NCT07281677

Immunogenicity and Safety of Sequential 2vHPV-9vHPV Vaccination in Girls Aged 9-14 Years

Immunogenicity and Safety of Sequential Bivalent and 9-Valent Human Papillomavirus Vaccine Immunization in Girls Aged 9-14 Years

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Zhejiang Provincial Center for Disease Control and Prevention · Other Government
• Sex: Female
• Age: 9 Years – 14 Years
• Healthy volunteers: Accepted

Summary

This study aims to assess the immunogenicity and safety of a sequential 2vhpv to 9vhpv immunization schedule in girls aged 9-14 years

Detailed description

A post-marketing study is being conducted in Zhejiang Province to evaluate the immunogenicity and safety of a sequential 2vhpv to 9vhpv immunization schedule in girls aged 9-14 years. The study plans to recruit 300 healthy participants, who will be randomly assigned in a 1:1:1 ratio to three groups. In Experimental Group A, participants will receive one dose of the bivalent HPV vaccine followed six months later by two doses of the 9-valent HPV vaccine. In Experimental Group B, participants will receive one dose of the 9-valent HPV vaccine six months after a single dose of the bivalent HPV vaccine. The control group will receive two doses of the 9-valent HPV vaccine at a six-month interval. Venous blood samples will be collected before the first dose, one month before and after each dose of the 9-valent vaccine, and at 12 and 24 months after full immunization to assess HPV vaccine-type-specific neutralizing antibodies. In addition, 100 healthy girls will be enrolled as an external control group receiving two doses of the bivalent vaccine, with blood samples collected before each dose and at 1, 12, and 24 months post-vaccination to assess HPV vaccine-type-specific neutralizing antibodies.

Conditions

• HPV Infection

Interventions

Type	Name	Description
BIOLOGICAL	bivalent HPV vaccine	Bivalent HPV vaccine produced by Shanghai Zerun Biotechnology Co.,Ltd. or Wantai BioPharm.
BIOLOGICAL	9-valent HPV vaccine	9-valent HPV vaccine is produced by Wantai BioPharm or Merck Sharp \& Dohme LLC.

Timeline

• Start date: 2025-12-20
• Primary completion: 2028-12-20
• Completion: 2029-11-13
• First posted: 2025-12-15
• Last updated: 2025-12-15

Locations

1 site across 1 country: China