A Phase III Study to Evaluate the Efficacy, Immunogenicity and Safety of the 9-valent HPV Vaccine in Chinese Males

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

9,000

Participants

Timeline

Start Date

July 11, 2024

Primary Completion Date

July 30, 2027

Study Completion Date

July 30, 2030

Conditions
Genital WartPenile CancerAnal CancerPIN-1PIN2PIN3AIN1AIN2AIN3HPV-Related Carcinoma
Interventions
BIOLOGICAL

9-valent Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) Recombinant Vaccine (Hansenula Polymorpha)

Subjects received 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule (0.5 mL intramuscular injection in the deltoid muscle).

BIOLOGICAL

Placebo

Subjects received 3 doses of Placebo according to a 0, 2, 6-month schedule (0.5 mL intramuscular injection in the deltoid muscle).

Trial Locations (5)

410153

Hunan Center for Disease Control and Prevention, Changsha

Unknown

Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention, Nanning

Shanxi Provincial Disease for Control and Prevention, Taiyuan

Sichuan Center for Disease Control and Prevention, Chengdu

Yunnan Center for Disease Control and Prevention, Kunming

All Listed Sponsors
lead

Shanghai Bovax Biotechnology Co., Ltd.

INDUSTRY

NCT06465914 - A Phase III Study to Evaluate the Efficacy, Immunogenicity and Safety of the 9-valent HPV Vaccine in Chinese Males | Biotech Hunter | Biotech Hunter