Evaluate the Immunogenicity and Safety of 4-valent and 9-valent HPV Recombinant Vaccine in Chinese Healthy Females

NCT ID: NCT04425291

Last Updated: 2022-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1680 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-28
• Study Completion Date: 2021-09-06

Brief Summary

The study will evaluate the immunogenicity and safety of 4-valent and 9-valent HPV recombinant vaccine in Chinese healthy females 20 to 45 years of age.

Conditions

Cervical Cancer; Vulvar Cancer; Vaginal Cancer; CIN1; CIN2; CIN3; VaIN1; VaIN2; VaIN3; Genital Wart; VIN 1; VIN 2; VIN 3; AIS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

4-valent HPV Vaccine

Participants in this arm would receive 4-valent Human Papillomavirus (Types 6, 11, 16 and18) Recombinant Vaccine (Hansenula Polymorpha)

Group Type: EXPERIMENTAL

4-valent HPV Vaccine

Intervention Type: BIOLOGICAL

Subjects received 3 doses of 4-valent HPV vaccine according to a 0, 2, 6-month schedule.

9-valent HPV Vaccine

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)

Group Type: EXPERIMENTAL

9-valent HPV Vaccine

Intervention Type: BIOLOGICAL

Subjects received 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule.

GARDASIL®

Participants in this arm would receive GARDASIL®

Group Type: ACTIVE_COMPARATOR

GARDASIL®

Intervention Type: BIOLOGICAL

Subjects received 3 doses of GARDASIL® according to a 0, 2, 6-month schedule.

Interventions

4-valent HPV Vaccine

Subjects received 3 doses of 4-valent HPV vaccine according to a 0, 2, 6-month schedule.

Intervention Type: BIOLOGICAL

9-valent HPV Vaccine

Subjects received 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule.

Intervention Type: BIOLOGICAL

GARDASIL®

Subjects received 3 doses of GARDASIL® according to a 0, 2, 6-month schedule.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Chinese women aged 20-45 who can provide legal identification;

2. The subject agreed to participate in the study, and voluntarily signs the informed consent;

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 );

Exclusion Criteria

1. 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;

2. Has a history of cervical diseases, such as cervical screening showing abnormal results including CIN or a history of hysterectomy (vaginal or total abdominal hysterectomy) or pelvic radiation therapy. Has a history of genital diseases (such as vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, genital warts, vulvar cancer, vaginal cancer and anal cancer, etc.) or has a previous sexual history (including syphilis, gonorrhea, chancre, venereal lymphatic granuloma, granuloma inguinal);

3. 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;

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. Subjects received inactivated or recombinant vaccines within 14 days prior to study enrollment, or attenuated live vaccines within 28 days prior to study enrollment;

6. Subjects present with immune impairment or have been diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease or other autoimmune diseases. Long-term immunosuppressive therapy, e.g., long-term (more than 2 weeks) treatment with glucocorticoids (e.g., prednisone or similar drugs);

7. Has been diagnosed with a severe congenital malformation or chronic disease such as Down syndrome, heart disease, liver disease, kidney disease, diabetes, etc., which may interfere with the conduct or completion of the study;

8. Subject receives any immunoglobulin or blood product within 3 months prior to the first dose of vaccination;

9. Participating in other (drug or vaccine) clinical trials prior to enrollment or planning to participate during the study;

10. Has been diagnosed with an infectious disease, such as tuberculosis, viral hepatitis and/or HIV infection;

11. A history or family history of convulsions, epilepsy, encephalopathy and mental illness;

12. Have contraindications to intramuscular injection, such as having been diagnosed with thrombocytopenia, any coagulation disorder or receiving anticoagulant therapy;

13. Absence of a spleen, functional absence of a spleen, and absence or removal of a spleen in any case;

14. Body temperature ≥37.3℃ (underarm body temperature);

15. Subjects may be unable to comply with the study procedure, comply with the agreement, or plan to permanently relocate from the region prior to completion of the study, or may be permanently absent from the region during the scheduled visit;

16. In the opinion of the investigators, the subjects had any other factors that made them unsuitable to participate in the clinical trial.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Chongqing Bovax Biopharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Shanghai Bovax Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Yangchun Center For Disease Prevention And Control

Yangchun, Guangdong, China

Countries

China

Other Identifiers

4-HPV-3001

Identifier Type: -

Identifier Source: org_study_id