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Clinical trial

A Phase II, Observer-blind, Randomized Study to Evaluate the Immunogenicity, Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Combined DssiTgdPa-HBV-IPV/Hib Vaccine Containing Diphtheria Toxoid From the Statens Serum Institute (SSI) of Denmark and Tetanus Toxoid From GSK Biologicals' Kft [GD], Compared to the Currently Licensed GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine (Infanrix Hexa TM) When Administered to Healthy Infants at 2, 3 and 4 Months of Age.

NCT00376779 is registered in ClinicalTrials.gov with GlaxoSmithKline as lead sponsor.

NCT NCT00376779
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Registry record

As filed in ClinicalTrials.gov.

Title
A Phase II, Observer-blind, Randomized Study to Evaluate the Immunogenicity, Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Combined DssiTgdPa-HBV-IPV/Hib Vaccine Containing Diphtheria Toxoid From the Statens Serum Institute (SSI) of Denmark and Tetanus Toxoid From GSK Biologicals' Kft [GD], Compared to the Currently Licensed GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine (Infanrix Hexa TM) When Administered to Healthy Infants at 2, 3 and 4 Months of Age.
Lead sponsor
GlaxoSmithKline
Phase
Phase 2
Overall status
Completed
Start date
October 31, 2006
Completion date
May 31, 2007
Enrollment
450
Sites
6

Conditions

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

acellular pertussis, diphtheria, haemophilus influenzae type b, hepatitis b, poliomyelitis, tetanus