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

Exclusion Criteria19

• 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;
• 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 infectious disease, such as: tuberculosis, viral hepatitis, etc.;
• 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 pressure ≥120mmHg and / or diastolic blood pressure ≥80mmHg);
• 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 medication for glucocorticoid (\>20mg/day or 2mg/kg/day, continuous use ≥2 weeks), but local medication can be used (such as ointment, eye drops, inhalants) Or nasal spray);
• 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);
• 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.