NCT05027776

Immunogenicity and Safety of Quadrivalent HPV Vaccine in Healthy Chinese Female Subjects Aged 9 to 19 Years

Evaluating the Immunogenicity and Safety of Quadrivalent Human Papillomavirus Recombinant Vaccine (Type 6, 11, 16, 18) in Healthy Chinese Female Subjects Aged 9 to 26 Years: A Phase 3, Open-label, Non-randomized Clinical Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,348 (estimated)
• Sponsor: Shanghai Bovax Biotechnology Co., Ltd. · Industry
• Sex: Female
• Age: 9 Years – 26 Years
• Healthy volunteers: Accepted

Summary

This phase 3 study will evaluate the immunogenicity and safety of Quadrivalent HPV recombinant vaccine in Chinese females aged 9 to 26 years

Detailed description

This is a singel-center study (protocol 4-HPV-3002) in which women are planned to receive q-HPV vaccine. Study participation will last approximately 60 months and involves a total of nine or eleven scheduled visits. This study will also assess whether the immunogenicity of the q-HPV vaccine given 2-dose schedule in 9-14 year old girls is noninferior to that in young women, aged 20-26, receiving 3 doses, and 3 doses in 9-19 year old girls is noninferior to that in young women receiving 3 doses, while assessing the safety of this vaccine.

Conditions

• HPV Infections
• Cervical Cancer Stage IIa
• Vaginal Cancer
• Genital Wart
• CIN1
• CIN2
• CIN3

Interventions

Type	Name	Description
BIOLOGICAL	2-doses Group among 9-14 years	Subjects were planned to receive two doses of the study vaccine administered intramuscularly according to a 0, 6 month vaccination schedule.
BIOLOGICAL	3-doses Group among 9-19 years	Subjects were planned to receive three doses of the study vaccine administered intramuscularly according to a 0, 2, 6 month vaccination schedule.
BIOLOGICAL	3-doses Group among 20-26 years	Subjects were planned to receive three doses of the study vaccine administered intramuscularly according to a 0, 2, 6 month vaccination schedule.

Timeline

• Start date: 2021-09-15
• Primary completion: 2023-11-22
• Completion: 2026-09-29
• First posted: 2021-08-30
• Last updated: 2024-04-17

Locations

1 site across 1 country: China