a study of v503 (a multivalent human papillomavirus [hpv] l1 virus-like particle [vlp] vaccine) in preadolescents and adolescents (v503-002)

Conditions: Cervical Cancers; Vulvar Cancer; Vaginal Cancer; Genital Lesions; PAP Test Abnormalities; HPV Infections

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 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 collected immunogenicity data through month 7 and safety data through month 12. an optional extension study (v503-002 ext1) collected safety and immunogenicity information through month 36. participants enrolled in the 16- to 26-year-old cohort in the base study were not included in ext1. per protocol, ext1 included immunogenicity data from a subset of 9- to 15-year-old females and safety data from all 9- to 15-year-old females regardless of lot administered. an optional second extension study (v503-002 ext2) collected long-term safety and immunogenicity information through approximately month 126. no study vaccine was administered in the extension studies. participants enrolled in the 16- to 26-year-old cohort in the base study were not included in ext2. per protocol, ext2 included immunogenicity data from a subset of 9- to 15-year-old females and effectiveness and safety data from all 9- to 15-year-old females regardless of lot administered.

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