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| Sponsor: | 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 Infection |
Biological: Infanrix hexa Vaccine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, 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| Finland | |
| GSK Investigational Site | |
| Jarvenpaa, Finland, 04400 | |
| GSK Investigational Site | |
| Oulu, Finland, 90100 | |
| GSK Investigational Site | |
| Vantaa, Finland, 01300 | |
| GSK Investigational Site | |
| Tampere, Finland, 33100 | |
| GSK Investigational Site | |
| Turku, Finland, 20520 | |
| GSK Investigational Site | |
| Pori, Finland, 28120 | |
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | 106786 |
| Study First Received: | September 14, 2006 |
| Last Updated: | April 30, 2009 |
| ClinicalTrials.gov Identifier: | NCT00376779 History of Changes |
| Health Authority: | Finland: Finnish Medicines Agency |
|
Haemophilus influenzae type b Double-blind phase 2 randomized |
DTPa-HBV-IPV/Hib GSK Biologicals Finland |
|
Bacterial Infections Haemophilus Infections Liver Diseases Spinal Cord Diseases Whooping Cough Hepatitis, Viral, Human Central Nervous System Viral Diseases Tetanus Infection Hepadnaviridae Infections Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Neuromuscular Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Corynebacterium Infections Hepatitis B Motor Neuron Disease Pasteurellaceae Infections RNA Virus Infections Nervous System Diseases Central Nervous System Diseases Picornaviridae Infections Diphtheria Actinomycetales Infections Bordetella Infections Hepatitis Virus Diseases Digestive System Diseases Central Nervous System Infections |