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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00197002 |
Purpose
This is a study to evaluate the immunogenicity and safety of GSK Biologicals 2-dose inactivated hepatitis A vaccine when administered with a pneumococcal conjugate vaccine in children as young as 15 months of age
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis A |
Biological: Hepatitis A |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Safety Study |
| Official Title: | A Multicenter Study of the Immunogenicity and Safety of GSK Biologicals' Inactivated Hepatitis A Vaccine (Havrix) Administered Concomitantly With Wyeth Lederle's Pneumococcal Conjugate Vaccine (Prevnar) in Healthy Children 15 Mths of Age |
| Estimated Enrollment: | 480 |
| Study Start Date: | September 2003 |
An open, controlled comparison of Havrix administered alone or with Prevnar. The three groups evaluated are: 1) Havrix alone, 2) Havrix plus Prevnar and 3) Prevnar 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, Colorado | |
| GSK Investigational Site | |
| Centennial, Colorado, United States, 80112 | |
| United States, Kentucky | |
| GSK Investigational Site | |
| Louisville, Kentucky, United States, 40202 | |
| GSK Investigational Site | |
| Bardstown, Kentucky, United States, 40004 | |
| United States, Massachusetts | |
| GSK Investigational Site | |
| Boston, Massachusetts, United States, 02118 | |
| GSK Investigational Site | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| GSK Investigational Site | |
| Kalamazoo, Michigan, United States, 49008 | |
| United States, Nebraska | |
| GSK Investigational Site | |
| Omaha, Nebraska, United States, 68131 | |
| United States, Nevada | |
| GSK Investigational Site | |
| Las Vegas, Nevada, United States, 89014 | |
| GSK Investigational Site | |
| North Las Vegas, Nevada, United States, 89025 | |
| United States, New York | |
| GSK Investigational Site | |
| Stony Brook, New York, United States, 11794 | |
| United States, North Carolina | |
| GSK Investigational Site | |
| Chapel Hill, North Carolina, United States, 27514 | |
| United States, Ohio | |
| GSK Investigational Site | |
| University Heights, Ohio, United States, 44118 | |
| United States, Pennsylvania | |
| GSK Investigational Site | |
| Pittsburgh, Pennsylvania, United States, 15241 | |
| United States, Texas | |
| GSK Investigational Site | |
| Dallas, Texas, United States, 75235 | |
| GSK Investigational Site | |
| San Antonio, Texas, United States, 78205-2489 | |
| United States, Utah | |
| GSK Investigational Site | |
| Salt Lake City, Utah, United States, 84109 | |
| United States, Washington | |
| GSK Investigational Site | |
| Vancouver, Washington, United States, 98664 | |
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | 208109/220 |
| Study First Received: | September 13, 2005 |
| Last Updated: | October 9, 2008 |
| ClinicalTrials.gov Identifier: | NCT00197002 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Virus Diseases Hepatitis RNA Virus Infections Liver Diseases Digestive System Diseases |
Picornaviridae Infections Hepatitis, Viral, Human Hepatitis A Enterovirus Infections |