Prevent cervical cancer, cervical intraepithelial neoplasia (CIN1/2/3), adenocarcinoma in situ (AIS) and persistent infection caused by vaccine-related human papillomavirus types.
Conditions
Interventions
Control group:recombinant human papillomavirus 9-valent vaccine
Trial group:recombinant human papillomavirus 9-valent vaccine
Sponsors
Xiamen Center for Disease Control and Prevention
Eligibility
Sex/Gender
Female
Age
12 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Female volunteers should be aged between 12 and 45 when receiving the first dose of the trial vaccine. 2. Volunteers (and their legal guardians) should be able to understand the research procedures and be capable of complying with the requirements of the protocol (such as collecting biological samples, filling diary cards, and attending follow-up visits on time), and sign the informed consent form (volunteers under 18 years old should sign it by themselves and their legal guardians, while volunteers over 18 years old can sign it by themselves). 3. Adult female volunteers are not in the process of pregnancy, are not pregnant or breastfeeding, and have no pregnancy plans within 8 months after the first vaccination and are using effective contraceptive measures, or are underage female volunteers. 4. Have previously completed two or three doses of the bivalent or quadrivalent HPV vaccine series (the full course of two doses is defined as completing two doses of HPV vaccine and being under 15 years old at the time of the second dose;
Exclusion criteria
Exclusion criteria: 1. Previous history of HPV vaccination (only for the control group population); 2.Axillary temperature > 37.0?; 3.Had a fever within 3 days before vaccination (axillary temperature >=38.0?) or had any serious acute disease requiring systemic antibiotic or antiviral treatment in the past 5 days, or had taken drugs containing antipyretic components within the past 24 hours; 4.Had severe immunodeficiency diseases, serious primary diseases in important organs, cancer (or precancerous lesions), immune diseases (including systemic lupus erythematosus, rheumatoid arthritis, any condition leading to aplasia or splenectomy resulting in immunodeficiency, and other immune diseases that the investigator considers may affect the immune response); 5.Had a history of severe allergies, including previous vaccination-related severe adverse reactions, such as anaphylactic shock, acute urticaria, breathing difficulties, angioneurotic edema, or allergies to any component of the vaccine used in this study (aluminum adjuvant, polysorbate, sodium dihydrogen phosphate, sodium hydrogen phosphate); 6. After the investigator inquired about the volunteer's medical history and related physical examinations, it was determined that various medical, psychological, social, occupational factors or other conditions may affect the conduct of the clinical study. 7.Exclusion criteria for the second and third vaccinations: 1) Severe adverse reactions that are causally related to the previous vaccination, such as high fever (>=39.5?) within 48 hours after vaccination and severe allergic reactions, for which the investigator deems it inappropriate to continue the vaccination Those who meet the exclusion criteria for the first vaccination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence rate of adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| serum antibody levels; | — |
Countries
China
Contacts
Public ContactMaShanshan
Xiamen Center for Disease Control and Prevention
Outcome results
None listed