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Sponsored by: |
GlaxoSmithKline |
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00611559 |
The new formulation administered as a 4th consecutive dose will be compared to the current formulation of the vaccine in this partially double blind study.
Condition | Intervention | Phase |
Diphtheria Tetanus Pertussis Hepatitis B Poliomyelitis Haemophilus Influenzae Type b Disease |
Biological: Infanrix hexa |
Phase IV |
MedlinePlus related topics: | Diphtheria Hepatitis Hepatitis B Polio and Post-Polio Syndrome Tetanus Whooping Cough |
ChemIDplus related topics: | Hepatitis B Vaccines Infanrix hexa |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Immunogenicity and Reactogenicity Study of a New Formulation of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine Administered as a Booster Dose to 18-23 Months Old Children |
Estimated Enrollment: | 320 |
Study Start Date: | February 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Months to 23 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Russian Federation | |||||
GSK Investigational Site | |||||
Perm, Russian Federation, 614022 | |||||
GSK Investigational Site | |||||
Murmansk, Russian Federation, 183046 | |||||
GSK Investigational Site | |||||
Syktyvkar, Russian Federation, 167000 |
GlaxoSmithKline |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 110478 |
First Received: | January 29, 2008 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00611559 |
Health Authority: | Russia: Ministry of Health and Social Development of the Russian Federation |
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