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

Shanghai Zerun Biotechnology

Status and phase

Active, not recruiting

Phase 3

Conditions

VIN

CIN

Papillomavirus Infections

Genital Wart

Cervical Cancer

Treatments

Biological: Zerun HPV-9

Biological: GARDASIL ®9

Study type

Interventional

Funder types

Industry

Identifiers

NCT05580341

312-HPV-2002

Details and patient eligibility

About

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.

Enrollment

1,200 patients

Sex

Female

Ages

16 to 26 years old

Volunteers

Accepts Healthy Volunteers

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.