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RECRUITING
NCT05027776
PHASE3

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

Sponsor: Shanghai Bovax Biotechnology Co., Ltd.

View on ClinicalTrials.gov

Summary

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

Official title: 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

Key Details

Gender

FEMALE

Age Range

9 Years - 26 Years

Study Type

INTERVENTIONAL

Enrollment

1348

Start Date

2021-09-15

Completion Date

2026-09-29

Last Updated

2024-04-17

Healthy Volunteers

Yes

Interventions

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.

Locations (1)

Center for Disease Control and Prevention

Mianyang, Sichuan, China