Clinical Trial of PCV24 in Adults Aged ≥18 Years (NCT07543198) | Clinical Trial Compass
CompletedPhase 1/2
Clinical Trial of PCV24 in Adults Aged ≥18 Years
China385 participantsStarted 2025-06-18
Plain-language summary
A Phase Ib/II clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24)developed by Sinovac Life Science Co., Ltd will be conducted in adults aged ≥18 years.
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/II clinical trial.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Healthy adults aged ≥18 years, who can provide legal identification documents
✓. Fully understand and agree to sign the informed consent form
✓. Willing and able to follow all study procedures and stay in contact during the study
Exclusion criteria
✕. Received any pneumococcal vaccine;
✕. History of invasive pneumococcal diseases or other pneumococcal diseases caused by Streptococcus pneumoniae, as confirmed by laboratory tests;
✕. History of allergy or serious adverse reactions to the vaccine or vaccine components, or history of allergy, such as urticaria, dyspnea, angioedema and anaphylactic shock;
✕. Congenital malformations or developmental disorders, genetic defects, severe malnutrition;
✕. Have uncontrolled chronic diseases or history of severe diseases, including but not limited to cardiovascular diseases, metabolic diseases, hematological diseases,liver and kidney diseases, digestive diseases, respiratory diseases , malignant tumors and major functional organ transplantation history;
✕. Autoimmune diseases or immunodeficiency diseases (including but not limited to systemic lupus erythematosus, rheumatoid arthritis,autoimmune thyroid disease, asplenia, functional asplenia, HIV infection);
✕. Abnormalities in coagulation function (such as deficiency of coagulation factors, coagulation disorders, and abnormalities of platelets);
. Have/have suffered from a serious neurological disorder (epilepsy , convulsions or seizures) or mental illness or have a family history of such diseases;