Efficacy, Immunogenicity and Safety Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli)

NCT ID: NCT04537156

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 9327 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-05
• Study Completion Date: 2027-12-31

Brief Summary

This phase III clinical study was designed to evaluate the efficacy,immunogenicity and safety of Recombinant Human Papillomavirus Vaccine (6,11,16,18,31,33,45,52,58 Type)(E.Coli) manufactured by Xiamen Innovax Biotech CO., LTD., in healthy women aged 18-45 years old.

Conditions

Cervical Intraepithelial Neoplasia; Cervical Cancer; Condylomata Acuminata

Study Design

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

Study Groups

HPV vaccine (6,11,16,18,31,33,45,52,58 Types)

Participants in this arm would receive 270μg/0.5ml HPV vaccines (6,11,16,18,31,33,45,52,58 Types).

Group Type: EXPERIMENTAL

Nonavalent HPV vaccine

Intervention Type: BIOLOGICAL

Nonavalent HPV vaccine (270μg/0.5ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule.

HPV vaccine (16,18 Types)

Participants in this arm would receive 60μg/0.5ml HPV vaccines (16,18 Types).

Group Type: ACTIVE_COMPARATOR

Bivalent HPV vaccine

Intervention Type: BIOLOGICAL

Bivalent HPV vaccine (60μg/0.5ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule.

Interventions

Nonavalent HPV vaccine

Nonavalent HPV vaccine (270μg/0.5ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule.

Intervention Type: BIOLOGICAL

Bivalent HPV vaccine

Bivalent HPV vaccine (60μg/0.5ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Female aged between 18 and 45 years at the first vaccination;

2. Be able to understand and comply with the request of the protocol(e.g. biological specimen collection, diary card entry and attend regular follow-up), and sign written informed consent;

3. Women who agree to use effective contraception within 8 months after the first vaccination, or women who have undergone tubal ligation, benign subtotal hysterectomy, benign ovarian tumor removal, or postmenopausal women;

4. The number of sexual partners so far less than four;

5. Have intact cervix and have no history of physical or surgical treatment;

6. No previous history of sexually transmitted diseases (including syphilis, gonorrhea, chancroid, venereal lymphogranuloma, groin granuloma, etc.);

7. No previous history of abnormal cervical screening results or cervical intraepithelial neoplasia (CIN), and no abnormality in gynecological examination;

8. Sexual intercourse has occurred.

Exclusion Criteria

1. Participants with acute cervicitis and acute lower genital tract infection, or with obvious condyloma;

2. Participants during menstruation, or have vaginal medication, sexual behavior (including anal, vaginal or external genital contact, regardless of the sex of parterner) within two days (48 hours) before the visit, which may affect gynecological examinations and specimens collection.

3. Axillary temperature > 37.0℃;

4. Participants who have positive urine pregnancy test, or are pregnant or breastfeeding;

5. Have used other investigational or unregistered products (drugs or vaccines) within 30 days before receiving the research vaccine or have participated in another clinical research in the past two years, or plan to use other research or unregistered products or participate in other research during the research period;

6. Long-term use (more than 14 continuous days) of immunosuppressors and other Immunoregulatory agents or systemic corticosteroids (Except intranasal steroid, the use of low dose topical, ophthalmic and inhaled steroid preparations will be permitted.) 6 months prior to vaccination.

7. Administration of immunoglobulin and/or blood products 3 months prior to vaccination or intending to use them during the study.

8. Administration of inactivated vaccine within 14 days before vaccination or live vaccine within 21 days;

9. Fever (Axillary temperature >38.0℃) 3 days prior to vaccination or system administration of antibiotics or antiviral agents (Anti-flu agents include but are not limited to Tamiflu, Tamiflu, Symmetrel and Flumadine) 5 days prior to vaccination.

10. Have received other HPV vaccines or participated in clinical research related to HPV or cervical cancer previously;

11. Immunodeficiency disease, primary disease of important viscera, cancer and autoimmune disease (including systemic lupus erythematosus, rheumatoid arthritis, asplenia or splenectomy due to any condition, and other autoimmune diseases that investigators believe may influence the immune response).

12. History of severe allergy (e.g., anaphylaxis, generalized urticaria, dyspnea, angioedema, and other significant reaction) to any previous vaccines, or allergy to any of the components of investigational vaccine.

13. Asthma, which has been unstable for the past two years and requires emergency treatment, hospitalization, oral or intravenous corticosteroids;

14. Suffered from a serious medical illness;

15. Self-report past coagulation disorders or abnormal coagulation function;

16. Epilepsy, excluding febrile epilepsy under 2 years of age, alcoholic epilepsy 3 years prior to abstinence or simple epilepsy that did not require treatment in the past 3 years;

17. According to the judgement of investigator, various medical, psychological, social, vocational or other factors that are not suitable for participating in the clinical trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Xiamen Innovax Biotech Co., Ltd

INDUSTRY

Sponsor Role: collaborator

Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Xiamen University

OTHER

Sponsor Role: lead

Responsible Party

Jun Zhang

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jun Zhang, master

Role: STUDY_CHAIR

Xiamen University

Hong-xing Pan, master

Role: PRINCIPAL_INVESTIGATOR

Jiangsu Provincial Centre for Disease Control and Prevention

Locations

Jiangsu Provincial Centre for Disease Control and Prevention

Nanjing, Jiangsu, China

Sichuan Provincial Centre for Disease Control and Prevention

Chengdu, Sichuan, China

Countries

China

Other Identifiers

HPV-PRO-009

Identifier Type: -

Identifier Source: org_study_id