Plateau Antibody Levels of a Recombinant (E.Coli) HPV Nonavalent Vaccine Versus Gardasil®9 in Young Women
NCT06197802 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 392
Last updated 2025-07-31
Summary
This study is designed to compare plateau antibody levels 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.
Conditions
- Cervical Cancer
- Condylomata Acuminata
Interventions
- BIOLOGICAL
-
Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli)
Three doses administered intramuscularly at 0, 45 day and 6 month.
- BIOLOGICAL
-
Gardasil®9
Three doses administered intramuscularly at 0, 45 day and 6 month.
Sponsors & Collaborators
-
Xiamen Innovax Biotech Co., Ltd
collaborator INDUSTRY -
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
collaborator INDUSTRY -
Xiamen University
lead OTHER
Principal Investigators
-
Jun Zhang, master · Xiamen University
-
Feng-cai Zhu, master · Jiangsu Provincial Centre for Disease Control and Prevention
Eligibility
- Min Age
- 20 Years
- Max Age
- 28 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-12-30
- Primary Completion
- 2024-04-05
- Completion
- 2025-09-01
Countries
- China
Study Locations
More Related Trials
-
Efficacy and Immunogenicity Study of Recombinant Human Papillomavirus Bivalent(Type 16/18 )Vaccine
NCT01735006 ·Status: COMPLETED ·Phase: PHASE3
-
Immuno-persistence Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Preadolescent Girls
NCT03206255 ·Status: COMPLETED
-
Efficacy, Immunogenicity and Safety Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli)
NCT04537156 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Long-term Effectiveness and Immuno-persistence Study of a Recombinant HPV 16/18 Bivalent Vaccine in Preadolescent Girls
NCT06243666 ·Status: ACTIVE_NOT_RECRUITING
-
Safety Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli)
NCT03813940 ·Status: COMPLETED ·Phase: PHASE1
-
Clinical Trial of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine
NCT01263327 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Immunogenicity and Safety of Nonavalent Human Papillomavirus (HPV) Vaccine
NCT06207175 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Immuno-persistence Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Preadolescent Girls (54m)
NCT04704908 ·Status: UNKNOWN
-
Immunogenicity of GlaxoSmithKline Biological's Human Papillomavirus (HPV) Vaccine (580299) Versus Merck's Gardasil® in Healthy Females 18-45 Years of Age
NCT00423046 ·Status: COMPLETED ·Phase: PHASE3
-
A Phase II Trial Evaluate the Immunogenicity and Safety Profile of HPV Vaccine
NCT05694728 ·Status: COMPLETED ·Phase: PHASE2
-
Dose-Ranging Study of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine
NCT01356823 ·Status: COMPLETED ·Phase: PHASE2
-
The Durability of Protection and Immuno-persistence Study of a Recombinant HPV 16/18 Bivalent Vaccine in Female
NCT05045755 ·Status: UNKNOWN
-
A Phase III Trial Evaluates the Efficacy, Immunogenicity and Safety Profile of HPV Vaccine
NCT05668572 ·Status: UNKNOWN ·Phase: PHASE3
-
Immunogenicity AND Safety Study of the 11 Valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha)
NCT04436133 ·Status: COMPLETED ·Phase: PHASE2
-
Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Human Papillomavirus (HPV) Vaccine (GSK-580299) and Merck's Gardasil Vaccine When Administered According to Alternative 2-dose Schedules in 9-14 Year Old Females
NCT01462357 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluate the Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females
NCT05372016 ·Status: COMPLETED ·Phase: PHASE3
-
Phase III Study Comparing the Immunogenicity of 9-valent HPV Recombinant Vaccine and Gardasil-9
NCT05580341 ·Status: UNKNOWN ·Phase: PHASE3
-
Evaluating the 2-dose Immunization Schedule of Human Papillomavirus (HPV)-16/18 in Adolescent Females
NCT02740777 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluate the Efficacy, Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females
NCT04422366 ·Status: RECRUITING ·Phase: PHASE3
-
Safety and Immunogenicity Study of Human Papilloma Virus Vaccine in Women Aged 9 to 30 and Men Aged 9 to 17
NCT02888418 ·Status: UNKNOWN ·Phase: PHASE1
-
A Phase I Study of Quadrivalent HPV Recombinant Vaccine
NCT03085381 ·Status: COMPLETED ·Phase: PHASE1
-
Nonavalent Prophylactic HPV Vaccine (GARDASIL9) After Local Conservative Treatment for Cervical Intra-epithelial Neoplasia
NCT03979014 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Safety, Immune Response, and Efficacy of Gardasil (V501, qHPV) in Mid-Adult Women (V501-019)
NCT00090220 ·Status: COMPLETED ·Phase: PHASE3
-
The Durability of Protection Study of a Recombinant HPV 16/18 Bivalent Vaccine in Female
NCT04969445 ·Status: UNKNOWN
-
A Study on the Immune Response and Safety of an Adjuvanted Human Papillomavirus Vaccine When Given to Healthy Women 16 to 26 Years of Age
NCT05496231 ·Status: COMPLETED ·Phase: PHASE1/PHASE2