A Phase 1b Clinical Trial of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (NCT06183216) | Clinical Trial Compass
CompletedPhase 1
A Phase 1b Clinical Trial of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine
China140 participantsStarted 2024-01-04
Plain-language summary
A phase 1b clinical trial of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV13) developed by Sinovac Life Science Co., Ltd will be conducted in children aged 2 months (42-89 days) and 2 to 5 years. The objective of the study is to evaluate the safety and immunogenicity of Sinovac PCV13. The trial is a randomized, double blinded, positive controlled study.
Who can participate
Age range6 Weeks ā 5 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Healthy infants aged 2 months (42-89 days); Healthy children aged 2-5 years.
ā. Proven vaccination certificate, birth certificate and legal identification documents
ā. The participants' guardians can understand and voluntarily sign the informed consent form.
ā. Participants and their guardians can obey requirements of the protocol.
Exclusion criteria
ā. Received any pneumococcal vaccine prior to enrollment.
ā. History of culture confirmed bacterial pneumonia or invasive pneumococcal disease (IPD) caused by Streptococcus pneumoniae.
ā. History of allergy to the vaccine or vaccine components, including pneumococcal polysaccharide for each serotype, diphtheria CRM197, aluminum phosphate, succinic acid, polysorbate 80 and sodium chloride; or serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioedema and asthma.
ā. History of dystocia, asphyxia rescue, nervous system damage at birth (only applicable to infants aged 2 months (42-89 days))
ā. Congenital malformations or developmental disorders, genetic defects, severe malnutrition, asthma etc.
ā. Autoimmune disease (such as systemic lupus erythematosus) or immunodeficiency/ immunosuppression (such as HIV, organ transplantation)
ā. Severe cardiovascular diseases, such as diabetes, liver diseases, kidney diseases, malignant tumors.