A Phase III Clinical Trial of a 11-valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 9-45 Years

ConditionsHPV InfectioN HPV-Related Carcinoma

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexFemale

Age18-45

SponsorNational Vaccine and Serum Institute, China

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

*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;

Disqualifiers

* 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.);

Trial design

Design model

Parallel

Treatments tested in this trial

11-valent recombinant human papilloma virus vaccine (Hansenula polymorpha)
Biological/Vaccine
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
Biological/Vaccine
According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the placebo

Treatment groups

13,500 Participants

are divided into 2 treatment groups

Group A: experiment groupExperimental treatment 1 intervention

Group B: placeboPlacebo comparator 1 intervention