Trial Title:
Phase III Study Comparing the Immunogenicity of 9-valent HPV Recombinant Vaccine and Gardasil-9
NCT ID:
NCT05580341
Condition:
Cervical Cancer
Genital Wart
CIN
VIN
Papillomavirus Infections
Conditions: Official terms:
Papillomavirus Infections
Condylomata Acuminata
Uterine Cervical Neoplasms
Conditions: Keywords:
Human Papillomavirus
Papillomavirus Vaccines
Genital Warts
Cervical Cancer
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Biological
Intervention name:
Zerun HPV-9
Description:
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
Arm group label:
Zerun HPV-9
Intervention type:
Biological
Intervention name:
GARDASIL ®9
Description:
GARDASIL®9 vaccine, 0.5mL, three doses, 0,2,6 months
Arm group label:
GARDASIL®9
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.
Criteria for 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.
Gender:
Female
Minimum age:
16 Years
Maximum age:
26 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
GuangXi Center for Diseases Control and Prevention
Address:
City:
Nanning
Country:
China
Start date:
September 1, 2022
Completion date:
December 2023
Lead sponsor:
Agency:
Shanghai Zerun Biotechnology Co.,Ltd
Agency class:
Industry
Collaborator:
Agency:
Walvax Biotechnology Co., Ltd.
Agency class:
Industry
Source:
Shanghai Zerun Biotechnology Co.,Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05580341
