AIS, Cervical Cancer, CIN1, CIN2, CIN3, Genital Wart, Vaginal Cancer, VaIN1, VaIN2, VaIN3, VIN 1, VIN 2, VIN 3, Vulvar Cancer
Conditions
Brief summary
This study is designed to evaluate the vaccine efficacy, immunogenicity and safety of the 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 20-45 Years .
Interventions
BIOLOGICAL9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha)
Subjects received 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule.
BIOLOGICALGARDASIL®
Subjects received 3 doses of Placebo according to a 0, 2, 6-month schedule
Sponsors
Shanghai Bovax Biotechnology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
(If the \* option is not met during screening, the visit can be rescheduled) * Chinese women aged 20-45 who can provide legal identification and have a sexual life history; * The subject fully understands the study procedures, understands the risks and benefits associated with participating in the study, and voluntarily signs the informed consent; * Subjects are able to read, understand and fill in application forms such as diary CARDS and contact CARDS, and participate in follow-up according to the study requirements; * Subjects have not been screened for cervical cancer, or have been screened for cervical cancer but the results are normal; * \*0 days before the gynecological visit, no sex within 48 hours, no flushing or vaginal cleaning within 72 hours, no use of vaginal drugs or preparations;Subject agrees to refrain from sexual intercourse (including anal, vaginal, or genital/genital contact of the same or opposite sex) for 48 hours prior to any visit that includes gynecological sample collection, and to refrain from vaginal flushing, vaginal cleansing, or use of vaginal medications or preparations for 72 hours; * When the subjects were enrolled, the urine pregnancy test was negative (sensitivity was 25mIU/ml cox-hcg), they were not in the lactation period and had no family planning within 7 months after enrollment (1 month before whole-course inoculation).2 weeks before included in the study, effective contraceptive measures has been adopted and agreed to in the first seven months after the study (vaccinations after 1 months ago) continue to adopt effective contraceptive measures (effective contraceptive measures include: the pill, injection or embedded contraception, slow-release local birth control pills, hormone patch, the intrauterine device (IUD), sterilization, abstinence, condom (men), diaphragm, cervical cap, etc.), rhythm, withdrawal and emergency contraception is unacceptable contraception; * \*body temperature \<37.3℃ (underarm body temperature)
Exclusion criteria
First dose
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The person-year incidence of HPV 31-, 33-, 45-, 52-, and 58-related high-grade cervical abnormalities (CIN 2/3) at least 1 month post Dose 3 | 1 month post vaccination 3 (Month 7) up to Month 84 |
Secondary
| Measure | Time frame |
|---|---|
| The person-year incidence of HPV 31-, 33-, 45-, 52-, and 58-related VIN 1/2/3, VaIN1/2/3, AIN1/2/3, vulvar cancer, vaginal cancer and anal cancer at least 1 month post Dose 3 | 1 month post vaccination 3 (Month 7) up to Month 84 |
| The person-year incidence of HPV 31-, 33-, 45-, 52-, and 58-related VIN 2/3, VaIN2/3, AIN2/3, vulvar cancer, vaginal cancer and anal cancer at least 1 month post Dose 3 | 1 month post vaccination 3 (Month 7) up to Month 84 |
| The person-year incidence of other HPV types related CIN 2/3 at least 1 month post Dose 3 | 1 month post vaccination 3 (Month 7) up to Month 84 |
| The person-year incidence of other HPV types related VIN 2/3, VaIN2/3, AIN2/3, vulvar cancer, vaginal cancer and anal cancer at least 1 month post Dose 1 | 1 month post vaccination 1 up to Month 84 |
| The person-year incidence of other HPV types related VIN 1/2/3, VaIN1/2/3, AIN1/2/3, vulvar cancer, vaginal cancer and anal cancer at least 1 month post Dose 3 | 1 month post vaccination 3 (Month 7) up to Month 84 |
| The person-year incidence of HPV 31-, 33-, 45-, 52-, and 58-related high-grade cervical abnormalities (CIN 2/3) at least 1 month post Dose 1 | 1 month post vaccination 1 up to Month 84 |
| The person-year incidence of HPV 31-, 33-, 45-, 52-, and 58-related 6-month and 12-month Persistent Infection at least 1 month post Dose 1 | 1 month post vaccination 1 up to Month 84 |
| The person-year incidence of HPV 31-, 33-, 45-, 52-, and 58-related VIN 2/3, VaIN2/3, AIN2/3, vulvar cancer, vaginal cancer and anal cancer at least 1 month post Dose 1 | 1 month post vaccination 1 up to Month 84 |
| The person-year incidence of HPV 31-, 33-, 45-, 52-, and 58-related VIN 1/2/3, VaIN1/2/3, AIN1/2/3, vulvar cancer, vaginal cancer and anal cancer at least 1 month post Dose 1 | 1 month post vaccination 1 up to Month 84 |
| The person-year incidence of HPV 31-, 33-, 45-, 52-, and 58-related 6-month and 12-month Persistent Infection at least 1 month post Dose 3 | 1 month post vaccination 3 (Month 7) up to Month 84 |
| The person-year incidence of other HPV types related CIN 2/3 at least 1 month post Dose 1 | 1 month post vaccination 1 up to Month 84 |
| The person-year incidence of other HPV types related VIN 1/2/3, VaIN1/2/3, AIN1/2/3, vulvar cancer, vaginal cancer and anal cancer at least 1 month post Dose 1 | 1 month post vaccination 1 up to Month 84 |
| Percentage of Participants Who Report at Least 1 Solicited Injection-site and Systemic Adverse Event 30 minutes post any vaccination | 30 minutes post any vaccination |
| Percentage of Participants Who Report at Least 1 Solicited Adverse Event 7 days post any vaccination | 7 days post any vaccination |
| Percentage of Participants Who Report at Least 1 Solicited and Unsolicited Adverse Event 30 days post any vaccination | 30 days post any vaccination |
| Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE) from 1st vaccination to the completion of study | 1 month post vaccination 3 (Month 7) up to Month 84 |
| Percentage of Participants Who Experience Pregnancy from 1st vaccination to the completion of study | 1 month post vaccination 3 (Month 7) up to Month 84 |
| neutralizing antibody level | 30 days post third dose of vaccination |
| The person-year incidence of other HPV types related VIN 2/3, VaIN2/3, AIN2/3, vulvar cancer, vaginal cancer and anal cancer at least 1 month post Dose 3 | 1 month post vaccination 3 (Month 7) up to Month 84 |
Countries
China
Contacts
Primary ContactYi Mo, Master
Outcome results
None listed