Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Chengdu Institute of Biological Products Co.,Ltd. | INDUSTRY |
| Simoon Record Pharma Information Consulting Co., Ltd. | INDUSTRY |
| Beijing Kantorico Statistical Technology Co., Ltd. | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
A total of 13500 Chinese women aged 18-45 years old were divided into three age groups: 18-26 years old, 27-35 years old, and 35-45 years old. The experimental group and the placebo group were randomly assigned in a ratio of 1:1. All subjects enrolled in the upper arm deltoid muscle were injected with 3 doses of test vaccine or placebo according to the 0, 2, and 6 months immunization program.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experiment group | Experimental | According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the experiment vaccine |
|
| placebo | Placebo Comparator | According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 11-valent recombinant human papilloma virus vaccine (Hansenula polymorpha) | Biological | According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the experiment vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Person-years incidence of CIN2+ associated with HPV6/11/16/18. | 1 month after 3 doses of vaccine | |
| Person-years incidence of CIN2+ associated with HPV31/33/45/52/58/59/68 | 1 month after 3 doses of vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Person-years incidence of PI12 and PI6 associated with HPV6/11/16/18 types. | 1 month after 3 doses of vaccine | |
| Person-years incidence of PI12 and PI6 associated with HPV31/33/45/52/58 | 1 month after 3 doses of vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Person-years incidence of PI12 and PI6 associated with HPV59/68 | 1 month after 3 doses of vaccine | |
| Person-years incidence of PI12 and PI6 associated with HPV59/68 | 1 month after 1 doses of vaccine |
Inclusion Criteria:
- non-gynecological related
*Chinese women with a history of sexual life who are 18-45 years old at the time of enrollment and can provide legal identification;
*Axillary body temperature <37.3℃ on the day of enrollment;
The subjects themselves have the ability to understand the clinical trial and voluntarily sign the informed consent;
Subjects have the ability to read, understand, and fill out research application forms such as diary cards/contact cards, and promise to follow the research requirements participate in follow-up visits;
No previous HPV vaccination history, no commercially available HPV vaccine during the study period (about 6 years after enrollment) plan of;
The subject has a negative urine pregnancy test on the day before vaccination.
- Gynecology related
*Effective contraception was taken from day 1 of last menstrual cycle to day 0 of the study, and no childbearing within 7 months after enrollment plan.
*Before the gynecological visit and within 48 hours before any subsequent visit that includes a gynecological sample collection: asexual life (including same-sex or opposite-sex anal, vaginal or genital contact), unwashed/washed vagina (Except for normal bathing outside the vagina), no vaginal drugs or preparations are used.
Exclusion Criteria:
First dose exclusion criteria:
(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.
Exclusion criteria for 2nd and 3rd dose vaccination:
If any of the following occurs, the investigator will terminate the subject's vaccination with the investigational vaccine.
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhaojun Mo | Contact | (+86)15177771508 | mozhj@126.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hechi Yizhou District Center for Disease Control and Prevention | Not yet recruiting | Hechi | Guangxi | 546300 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Guangxi Center for Disease Control and Prevention | OTHER_GOV |
| Hunan Provincial Center for Disease Control and Prevention | OTHER |
| Sichuan Center for Disease Control and Prevention | OTHER_GOV |
| Centers for Disease Control and Prevention, China | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
| placebo | Biological | According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the placebo |
|
| Person-years incidence of HPV6/11/16/18/31/33/45/52/58/59/68 types associated with CIN2+, CIN1+, PI12 and PI6 | 1 month after 3 doses of vaccine |
| Person-years incidence of HPV6/11/16/18/31/33/45/52/58/59/68-associated anogenital and vaginal lesions (including: genital warts, VIN1+, VaIN1+, and AIN1+). | 1 month after 3 doses of vaccine |
| Person-years incidence of CIN2+, PI12 and PI6 associated with HPV6/11/16/18 | After at least 1 dose of vaccine |
| Person-years incidence of CIN2+, PI12 and PI6 associated with HPV31/33/45/52/58/59/68 | After at least 1 dose of vaccine |
| Person-years incidence of CIN2+, CIN1+, PI12 and PI6 associated with HPV6/11/16/18/31/33/45/52/58/59/68 types. | After at least 1 dose of vaccine |
| Person-years incidence of HPV6/11/16/18/31/33/45/52/58/59/68-associated anogenital and vaginal lesions (including: genital warts, VIN1+, VaIN1+, and AIN1+). | After at least 1 dose of vaccine |
| AE incidence and severity distribution | The first dose of vaccination to within 1 month after the full vaccination |
| AE incidence and severity distribution | 0-30 days after each dose vaccination (including 30 minutes, 0-7 days, 8-30 days) |
| SAE incidence | During the study,an average of 6 year |
| Number of pregnant | The first dose of vaccination to within 6 months after the full vaccination |
| Obtain pregnancy outcomes in pregnant subjects( pregnancy event report form) | Previous pregnancy, current pregnancy mode, neonatal information | The first dose of vaccination to within 6 months after the full vaccination |
| To evaluate the positive conversion rate of neutralizing antibodies in subjects who completed 3 doses of 11-valent recombinant human papillomavirus vaccine (Hansenula) | 7 (1 month after the first dose), 12, 24, 36, 48, 60 and 72 months after the whole course of vaccination |
| To evaluate the GMT in subjects who completed 3 doses of 11-valent recombinant human papillomavirus vaccine (Hansenula) | 7 (1 month after the first dose), 12, 24, 36, 48, 60 and 72 months after the whole course of vaccination |
| Hezhou Center for Disease Control and Prevention | Not yet recruiting | Hezhou | Guangxi | 542899 | China |
|
| Lianyuan Center for Disease Control and Prevention | Recruiting | Lianyuan | Hunan | 417100 | China |
|
| Qiyang Center for Disease Control and Prevention | Recruiting | Wuxi | Hunan | 426100 | China |
|
| Yongji Center for Disease Control and Prevention | Not yet recruiting | Yongji | Shanxi | 044500 | China |
|
| Yuanqu Center for Disease Control and Prevention | Not yet recruiting | Yuncheng | Shanxi | 043700 | China |
|
| Mianyang Youxian District Center for Disease Control and Prevention | Not yet recruiting | Mianyang | Sichuan | 621000 | China |
|
| Neijiang Shizhong District Center for Disease Control and Prevention | Not yet recruiting | Neijiang | Sichuan | 641000 | China |
|
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided