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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00197015 |
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 measles/mumps/rubella vaccine and a varicella (chickenpox) vaccine in children as young as 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: Havrix™ Biological: VARIVAX™ Biological: M-M-RII |
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 Merck & Company, Inc. Measles-Mumps-Rubella Vaccine (M-M-RII) & Merck & Co Varicella Vaccine (VARIVAX™) to Children 15 m of Age |
| Enrollment: | 1474 |
| Study Start Date: | October 2003 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| HAV Group: Active Comparator |
Biological: Havrix™
2 IM injections, 6 months apart
|
| MMR+V→HAV Group: Active Comparator |
Biological: VARIVAX™
1 SC injection, in the right deltoid
Biological: M-M-RII
1 SC injection, in the left deltoid
|
| HAV+MMR+V Group: Experimental |
Biological: VARIVAX™
1 SC injection, in the right deltoid
Biological: M-M-RII
1 SC injection, in the left deltoid
|
An open, controlled comparison of Havrix™ administered alone or with MMR II and Varivax™. The three groups evaluated are: 1) Havrix™ alone, 2) Havrix™ + MMR II and Varivax™ and 3) MMR II and Varivax™ 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
Hide Study Locations| United States, Arkansas | |
| GSK Investigational Site | |
| Jonesboro, Arkansas, United States, 72401 | |
| GSK Investigational Site | |
| North Little Rock, Arkansas, United States, 72117 | |
| United States, California | |
| GSK Investigational Site | |
| Rolling Hills Estates, California, United States, 90274 | |
| GSK Investigational Site | |
| Oakland, California, United States, 94609 | |
| GSK Investigational Site | |
| Huntington Beach, California, United States, 92647 | |
| United States, Connecticut | |
| GSK Investigational Site | |
| Norwich, Connecticut, United States, 06360 | |
| United States, Florida | |
| GSK Investigational Site | |
| Jacksonville, Florida, United States, 32209 | |
| United States, Georgia | |
| GSK Investigational Site | |
| Marietta, Georgia, United States, 30062 | |
| United States, Iowa | |
| GSK Investigational Site | |
| Waukee, Iowa, United States, 50263 | |
| United States, Kentucky | |
| GSK Investigational Site | |
| Lexington, Kentucky, United States, 40503 | |
| United States, Louisiana | |
| GSK Investigational Site | |
| Bossier City, Louisiana, United States, 71111 | |
| United States, Maryland | |
| GSK Investigational Site | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Nevada | |
| GSK Investigational Site | |
| Las Vegas, Nevada, United States, 89014 | |
| GSK Investigational Site | |
| Henderson, Nevada, United States, 89015 | |
| United States, New York | |
| GSK Investigational Site | |
| Albany, New York, United States, 12208 | |
| GSK Investigational Site | |
| Brooklyn, New York, United States, 11203 | |
| GSK Investigational Site | |
| Rochester, New York, United States, 14620 | |
| United States, North Carolina | |
| GSK Investigational Site | |
| Lumberton, North Carolina, United States, 28358 | |
| GSK Investigational Site | |
| Sylva, North Carolina, United States, 28779 | |
| United States, Ohio | |
| GSK Investigational Site | |
| Cleveland, Ohio, United States, 44109 | |
| United States, Oklahoma | |
| GSK Investigational Site | |
| Tulsa, Oklahoma, United States, 74104 | |
| United States, Pennsylvania | |
| GSK Investigational Site | |
| Beaver Falls, Pennsylvania, United States, 15010 | |
| GSK Investigational Site | |
| Norristown, Pennsylvania, United States, 19401 | |
| GSK Investigational Site | |
| Rydal, Pennsylvania, United States, 19046 | |
| GSK Investigational Site | |
| Pittsburgh, Pennsylvania, United States, 15241 | |
| GSK Investigational Site | |
| Sellersville, Pennsylvania, United States, 18960 | |
| GSK Investigational Site | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Rhode Island | |
| GSK Investigational Site | |
| Warwick, Rhode Island, United States, 02886 | |
| United States, Tennessee | |
| GSK Investigational Site | |
| Kingsport, Tennessee, United States, 37664 | |
| GSK Investigational Site | |
| Bristol, Tennessee, United States, 37620 | |
| GSK Investigational Site | |
| Kingsport, Tennessee, United States, 37660 | |
| United States, Texas | |
| GSK Investigational Site | |
| Temple, Texas, United States, 76508 | |
| GSK Investigational Site | |
| Austin, Texas, United States, 78758 | |
| GSK Investigational Site | |
| San Antonio, Texas, United States, 78205-2489 | |
| United States, Utah | |
| GSK Investigational Site | |
| Layton, Utah, United States, 84041 | |
| GSK Investigational Site | |
| South Jordan, Utah, United States, 84095 | |
| United States, Virginia | |
| GSK Investigational Site | |
| Norfolk, Virginia, United States, 23510 | |
| United States, Wisconsin | |
| GSK Investigational Site | |
| Marshfield, Wisconsin, United States, 54449 | |
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | 208109/231 |
| Study First Received: | September 13, 2005 |
| Last Updated: | October 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00197015 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 Chickenpox DNA Virus Infections Enterovirus Infections Herpesviridae Infections |