{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.0","spread":"0.0","upperLimit":"28.9","value":"0.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"261"}],"units":"Participants"}],"description":"The combined incidence of penile intraepithelial neoplasia, penile/perineal/perianal cancers, and genital warts related to HPV6/11/16/18/31/33/45/52/58 was assessed. This outcome measure was determined by clinical/pathologic criteria and positive PCR assay for HPV type. Incidence was estimated as cases per 10,000 person-years. For each study participant, person-years follow up was calculated starting from the beginning of the long-term follow-up study or the date when the study participant reached 16 years of age, whichever came later.","dispersionType":"95% Confidence Interval","groups":[{"description":"In the base study, participants received the 9vHPV L1 VLP vaccine (0.5 mL intramuscular injection) at Day 1, Month 2, and Month 6 and were evaluated through Month 12. In the extension studies, the participants were followed up for safety and immunogenicity up to Month 36 (EXT1) and for immunogenicity, effectiveness, and safety up to Month 126 (EXT2).","id":"OG000","title":"Extension Study: 9- to 15-Year-Old Males"}],"paramType":"NUMBER","populationDescription":"The per-protocol effectiveness population, which included participants who were seronegative (by cLIA) to the relevant HPV type(s) at Day 1 (seronegative to both HPV 6 and 11 for analysis of HPV 6 and 11-related endpoints), received all 3 doses of 9vHPV vaccine with the correct dose of the clinical material within 1 year, and had no other protocol violation that could interfere with evaluation of vaccine effectiveness.","reportingStatus":"POSTED","timeFrame":"Up to ~Month 126","title":"Extension Study: Combined Incidence of Penile Intraepithelial Neoplasia, Penile/Perineal/Perianal Cancers and Genital Warts Related to HPV 6/11/16/18/31/33/45/52/58 in Males","type":"SECONDARY","unitOfMeasure":"Cases per 10,000 person-years"}