Actively Recruiting
Clinical Trial of 13-Valent Pneumococcal Conjugate Vaccine
Led by Sinovac Life Sciences Co., Ltd. · Updated on 2026-01-28
3080
Participants Needed
1
Research Sites
92 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Phase Ⅲ clinical trial of 13-valent pneumococcal conjugate vaccine (PCV13) developed by Sinovac Life Science Co., Ltd will be conducted in pediatric population aged 2 months (minimum 6 weeks)-5 years (before 6th birthday). The objective of the study is to evaluate the immunogenicity and safety of Sinovac PCV13.
CONDITIONS
Official Title
Clinical Trial of 13-Valent Pneumococcal Conjugate Vaccine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy infants or children aged 2 months (at least 6 weeks), 7-11 months, 12-23 months, or 2-5 years (before 6th birthday)
- Guardians provide legal identity documents and vaccination records
- Guardians understand and voluntarily sign informed consent
- Guardians can follow all study procedures and maintain contact during the study
You will not qualify if you...
- Previously received any pneumococcal vaccine
- History of bacterial pneumonia or invasive pneumococcal diseases caused by Streptococcus pneumoniae
- History of allergy or adverse reactions to vaccines or vaccine components including urticaria, dyspnea, angioedema, abdominal pain
- History of birth complications such as dystocia, asphyxia rescue, or nervous system damage for infants under 2 years
- Congenital malformations, developmental disorders, genetic defects, severe malnutrition, or history of asthma
- Autoimmune diseases, immunodeficiency, or immunosuppressive diseases including AIDS or organ transplantation
- Severe cardiovascular, liver, kidney diseases, diabetes, or malignant tumors
- Serious neurological disorders, mental illness, or family history of these conditions
- History of thyroidectomy, asplenia, or functional asplenia
- Abnormal blood coagulation, history of bleeding or bruising after injections
- Use of corticosteroids or immunosuppressive therapy as specified prior to enrollment
- Receipt of blood products within specified timeframes except hepatitis B immunoglobulin
- Use of investigational drugs within 60 days prior or planned during study
- Receipt of live attenuated vaccines within 14 days prior
- Receipt of subunit, inactivated, or other vaccines within 7 days prior
- Acute diseases or acute onset of chronic diseases within 7 days prior
- Fever (axillary temperature ≥ 37.3°C) before vaccination
- Any other conditions deemed by investigators to make participation unsuitable
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Henan Provincial Center for Disease Control and Prevention
Zhengzhou, Henan, China
Actively Recruiting
Research Team
Y
Yanxia Wang
CONTACT
X
Xiaoqiang Liu
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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