Evaluate the Safety and Immunogenicity of a 9-valent HPV Vaccine in Chinese Healthy Male Aged 9-45 Year-old
NCT05518201 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2024-04-17
Summary
To evaluate the safety and tolerability of the 9vHPV vaccine in Chinese healthy male aged 9 to 45 years.
Conditions
- Penile Cancer
- Anal Cancer
- PIN-1
- PIN-2
- PIN-3
- AIN1
- AIN2
- AIN3
- Genital Wart
Interventions
- BIOLOGICAL
-
Placebo among 18-45 yrs
Subjects received 3 doses of placebo according to a 0, 2, 6-month schedule (0.5mL/each dose).
- BIOLOGICAL
-
Placebo among 9-17 yrs
Subjects received 3 doses of placebo according to a 0, 2, 6-month schedule (0.5mL/each dose).
Sponsors & Collaborators
-
Shanghai Bovax Biotechnology Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Ting Huang · Sichuan Provincial Center for Disease Control and Prevention
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 9 Years
- Max Age
- 45 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-09-23
- Primary Completion
- 2023-11-20
- Completion
- 2023-11-20
Countries
- China
Study Locations
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