Immunobridging Study of 9-valent Human Papillomavirus Recombinant Vaccine in Chinese Females Aged 9 to 19 Years

Inclusion Criteria: Inclusion Criteria for the first stage:

1. Healthy Chinese females aged 9 to 45 years; Provide legal identification;
2. The subject voluntarily agrees to enroll in this study. If the subject is a minor,both the subject and subject's legal guardian should voluntarily agree to enroll inthis study and sign an informed consent form;
3. Be able to understand the study procedures and promise to participate in regularfollow-ups under the requirements;
4. Had a negative urine pregnancy test on the day of enrollment, among the subjects ofchildbearing age; Not in the duration of breast-feeding and no birth plan within 7months; According to the investigator's judgment that there is no possibility ofpregnancy at that time: subjects have taken effective contraception, or asexual lifeafter the last menstrual period, or use IUD, or had undergone ligation; subjects agreeto continue take effective contraception such as taking OCS and condom use;
5. No fever symptoms on the day of enrollment (aged> 14 years old, axillarytemperature<37.3°C; aged ≤ 14 years old, axillary temperature<37.5°C ); Inclusion Criteria for the second stage:
6. Received all 3 doses of trial vaccination;
7. Subjects aged 9 to 19 years at the first stage.

Exclusion Criteria:

1. Received marketed HPV vaccine or plan to receive marketed HPV vaccine during thisstudy period or have enrolled in HPV vaccine clinical trials;
2. History of positive test to HPV, history of cervical cancer (e.g. abnormal screeningtest results, abnormal cervical biopsy results, including CIN, AIS, and cervicalcancer) or history of hysterectomy (vaginal or abdominal radical hysterectomy), orhistory of pelvic radiotherapy; History of genital diseases related to HPV infection (e.g. uterine peristalsis, VIN, VAIN, AIN, and related cancers); History of STDs,including syphilis, gonorrhea, genital herpes, Mycoplasma genitalium, LymphgranulomaVenereum, granuloma inguinale, etc.;
3. Known allergy to any vaccine components or history of severe allergic diseasesrequiring treatment, including shock, laryngeal edema, urticarial, Henoch-Schonleinpurpura, Arthus reaction, etc.;
4. Had primary or acquired immunodeficiency such as HIV, SLE, JRA, etc. or receivedimmunosuppressive treatment within one month before study such as long-termglucocorticoid use(≥2mg per kg per day, lasted more than two wks), or plan to receivesuch treatment from day 0 to month 7 after the last dose;
5. Had chronic diseases or congenital malformations, which might interfere with theprocess and completion of this study, such as Down Syndrome, heart diseases, liverdiseases, chronic diabetes complications, and malignant tumor;
6. Enrolling or plan to enroll in other clinical trials (drug or vaccine);
7. Had infectious diseases such as TB, viral hepatitis, and/or HIV infection;
8. Had convulsions, epilepsy, encephalopathy, and mental illness or family history;
9. With prohibitive contraindications such as Thrombocytopenia or coagulopathy;
10. Asplenic, functionally asplenic, or splenectomy caused by any condition;
11. Within 3 days prior to vaccination, have an acute disease or are in the acute attackof a chronic disease or have used antipyretic, analgesic and anti-allergic drugs (suchas: acetaminophen, ibuprofen, aspirin, loratadine, ceti Rizine, etc.);
12. Receipt of inactivated or recombinant vaccines within 14 days, live vaccines within 28days;
13. Receipt of immune globulin or blood-related products within 3 months; or plan toreceive such products during this study period;
14. Had fever symptoms within 24 hours on the first day (aged> 14 years old, axillarytemperature ≥ 37.3°C; aged ≤ 14 years old, axillary temperature ≥37.5°C );
15. Untreated/uncontrolled hypertension before vaccination (aged 9 to 17 years: systolicBP>120mmHg and/or diastolic BP>80mmHg; aged more than 18 years: Systolic BP≥140mmHgand/or diastolic BP ≥90mmHg);
16. Plan to permanently relocate from the area before the end of the study or leave thelocal area for a long time during the study visit (affecting the scheduled visittime);
17. According to the investigator's judgment, the subject has any condition may interferewith process of evaluation or participating in this study cannot guarantee theobject's maximum benefit.