| Eligibility |
Inclusion Criteria:
- 1. Chinese women aged 9-45 who can provide legal identification; 2. The legal guardian
of the subject and/or subject has the ability to understand the research procedure and
sign an informed consent form (a 9-17 year old subject signs an informed
notification); 3).The legal guardian of the subject and / or subject has the ability
to read, understand, fill in the journal card / contact card, and promise to
participate in regular follow-up as required by the study; 4. Female children of
childbearing age were not pregnant at the time of enrollment (negative urine pregnancy
test), did not have lactation period and had no birth plan within the first 7 months
after enrollment; effective contraceptive measures were taken within 2 weeks before
enrollment in the study. And agree to continue to take effective contraceptive
measures within the first 7 months after the study (effective contraceptives include:
oral contraceptives, injection or embedding contraceptives, sustained release topical
contraceptives, hormone patches, intrauterine devices) (IUD), sterilization,
abstinence, condoms (male), diaphragms, cervical caps, etc.
Exclusion Criteria:
- 1. Previously vaccinated with commercially available HPV vaccines or planned to
vaccinate commercially available HPV vaccines during the study period or have
participated in HPV vaccine clinical trials and have received vaccine/placebo
vaccination; 2. History of cervical lesions (such as cervical cancer screening
abnormalities, history of CIN disease) or history of hysterectomy (vaginal or total
abdominal hysterectomy) or history of pelvic radiation therapy; history of external
genital diseases (such as vulvar epithelialization) Tumor, vaginal intraepithelial
neoplasia and genital warts, etc. or acute genital infections (eg acute vaginitis,
acute endometritis, acute salpingitis and oophoritis); or previous history of sexually
transmitted diseases (including syphilis) Gonorrhea, genital warts, genital chlamydia
infection, genital herpes, soft chancre, sexually transmitted lymphogranuloma,
inguinal granuloma, etc.); 3. Have a history of severe allergies to any of the
components of the test vaccine, including yeast, L-histidine, sodium chloride,
aluminum hydroxide and water for injection, eg anaphylactic shock, allergic laryngeal
edema, allergic purpura, thrombocytopenia Sexual purpura, local allergic necrosis
(Arthus reaction); or any previous history of serious side effects of vaccines or
drugs, such as: allergies, urticaria, skin eczema, dyspnea, angioedema, etc.; 4. There
is thrombocytopenia or other coagulopathy that can be a contraindication to
intramuscular injection; 5. impaired immune function or has been diagnosed as having
congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection,
lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile
Rheumatoid arthritis (JRA), inflammatory bowel disease or other autoimmune diseases;
6. no spleen or functional spleen, and no spleen or splenectomy caused by any
condition; 7. has been diagnosed as having an infectious disease, such as:
tuberculosis, hepatitis B, hepatitis C, etc.; 8. Before the enrollment, the physical
examination was hypertension (systolic blood pressure =140mmHg and / or diastolic
blood pressure =90mmHg) (applicable to 18-45 year olds); 9. suffering from severe
cardiovascular disease (pulmonary heart disease, pulmonary edema), severe liver and
kidney disease, and complications of diabetes; 10. 3 days before vaccination,
suffering from acute illness or acute exacerbation of chronic disease; 11. have
convulsions, epilepsy, encephalopathy, mental illness or family history; 12.
Inactivated vaccine or recombinant vaccine within 14 days before vaccination, or
vaccinated with any live vaccine within 28 days; 13. Participated in other
gynecological related clinical trials within 6 months, participated in other research
or unregistered products (drugs or vaccines) within 3 months, or planned to
participate in other clinical studies after the clinical study was enrolled; 14.
receive any immunoglobulin or blood product within 6 months prior to the first
injection, or plan to receive such product by the 7th month of the study; 15. In the
past 6 months, there have been immunosuppressive drugs, systemic medication for
corticosteroids (=2mg/kg/day, continuous use =14 days), but local medication (such as
ointment, eye drops, inhalants) Or nasal spray), the topical medication should not
exceed the recommended dose in the instructions or have any systemic exposure signs;
16. The body temperature before inoculation on the day of enrollment> 37.0 ° C (armpit
temperature); 17. Before the first dose is vaccinated, the laboratory test indicators
specified in the program are abnormal and clinically determined by the clinician; 18.
plan to move out of the country before the end of the study or leave the local area
for a long time during the scheduled study visit; 19. The investigator believes that
the subject has any condition that may interfere with the assessment of the purpose of
the study.
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