Immunogenicity and Safety of Quadrivalent HPV Vaccine in Healthy Chinese Female Subjects Aged 9 to 19 Years

Exclusion Criteria17

• Received marketed HPV vaccine or plan to receive marketed HPV vaccine during this study period or have enrolled in HPV vaccine clinical trials;
• Enrolling or plan to enroll in other clinical trials (drug or vaccine);
• History of positive test to HPV, history of cervical cancer (e.g. abnormal screening test results, abnormal cervical biopsy results, including CIN, LSIL, and cervical cancer) or history of pelvic radiotherapyherpes;
• History of diseases related to HPV infection (e.g. genital warts, VIN, VaIN, and related cancers) or history of STDs, including syphilis, gonorrhea, genital herpes, Mycoplasma genitalium, Lymphgranuloma Venereum, granuloma inguinale, etc.;
• Known allergy to any vaccine components or history of severe allergic diseases requiring treatment, including shock, laryngeal edema, urticarial, Henoch-Schonlein purpura, Arthus reaction, etc.;
• Had primary or acquired immunodeficiency such as HIV, SLE, JRA, etc;
• History of epilepsy and convulsions (except fever convulsions in children under 5 years of age);
• Subjects with existing infectious diseases such as TB, viral hepatitis, and/or HIV infection; or existing liver or kidney conditions, CVDs, and malignancy;
• Untreated/uncontrolled hypertension before vaccination (aged 9 to 17 years: systolic BP≥120mmHg and/or diastolic BP≥80mmHg; aged more than 18 years: Systolic BP≥140mmHg and/or diastolic BP ≥90mmHg);
• With prohibitive contraindications such as Thrombocytopenia or coagulopathy;
• Asplenic, functionally asplenic, or splenectomy caused by any condition;
• Received immunosuppressive treatment within one month before study such as long-term glucocorticoid use(≥2mg per kg per day, lasted more than two wks), or plan to receive such treatment from month 0 to month 7；
• Receipt of immune globulin or blood-related products within 3 months; or plan to receive such products during this study period（month 0 to month 7）;
• Within 3 days prior to vaccination, have an acute disease or are in the acute attack of a chronic disease or have used antipyretic, analgesic and anti-allergic drugs (such as: acetaminophen, ibuprofen, aspirin, loratadine, ceti Rizine, etc.);
• Receipt of inactivated, RNA, and recombinant vaccines within 14 days, live vaccines within 28 days;
• Subjects with existing mental illness, History of mental illness, or Family History;
• According to the investigator's judgment, the subject has any condition may interfere with process of evaluation or participating in this study cannot guarantee the object's maximum benefit.