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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)

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Trial Profile

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)

Status: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 15 Nov 2023

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At a glance

  • Drugs Human papillomavirus vaccine recombinant quadrivalent Serum Institute of India (Primary) ; Human papillomavirus vaccine recombinant quadrivalent Merck
  • Indications Human papillomavirus infections
  • Focus Pharmacodynamics; Registrational
  • Sponsors Serum Institute of India

    • Most Recent Events

    • 07 Nov 2023 Results (n=2341) assessing the immunogenicity and safety of a quadrivalent HPV vaccine (targeting HPV types 6, 11, 16, and 18), developed and manufactured by the Serum Institute of India published in the Lancet Oncology
    • 13 Nov 2018 New trial record
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