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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00197236 |
This is a study to evaluate the immune response and safety of GSK Biologicals 2-dose inactivated hepatitis A vaccine when administered with a diphtheria, tetanus and pertussis combination (DTaP) vaccine and a Haemophilus influenza type B (Hib) vaccine in children 15 months of age. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Condition | Intervention | Phase |
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Hepatitis A |
Biological: Havrix™ Biological: Infanrix™ Biological: ActHIB™ |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Immunogenicity and Safety of GSK Biologicals' Inactivated Hepatitis A Vaccine (Havrix™) Co-administered With GSK Biologicals' DTaP Vaccine (Infanrix™) and Aventis Pasteur's Haemophilus b Conjugate Vaccine (ActHIB) in Healthy Children 15 Months of Age |
Enrollment: | 468 |
Study Start Date: | November 2003 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Havrix + Infanrix + ActHIB Group: Active Comparator
Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
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Biological: Havrix™
2 intramuscular injections, 6 months apart
Biological: Infanrix™
1 intramuscular injection
Biological: ActHIB™
1 intramuscular injection
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Infanrix + ActHIB→Havrix Group: Experimental
Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
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Biological: Havrix™
2 intramuscular injections, 6 months apart
Biological: Infanrix™
1 intramuscular injection
Biological: ActHIB™
1 intramuscular injection
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Havrix Group: Active Comparator
Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
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Biological: Havrix™
2 intramuscular injections, 6 months apart
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An open, controlled comparison of Havrix™ administered alone or with Infanrix™ and ActHIB. The three groups evaluated are: 1) Havrix™ alone, 2) Havrix™ + Infanrix™ and ActHIB and 3) Infanrix™ and ActHIB followed by Havrix™ one month later.
Ages Eligible for Study: | 12 Months to 13 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
GSK Investigational Site | |
San Ramon, California, United States, 94583 | |
GSK Investigational Site | |
Oakland, California, United States, 94612 | |
United States, Florida | |
GSK Investigational Site | |
Pembroke Pines, Florida, United States, 33027 | |
United States, Georgia | |
GSK Investigational Site | |
Martinez, Georgia, United States, 30907 | |
United States, Louisiana | |
GSK Investigational Site | |
Bossier City, Louisiana, United States, 71111 | |
United States, North Dakota | |
GSK Investigational Site | |
Bismarck, North Dakota, United States, 58501 | |
United States, Pennsylvania | |
GSK Investigational Site | |
Pittsburgh, Pennsylvania, United States, 15241 | |
GSK Investigational Site | |
Pittsburgh, Pennsylvania, United States, 15213 | |
GSK Investigational Site | |
Hershey, Pennsylvania, United States, 17033 | |
GSK Investigational Site | |
Bellevue, Pennsylvania, United States, 15202 | |
United States, South Carolina | |
GSK Investigational Site | |
Charleston, South Carolina, United States, 29425 | |
United States, Texas | |
GSK Investigational Site | |
Beaumont, Texas, United States, 77701 | |
GSK Investigational Site | |
Dallas, Texas, United States, 75235 | |
United States, Virginia | |
GSK Investigational Site | |
Mechanicsville, Virginia, United States, 23111 | |
United States, Wisconsin | |
GSK Investigational Site | |
La Crosse, Wisconsin, United States, 54601 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 208109/232 |
Study First Received: | September 15, 2005 |
Results First Received: | December 2, 2008 |
Last Updated: | July 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00197236 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Hepatitis A |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Picornaviridae Infections Hepatitis, Viral, Human |
Hepatitis A Whooping Cough Healthy Enterovirus Infections Diphtheria Tetanus |
Virus Diseases Hepatitis RNA Virus Infections Liver Diseases Digestive System Diseases |
Picornaviridae Infections Hepatitis, Viral, Human Hepatitis A Enterovirus Infections |