Phase 3 Trial to Study Alternate 2-Dose Regimens of a Bivalent HPV Vaccine (Cecolin®) in Young Girls

INTERVENTION: Cecolin Gardasil Gardasil and Cecolin CONDITION: ; Cancer Cancer PRIMARY OUTCOME: Anti‐HPV 16 and 18 IgG antibody geometric mean concentration (GMC), measured by enzyme‐linked immunosorbent assay (ELISA) one month after the second dose on Month 7 (for the 0, 6‐month arms), Month 13 (for the 0, 12‐month arm) or Month 25 (for the 0, 24‐month arm) following vaccination SECONDARY OUTCOME: Anti‐HPV 16 and 18 serum neutralizing antibody geometric mean titer measured by PBNA compared to ELISA at all time points (in a representative subset) Anti‐HPV16 and 18 IgG antibody GMC measured by ELISA 24 months following the first dose of the Gardasil® 0‐6 month two dose regimen and the Cecolin® 0‐6 month two dose regimen Anti‐HPV16 and 18 IgG antibody GMC measured by ELISA one month following the last dose of the Gardasil® 0‐6 month two dose regimen and the Gardasil®‐Cecolin® 0‐24 month two dose regimen Number of subjects in each study arm reporting solicited adverse events within 7 days after each dose, Number of subjects in each study arm reporting unsolicited adverse events within one month after each dose, Number of subjects in each study arm reporting serious adverse events (SAEs) occurring at any time throughout study participation Seroconversion rate, defined as a 4‐fold rise in anti‐HPV 16 and 18 IgG antibody as measured by ELISA, at baseline and one month following the last dose INCLUSION CRITERIA: 1. Healthy female between the ages of 9 ‐ 14 years. (all inclusive) at time of enrollment 2. Ability and willingness to provide parental consent and, if applicable based on local in‐country regulations, participant assent 3. Parent/LAR provides informed consent 4. Anticipated ability and willingness to complete all study visits and evaluations 5. Living within the catchment area of the study without plans to move during the conduct of the study