A Study of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (V503-002)
A Study of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (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.
The base study V503-002 was a 12-month study that is collecting safety and immunogenicity
 information for six months following the subjects' third dose of study vaccine.

 An optional extension study (V503-002 EXT1) will collect safety and immunogenicity
 information through Month 36. Participants enrolled in the 16- to 26-year-old cohort in the
 base study will not be included in EXT1.

 An optional second extension study (V503-002 EXT2) will collect long-term safety and
 immunogenicity information through approximately 10 years. No study vaccine will be
 administered in the extension studies. Participants enrolled in the 16- to 26-year-old cohort
 in the base study will not be included in EXT2.
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