Observational Active not recruiting
NCT06197802 on ClinicalTrials.gov
Plateau Antibody Levels of a Recombinant (E.Coli) HPV Nonavalent Vaccine Versus Gardasil®9 in Young Women
Official title: An Observational Study to Compare Plateau Antibody Levels of a Recombinant (E.Coli) Human Papillomavirus Nonavalent (Type 6/11/16/18/31/33/45/52/58) Vaccine Versus Gardasil®9 in Healthy Females 18-26 Years of Age
- Sponsor: Xiamen Hospital of Traditional Chinese Medicine
- Collaborators: Xiamen Innovax Biotech Co., Ltd, Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
- Enrollment: 392 (Estimated)
- Study start: 2023-12-30 (Actual)
- Primary completion: 2024-04-05 (Actual)
- Study completion: 2025-09-01 (Estimated)
- Allocation: N/a
- InterventionModel: N/a
- Masking: None
- PrimaryPurpose: Other
Brief 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
Intervention / Treatment
- Biological: Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli)
- Biological: Gardasil®9
Primary Outcome Measures
-
Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 type specific neutralizing antibody level
(30-36 months after the first dose)
Anti-HPV 6,11,16,18,31,33,45,52 and 58 seropositive rates and geometric mean concentrations at months 30-36
Countries
China
Locations and Investigators
- Jiangsu Provincial Centre for Disease Control and Prevention, Nanjing, China
Study Officials
- Jun Zhang, master (Study Chair) — Xiamen University
- Feng-cai Zhu, master (Principal Investigator) — Jiangsu Provincial Centre for Disease Control and Prevention