Cervical Cancer
Conditions
Interventions
Group 1:None
Group 2:None
Sponsors
He'nan Provincial Centre for Disease Control and Prevention
Eligibility
Sex/Gender
Female
Age
9 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Research on the protection effectiveness of 18-45 years old: (1) Healthy women with a history of sexual life; (2) Have the ability to understand clinical trials and agree to sign an informed consent form; (3) Non-lactating period and no pregnancy or birth plan within 7 months, and agree to take effective contraceptive measures during this period; (4) Two days (48 hours) before the visit, it is possible to avoid vaginal sex, without vaginal douche, vaginal medication, etc.; (5) Ability to comply with program requirements (fill in diary cards, contact cards and participate in regular follow-ups). 2. 9-17 years old age bridging research: (1) Healthy women; (2) Patients and legal guardian or trustee shall voluntarily sign an informed consent form with informed consent; (3) Ability to comply with program requirements (fill in diary cards, contact cards and participate in regular follow-ups). 3. Research on immunogenic bridging between 16-26 years old: (1) Healthy women; (2) Patients aged 16-17 years and legal guardian or trustee have voluntarily signed an informed consent form with informed consent; (3) Patients aged 18-26 years have the ability to understand clinical trials and agree to sign an informed consent form; (4) Non-lactating period and no pregnancy and birth plan within 7 months, and agree to take effective contraceptive measures during this period; (5) Ability to comply with program requirements (fill in diary cards, contact cards and participate in regular follow-ups).
Exclusion criteria
Exclusion criteria: 1. First dose exclusion criteria (if you meet the * option during screening, you can reschedule the visit): (1) The axillary temperature of subjects >14 years old is >= 37.3?, and the axillary temperature of subjects = 37.5?*; (2) Have history of HPV vaccination; (3) Receive immune enhancement or inhibitor therapy within 1 month (continuous oral or intravenous drip for more than 14 days); local medication (such as ointment, eye drops, inhalation or nasal spray) is allowed, and local medication shall not exceed the instructions or have any signs of systemic exposure, or plan to receive such treatment within the next 7 months (1 month after the full course of vaccination); (4) Have received live attenuated vaccine within 28 days; have received other vaccines within 14 days*; (5) Receive any immunoglobulin or blood products within 3 months, or plan to receive such products within the next 7 months (1 month after the full vaccination); (6) A history of severe side effects from previous vaccination or a history of severe allergies (such as oral and throat swelling) to any component of the experimental vaccine (aluminum adjuvant, histidine, sodium chloride, polysorbate and water for injection) , breathing difficulties, hypotension or shock, severe urticaria, etc.); (7) Have a history of epilepsy, convulsions or convulsions (not including fever due to under 2 years old), or have a family history of mental illness; (8) The presence/existence of immunocompromised or has been diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), juvenile rheumatoid arthritis, or other self-immune disease (9) No spleen or spleen dysfunction caused by any situation; 10) Severe liver and kidney diseases, drug-uncontrollable hypertension (systolic blood pressure >=140mmHg, diastolic blood pressure >=90mmHg), diabetic complications, and malignant tumors; (11) Various acute diseases occurred within 3 days before vaccination or in the acute onset of chronic diseases or used antipyretic, analgesic and anti-allergic drugs (such as: acetaminophen, ibuprofen, aspirin, lorrel (12) or with a history of abnormal blood coagulation (such as coagulation factor deficiency, coagulopathy); (13) History of venereal diseases (including syphilis, gonorrhea, chancroid, venereal lymphogranuloma, inguinal granuloma, etc.) or with obvious condyloma; (14) Severe acute vaginitis, purulent cervicitis (with a large amount of purulent discharge visible), or suspected genital warts found by the naked eye during a gynecological examination, suspected of precancerous lesions and cancers of the vulva, vagina or cervix based on clinical symptoms and signs; (15) Have participated in other gynecological related clinical trials within 6 months, have used or planned to use other research or unregistered products (drugs or vaccines) that are not the vaccine of this research within 3 months; (16) Testing due to psychological conditions that cannot comply with the research requirements, past or present mental illness, bipolar affective psychosis, which has not been well controlled in the past two years, mental illness requires medication, and suicidal tendencies in the past five years; (17) The investigator judges that the volunteers have other reasons not suitable for participating in this clinical trial. 2. Study on the protection effectiveness of 18-45 years old: (1) In the menstrual period*;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gynecological examination;High risk HPV-DNA typing test;Cytological test;Immunogenicity test; | — |
Countries
China
Contacts
Public ContactXia Shengli
Outcome results
None listed