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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00290342 |
DTPa and IPV vaccines are recommended for immunization of infants in Korea. The use of combination vaccines simplifies routine paediatric vaccination.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Condition | Intervention | Phase |
---|---|---|
Diphtheria, Tetanus, Pertussis, Poliomyelitis |
Biological: DTPa Biological: IMOVAX Polio® Biological: DTPa-IPV |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicentric Study to Compare the Immunogenicity, Safety & Reactogenicity of GSK Biologicals' DTPa-IPV Vaccine vs. co-Administration of GSK's DTPa Vaccine & Sanofi-Pasteurs' IPV Vaccine at Different Injection Sites, to Healthy Children |
Enrollment: | 452 |
Study Start Date: | January 2006 |
Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group B: Active Comparator |
Biological: DTPa
3 intramuscular injections
Biological: IMOVAX Polio®
3 intramuscular injections
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Group A: Experimental |
Biological: DTPa-IPV
3 intramuscular injections
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Participants in this Phase IIIb study will either receive GSK Biologicals' combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus (DTPa-IPV) vaccine or co-administration of GSK Biologicals' combined diphtheria-tetanus-acellular pertussis (DTPa) vaccine and Sanofi-Pasteurs' inactivated poliovirus vaccine. Vaccines for both groups will be administered at 2, 4 and 6 months of age. Two blood samples will be collected during the course of the study: prior to vaccination and one month after the third vaccine dose.
Ages Eligible for Study: | 8 Weeks to 12 Weeks |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
Exclusion criteria:
Korea, Republic of | |
GSK Investigational Site | |
Bucheon-si,, Korea, Republic of, 420-767 | |
GSK Investigational Site | |
Jeonju, Korea, Republic of | |
GSK Investigational Site | |
Seoul, Korea, Republic of | |
GSK Investigational Site | |
Daegu, Korea, Republic of, 700-712 | |
GSK Investigational Site | |
Kwangju, Korea, Republic of | |
GSK Investigational Site | |
Seoul, Korea, Republic of, 150-030 | |
GSK Investigational Site | |
Incheon, Korea, Republic of |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 104871 |
Study First Received: | February 10, 2006 |
Last Updated: | October 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00290342 History of Changes |
Health Authority: | Korea: Food and Drug Administration |
Bacterial Infections Spinal Cord Diseases Central Nervous System Diseases Picornaviridae Infections Whooping Cough Cough Healthy Diphtheria Tetanus Gram-Negative Bacterial Infections Pentetic Acid Virus Diseases |
Gram-Positive Bacterial Infections Neuromuscular Diseases Central Nervous System Infections Respiratory Tract Infections Respiratory Tract Diseases Poliomyelitis Myelitis Chelating Agents Enterovirus Infections Iron Degenerative Motor System Disease Motor Neuron Disease |
Bacterial Infections Molecular Mechanisms of Pharmacological Action Spinal Cord Diseases Physiological Effects of Drugs Whooping Cough Central Nervous System Viral Diseases Infection Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Respiratory Tract Diseases Respiratory Tract Infections Neuromuscular Diseases Corynebacterium Infections Motor Neuron Disease Antidotes |
RNA Virus Infections Nervous System Diseases Iron Chelating Agents Picornaviridae Infections Central Nervous System Diseases Diphtheria Protective Agents Pharmacologic Actions Actinomycetales Infections Bordetella Infections Virus Diseases Pentetic Acid Central Nervous System Infections Poliomyelitis Myelitis |