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First dose exclusion criteria(If the "" option is met during screening, the visit can be
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rescheduled)
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Have been vaccinated with commercially available HPV vaccine in the past or planned to
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Previous positive history of HPV
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be vaccinated with commercially available HPV vaccine during the study period;Or have
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participated in a clinical trial of the HPV vaccine and have received a
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vaccine/placebo vaccination
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Received total hysterectomy or pelvic radiotherapy
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Has a history of abnormal cervical cytology, including squamous intraepithelial
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lesions (SIL) or not clear meaning of the atypical squamous cells (ASC - US), except
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the atypical squamous cells - not highly squamous intraepithelial lesion (ASC - H)
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atypical glandular epithelial cells, or those with cervical intraepithelial neoplasia
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(CIN) and carcinoma in situ or abnormal cervical biopsy results such as the history
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Past history of anal and genital diseases (such as vulvar intraepithelial neoplasia
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vaginal intraepithelial neoplasia, genital warts, vulvar cancer, vaginal cancer and
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anal cancer, etc.)
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Cervical insufficiency or abnormal cervical structure (judged by the results of
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routine gynecological examination)
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Previous sexual history (including syphilis, gonorrhea, chancre, venereal lymphatic
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granuloma, granuloma inguinal) or have obvious condyloma
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A history of seizures, convulsions or convulsions, or a family history of mental
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illness
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the subject is in the menstrual period
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Have participated in other gynecology-related clinical trials within 6 months, and
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have used or plan to use other investigational or unregistered products (drugs or
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vaccines) other than the vaccine in this study within 3 months
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A history of severe allergies requiring medical intervention, such as anaphylactic
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shock, anaphylactic laryngeal edema, allergic purpura, thrombocytopenic purpura, local
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allergic necrosis reaction (Arthus reaction), etc.A history of severe adverse
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Second and third doses of vaccine were excluded criteria
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reactions to previous vaccinations or a history of severe allergies to any of the
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components of the vaccine under study (histidine, polysorbate, aluminum phosphate
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sodium borate, amorphous aluminum phosphate sulfate adjuvant and water for injection)
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(such as swelling of the mouth and throat, dyspnea, hypotension or shock, severe
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Second and third doses of vaccine were delayed criteria
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urticaria, etc.)
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Vaccination may be postponed if
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Subject receives any immunoglobulin or blood product within 3 months prior to the
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first dose of vaccination, or plans to receive such product within the next 7 months
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(1 month prior to the full course of vaccination)
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Subjects present/present with immune impairment or have been diagnosed with congenital
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or acquired immune deficiency, HIV infection, lymphoma, leukemia, systemic lupus
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erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA)
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other circumstances that can be postponed as judged by the researcher
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inflammatory bowel disease or other autoimmune diseases
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Immunosuppressant therapy within 1 month before the first dose of vaccination, such as
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long-term use of systemic glucocorticoid therapy (≥2mg/kg/ day, for more than 2 weeks
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such as prednisone or similar drugs;Topical administration (such as ointment, eye
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drops, inhalant or nasal spray) not exceeding the recommended dosage in the directions
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or showing any signs of systemic exposure) or planning to receive such treatment
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within the next 7 months (1 month before the full course of inoculation)
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Absence of spleen or functional absence of spleen, and absence of spleen or
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splenectomy in any case
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Patients with severe liver, kidney and cardiovascular diseases, diabetes or malignant
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tumor with complications
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Patients with thrombocytopenia or any coagulation disorders that may be
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contraindications to intramuscular injection
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subjects received inactivated or recombinant vaccines within 14 days prior to study
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enrollment, or attenuated live vaccines within 28 days prior to study enrollment
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an acute illness or an acute episode of a chronic illness within 3 days prior to
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vaccination or the use of antipyretic, analgesic and antiallergic drugs (e.g
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acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.)
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the first dose of vaccine was in pregnancy at the time of vaccination, or the end of
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pregnancy had not exceeded 6 weeks
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after questioning, subjects had fever symptoms (subaxillary body temperature ≥37.3℃)
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before the first day of vaccination (within 24 hours before vaccination)
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severe acute vaginitis and suppurative cervicitis found by naked eye during
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gynecological examination (purulent secretion visible by naked eye)
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Blood pressure on physical examination before the first dose of vaccination was higher
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than normal or increased (systolic blood pressure ≥140mmHg and/or diastolic blood
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pressure ≥90mmHg)
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Gynecological examination before the first dose of vaccination suspected genital
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warts, or on the basis of clinical symptoms and signs suspected vulva, vagina or
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cervical precancerous lesions and the possibility of cancer
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Subjects may be unable to comply with the study procedure, comply with the agreement
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or plan to permanently relocate from the region prior to completion of the study, or
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may be permanently absent from the region during the scheduled visit
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In the opinion of the investigators, the subjects had any other factors that made them
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unsuitable to participate in the clinical trial, so that continued participation in
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the study could not guarantee the maximum benefit of the subjects
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new discoveries or new occurrences that meet the first dose exclusion criteria (except
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for articles 2, 3, 4, 21)
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other serious adverse events: the investigator decides whether to terminate the
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experimental vaccination according to its treatment needs
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the investigator assays for any other reasons that may be considered necessary to
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terminate the trial vaccination
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fever (underarm body temperature ≥37.3℃)
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before inoculation (on the day of inoculation), the urine pregnancy test was positive
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(sensitivity was 25mIU/ml n-hcg)
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acute illness or acute attack of a chronic disease or use of antipyretic, analgesic
|
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and antiallergic drugs (e.g., acetaminophen, ibuprofen, aspirin, loratadine
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cetirizine, etc.) within 3 days before vaccination
|
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insufficient interval between other vaccines (inactivated or recombinant vaccines
|
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received within 14 days prior to vaccination, or any live attenuated vaccine received
|
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within 28 days)
|
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any immunoglobulin or blood products received during vaccination should be
|
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administered at least 3 months after the vaccination
|
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