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.
*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;
* 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.);
National Vaccine and Serum Institute, China
Lead sponsor
Chengdu Institute of Biological Products Co.,Ltd.
Collaborator
Simoon Record Pharma Information Consulting Co., Ltd.
Collaborator
Beijing Kantorico Statistical Technology Co., Ltd.
Collaborator
Guangxi Center for Disease Control and Prevention
Collaborator
Hunan Provincial Center for Disease Control and Prevention
Collaborator
Sichuan Center for Disease Control and Prevention
Collaborator
Centers for Disease Control and Prevention, China
Collaborator