|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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 |
|---|---|---|
|
Poliomyelitis Hepatitis B Diphtheria Pertussis Haemophilus Infection Tetanus |
Biological: Infanrix hexa Vaccine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| 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) |
| Estimated Enrollment: | 450 |
| Study Start Date: | October 2006 |
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 | |
| Pori, Finland, 28120 | |
| GSK Investigational Site | |
| Tampere, Finland, 33100 | |
| GSK Investigational Site | |
| Turku, Finland, 20520 | |
| GSK Investigational Site | |
| Vantaa, Finland, 01300 | |
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00376779 History of Changes |
| Other Study ID Numbers: | 106786 |
| Study First Received: | September 14, 2006 |
| Last Updated: | September 29, 2011 |
| Health Authority: | Finland: Finnish Medicines Agency |
|
Haemophilus influenzae type b Double-blind Finland randomized |
phase 2 GSK Biologicals DTPa-HBV-IPV/Hib |
|
Diphtheria Haemophilus Infections Hepatitis Hepatitis A Hepatitis B Whooping Cough Poliomyelitis Tetanus Corynebacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Pasteurellaceae Infections Gram-Negative Bacterial Infections Liver Diseases |
Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections Bordetella Infections Respiratory Tract Infections Infection Respiratory Tract Diseases Myelitis Central Nervous System Viral Diseases Central Nervous System Infections |