Actively Recruiting
Clinical Trial of PCV24 in Infants Aged 2-23 Months
Led by Sinovac Life Sciences Co., Ltd. · Updated on 2026-01-28
180
Participants Needed
2
Research Sites
55 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Phase 1b clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Sinovac Life Science Co., Ltd will be conducted in pediatric population aged 2 months (minimum 42 days)-23 months. 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 Ib clinical trial.
CONDITIONS
Official Title
Clinical Trial of PCV24 in Infants Aged 2-23 Months
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy infants aged 2 months (42-89 days), 7-11 months, or 12-23 months
- Participant's guardian provides legal identity documents and vaccination records
- Guardian understands and voluntarily signs informed consent
- Will follow all study procedures and maintain contact during the study
You will not qualify if you...
- Received any pneumococcal vaccine before enrollment
- History of invasive or other pneumococcal diseases confirmed by lab tests
- History of severe allergic reactions to vaccines or components, including urticaria, breathing difficulty, angioneurotic edema, or anaphylactic shock
- Low birth weight (<2.5 kg) or premature birth (<37 weeks gestation) for infants under 12 months
- History of abnormal labor (except planned cesarean), asphyxia rescue, or nervous system damage for infants under 12 months
- Congenital malformations, developmental disorders, genetic defects, or severe malnutrition
- Uncontrolled chronic diseases or severe illnesses including heart, blood, liver, kidney, digestive, respiratory diseases, tumors, or organ transplant history
- Autoimmune or immunodeficiency diseases including lupus, rheumatoid arthritis, autoimmune thyroid disease, asplenia, HIV infection
- Abnormal blood clotting or bleeding history, including bruising after injections or blood draws
- Serious neurological disorders (epilepsy or convulsions, except febrile convulsions), mental illness, or family history of these
- Immunosuppressive or immunoregulatory therapy over 14 days within 6 months before vaccination or planned during study, excluding certain corticosteroid sprays
- Received blood products within 3 months before enrollment or planned during study (except Hepatitis B immunoglobulin one month prior)
- Received investigational drugs or vaccines within 30 days before enrollment or planned during study
- Received live attenuated vaccine within 14 days before enrollment
- Received subunit or inactivated vaccine within 7 days before enrollment
- Acute illness or active infection within 7 days before enrollment
- Axillary temperature of 37.3°C or higher before vaccination
- Any other factor making participation unsuitable as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Shandong Provincial Center for Disease Control and Prevention
Jinan, Shandong, China, 250014
Not Yet Recruiting
2
Shanxian Center for Disease Control and Prevention
Shancheng, Shandong, China, 250014
Actively Recruiting
Research Team
Q
Qing Xu
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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