RecruitingPhase 2

To Evaluate the Safety and Immunogenicity of 15-valent HPV Recombinant Vaccine in Chinese People Aged 9-45 Years

China330 participantsStarted 2025-01-15

Plain-language summary

To evaluate the safety and Immunogenicity of 15-valent HPV vaccine in 9-45year-old participants.

Who can participate

Age range9 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Participants aged 9-45；
✓. Participants aged 18-45 who can provide legal identification，participants aged 9-17 and their guardian can provide legal identification；
✓. Participants and/or their guardian sign an informed consent form;
✓. Axillary temperature less than 37.3 ℃（\>14 years old）or less than 37.5℃（≤14 years old）at the time of enrollment；
✓. Be able to comply with study protocol requirements；
✓. Women with reproductive age take effective contraceptive measures within 2 weeks before enrollment in the study, and were not pregnant at the time of enrollment (negative blood pregnancy test), did not have lactation period, and had no birth plan within the 30 days after receiving the whole vaccination;
✓. Agree to take effective contraceptive measures within 30 days after receiving the whole vaccination (effective contraceptives include: oral contraceptives, injection or embedding contraceptives, sustained release topical contraceptives, hormone patches, intrauterine devices), sterilization, abstinence, condoms (male), diaphragms, cervical caps, etc.

Exclusion criteria

✕. Have been vaccinated with other HPV vaccines or planned to vaccinate other HPV vaccines during the study period；
✕. Plan to participate other clinical trials during the study period，or participated other clinical trials （including vaccine or drug）and received medication or vaccine within 3 months before enrollment ,
✕. History of positive HPV testing (including types not covered by the trial vaccine) among the participants aged 18-45 years old;
✕. History of CIN2/AIS/Cervical Cancer/Pelvic radiation therapy in female participants;
✕. History of HPV-related external genital diseases (such as genital warts, Vulvar intraepithelial neoplasia, Vaginal intraepithelial neoplasia, Penis/perianal/perineum intraepithelial neoplasia, Penile/perianal/perineal cancer) 、anal intraepithelial neoplasia and related cancer, or head and neck cancer；history of sexually transmitted diseases (including syphilis， Gonorrhea, genital chlamydia infection, genital herpes, soft chancre, sexually transmitted lymphogranuloma, inguinal granuloma, etc.);
✕. Has been diagnosed as having congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection/AIDS, SCID; Or Autoimmune Diseases (such as systemic lupus erythematosu, Rheumatoid arthritis, juvenile Rheumatoid arthritis, Pernicious Anemia, Ulcerative colitis, Type 1 diabetes, Graves' disease, hashimoto thyroiditi, etc.);
✕. History of convulsions, epilepsy, except of febrile convulsions in children 5 years of age and younger;
✕. History of severe allergy that requires medical intervention, including but not limited to severe adverse reactions caused by vaccine or drug, eg anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenia sexual purpura, local allergic necrosis (Arthus reaction), widespread urticaria, dyspnea, angioedema, etc.; History of severe side effect caused by vaccination or severe allergy to any of the components of the investigational vaccine, including histidine, sodium chloride, aluminium phosphate, Polysorbate 80 and water for injection;

What they're measuring

Percentage of Participants With Adverse Events

Timeframe: Up to 30 minutes after any vaccination

Percentage of Participants With Solicited Adverse Events

Timeframe: Up to 14 days after any vaccination

Percentage of Participants With Unsolicited Adverse Events

Timeframe: Up to 30 days after any vaccination

Percentage of Participants With Serious Adverse Events

Timeframe: From Day 0 after the first dose of vaccination to 6 months after the thrid dose

Percentage of Female Participants With Pregnancy Events

Timeframe: From Day 0 after the first dose of vaccination to 6 months after the thrid dose

Trial details

NCT IDNCT06756269

SponsorShanghai Bovax Biotechnology Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-30

Contact for this trial

Dabin Liang

+86 15977783657 gxirb2018@163.com

View on ClinicalTrials.gov More HPV Infection trials

Who can participate

Age range9 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Participants aged 9-45；
✓. Participants aged 18-45 who can provide legal identification，participants aged 9-17 and their guardian can provide legal identification；
✓. Participants and/or their guardian sign an informed consent form;
✓. Axillary temperature less than 37.3 ℃（\>14 years old）or less than 37.5℃（≤14 years old）at the time of enrollment；
✓. Be able to comply with study protocol requirements；
✓. Women with reproductive age take effective contraceptive measures within 2 weeks before enrollment in the study, and were not pregnant at the time of enrollment (negative blood pregnancy test), did not have lactation period, and had no birth plan within the 30 days after receiving the whole vaccination;
✓. Agree to take effective contraceptive measures within 30 days after receiving the whole vaccination (effective contraceptives include: oral contraceptives, injection or embedding contraceptives, sustained release topical contraceptives, hormone patches, intrauterine devices), sterilization, abstinence, condoms (male), diaphragms, cervical caps, etc.

Exclusion criteria

✕. Have been vaccinated with other HPV vaccines or planned to vaccinate other HPV vaccines during the study period；
✕. Plan to participate other clinical trials during the study period，or participated other clinical trials （including vaccine or drug）and received medication or vaccine within 3 months before enrollment ,
✕. History of positive HPV testing (including types not covered by the trial vaccine) among the participants aged 18-45 years old;
✕. History of CIN2/AIS/Cervical Cancer/Pelvic radiation therapy in female participants;
✕. History of HPV-related external genital diseases (such as genital warts, Vulvar intraepithelial neoplasia, Vaginal intraepithelial neoplasia, Penis/perianal/perineum intraepithelial neoplasia, Penile/perianal/perineal cancer) 、anal intraepithelial neoplasia and related cancer, or head and neck cancer；history of sexually transmitted diseases (including syphilis， Gonorrhea, genital chlamydia infection, genital herpes, soft chancre, sexually transmitted lymphogranuloma, inguinal granuloma, etc.);
✕. Has been diagnosed as having congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection/AIDS, SCID; Or Autoimmune Diseases (such as systemic lupus erythematosu, Rheumatoid arthritis, juvenile Rheumatoid arthritis, Pernicious Anemia, Ulcerative colitis, Type 1 diabetes, Graves' disease, hashimoto thyroiditi, etc.);
✕. History of convulsions, epilepsy, except of febrile convulsions in children 5 years of age and younger;
✕. History of severe allergy that requires medical intervention, including but not limited to severe adverse reactions caused by vaccine or drug, eg anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenia sexual purpura, local allergic necrosis (Arthus reaction), widespread urticaria, dyspnea, angioedema, etc.; History of severe side effect caused by vaccination or severe allergy to any of the components of the investigational vaccine, including histidine, sodium chloride, aluminium phosphate, Polysorbate 80 and water for injection;

What they're measuring

Percentage of Participants With Adverse Events

Timeframe: Up to 30 minutes after any vaccination

Percentage of Participants With Solicited Adverse Events

Timeframe: Up to 14 days after any vaccination

Percentage of Participants With Unsolicited Adverse Events

Timeframe: Up to 30 days after any vaccination

Percentage of Participants With Serious Adverse Events

Timeframe: From Day 0 after the first dose of vaccination to 6 months after the thrid dose

Percentage of Female Participants With Pregnancy Events

Timeframe: From Day 0 after the first dose of vaccination to 6 months after the thrid dose