A Phase I Clinical Trial to Evaluate the Safety of 15-valent HPV Vaccine in Healthy Chinese People Aged 18-45 Years

Inclusion Criteria:

1. Participants aged 9-45；

2. Participans aged 18-45 who can provide legal identification，participants aged 9-17and their guardian can provide legal identification；

3. Participants and/or their guardian sign an informed consent form (a 9-17 year oldparticipant signs an informed notification);

4. Axillary temperature was less than 37.3 ℃（>14 years old）or less than 37.5℃（≤14 yearsold）at the time of enrollment；

5. Be able to comply with study protocol requirements；

6. 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 receivingthe whole vaccination;

7. Women with reproductive age take effective contraceptive measures within 2 weeksbefore enrollment in the study;

8. Agree to take effective contraceptive measures within 30 days after receiving thewhole vaccination (effective contraceptives include: oral contraceptives, injectionor embedding contraceptives, sustained release topical contraceptives, hormonepatches, intrauterine devices), sterilization, abstinence, condoms (male),diaphragms, cervical caps, etc.

9. Women who receiving hormone test has a regular menstruation for more than one year

Exclusion Criteria:

1. Have been vaccinated with other HPV vaccines or planned to vaccinate other HPVvaccines during the study period；

2. Plan to participate other clinical trials during the study period，or participatedother clinical trials within 3 months before enrollment, including vaccine or drug;

3. Before the first dose is vaccinated, the laboratory test indicators specified in theprogram are abnormal, except for NCS determined by the clinician;

4. History of CIN2/AIS/Cervical Cancer/Pelvic radiation therapy;

5. History of HPV-related external genital diseases (such as genital warts, Vulvarintraepithelial neoplasia, Vaginal intraepithelial neoplasia,Penis/perianal/perineum intraepithelial neoplasia, Penile/perianal/perineal cancer) 、anal intraepithelial neoplasia and related cancer, or head and neck cancer；historyof sexually transmitted diseases (including syphilis， Gonorrhea, genital chlamydiainfection, genital herpes, soft chancre, sexually transmitted lymphogranuloma,inguinal granuloma, etc.);

6. Has been diagnosed as having congenital or acquired immunodeficiency, humanimmunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupuserythematosu, rheumatoid arthritis, juvenile Rheumatoid arthritis, PerniciousAnemia, Ulcerative colitis or other autoimmune conditions (such as Type 1 diabetes,Graves' disease, hashimoto thyroiditi, etc.);

7. History of convulsions, epilepsy, except of febrile convulsions in children 5 yearsof age and younger;

8. History of severe allergy that requires medical intervention, including but notlimited to severe adverse reactions caused by vaccine or drug, eg anaphylacticshock, 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 severeallergy to any of the components of the investigational vaccine, includinghistidine, sodium chloride, aluminium phosphate, Polysorbate 80 and water forinjection;

9. Suffering from severe cardiovascular disease, severe liver and kidney disease,malignant tumor, and serious infectious disease, such as: tuberculosis, viralhepatitis, etc.;

10. Before the enrollment, the physical examination was untreatment or uncontrolledhypertension, (18-45 year olds: systolic blood pressure ≥140mmHg and / or diastolicblood pressure ≥90mmHg, 9-17 year olds: systolic blood pressure ≥120mmHg and / ordiastolic blood pressure ≥80mmHg);

11. Coagulation disorders: such as Congenital or acquired hemophilia, Coagulation factordeficiency, clotting disorders, thrombocytopenia, etc.;

12. No spleen or functional spleen, and no spleen caused by any condition;

13. Receive any Immunosuppressive therapy product within 1 month prior to the firstvaccination, or plan to receive such product from Day 0 to Month 7 (30 days afterreceiving 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);

14. Receive any immunoglobulin or blood product within 3 months prior to the firstinjection, or plan to receive such product from Day 0 to Month 7 (30 days afterreceiving the third dose of vaccination);

15. 3 days before vaccination, suffering from acute illness or acute exacerbation ofchronic disease; using fever reducer, Antihistamines, and Analgesics(such as:Acetaminophen, Ibuprofen, Aspirin, loratadine, Cetirizine, etc. )

16. Receiving inactivated vaccine or recombinant vaccine or live-attenuated vaccine ornucleic acid vaccine or adenovirus vaccine within 14 days before vaccination;

17. History of mental disorders or family history of mental health disorder (immediatefamily)

18. Plan to move out of the city before the end of the study or leave the local area fora long time during the scheduled study visit;

19. The investigator believes that the participant has any condition that may interferewith the assessment of the purpose of the study.