 10 and 14 weeks of age.
BIOLOGICAL	Tritanrix™-HepB	One dose as intramuscular injection at 6, 10 and 14 weeks of age.
BIOLOGICAL	Hiberix™	One dose as intramuscular injection at 6, 10 and 14 weeks of age.
BIOLOGICAL	Unconjugated Hib vaccine (plain PRP)	One dose as intramuscular injection at 10 months of age

Timeline

• Start date: 2003-08-01
• Primary completion: 2004-01-01
• Completion: 2004-08-01
• First posted: 2010-02-03
• Last updated: 2016-09-09

Locations

1 site across 1 country: Philippines