Clinical Trial of 13-Valent Pneumococcal Conjugate Vaccine
China3,080 participantsStarted 2024-10-23
Plain-language summary
A Phase â…¢ 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.
Who can participate
Age range6 Weeks – 5 Years
SexALL
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Inclusion criteria
✓. Healthy infants or children who are aged 2 months (at least 6 weeks), 7-11 months, 12-23 months and 2-5 years (before the 6th birthday);
✓. Participants' guardians provide legal identity document and participants' vaccination record;
✓. Participants' guardians understand and voluntarily sign the informed consent form;
✓. Participants' guardians can follow all study procedures and stay in contact during the study.
Exclusion criteria
✕. Received any pneumococcal vaccine prior to enrollment;
✕. History of bacterial pneumonia or invasive pneumococcal diseases (IPDs) caused by Streptococcus pneumoniae, as confirmed by laboratory tests;
✕. History of allergy or adverse reactions to the vaccine or vaccine components, or history of allergy, such as urticaria, dyspnea, angioedema and abdominal pain;
✕. History of dystocia, asphyxia rescue and nervous system damage at birth for infants under 2 years of age;
✕. Congenital malformations or developmental disorders, genetic defects, severe malnutrition, history of asthma;
✕. Autoimmune diseases (such as systemic lupus erythematosus), immunodeficiency diseases or immunosuppressive diseases (such as AIDS, organ transplantation);