CTRI/2009/091/000767
Completed
Phase 3
A Phase III Clinical Trial to Study the Immunogenicity, Tolerability, and Manufacturing Consistency of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (9 to 15 Year Olds) With a Comparison to Young Women (16 to 26 Year Olds)
Merck Sharp and Dohme0 sites2,800 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified
- Sponsor
- Merck Sharp and Dohme
- Enrollment
- 2800
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Not specified
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