- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05580341
Phase III Study Comparing the Immunogenicity of 9-valent HPV Recombinant Vaccine and Gardasil-9
October 26, 2022 updated by: Shanghai Zerun Biotechnology Co.,Ltd
A Phase III, Randomized, Blinded, Positive-controlled Study to Compare the Immunogenicity of Zerun 9-valent Human Papillomarivus (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) Recombinant Vaccine (Pichia Pastoris) in Healthy Female Subjects Aged 16-26 Years.
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1200
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Guangxi
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Nanning, Guangxi, China
- GuangXi Center for Diseases Control and Prevention
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 24 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Zerun HPV-9
Subjects receive 3 doses of Zerun HPV-9 vaccine
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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
|
Active Comparator: GARDASIL®9
Subjects receive 3 doses of GARDASIL®9
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GARDASIL®9 vaccine, 0.5mL, three doses, 0,2,6 months
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Geometric Mean Titers (GMT) of HPV neutralizing antibodies
Time Frame: 30 days postdose 3 (Month 7)
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HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 neutralizing antibodies GMT
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30 days postdose 3 (Month 7)
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Seroconversion Percentages to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Time Frame: 30 days postdose 3 (Month 7)
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Seroconversion is defined as a participant in PPS who was anti-HPV seronegative at Day 0 (before vaccination) and became seropositive 30days after the third dose (Month 7).
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30 days postdose 3 (Month 7)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of subjects reporting solicited local symptoms
Time Frame: 0-7 days after each dose
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Solicited local symptoms assessed including pain, redness, swelling, induration and pruritus.
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0-7 days after each dose
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Percentage of subjects reporting solicited general symptoms
Time Frame: 0-7 days after each dose
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Solicited general symptoms assessed including fever, headache, fatigue, nausea, diarrhea, vomiting, myalgia, allergic reaction
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0-7 days after each dose
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Percentage of subjects reporting unsolicited adverse events (AEs)
Time Frame: 0-30 days after each dose
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An unsolicited adverse event is defined as any adverse event (AE) reported in addition to those solicited during the clinical study.
|
0-30 days after each dose
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Percentage of subjects reporting serious adverse events (SAEs)
Time Frame: Month 0 to Month 12
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Serious adverse events are defined as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
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Month 0 to Month 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2022
Primary Completion (Anticipated)
June 1, 2023
Study Completion (Anticipated)
December 1, 2023
Study Registration Dates
First Submitted
October 11, 2022
First Submitted That Met QC Criteria
October 11, 2022
First Posted (Actual)
October 14, 2022
Study Record Updates
Last Update Posted (Actual)
October 28, 2022
Last Update Submitted That Met QC Criteria
October 26, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Virus Diseases
- Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- DNA Virus Infections
- Skin Diseases, Infectious
- Warts
- Skin Diseases, Viral
- Tumor Virus Infections
- Uterine Cervical Neoplasms
- Papillomavirus Infections
- Condylomata Acuminata
Other Study ID Numbers
- 312-HPV-2002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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