Clinical Trial of PCV24 in Children Aged 2-17 Years
NCT06550830 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 119
Last updated 2026-01-28
Summary
A Phase Ia clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Sinovac Life Science Co., Ltd will be conducted in children aged 2-17 years. The objective of the study is to evaluate the safety and immunogenicity of Sinovac PCV24. The trial is a randomized, double-blind, controlled combined with open-label phase Ia clinical trial.
Conditions
- Pneumococcal Infectious Disease
Interventions
- BIOLOGICAL
-
Sinovac PCV24 formulation 1
One dose of Sinovac PCV24 formulation 1(0.5mL)
- BIOLOGICAL
-
Sinovac PCV24 formulation 2
One dose of Sinovac PCV24 formulation 2(0.5mL)
- BIOLOGICAL
-
Prevenar13®
One dose of PCV13 manufactured by Pfizer
Sponsors & Collaborators
-
Sinovac Life Sciences Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Kai Chu · Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Provincial Academy of Preventive Medicine)
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 2 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-09-07
- Primary Completion
- 2025-06-25
- Completion
- 2025-06-25
Countries
- China
Study Locations
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