A Randomized, Observer-Blind, Placebo-Controlled, Proof-of-Concept Study to Assess the Safety, Tolerability and Immunogenicity of a Bivalent Human Papillomavirus (HPV) Vaccine in 9 and 15 Month Old Infants and Toddlers, 2-5 Year Old Children and an Open Label Single Dose Study in Young Unmarried Females Aged 15-20 Years in Ghana
This is a randomized observer-blind placebo-controlled proof-of-concept study with the aim to assess the safety and tolerability, and the immunogenicity of a bivalent HPV vaccine administered in healthy infants and toddlers (9- and 15-month-olds) comparing them to an immune-bridging population of 15-20-year-old unmarried females in an open label study in Ghana at the Dodowa Health Research Center.
• Healthy male and female individuals aged 9 months, 15 months, 2-5 years and unmarried females aged 15-20 years at the time of vaccination
• Participants aged 9 months, 15 months and 2-5 years who are up to date with their EPI vaccinations.
• Residing within the area of the study and planning to stay for the study duration.
• Participants that are HIV negative at screening (for the 9-15-month-olds a documented negative maternal ANC HIV screening).
• Unmarried females with a negative pregnancy test at screening practicing/willing to practice continuous effective contraception as recommended by the Ghana Health Services guidance in Ghana
• Able and willing to comply with all study requirements.
• Willingness to provide written informed consent before any trial procedure. Assent will be required for young female participants aged 15-17 years at vaccination in addition to their parent's/LAR's consent.