Title: “A Phase-II/III, Partially Double-blind, Randomized, Active-controlled, Multicentric Study to Assess the Immunogenicity and Safety of SIIPL’s qHPV Vaccine Administered Intramuscularly in Healthy Volunteers According to a Two-dose Schedule to Cohort 1 (Girls and Boys Aged 9-14 years) and a Three-dose Schedule to Cohort 2 (Women and Men Aged 15-26 years) as Compared to Merck’s HPV6/11/16/18 vaccine (Gardasil®)” is ongoing at KEMHRC, Vadu.

Sponsor and funder:Serum Institute of India Pvt. Ltd.(SIIPL)

Objective: The Primary objective of this study is to assess the reactogenicity and safety of SIIPL qHPV and Gardasil vaccines in 9-14 years cohort receiving 2 doses and 15-26 years receiving 3 doses of the vaccine.All the participants would be followed for seven months for immunogenicity and followed further for three years. Secondary objective of this study isto demonstrate antibody response to HPV types 6, 11, 16 & 18 at 7 months among cohort I male and female receiving 2 doses of SIIPL qHPV vaccine is non-inferior to girls of age 9-14 yrs of age receiving 2 doses of Gardasil. In India, cervical cancer is the second most prevalent cancer among females aged 15 to 44 years and HPV prevalence among cervical cancer patients is varied from 87.8% to 96.67%.High cost of HPV vaccine is main hindrance for its’ introduction in NIP. SIIL have developed a low cost qHPV vaccine with hopes to eradicate cervical disease in under-developed and developing countries like India. This is one of the study in which males are also receiving qHPV vaccine which will provide data to introduce vaccine in Indian male population and eradicate male genital and anal cancers caused by HPV. Phase 2 recruitment and 7 month follow up was successfully completed and planned to start Phase III in Jan 2020.

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