A Randomized, Single-blind Study to Compare Immunogenicity of a Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58) Vaccine(E.Coli) (Xiamen Innovax Biotech Co.,Ltd.) Versus Gardasil®9 (Merck & Co., Inc.) in Healthy Females 18-26 Years of Age

Xiamen University1 site in 1 country488 target enrollmentMarch 14, 2021

ConditionsCervical Cancer Condylomata Acuminata

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Cervical Cancer
Sponsor: Xiamen University
Enrollment: 488
Locations: 1
Primary Endpoint: Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 type specific neutralizing antibody level
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is designed to compare the immunogenicity of a novel recombinant human papillomavirus vaccine (types 6,11,16,18,31,33,45,52,58 )(E.Coli) manufactured by Xiamen Innovax Biotech CO., Ltd., with Gardasil®9 in females 18-26 Years of Age.

Registry

clinicaltrials.gov

Start Date

March 14, 2021

End Date

July 25, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Xiamen University

Responsible Party

Principal Investigator

Jun Zhang

professor

Xiamen University

Eligibility Criteria

Inclusion Criteria

•Subject is female, between and including 18-26 years of age at the first vaccination;
•Subject 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;
•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.);
•No previous history of abnormal cervical screening results or cervical intraepithelial neoplasia (CIN);

Exclusion Criteria

•Axillary temperature \> 37.0℃;
•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 prior to vaccination;
•Subject has received other HPV vaccines or participated in clinical research related to HPV or cervical cancer previously;
•Subject has immunodeficiency disease, 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.

Outcomes

Primary Outcomes

Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 type specific neutralizing antibody level

Time Frame: 7 months after the first dose

Anti-HPV 6,11,16,18,31,33,45,52 and 58 seroconversion rates and geometric mean concentrations at months 7

Secondary Outcomes

safety2:Adverse events/reactions occurred within 30 days after each vaccination.(Within 30 days (Day 0-30) after any vaccination)
safety3:Severe adverse events occurred throughout the study. To evaluate number of SAEs compared with the control vaccine.(Up to 8 month)
safety4:Pregnancy and pregnancy outcome. To evaluate number of births and terminations compared with the control vaccine.(Up to 8 month)
safety1:Local and systematic adverse events/reactions occurred within 7 days after each vaccination.(During the 7-day period following each vaccination)