AIS, Cervical Cancer, CIN1, CIN2, CIN3, Genital Wart, HPV Infections, Vaginal Cancer, VaIN1, VaIN2, VaIN3, VIN 1, VIN 2, VIN 3, Vulvar Cancer
Conditions
Brief summary
The study will evaluate the immunogenicity and safety of 9-valent HPV recombinant vaccine in Chinese healthy females16 to 26 years of age.
Interventions
BIOLOGICALExperimental: Experimental: 9-valent Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58)
9vHPV vaccine ,0.5mL, three doses, 0,2,6 months
BIOLOGICALActive Comparator: GARDASIL ®9
GARDASIL®9 vaccine, 0.5mL, three doses, 0,2,6 months
Sponsors
Chongqing Bovax Biopharmaceutical Co., Ltd.
Shanghai Bovax Biotechnology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
Double (Participant, Investigator)
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 26 Years
Healthy volunteers
Yes
Inclusion criteria
(If the \* option is not met during screening, the visit can be rescheduled) 1. Chinese women aged 16-26 who can provide legal identification(If the subject is under 18 years old, proof of legal guardian's identity is also required); 2. The subject agreed to participate in the study, and voluntarily signs the informed consent;for subjects aged 16-18 years, they and their legal guardian(s) are supposed to understand and sign informed consent form together； supposed to understand and sign informed consent form together 3. Subjects are able to understand the study procedures and participate in follow-up according to the study requirements; 4. When the subjects were enrolled, the urine pregnancy test was negative, they were not in the lactation period and had no family planning within 7 months after enrollment.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 including the pill or condoms, etc ); 5.4. Have an acute illness or an acute episode of a chronic illness within 3 days prior to vaccination or the use of antipyretic, analgesic and antiallergic drugs (e.g., acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.); 5. \*body temperature \<37.3# (underarm body temperature)
Exclusion criteria
First dose
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The seroconversion rate of neutralizing antibodies | 30 days after the last dose | The seroconversion rate of neutralizing antibodies dected after immunization in pre-immune negative subjects from 30 days after the last dose HPV vaccine to HPV 6, 11, 16, 18, 31, 33, 45, 52 , and 58. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number and rate of pregnancy events | Day 0 to 6 months post vaccination 3 | Pregnant event and pregnant outcome reported during the study period |
| Number of subjects with postive antibodies after the whole schedule vaccination from the former negative subjects | 30 days after the last dose | To evaluate the vaccine immunogenicity is the geometric mean titer from 30 days after the last dose to HPV 6, 11, 16, 18, 31, 33, 45, 52 , and 58. |
| The level of neutralizing antibody elicited by the vaccine among the subjects with pre-immune positive after the whole schedule vaccination | 30 days after the last dose | The growth rate of GMTs of anti-HPV 6, 11, 16, 18, 31, 33, 45, 52 and 58 neutralizing antibodies in pre-immune positive subjects from 30 days after immunization |
| Number of all SAE during the study period | Day 0 to 6 months post vaccination 3 | Serious adverse events reported during the study periodfrom 1st vaccination to the completion of study |
| Number of AE within 30 minutes after each dose | 30 mins after each dose | Adverse events reported within 30 minutes after each dose |
| Number of SAE within 7days after each dose | day 0 to day 7 after each dose | Solicited adverse events reported between day 0 to day 7 after each dose |
| Number of unsolicited adverse events within 30days after each dose | day 0 to day 30 after each dose | Unsolicited adverse events reported between day 0 to day 30 after each dose |
| Number of subjects with seroconversion rate (4-fold increase) after the whole schedule vaccination | 30 days after the last dose | The seroconversion rate (4-fold increase) of anti-HPV 6, 11, 16, 18, 31, 33, 45, 52 and 58 neutralizing antibodies in subjects aged 16-26-year-old from 30 days after immunization |
Countries
China
Outcome results
None listed