- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05056402
An Immuno-bridging Study of a Nonavalent HPV Vaccine (E.Coli) in Healthy Population Aged 9-17 vs Aged 18-26 Years Old
December 26, 2023 updated by: Jun Zhang, Xiamen Ophthalmology Center Affiliated to Xiamen University
Immunogenicity Non-inferiority Immuno-bridging Study of a Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58) Vaccine (E.Coli) in Healthy Population Aged 9-17 Years Old vs Aged 18-26 Years Old
This is a open label clinical trial to evaluate the safety and immunogenicity of a Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58)Vaccine(E.Coli) manufactured by Xiamen Innovax Biotech CO., Ltd., in healthy population aged 9-17 years old in comparison with aged 18-26.
Study Overview
Status
Active, not recruiting
Conditions
Study Type
Interventional
Enrollment (Actual)
1382
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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Sichuan
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Chengdu, Sichuan, China, 610041
- Sichuan Provincial Centre for Disease 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
9 years to 26 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Subject is female between and including 9-26 years of age, or male between and including 9-17 years of age at the first vaccination;
- Subject (and their legal guardian) is able to understand and comply with the requirements of the protocol(e.g. biological specimen collection, completion of the diary cards, return for follow-up visits), and written informed consent must be obtained from the subject prior to enrollment;
- Adolescent female subject who agrees to practice effective contraception within 8 months after the first vaccination or has undergone tubal ligation,subtotal hysterectomy for benign lesion, ovarian benign tumor resection;
- No previous history of sexually transmitted diseases (including syphilis, gonorrhea, chancroid, venereal lymphogranuloma, groin granuloma, etc.);
- Male, or female without previous history of abnormal cervical screening results or cervical intraepithelial neoplasia (CIN);
Exclusion Criteria:
- Axillary temperature > 37.2℃;
- Adolescent female subject who has a positive urine pregnancy test, or is pregnant or breastfeeding;
- Subject has used of any investigational or non-registered product (drug or vaccine) within 30 days preceding the first dose of study vaccine or plans to use during the study period , or has participated in another clinical research in the past two years, or plans to participate in another research during the study period;
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs or systemic corticosteroids (Except intranasal steroid, the use of low dose topical, ophthalmic and inhaled steroid preparations will be permitted.) within 6 months prior to vaccination.
- Administration of immunoglobulin and/or blood products within 3 months prior to vaccination or planned to use them within 7 months after the first dose.
- Administration of inactivated vaccine within 14 days prior to vaccination or live vaccine within 21 days;
- Fever (Axillary temperature ≥38.0℃) 3 days prior to vaccination or system administration of antibiotics or antiviral agents within 5 days, or medicines containing antipyretic ingredients within 24 hours prior to vaccination;
- Subject has received other HPV vaccines or participated in clinical research related to HPV or cervical cancer previously;
- Subject has severe immunodeficiency disease, severe primary disease of important viscera, cancer and autoimmune disease (including systemic lupus erythematosus, rheumatoid arthritis, asplenia or splenectomy due to any condition, and other immunological diseases that investigators believe may influence the immune response).
- History of severe allergy (e.g., anaphylaxis, generalized urticaria, dyspnea, angioedema, and other significant reaction) to any previous vaccination, or be allergic to any of the components of the study vaccines.
- Asthma, which has been unstable for the past two years and requires emergency treatment, hospitalization, oral or intravenous corticosteroids;
- Subject has serious medical disorders;
- Self-report (subject and their legal guardian) coagulation disorders or abnormal coagulation function;
- Epilepsy, excluding febrile epilepsy under 2 years of age, alcoholic epilepsy 3 years prior to abstinence or simple epilepsy that does not require treatment in the past 3 years;
- Medical, psychological, social conditions, occupation or other factors, which considered by the investigator that may influence the conduct of the clinical study.
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 9-17y (0,6m)
Subjects who aged 9-17 years old would receive 2 doses of 270μg/0.5ml
Recombinant HPV nonavalent (Types 6/11/16/18/31/33/45/52/58) Vaccine(E.Coli) .
|
Two doses administered intramuscularly at 0 and 6 month.
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Experimental: 9-17y (0,1,6m)
Subjects who aged 9-17 years old would receive 3 doses of 270μg/0.5ml
Recombinant HPV nonavalent (Types 6/11/16/18/31/33/45/52/58) Vaccine(E.Coli) .
|
Three doses administered intramuscularly at 0, 1 and 6 month.
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Experimental: 18-26y (0,1,6m)
Subjects who aged 18-26 years old would receive 3 doses of 270μg/0.5ml
Recombinant HPV nonavalent (Types 6/11/16/18/31/33/45/52/58) Vaccine(E.Coli) .
|
Three doses administered intramuscularly at 0, 1 and 6 month.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immunogenicity1: Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 type specific antibody levels at Months 7 in the population aged 9-26 years old receiving 3 doses of the nanovalent vaccine
Time Frame: 7 months after the first dose
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To determine whether the immune responses (antibodies to HPV-6, 11, 16, 18, 31, 33, 45, 52, and 58) at month 7 (one month after the final dose) in the population aged 9-17 years receiving 3 doses of the nanovalent vaccine are noninferior to those in women aged 18-26 years receiving 3 doses of vaccine.
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7 months after the first dose
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immunogenicity2: Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 type specific antibody levels at Months 7 in the population aged 9-17 years old receiving 2 doses of the nanovalent vaccine
Time Frame: 7 months after the first dose
|
To determine whether the immune responses (antibodies to HPV-6, 11, 16, 18, 31, 33, 45, 52, and 58) at month 7 (one month after the final dose) in the population aged 9-17 years receiving 2 doses of the nanovalent vaccine are noninferior to those in women aged 18-26 years receiving 3 doses of vaccine.
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7 months after the first dose
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Safety1: Local and systematic adverse events/reactions occurred within 7 days after each vaccination.
Time Frame: During the 7-day period following each vaccination
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Local and systematic adverse events/reactions occurred within 7 days after each vaccination.
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During the 7-day period following each vaccination
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Safety2: Adverse events/reactions occurred within 30 days after each vaccination.
Time Frame: Within 30 days (Day 0-30) after any vaccination
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Adverse events/reactions occurred within 30 days after each vaccination.
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Within 30 days (Day 0-30) after any vaccination
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Safety3: Severe adverse events occurred throughout the study.
Time Frame: Up to 8 month
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Severe adverse events occurred throughout the study.
To evaluate number of SAEs between the different arms.
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Up to 8 month
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Safety4: Pregnancy and pregnancy outcome.
Time Frame: Up to 8 month
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Pregnancy and pregnancy outcome.
To evaluate number of births and terminations between the different arms.
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Up to 8 month
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Immunogenicity3: Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 type specific antibody levels at Months 7 in the population aged 9-17 years old receiving 2 doses of the nanovalent vaccine
Time Frame: 30 months after the first dose
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To determine the immune responses (antibodies to HPV-6, 11, 16, 18, 31, 33, 45, 52, and 58) at months 18 and 30 in the population receiving 2 doses or 3 doses of the nanovalent vaccine
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30 months after the first dose
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Xue-cheng Liu, master, Sichuan Provincial Centre for Disease Control and Prevention
- Study Chair: Jun Zhang, master, Xiamen Ophthalmology Center Affiliated to Xiamen University
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 19, 2021
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
September 13, 2021
First Submitted That Met QC Criteria
September 23, 2021
First Posted (Actual)
September 24, 2021
Study Record Updates
Last Update Posted (Estimated)
January 1, 2024
Last Update Submitted That Met QC Criteria
December 26, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Uterine Cervical Neoplasms
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
Other Study ID Numbers
- HPV-PRO-012
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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