Immunogenicity of a Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58)Vaccine(E.Coli) Versus Gardasil®9 in Healthy Females 18-26 Years of Age

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cervical Cancer, Condylomata Acuminata

Intervention / Treatment
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* Biological: Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli)
* Biological: Gardasil®9


Participation Criteria
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Eligibility Criteria
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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. 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 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 26 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58) Vaccine(E.Coli) group<br>Subjects would receive 3 doses of 270μg/0.5ml Recombinant HPV nonavalent (Types 6/11/16/18/31/33/45/52/58) Vaccine(E.Coli) . | Biological: Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli)<br>* Three doses administered intramuscularly at 0, 45 day and 6 month.<br>|
| Active Comparator: Gardasil®9 group<br>Subjects would receive 3 doses of 270μg/0.5ml Gardasil®9 . | Biological: Gardasil®9<br>* Three doses administered intramuscularly at 0, 45 day and 6 month.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 type specific neutralizing antibody level | Anti-HPV 6,11,16,18,31,33,45,52 and 58 seroconversion rates and geometric mean concentrations at months 7 | 7 months after the first dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety1:Local and systematic adverse events/reactions occurred within 7 days after each vaccination. | Local and systematic adverse events/reactions occurred within 7 days after each vaccination. | During the 7-day period following each vaccination | 
| safety2:Adverse events/reactions occurred within 30 days after each vaccination. | 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. | 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. | Pregnancy and pregnancy outcome. To evaluate number of births and terminations compared with the control vaccine. | Up to 8 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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human papillomavirus vaccine, immunogenicity