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| Sponsored by: |
GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00197236 |
Purpose
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 |
|---|---|---|
|
Hepatitis A |
Biological: ActHib™ Biological: Havrix™ Biological: Infanrix™ |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Immunogenicity & Safety of GSK Biologicals' Inactivated Hepatitis A Vaccine (Havrix™) co-Administered With GSK Biologicals' DTaP Vaccine (Infanrix™)
|
| 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 |
|---|---|
| HAV Group: Active Comparator |
Biological: Havrix™
2 IM injections, 6 months apart
|
| HAV+DTaP+HIB Group: Experimental |
Biological: ActHib™
1 IM injection
Biological: Havrix™
2 IM injections, 6 months apart
Biological: Infanrix™
1 IM injection
|
| DTaP+HIB→HAV Group: Active Comparator |
Biological: ActHib™
1 IM injection
Biological: Havrix™
2 IM injections, 6 months apart
Biological: Infanrix™
1 IM injection
|
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.
Eligibility| Ages Eligible for Study: | 12 Months to 13 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations| 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 |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | 208109/232 |
| Study First Received: | September 15, 2005 |
| Last Updated: | November 6, 2008 |
| 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 |