A Trial to Establish Non-inferiority of Immunogenicity of a Single-dose of CERVAVAC® Quadrivalent HPV Vaccine Compared to the Gardasil® Quadrivalent Vaccine Among Girls and Boys Aged 9 to 14 Years and in Girls/Women Aged 15 to 20 Years in Zambia

The goal of this study is to compare the immune response of the single dose of the CERVAVAC vaccine with the single dose of Gardasil vaccine in girls/women aged 9 to 20 and boys aged 9 to 14 at 6 months, 12 months and 24 months post vaccination. The vaccine will be given randomly to the boys and girls/women in these age group and they will be followed up to check the immune status developed in them after vaccination. The status of immune response developed by the two differnet vaccines will be compared in these group of participants of the study.

NCT Number	NCT07256912
Lead Sponsor	International Agency for Research on Cancer
Conditions	Vaccine Effectiveness, HPV Vaccination, Single Dose, Immunogenicity, Cervical Cancer Prevention, Quadrivalent HPV Vaccine
Enrollment	1,266 participants
Start Date	2026-04-01
Primary Completion	2028-12-01 (estimated)
Study Completion	2029-01-15 (estimated)
Updated on ClinicalTrials.gov	2026-03-24