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A Study of V503 in Preadolescents and Adolescents - NCT00943722-10467(Clinical Trial 366260)



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City:  Bronx
State:  
NY
Zip Code: 10467
Conditions: Cervical Cancer - Vulvar Cancer - Vaginal Cancer - Genital Lesions - PAP Test Abnormalities - HPV Infections
Purpose: This study will evaluate the immunogenicity and tolerability of V503 in preadolescent and adolescent subjects between 9 and 15 years old and demonstrate the consistency of the manufactured vaccine through assessment of 3 different final manufacturing process lots of V503.
Study summary:
Criteria: Inclusion Criteria: Boys and Girls Age 9 to 15: - Subject is not sexually active Women Age 16 to 26: - Subject has never had Pap testing or has had only normal results - Subject has had 0 to 4 sexual partners at the time of enrollment Exclusion Criteria: Boys and Girls Age 9 to 15: - History of allergic reaction that required medical intervention - Currently enrolled in any other clinical study - Subject is pregnant - Subject is immunocompromised or has taken immunosuppressants in the last year - Subject has received a marketed HPV vaccine or participated in an HPV vaccine clinical trial - Subject has a history of positive test for HPV Women Age 16 to 26: - History of allergic reaction that required medical intervention - Currently enrolled in any other clinical study - Subject is pregnant - Subject is immunocompromised or has taken immunosuppressants in the last year - Subject has received a marketed HPV vaccine or participated in an HPV vaccine clinical trial - Subject has a history of positive test for HPV - Subject has a history of abnormal cervical biopsy result - Subject has a history of external genital lesions
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Data Source: ClinicalTrials.gov
Date Processed: March 16, 2010
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