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| Sponsored by: |
GlaxoSmithKline |
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00376779 |
Purpose
The purpose of this study is to show that the immunogenicity of newly formulated DTPa-HBV-IPV/Hib vaccine is as good as the immunogenicity of the currently licensed formulation of the vaccine. The vaccine will be administered as a primary vaccination course to healthy infants at 2, 3 and 4 months of age and its safety and reactogenicity will also be assessed.
| Condition | Intervention | Phase |
|
Diphtheria Tetanus Pertussis Hepatitis B Poliomyelitis Haemophilus Infections |
Biological: Infanrix hexa Vaccine |
Phase II |
| MedlinePlus related topics: | Diphtheria Hepatitis Hepatitis B Polio and Post-Polio Syndrome Tetanus Whooping Cough |
| ChemIDplus related topics: | Infanrix hexa |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Study to Evaluate the Immunogenicity and Safety of a New Formulation of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine as Compared to the Currently Licensed Infanrix Hexa in Healthy Infants (2,3,4 M) |
Eligibility
| Ages Eligible for Study: | 8 Weeks to 12 Weeks |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Study ID Numbers: | 106786 |
| First Received: | September 14, 2006 |
| Last Updated: | September 24, 2007 |
| ClinicalTrials.gov Identifier: | NCT00376779 |
| Health Authority: | Finland: National Agency for Medicines |
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