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Clinical trial

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

NCT01061541 is registered in ClinicalTrials.gov with GlaxoSmithKline as lead sponsor.

NCT NCT01061541
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Registry record

As filed in ClinicalTrials.gov.

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
Lead sponsor
GlaxoSmithKline
Phase
Phase 2
Overall status
Completed
Start date
August 31, 2003
Completion date
August 31, 2004
Enrollment
192 (actual)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

haemophilus influenzae type b