Phase III Study Comparing the Immunogenicity of 9-valent HPV Recombinant Vaccine and Gardasil-9

NCT ID: NCT05580341

Last Updated: 2022-10-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2023-12-31

Brief Summary

This study will evaluate the immunogenicity and safety of Zerun 9-valent HPV recombinant vaccine in healthy female 16-26 years of age by comparing with GARDASIL®9.

Conditions

Cervical Cancer; Genital Wart; CIN; VIN; Papillomavirus Infections

Study Design

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

Study Groups

Zerun HPV-9

Subjects receive 3 doses of Zerun HPV-9 vaccine

Group Type: EXPERIMENTAL

Zerun HPV-9

Intervention Type: BIOLOGICAL

Zerun 9-valent Human Papillomarivus (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) Recombinant Vaccine (Pichia Pastoris), 0.5mL, three doses, 0,2,6 months

GARDASIL®9

Subjects receive 3 doses of GARDASIL®9

Group Type: ACTIVE_COMPARATOR

GARDASIL ®9

Intervention Type: BIOLOGICAL

GARDASIL®9 vaccine, 0.5mL, three doses, 0,2,6 months

Interventions

Zerun HPV-9

Zerun 9-valent Human Papillomarivus (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) Recombinant Vaccine (Pichia Pastoris), 0.5mL, three doses, 0,2,6 months

Intervention Type: BIOLOGICAL

GARDASIL ®9

GARDASIL®9 vaccine, 0.5mL, three doses, 0,2,6 months

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Healthy female 16-26 years of age
• 16-17 years old subjects and their guardians able to provide legal identification; 18-26 years old subjects able to provide their legal identification;
• Able to understand (not illiterate) and sign the informed consent;
• Able to make a decision to participate in the clinical trial and the subject agrees to participate in the clinical trial;
• Women of child-bearing age (WOCBA): subjects must have a negative urine pregnancy test result, have used effective contraceptive measures within 2 weeks before enrollment, have no pregnancy plans, and agree to use adequate contraceptive precautions from enrollment to the 7th month (one month after full immunization).

Exclusion Criteria

• Abnormal cervical cancer screen test results (ASC-US or worse), history of HPV infection, history of abnormal cervical biopsy results, or history of genital warts;
• Subjects with severe congenital malformations or that cause serious organ damage, developmental disorders, genetic defects, or severe malnutrition;
• Subjects have received a marketed HPV vaccine or participated in an HPV vaccine clinical trial, or participated in clinical trials of other vaccines within the past 6 months;
• Fever prior to vaccination (axillary body temperature ≥37.3℃);
• History of severe allergic reaction that required medical intervention (such as swelling of the mouth and throat, dyspnea, hypotension or shock, etc.);
• History of allergic to vaccine, or to any ingredient of vaccine (Aluminum phosphate adjuvant, sodium chloride, histidine, polysorbate 80),or history of severe adverse reaction
• History of epilepsy, psychosis, major depression requiring medication, seizures, convulsions, or family history of mental illness
• Subjects are immunocompromised or have been diagnosed as suffering from congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis inflammation (JRA), inflammatory bowel disease or other autoimmune diseases, administration of immunosuppressants with six months prior to the first vaccine dose
• History of asthma, thyroidectomy, angioedema, severe liver, kidney, or cardiovascular disease, diabetes mellitus that can not be controlled by stable doses of insulin, or malignancy;
• Asplenia, functional asplenia, or any circumstances result of asplenia or splenectomy;
• Medical diagnosis of coagulation abnormalities (eg, clotting factor deficiency, coagulation disorders, platelet anomaly) or obvious bruising or coagulation disorder
• Acute diseases or acute stage of chronic diseases or use of antipyretic, analgesic drugs (eg: acetaminophen, ibuprofen, aspirin, etc.) and anti-allergic drugs (such as: loratadine, cetirizine, etc.) within 3 days preceding the vaccination;
• Untreated/uncontrolled hypertension before vaccination (16-17 years of age > 120 mmHg and / or diastolic blood pressure > 80 mmHg; 18-26 years of age with physical examination systolic blood pressure ≥140 mmHg and / or diastolic blood pressure ≥90 mmHg);
• Subjects who received whole blood, plasma, or immunoglobulin therapy within 3 months prior to vaccination;
• Received live attenuated vaccine within 28 days prior to vaccination;
• Received subunits or inactivated vaccines within 14 days prior to vaccination;
• Breastfeeding or pregnant, or within 6 weeks after the end of pregnancy;
• According to the judgment of the investigator, subjects who have any other factors that are not suitable for participating in this clinical trial.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Walvax Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Shanghai Zerun Biotechnology Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

GuangXi Center for Diseases Control and Prevention

Nanning, Guangxi, China

Countries

China

Other Identifiers

312-HPV-2002

Identifier Type: -

Identifier Source: org_study_id