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Sponsored by: |
Merck |
---|---|
Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00092547 |
This study is to evaluate the safety, tolerability, and immune response of an investigational vaccine, Gardasil (V501), in preadolescent and adolescent boys and girls for the prevention of Human Papilloma Virus (HPV).
Condition | Intervention | Phase |
---|---|---|
Healthy Papillomavirus Infections |
Biological: V501, Gardasil, human papillomavirus (types 6, 11, 16, 18) recombinant vaccine / Duration of Treatment: 1.5 years |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | A Safety and Immunogenicity Study of Gardasil (V501) Quadravalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Preadolescents and Adolescents |
Ages Eligible for Study: | 9 Years to 15 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2004_084, V501-018 |
Study First Received: | September 23, 2004 |
Last Updated: | February 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00092547 |
Health Authority: | United States: Food and Drug Administration |
Virus Diseases DNA Virus Infections Papillomavirus Infections Healthy |
Tumor Virus Infections Infection |