An Immuno-bridging Study of a Nonavalent HPV Vaccine (E.Coli) in Healthy Population Aged 9-17 vs … (NCT05056402) | Clinical Trial Compass
Active — Not RecruitingPhase 3
An Immuno-bridging Study of a Nonavalent HPV Vaccine (E.Coli) in Healthy Population Aged 9-17 vs Aged 18-26 Years Old
China1,382 participantsStarted 2021-09-19
Plain-language summary
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.
Who can participate
Age range9 Years – 26 Years
SexALL
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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.
What they're measuring
1
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 nonavalent vaccine
✕. 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;