A Multicenter,Randomized,Blind and Positive-Controlled Phase Ⅲ Study to Evaluate the 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

Who is this study for? Chinese female patients aged 20-45 years
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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 .

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 20
Maximum Age: 45
Healthy Volunteers: t
View:

⁃ (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)

Locations
Other Locations
China
Liuzhou center for disease control and prevention
RECRUITING
Liuzhou
Contact Information
Primary
Yi Mo, Master
moyi0415@qq.com
+8613788686968
Time Frame
Start Date: 2020-04-28
Estimated Completion Date: 2029-09-15
Participants
Target number of participants: 8000
Treatments
Experimental: 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52
Participants in this arm would receive 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha)
Active_comparator: GARDASIL®
Participants in this arm would receive GARDASIL®
Sponsors
Leads: Shanghai Bovax Biotechnology Co., Ltd.

This content was sourced from clinicaltrials.gov