Phase
Condition
N/ATreatment
Sinovac PCV13
Prevnar®
Clinical Study ID
Ages 6-5 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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 duringthe study.
Exclusion
Exclusion Criteria:
Received any pneumococcal vaccine prior to enrollment;
History of bacterial pneumonia or invasive pneumococcal diseases (IPDs) caused byStreptococcus pneumoniae, as confirmed by laboratory tests;
History of allergy or adverse reactions to the vaccine or vaccine components, orhistory of allergy, such as urticaria, dyspnea, angioedema and abdominal pain;
History of dystocia, asphyxia rescue and nervous system damage at birth for infantsunder 2 years of age;
Congenital malformations or developmental disorders, genetic defects, severemalnutrition, history of asthma;
Autoimmune diseases (such as systemic lupus erythematosus), immunodeficiencydiseases or immunosuppressive diseases (such as AIDS, organ transplantation);
Severe cardiovascular diseases, diabetes, liver diseases, kidney diseases, malignanttumours.
Have/have suffered from a serious neurological disorder (epilepsy or convulsions) ormental illness or have a family history of such diseases.
History of thyroidectomy, asplenia, functional asplenia; asplenia or splenectomycaused by any reasons;
Diagnosed abnormal blood coagulation function (eg, lack of blood coagulationfactors, blood coagulopathy, abnormal platelets level), history of obvious bleeding,hematoma or bruising after intramuscular injection or venipuncture.
Consecutively received ≥14 days of corticosteroid, any other immunosuppressivetherapy (excluding corticosteroid spray therapy for allergic rhinitis and surfacecorticosteroid therapy for acute non-concurrent dermatitis), or cytotoxic therapyprior to enrollment for infants aged 6 weeks to 2 months or within 6 months prior toenrollment for children aged 7 months to 5 years.
Received blood products prior to enrollment for children aged 2 months or within 3months prior to enrollment for children aged 7 months to 5 years. Receipt ofHepatitis B immunoglobulin one month prior to enrollment is an exception.
Received other investigational drugs within 60 days prior to enrollment, or plan toreceive such drugs during the study;
Received live attenuated vaccine within 14 days prior to enrollment;
Received subunit or inactivated or other vaccine within 7 days prior to enrollment;
Acute diseases or acute onset of chronic diseases within 7 days prior to enrollment;
Had fever (axillary temperature≥ 37.3 Degree Celsius) before vaccination;
In the investigator's judgment, the participant has any other factors that make himor her unfit to participate in the clinical trial.
Study Design
Study Description
Connect with a study center
Henan Provincial Center for Disease Control and Prevention
Zhengzhou, Henan
ChinaSite Not Available
Henan Provincial Center for Disease Control and Prevention
Zhengzhou 1784658, Henan 1808520
ChinaActive - Recruiting

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