Actively Recruiting
Clinical Trial of PCV24 in Infants and Children Aged 2 Months to 5 Years
Led by Sinovac Life Sciences Co., Ltd. · Updated on 2025-12-24
420
Participants Needed
3
Research Sites
105 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Phase 2 clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Sinovac Life Science Co., Ltd will be conducted in the pediatric population aged 2 months (minimum 42 days) to 5 years. The objective of the study is to evaluate the safety and immunogenicity of Sinovac PCV24. The trial is a randomized, double-blind, positive controlled phase 2 clinical trial.
CONDITIONS
Official Title
Clinical Trial of PCV24 in Infants and Children Aged 2 Months to 5 Years
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy infants and children aged 2 months (42-89 days), 7-11 months, 12-23 months, and 2-5 years
- Participant's guardian provides legal identity documents and vaccination records
- Guardian understands and voluntarily signs informed consent
- Ability to follow all study procedures and maintain contact during the study
You will not qualify if you...
- Previous pneumococcal vaccination before enrollment
- History of invasive pneumococcal disease or other pneumococcal infections confirmed by lab tests
- History of severe allergic reactions to vaccines or vaccine components, including urticaria, breathing difficulties, angioneurotic edema, or anaphylactic shock
- Low birth weight (<2.5kg) or premature birth (gestation <37 weeks) for infants under 12 months
- History of abnormal labor (except planned cesarean), asphyxia rescue, or nervous system damage for infants under 12 months
- Severe congenital malformations, developmental disorders, genetic defects, or malnutrition
- Uncontrolled chronic diseases or severe diseases such as heart, blood, liver, kidney, digestive, respiratory diseases, active tuberculosis, cancer, or major organ transplant
- Autoimmune or immunodeficiency diseases including lupus, rheumatoid arthritis, autoimmune thyroid disease, asplenia, functional asplenia, or HIV infection
- Abnormal blood clotting function or platelet disorders
- Serious neurological disorders or mental illness, or family history of such diseases
- Immunosuppressive therapy lasting over 14 days within 6 months before vaccination, or planned during the study (excluding some corticosteroid sprays or topical treatments)
- Receipt of immunoglobulins or blood products within 3 months before vaccination, except certain immunoglobulins used within 1 month, or planned use during the study
- Use of other investigational drugs or vaccines within 30 days before enrollment or planned use during the study
- Receipt of live attenuated vaccine within 14 days before enrollment
- Receipt of subunit or inactivated vaccine within 7 days before enrollment
- Acute diseases or acute flare-up of chronic diseases within 7 days before enrollment, or known/potential infection
- Axillary temperature of 37.3°C or higher before vaccination
- Any other factors determined by the investigator to make participation unsuitable
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Qichun District Center for Disease Prevention and Control
Huanggang, Hubei, China
Actively Recruiting
2
Xiangzhou District Center for Disease Prevention and Control
Xiangyang, Hubei, China
Actively Recruiting
3
Xian'an District Center for Disease Prevention and Control
Xianning, Hubei, China
Actively Recruiting
Research Team
Y
Ye-qing Tong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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