Status:
RECRUITING
A Phase III Clinical Trial of a 11-valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 9-45 Years
Lead Sponsor:
National Vaccine and Serum Institute, China
Collaborating Sponsors:
Chengdu Institute of Biological Products Co.,Ltd.
Simoon Record Pharma Information Consulting Co., Ltd.
Conditions:
HPV InfectioN
HPV-Related Carcinoma
Eligibility:
FEMALE
18-45 years
Phase:
PHASE3
Brief Summary
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 randoml...
Eligibility Criteria
Inclusion
- \- 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
- 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.
- Meet the first dose exclusion criteria 5, 6, 7, 8, 9, 12;
- Any other reasons that, in the judgment of the investigator, warrant discontinuation of the investigational vaccination.
Key Trial Info
Start Date :
June 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
13500 Patients enrolled
Trial Details
Trial ID
NCT05262010
Start Date
June 4 2022
End Date
June 1 2028
Last Update
April 9 2024
Active Locations (8)
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1
Hechi Yizhou District Center for Disease Control and Prevention
Hechi, Guangxi, China, 546300
2
Hezhou Center for Disease Control and Prevention
Hezhou, Guangxi, China, 542899
3
Lianyuan Center for Disease Control and Prevention
Lianyuan, Hunan, China, 417100
4
Qiyang Center for Disease Control and Prevention
Wuxi, Hunan, China, 426100