A Study of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (V503-002)
Cervical Cancers, Vulvar Cancer, Vaginal Cancer
About this trial
This is an interventional prevention trial for Cervical Cancers
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
9- to 15-Year-Old Females (Lot 1)
9- to 15-Year-Old Females (Lot 2)
9- to 15-Year-Old Females (Lot 3)
9- to 15-Year-Old Males (Lot 1)
16- to 26-Year-Old Females (Lot 1)
9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 2.
9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 3.
9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.