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NCT06465914 · ClinicalTrials.gov record · last posted 2024-12-12

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

StatusActive, Not Recruiting
PhasePhase 3
Started2024-07-11
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
This study is designed to evaluate the vaccine efficacy, immunogenicity and safety of the 9-valent (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) Human Papillomavirus (HPV) Recombinant Vaccine (Hansenula Polymorpha) in Chinese male subjects aged 18-45 years. The primary hypothesis in the study is the 9-valent HPV recombinant vaccine reduces the incidence of vaccine HPV types-related genital warts compared with placebo in Chinese men.

Amendment record 3 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 3 times since 2024-06-14; most recent amendment 2024-12-08. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2024-12-08
Status change Recruiting→Active, Not Recruitingv3
2024-07-11
Status change Not Yet Recruiting→Recruitingv1
Trial Details
NCT Number NCT06465914
Lead Sponsor Shanghai Bovax Biotechnology Co., Ltd.
Conditions Genital Wart, Penile Cancer, Anal Cancer, PIN-1, PIN2, PIN3, AIN1, AIN2 +2 more
Enrollment 9,000 participants
Start Date 2024-07-11
Primary Completion 2027-07-30 (estimated)
Study Completion 2030-07-30 (estimated)
Updated on ClinicalTrials.gov 2024-12-12