A Phase III Clinical Trial of a 11-valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 9-45 Years

Exclusion Criteria24

• (Visits may be rescheduled if the criteria described in the "*" option are met at screening)
• \- Non-gynecological related
• * Those with abnormal blood pressure (systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90mmHg) on physical examination before vaccination;
• *3 months prior to vaccination or planned to receive any immune globulin or blood products within 7 months of enrollment;
• *Received any vaccine within 14 days prior to vaccination, or received live vaccine within 28 days;
• *3 days before vaccination, suffering from acute febrile illness (body temperature ≥38.5℃) or using antipyretic, analgesic and antiallergic drugs (eg: acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.);
• History of severe allergies/conditions requiring medical intervention (e.g. Anaphylactic shock, anaphylactic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, local allergic necrosis(Arthus reaction) etc.);
• Immunocompromised or diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia Blood disease, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammation STD or other autoimmune disease;
• 1 month before vaccination or plan to receive immunosuppressive therapy within 7 months after enrollment, such as oral administration for more than 2 consecutive weeks Oral or injectable systemic corticosteroid therapy (≥2 mg/kg/day or ≥20 mg/day prednisone or equivalent to prednisone) amount); however, topical medications (such as ointments, eye drops, inhalers, or nasal sprays) are not limited;
• Previous splenectomy or impaired spleen function;
• Those with previous or current severe liver, kidney and cardiovascular diseases, complicated diabetes, and malignant tumors;
• Have a history of epilepsy, convulsions, mental illness or a family history of mental illness;
• Suffering from thrombocytopenia or any coagulation disorder that can become a contraindication to intramuscular injection;
• Participate in other clinical studies (drugs, vaccines and medical devices) within 3 months before vaccination or during the planned study period;
• The investigator believes that the subject has any other factors that are not suitable for participating in the clinical trial (such as: poor compliance or planning Permanent relocation from the area before the study is completed, etc.).
• \- Gynecology related
• *Pregnant, breastfeeding, or within 6 weeks of pregnancy at the time of the first dose of the vaccine;
• *The subject is in the menstrual period;
• *Acute lower genital tract infection (such as acute vulvitis/vaginitis/cervicitis, etc.) found by the naked eye during gynecological examination;
• Previous history of abnormal cervical cancer screening or lesions (including HPV DNA positive, squamous intraepithelial lesion (SIL)or atypical squamous cells of undetermined significance (ASC-US), atypical squamous epithelial cells - excluding high-grade squamous cells Intraepithelial lesions (ASC-H), atypical glandular cells (AGC) or with cervical intraepithelial neoplasia (CIN),Adenocarcinoma in situ (AIS) or cervical cancer, etc.);
• Past or current anal and genital diseases (such as vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, genital warts,vulvar cancer, vaginal cancer and anal cancer, etc.);
• Previous hysterectomy or pelvic radiation therapy or severe cervical/vaginal dysplasia.
• If any of the following occurs, the investigator will terminate the subject's vaccination with the investigational vaccine.
• Any other reasons that, in the judgment of the investigator, warrant discontinuation of the investigational vaccination.