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Evaluate the Efficacy, Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females | Clinical Trials | Clareo Health

RECRUITINGPHASE3

Evaluate the Efficacy, Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females

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

NCT04422366•Shanghai Bovax Biotechnology Co., Ltd.

View on ClinicalTrials.gov

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

Age

20 - 45 years

Sex

FEMALE

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

•Have been vaccinated with commercially available HPV vaccine in the past or planned to be vaccinated with commercially available HPV vaccine during the study period;Or have participated in a clinical trial of the HPV vaccine and have received a vaccine/placebo vaccination;
•Previous positive history of HPV;
•Has a history of abnormal cervical cytology, including squamous intraepithelial lesions (SIL) or not clear meaning of the atypical squamous cells (ASC - US), except the atypical squamous cells - not highly squamous intraepithelial lesion (ASC - H), atypical glandular epithelial cells, or those with cervical intraepithelial neoplasia (CIN) and carcinoma in situ or abnormal cervical biopsy results such as the history;
•Past history of anal and genital diseases (such as vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, genital warts, vulvar cancer, vaginal cancer and anal cancer, etc.);
•Received total hysterectomy or pelvic radiotherapy;
•Cervical insufficiency or abnormal cervical structure (judged by the results of routine gynecological examination);
•Previous sexual history (including syphilis, gonorrhea, chancre, venereal lymphatic granuloma, granuloma inguinal) or have obvious condyloma;
•A history of seizures, convulsions or convulsions, or a family history of mental illness;
•Have participated in other gynecology-related clinical trials within 6 months, and have used or plan to use other investigational or unregistered products (drugs or vaccines) other than the vaccine in this study within 3 months;
•A history of severe allergies requiring medical intervention, such as anaphylactic shock, anaphylactic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), etc.A history of severe adverse reactions to previous vaccinations or a history of severe allergies to any of the components of the vaccine under study (histidine, polysorbate, aluminum phosphate, sodium borate, amorphous aluminum phosphate sulfate adjuvant and water for injection) (such as swelling of the mouth and throat, dyspnea, hypotension or shock, severe urticaria, etc.);
+27 more criteria

Locations (1)

Liuzhou center for disease control and prevention

Liuchow, Guangxi, China

Key Dates

Start Date

April 28, 2020

Primary Completion Date

September 15, 2027

Completion Date

September 15, 2029

Last Updated

June 7, 2024

Enrollment

8,000

ESTIMATED participants

Conditions

Cervical CancerVulvar CancerVaginal CancerCIN1CIN2CIN3VaIN1VaIN2VaIN3Genital WartVIN 1VIN 2VIN 3AIS

Interventions

9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha)

BIOLOGICAL

GARDASIL®

BIOLOGICAL

Contacts

Yi Mo, Master

CONTACT

+8613788686968 moyi0415@qq.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 7, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluate the Efficacy, Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females

Inclusion Criteria

Exclusion Criteria

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