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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

NCT07256912 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1266

Last updated 2026-03-24

No results posted yet for this study

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

BIOLOGICAL

quadrivalent HPV vaccine

CERVAVAC-4 single dose vaccine

BIOLOGICAL

quadrivalent HPV vaccine

Gardasil-4 single dose

Sponsors & Collaborators

  • International Agency for Research on Cancer

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2028-12-01
Completion
2029-01-15

Countries

  • Zambia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07256912 on ClinicalTrials.gov