NCT06866574View on ClinicalTrials.gov

A Phase III Trial to Evaluate the Efficacy, Immunogenicity and Safety of a Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E.Coli) in Chinese Males

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

9,300

Participants

Timeline

Start Date

April 11, 2025

Primary Completion Date

September 30, 2031

Study Completion Date

September 30, 2031

Conditions
Penile/Perineal /Perianal Intraepithelial NeoplasiaAnal Intraepithelial NeoplasiaPenile/Perianal/Perineal CancerAnal CancerGenital Warts
Interventions
BIOLOGICAL

Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E.coli)

Participants received 3 doses of 9-valent HPV vaccine according to a 0, 1, 6-month schedule (0.5 mL intramuscular injection in the deltoid muscle of the upper arm)

BIOLOGICAL

Aluminum Adjuvant

Participants received 3 doses of Aluminum Adjuvant according to a 0, 1, 6-month schedule (0.5 mL intramuscular injection in the deltoid muscle the upper arm).

Trial Locations (4)

Unknown

Fujian Provincial Center for Disease Control and Prevention, Fuzhou

Sichuan Provincial Center for Disease Control and Prevention, Chengdu

Yunnan Provincial Center for Disease Control and Prevention, Kunming

Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou

All Listed Sponsors
collaborator

Xiamen Innovax Biotech Co., Ltd

INDUSTRY

lead

Xiamen University

OTHER

NCT06866574 - A Phase III Trial to Evaluate the Efficacy, Immunogenicity and Safety of a Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E.Coli) in Chinese Males | Biotech Hunter | Biotech Hunter