NCT07256912

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

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,266 (estimated)
• Sponsor: International Agency for Research on Cancer · Academic / Other
• Sex: All
• Age: 9 Years – 20 Years
• Healthy volunteers: Accepted

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.

Conditions

• Vaccine Effectiveness
• HPV Vaccination
• Single Dose
• Immunogenicity
• Cervical Cancer Prevention
• Quadrivalent HPV Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	quadrivalent HPV vaccine	CERVAVAC-4 single dose vaccine
BIOLOGICAL	quadrivalent HPV vaccine	Gardasil-4 single dose

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-12-01
• Completion: 2029-01-15
• First posted: 2025-12-01
• Last updated: 2026-03-24

Locations

1 site across 1 country: Zambia