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Tests treatment safety and results for HPV Infection
Official title To Evaluate the Safety and Immunogenicity of 15-valent HPV Recombinant Vaccine in Chinese People Aged 9-45 Years
ClinicalTrials.gov ID: NCT06756269
What this study is testing
What is Medium dose for 15-HPV vaccine?
Medium dose for 15-HPV vaccine is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for hpv infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To evaluate the safety and Immunogenicity of 15-valent HPV vaccine in 9-45year-old participants.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 9 to 45. Healthy volunteers may be eligible.
You may be able to join if
- 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；
You likely can't join if
- 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...
- 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...
- Has been diagnosed as having congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection/AIDS, SCID; Or Autoimmune Diseases...
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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...
- Severe diseases, as determined by the investigator, that affect vaccination eligibility, whether past or current, include severe cardiovascular disease, severe liver and kidney disease, malignant tumor, and serious...
- Before the enrollment, the physical examination was untreatment or uncontrolled hypertension, (18-45 year old: systolic blood pressure ≥140mmHg and / or diastolic blood pressure ≥90mmHg, 9-17 year old: systolic blood...
- Coagulation disorders: such as Congenital or acquired hemophilia, Coagulation factor deficiency, clotting disorders, thrombocytopenia, etc.;
- No spleen or functional spleen, and no spleen caused by any condition;
- Receive any Immunosuppressive therapy product within 1 month prior to the first vaccination, or plan to receive such product from Day 0 to Month 7 (30 days after receiving the third dose of vaccination)，e.g. systemic...
- Receive any immunoglobulin or blood product within 3 months prior to the first injection, or plan to receive such product from Day 0 to Month 7 (30 days after receiving the third dose of vaccination);
- 3 days before vaccination, suffering from acute illness or acute exacerbation of chronic disease; using fever reducer, Antihistamines, and Analgesics(such as: Acetaminophen, Ibuprofen, loratadine, Cetirizine, etc. )
- Receiving inactivated vaccine or recombinant vaccine or live-attenuated vaccine or nucleic acid vaccine or adenovirus vaccine within 14 days before vaccination;
- History of mental disorders or family history of mental health disorder (immediate family);
- Plan to move out of the city before the end of the study or leave the local area for a long time during the scheduled study visit;
- The investigator believes that the participant has any condition that may interfere with the assessment of the purpose of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Nanning, Guangxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 9 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanning, Guangxi, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.