Safety and Immunogenicity of Extended 2-dose Regimens of 9-valent Human Papillomavirus (9vHPV) Vaccine (V503-069)
Safety and Immunogenicity of Extended 2-dose Regimens of 9-valent Human Papillomavirus (9vHPV) Vaccine (V503-069)
This is a 96-month safety and immunogenicity study conducted in boys and girls 9 to 14 years
 of age and in young women 16 to 26 years of age. From this study, the goal is to establish
 that the investigational extended 2-dose regimens (0, 12 months; 0, 24 months; 0, 36 months;
 and 0, 60 months) studied in boys and girls 9 to 14 years of age are generally safe and
 immunogenic, with an antibody response that is not inferior to that observed in young women
 16 to 26 years of age who receive the standard 3-dose regimen of 9-valent human
 papillomavirus (9vHPV) vaccine at 0, 2, and 6 months (i.e., the population and dose regimen
 used to establish 9vHPV vaccine efficacy).
Inclusion Criteria:

 Boys and Girls 9 to 15 Years:

 - Must not have had coitarche and does not plan on becoming sexually active during the
 vaccination period

 Women 16 to 26 Years:

 -  Has never had a Papanicolaou (Pap) test or only had normal Pap test results

 -  A lifetime history of 0 to 4 male and/or female sexual partners

 Cohort 0 Participants:

 - Received 1 dose of 9vHPV vaccine at least 1 year prior to enrollment and did not receive
 a second dose of any HPV vaccine

 Exclusion Criteria:

 All Participants:

 -  Known allergy to any vaccine component

 -  History of severe allergic reaction that required medical intervention

 -  Thrombocytopenia or any coagulation disorder

 -  Females only: participant is pregnant or expecting to donate eggs during day 1 through
 month 7

 -  Currently immunocompromised, or been diagnosed with immunodeficiency

 -  Had a splenectomy

 -  Receiving or has received immunosuppressive therapies within the last year

 -  Received any immunoglobulin product or blood-derived product within 3 months

 -  Has received more than 1 dose of an HPV vaccine (Cohort 0)

 -  Received a marketed HPV vaccine or has participated in an HPV vaccine clinical trial
 (Cohorts 1-5)