Phase III Study Comparing the Immunogenicity of 9-valent HPV Recombinant Vaccine and Gardasil-9
NCT05580341 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1200
Last updated 2022-10-28
Summary
This study will evaluate the immunogenicity and safety of Zerun 9-valent HPV recombinant vaccine in healthy female 16-26 years of age by comparing with GARDASIL®9.
Conditions
- Cervical Cancer
- Genital Wart
- CIN
- VIN
- Papillomavirus Infections
Interventions
- BIOLOGICAL
-
Zerun HPV-9
Zerun 9-valent Human Papillomarivus (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) Recombinant Vaccine (Pichia Pastoris), 0.5mL, three doses, 0,2,6 months
- BIOLOGICAL
-
GARDASIL ®9
GARDASIL®9 vaccine, 0.5mL, three doses, 0,2,6 months
Sponsors & Collaborators
-
Walvax Biotechnology Co., Ltd.
collaborator INDUSTRY -
Shanghai Zerun Biotechnology Co.,Ltd
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 16 Years
- Max Age
- 26 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-09-01
- Primary Completion
- 2023-06-30
- Completion
- 2023-12-31
Countries
- China
Study Locations
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