Cervical cancer
Conditions
Interventions
trial group:3 doses of trial vaccine for 2months,6months interval
control group :3 doses of trial vaccine for 2months,6months interval
Sponsors
Hunan provincial center for disease control and prevention
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Chinese women who can provide legal identity certificate for their sexual life from 18 to 45 years old; 2. The person who have the ability to understand (non-illiterate) research procedures and sign informed consent; 3. The researchers judged that the subjects were able to comply with the program requirements (fill in the diary card and participate in regular follow-up); 4. Non-genital acute infection (for example: acute vaginitis, acute endometritis, acute fallopian tube inflammation and ovarian inflammation); 5. Before any include visits to samples within 48 hours to avoid sex, including homosexual or heterosexual anal, vaginal or genital/genital contact), and avoid using vaginal rinse the vagina, the vagina clean or drugs or agents; if participants in the selected supervision, did not meet the criteria for the selected supervision should be delay until satisfy the criteria for 48 hours; 6. The subjects were not pregnant at the time of enrollment (the urine pregnancy test was negative), were not breast-feeding and had no fertility plan within 7 months after enrollment;2 weeks before included in the study, effective contraceptive measures has been adopted and agreed to in the first seven months after the study continue to adopt effective contraceptive measures (effective contraceptive measures include: the pill, injection or embedded contraception, slow-release local birth control pills, hormone patch, the intrauterine device (IUD), sterilization, abstinence, condom (men), diaphragm, cervical cap, etc.); 7. The group on the day of the temperature is 37.0 degree C or less (axillary temperature).
Exclusion criteria
Exclusion criteria: 1. Previous vaccination against HPV or planned vaccination against HPV during the study period; 2. Underwent hysterectomy; 3. Previous history of cervical disease (such as cervical cancer screening and the history of CIN disease); 4. Previous history of genital diseases (such as epithelial neoplasia, vaginal epithelial neoplasia and genital warts); 5. Received previous pelvic radiation therapy; 6. 6 months in other related clinical trials of department of gynaecology, participated in other research within three months or unregistered product (drug or vaccine), or the clinical research into group has plans to attend other clinical research; 7. Subjects were allergic to any component of the vaccine (l-histidine, sodium chloride, aluminum hydroxide and water injection); 8. The researchers believe that any patient's disease history may have a confounding effect on the study results or an additional risk to the subjects; 9. Subjects have a history of severe allergic reactions requiring medical intervention (such as swelling of the mouth and throat, dyspnea, hypotension or shock); 10. Subjects receive any immunoglobulins or blood products within 6 months prior to the first injection, or plan to receive such products before the seventh month of study; 11. The subjects has a splenectomy, immune diseases (such as systemic lupus erythematosus, rheumatoid arthritis) or immunosuppressive therapy (such as known to the drug or treatment of the immune response can be reduced, such as radiation therapy, drug metabolism and antilymphocyte serum, systemic glucocorticoids) history.Regular immunosuppressant therapy (defined as 1 year before included in the study, to accept at least three courses of oral corticosteroids, each course lasts at least 1 week) of the subjects be ruled out.Subjects treated with topical glucocorticoid (e.g. inhaled agents, nasal agents or topical agents) are eligible for vaccination; 12. Subjects have immunodeficiency or have been diagnosed with HIV infection; 13. The presence of thrombocytopenia or other coagulation disorders that can become a contraindication for muscular injection; 14. The subject plans to move before the end of the study or leave the place for a long time during the scheduled study visit; 15. Within 14 days prior to the study, the subjects were vaccinated against live vaccines or were vaccinated within 28 days of the study. 16. The researchers believe that there is any possibility that the subject may interfere with the assessment of the purpose of the study. Physical examination exclusion project: 1) positive urine pregnancy test; 2) hypertension (systolic blood pressure >150mmHg and/or diastolic blood pressure >100mmHg); 3) genital lesions (external genital, vaginal and cervical lesions).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12 months of continuous infection associated with HPV6, 11, 16, and 18 types (PI12);Prevention of HPV6/11/16/18 type-specific CIN2+ lesions; | — |
Countries
China
Contacts
Public ContactYe Jianjun
Hubei provincial center for disease control and prevention
Outcome results
None listed