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)

V503-002

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 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. The primary hypotheses are as follows: 1. The 9-valent HPV L1 VLP vaccine when administered to preadolescent and adolescent boys and girls 9 to 15 years of age and young women 16 to 26 years of age is generally well-tolerated. 2. 9-valent HPV L1 VLP vaccine induces non-inferior immune responses in preadolescent and adolescent girls 9 to 15 years of age who are seronegative at Day 1 to the relevant HPV type compared to young women 16 to 26 years of age who are seronegative at Day 1 and polymerase chain reaction (PCR)-negative Day 1 through Month 7 to the relevant HPV type, as measured by anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 geometric mean titers (GMTs) at 4 weeks post-dose 3. 3. The 9-valent HPV L1 VLP vaccine induces non-inferior immune responses in preadolescent and adolescent boys 9 to 15 years of age who are seronegative at Day 1 to the relevant HPV type compared to young women 16 to 26 years of age who are seronegative at Day 1 and PCR-negative Day 1 through Month 7 to the relevant HPV type, as measured by anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 GMTs at 4 weeks post-dose 3. 4. Three separate final manufacturing process (FMP) lots of the 9-valent HPV L1 VLP vaccine induce similar immune responses, as measured by anti-HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 GMTs at 4 weeks post-dose 3.

2009-08-27

2011-04-30

2021-04-22

Completed

Early phase I

3074

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 3074, 'type': 'ACTUAL'}}

2022-10-03