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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00871741 |
This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine given as a three-dose vaccination course at 3, 5 and 11 months of age.
Condition | Intervention | Phase |
---|---|---|
Diphtheria Haemophilus Influenzae Type B Hepatitis B Pertussis Poliomyelitis Serogroup C Meningococcal Diseases Tetanus |
Biological: Menjugate Biological: GSK2202083A vaccine Biological: Infanrix hexa |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 3, 5 and 11 Months of Age. |
Estimated Enrollment: | 468 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Control Group: Active Comparator |
Biological: Menjugate
Intramuscular, two doses
Biological: Infanrix hexa
Intramuscular, three doses
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Combo Group: Experimental |
Biological: GSK2202083A vaccine
Intramuscular, three doses
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Ages Eligible for Study: | 8 Weeks to 16 Weeks |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Slovakia | |
GSK Investigational Site | Not yet recruiting |
Banska Bystrica, Slovakia, 974 01 | |
GSK Investigational Site | Not yet recruiting |
Nitra, Slovakia, 949 01 | |
GSK Investigational Site | Recruiting |
Dunajska Streda, Slovakia, 929 01 | |
GSK Investigational Site | Recruiting |
Bratislava, Slovakia, 851 05 | |
GSK Investigational Site | Recruiting |
Dolny Kubin, Slovakia, 026 01 | |
GSK Investigational Site | Recruiting |
Nove Zamky, Slovakia, 940 01 | |
GSK Investigational Site | Not yet recruiting |
Puchov, Slovakia, 020 01 | |
GSK Investigational Site | Not yet recruiting |
Zvolen, Slovakia, 960 01 | |
GSK Investigational Site | Not yet recruiting |
Nova Dubnica, Slovakia, 018 51 | |
GSK Investigational Site | Not yet recruiting |
Povazska Bystrica, Slovakia, 017 01 | |
GSK Investigational Site | Not yet recruiting |
Trnava, Slovakia, 917 01 | |
GSK Investigational Site | Not yet recruiting |
Sturovo, Slovakia, 943 01 | |
GSK Investigational Site | Not yet recruiting |
Ruzomberok, Slovakia, 034 01 | |
GSK Investigational Site | Recruiting |
Bratislava, Slovakia, 841 08 | |
GSK Investigational Site | Not yet recruiting |
Nove Mesto nad Vahom, Slovakia, 915 01 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 111761 |
Study First Received: | March 26, 2009 |
Last Updated: | April 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00871741 History of Changes |
Health Authority: | Slovakia: State Institute for Drug Control |
Primary vaccination Combined vaccine |
Bacterial Infections Liver Diseases Spinal Cord Diseases Whooping Cough Hepatitis, Viral, Human Meningococcal Infection Healthy Orthomyxoviridae Infections Tetanus Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Neuromuscular Diseases Respiratory Tract Diseases Respiratory Tract Infections Meningococcal Infections |
Hepatitis B Degenerative Motor System Disease Motor Neuron Disease Neisseriaceae Infections Haemophilus Influenzae Central Nervous System Diseases Cough Picornaviridae Infections Diphtheria Hepatitis Virus Diseases Digestive System Diseases Central Nervous System Infections Poliomyelitis Influenza, Human |
Bacterial Infections Liver Diseases Spinal Cord Diseases Whooping Cough Hepatitis, Viral, Human Central Nervous System Viral Diseases Orthomyxoviridae Infections Infection Hepadnaviridae Infections Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Neuromuscular Diseases Respiratory Tract Diseases Respiratory Tract Infections Corynebacterium Infections |
Meningococcal Infections Hepatitis B Motor Neuron Disease Neisseriaceae 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 |