A Phase I Clinical Trial to Evaluate the Safety of 15-valent HPV Vaccine in Healthy Chinese Peopl… (NCT06454175) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Phase I Clinical Trial to Evaluate the Safety of 15-valent HPV Vaccine in Healthy Chinese People Aged 18-45 Years
China72 participantsStarted 2024-08-03
Plain-language summary
To evaluate the safety and tolerability of 15-valent HPV vaccine in 9-45year-old participants.
Who can participate
Age range
9 Years – 45 Years
Sex
ALL
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；
. Participans 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 (a 9-17 year old participant signs an informed notification);
. Axillary temperature was 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 were not pregnant at the time of enrollment (negative blood pregnancy test), did not have lactation period，had no birth plan within the 30 days after receiving the whole vaccination;
. Women with reproductive age take effective contraceptive measures within 2 weeks before enrollment in the study;
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants With Adverse Events
Timeframe: Up to 30 minutes after any vaccination
2
Percentage of Participants With Solicited Adverse Events
Timeframe: Up to 14 days after any vaccination
3
Percentage of Participants With Unsolicited Adverse Events
Timeframe: Up to 30 days after any vaccination
4
Percentage of Participants With Serious Adverse Events
Timeframe: From Day 0 after the first dose of vaccination to 6 months after the thrid dose
5
Percentage of Female Participants With Pregnancy Events
Timeframe: From Day 0 after the first dose of vaccination to 6 months after the thrid dose
. 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 within 3 months before enrollment, including vaccine or drug;
. Before the first dose is vaccinated, the laboratory test indicators specified in the program are abnormal, except for NCS determined by the clinician;
. History of CIN2/AIS/Cervical Cancer/Pelvic radiation therapy;
. 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, lymphoma, leukemia, systemic lupus erythematosu, rheumatoid arthritis, juvenile Rheumatoid arthritis, Pernicious Anemia, Ulcerative colitis or other autoimmune conditions (such as 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;