NCT06632912

Phase IIIb Clinical Trial of Quadrivalent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) for Age/Immunization Schedule Bridging

A Randomized, Open-label, Non-inferiority Phase IIIb Clinical Trial to Evaluate the Immunogenicity Age/Schedule Bridging Between Adolescent Girls Aged 9-14 Years Receiving a 2-dose Regimen or Adolescent Girls Aged 9-17 Years Receiving a 3-dose Regimen of a Quadrivalent Recombinant Human Papillomavirus (HPV) Vaccine (Hansenula Polymorpha) and Women Aged 18-35 Years.

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,800 (actual)
• Sponsor: National Vaccine and Serum Institute, China · Industry
• Sex: Female
• Age: 9 Years – 35 Years
• Healthy volunteers: Accepted

Summary

This vaccine was jointly developed by Chengdu Institute of Biological Products Co., Ltd. and National Vaccine and Serum Institute, China, is co-sponsoring this clinical trial. This trial plans to enroll 1,800 female subjects aged 9-35 years, 450 in each of the 18-25 years old 3-dose group, 26-35 years old 3-dose group, 9-17 years old 3-dose group and 9-14 years old 2-dose group. All subjects in the 9-14 years old 2-dose group will be injected with 2 doses of the experimental vaccine in the deltoid muscle of the upper arm according to the 0-6 month immunization schedule. Subjects in the non-immune persistence subgroup will need to complete 6 on-site visits and subjects in the immune persistence subgroup will need to complete 13 on-site visits ; All subjects in the 9-17 years old 3-dose group and the 18-35 years old 3-dose group will be injected with 3 doses of the experimental vaccine in the deltoid muscle of the upper arm according to the 0, 2, and 6 month immunization schedule. Subjects in the non-immune persistence subgroup will need to complete 9 on-site visits and subjects in the immune persistence subgroup will need to complete 16 on-site visits

Conditions

• Human Papillomavirus (HPV) Infection
• HPV (Human Papillomavirus)-Associated Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	2 doses of vaccine Quadrivalent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha)	Two doses of the experimental vaccine were injected into the deltoid muscle of the upper arm according to the immunization schedule at 0 and 6 months.
BIOLOGICAL	3 doses of vaccine Quadrivalent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha)	Three doses of the experimental vaccine were injected into the deltoid muscle of the upper arm according to the immunization schedule at 0, 2, and 6 months.

Timeline

• Start date: 2025-11-21
• Primary completion: 2032-07-01
• Completion: 2032-07-01
• First posted: 2024-10-09
• Last updated: 2026-01-23

Locations

3 sites across 1 country: China