Clinical Trial of PCV24 in Children Aged 2-17 Years (NCT06550830) | Clinical Trial Compass
CompletedPhase 1
Clinical Trial of PCV24 in Children Aged 2-17 Years
China119 participantsStarted 2024-09-07
Plain-language summary
A Phase Ia clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Sinovac Life Science Co., Ltd will be conducted in children aged 2-17 years. The objective of the study is to evaluate the safety and immunogenicity of Sinovac PCV24. The trial is a randomized, double-blind, controlled combined with open-label phase Ia clinical trial.
Who can participate
Age range2 Years – 17 Years
SexALL
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Inclusion criteria
✓. Healthy volunteers who are aged 2-17 years;
✓. Participants and their guardians provide legal proof of identity, as well as vaccination record (for children aged 2-5 years);
✓. Participants' guardians understand and voluntarily sign the informed consent form; participants aged 8-17 years sign the written assent;
✓. Participants can follow all study procedures and stay in contact during the study.
Exclusion criteria
✕. Received any pneumococcal vaccine prior to enrollment;
✕. History of invasive pneumococcal diseases (IPDs) or other pneumococcal diseases 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 anaphylactic shock;
✕. Congenital malformations or developmental disorders, genetic defects (such as Down syndrome, thalassemia, or G6PD deficiency), severe malnutrition;
✕. Have uncontrolled chronic diseases or history of severe diseases, including but not limited to cardiovascular diseases, such as cardiovascular diseases (e.g. congenital heart disease), metabolic diseases (such as diabetes), hematological diseases (e.g. severe anemia),liver and kidney diseases, digestive diseases, respiratory diseases (such as active tuberculosis), 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)
✕. Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets level), history of obvious bleeding, hematoma or bruising after intramuscular injection or venipuncture.
✕. Have/have suffered from a serious neurological disorder (epilepsy or convulsions) or mental illness or have a family history of such diseases.