Status:
COMPLETED
A Study of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (V503-002)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Cervical Cancers
Vulvar Cancer
Eligibility:
All Genders
9-26 years
Phase:
PHASE3
Brief Summary
This study will evaluate the immunogenicity and tolerability of V503 (a multivalent human papillomavirus \[HPV\] L1 virus-like particle \[VLP\] vaccine) in preadolescent and adolescent participants be...
Detailed Description
The base study V503-002 was a 12-month study that collected immunogenicity data through Month 7 and safety data through Month 12. An optional extension study (V503-002 EXT1) collected safety and immu...
Eligibility Criteria
Inclusion
- Boys and Girls Age 9 to 15:
- Participant has not had sexual intercourse prior to the study and does not plan to become sexually active during the study period Day 1 to Month 7
- Women Age 16 to 26:
- Participant has never had Pap testing or has had only normal results
- Participant has had 0 to 4 sexual partners at the time of enrollment
Exclusion
- Boys and Girls Age 9 to 15:
- History of allergic reaction that required medical intervention
- Currently enrolled in any other clinical study
- Participant is pregnant
- Participant is immunocompromised or has taken immunosuppressants in the last year
- Participant has received a marketed HPV vaccine or participated in an HPV vaccine clinical trial
- Participant 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
- Participant is pregnant
- Participant is immunocompromised or has taken immunosuppressants in the last year
- Participant has received a marketed HPV vaccine or participated in an HPV vaccine clinical trial
- Participant has a history of positive test for HPV
- Participant has a history of abnormal cervical biopsy result
- Participant has a history of external genital lesions
Key Trial Info
Start Date :
August 27 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 22 2021
Estimated Enrollment :
3074 Patients enrolled
Trial Details
Trial ID
NCT00943722
Start Date
August 27 2009
End Date
April 22 2021
Last Update
October 3 2022
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