Active — Not RecruitingPhase 3

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

China9,000 participantsStarted 2024-07-11

Plain-language summary

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.

Who can participate

Age range18 Years – 45 Years

SexMALE

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Inclusion criteria

✓. Chinese men aged 18-45 years who can provide legal identification and have a sexual life history;
✓. Subjects fully understands the study procedures, understands the risks and benefits associated with participating in the study, and voluntarily signs the informed consent;
✓. Subjects are able to read, understand and fill in the research application forms such as diary CARDS and contact CARDS, and promise to participate in regular follow-up according to the study requirements;
✓. Heterosexual men subjects must have exclusively female sexual partners and no more than 5 before enrollment;
✓. MSM subject must have had sex with men within the past year (either insertive or receptive anal intercourse); and the cumulative number of sexual partners (including male and female sexual partners) does not exceed 5 before enrollment;
✓. Subjects agree to provide effective contact information that can be used for communication with the researchers during the study;
✓. Subjects consent to external anogenital lesion inspection and sample collection (including but not limited to wet swab collection and necessary biopsy) during the study period;
✓. Subjects agree to take effective contraceptive measures from the first dose to 1 month after the last dose \[male effective contraception including abstinence, male condom, vasectomy, etc.; female valid contraception including the pill (excluding emergency contraception), injection or embedded contraception, sustained-release topical contraceptives, hormonal patch, intrauterine devices (IUD), sterilization, diaphragm, cervical caps, etc.; safe period contraception, extracorporeal ejaculation, and emergency contraception are unacceptable contraception.\]

Exclusion criteria

What they're measuring

The incidence of genital wart

Timeframe: 0-72 month

Trial details

NCT IDNCT06465914

SponsorShanghai Bovax Biotechnology Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-07-30

View on ClinicalTrials.gov More Genital Wart trials