A Phase 4 3 Randomized, Active-Comparator Controlled, Open-Label Trial to Evaluate the Immunogenicity and Safety of Alternate Two-Dose Regimens of a Bivalent Human Papillomavirus (HPV) Vaccine (Cecolin®) Compared to a Licensed Quadrivalent HPV Vaccine

Full Project Title: A Phase 4 3 Randomized, Active-Comparator Controlled, Open-Label Trial to Evaluate the Immunogenicity and Safety of Alternate Two-Dose Regimens of a Bivalent Human Papillomavirus (HPV) Vaccine (Cecolin®) Compared to a Licensed Quadrivalent HPV Vaccine (Gardasil®) in Healthy 9-14 Year-Old Girls in Low and Low-Middle Income Countries.

Description: This study will evaluate the immunogenicity and safety of bivalent HPV vaccine (Cecolin) in adolescent girls aged 9 to 14 years randomized to one of three two-dose vaccination schedules (0,6 months standard or 0,12 month extended or 0,24 month extended) compared to the standard 0,6 month schedule of quadrivalent HPV vaccine (Gardasil). An additional arm will compare the same measures amongst girls who receive an initial dose of quadrivalent HPV vaccine and a second dose of bivalent HPV vaccine (Cecolin) 24 months later.