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A Study of V503 in Females 12-26 Years of Age Who Have Previously Received GARDASIL™ - NCT01047345-02906(Clinical Trial 590994)



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City:  Providence
State:  
RI
Zip Code: 02906
Conditions: Cervical Cancers - Vulvar Cancers - Vaginal Cancers - Genital Warts - Human Papillomavirus (HPV) Infection
Purpose: This study will evaluate whether V503, a multivalent HPV vaccine, is well-tolerated in girls and women between 12 and 26 years old who have previously been vaccinated with GARDASIL™
Study summary:
Criteria: Inclusion Criteria: Girls Age 12 to 15 Years: - Subject is in good health - Parent/legal guardian and subject agree to provide a primary telephone number for follow-up - Subject received a 3-dose regimen of marketed GARDASIL™ within a 1 year period and the last dose of GARDASIL™ was at least 1 year from study day 1 - Subject has not received any other HPV vaccine - Subject is not yet sexually active Women Age 16 to 26 Years: - Subject is in good health - Subject agrees to provide a primary telephone number for follow-up - Subject received a 3-dose regimen of marketed GARDASIL™ within a 1 year period and the last dose of GARDASIL™ was at least 1 year from study day 1 - Subject has not received any other HPV vaccine - Subject has never had Pap testing or has had only normal results - Subject has a history of 0 to 4 lifetime sexual partners at enrollment Exclusion Criteria: All Subjects: - Subject has a history of severe allergic reaction that required medical intervention - Subject has any disorder that would contraindicate intramuscular injection - Subject is pregnant - Subject is immunocompromised or has an autoimmune condition - Subject has had a splenectomy - Subject has received any immune globulin product or blood-derived product - Subject has participated in an HPV clinical trial Women Age 16 to 26 Only: - Subject expects to donate eggs during the study - Subject has a history of abnormal cervical biopsy result (showing cervical intraepithelial neoplasia (CIN) or worse) - Subject has a history of HPV-related external genital lesions, external genital cancer, HPV-related vaginal lesions, or vaginal cancer
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Data Source: ClinicalTrials.gov
Date Processed: September 22, 2010
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