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NOT YET RECRUITING
NCT07256912
PHASE4

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

Sponsor: International Agency for Research on Cancer

View on ClinicalTrials.gov

Summary

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.

Official title: A Randomized, Active Controlled, Assessors-blind 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

Key Details

Gender

All

Age Range

9 Years - 20 Years

Study Type

INTERVENTIONAL

Enrollment

1266

Start Date

2026-04-01

Completion Date

2029-01-15

Last Updated

2026-03-24

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

quadrivalent HPV vaccine

CERVAVAC-4 single dose vaccine

BIOLOGICAL

quadrivalent HPV vaccine

Gardasil-4 single dose

Locations (1)

Chipata and Matero First Level Hospitals

Lusaka, Zambia