Clinical Trial of 13-Valent Pneumococcal Conjugate Vaccine
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. 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); 2. Participants' guardians provide legal identity document and participants' vaccination record; 3. Participants' guardians understand and voluntarily sign the informed consent form; 4. Participants' guardians can follow all study procedures and stay in contact during the study. Exclusion Criteria: 1. Received any pneumococcal vaccine prior to enrollment; 2. History of bacterial pneumonia or invasive pneumococcal diseases (IPDs) caused by Streptococcus pneumoniae, as confirmed by laboratory tests; 3. History of allergy or adverse reactions to the vaccine or vaccine components, or history of allergy, such as urticaria, dyspnea, angioedema and abdominal pain; 4. History of dystocia, asphyxia rescue and nervous system damage at birth for infants under 2 years of age; 5. Congenital malformations or developmental disorders, genetic d