Efficacy, Immunogenicity and Safety of S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine in Volunteers Aged From 6 Months to 5 Years

Exclusion Criteria

• •Previous proven history of bacillary dysentery;
• •Subjects who are allergic to tetanus toxoid, and have any history of other vaccination or drug allergy, or a fever above 39.5 ℃ after previous vaccination;
• •Within 3 days before vaccination, suffering from acute diseases or in the acute episode of chronic disease or using antipyretic, analgesic and antiallergic drugs (such as acetaminophen, ibuprofen, etc.);
• •Had severe bowel disease, and had symptoms such as diarrhea, abdominal pain, pus and blood stool and other symptoms in the past 3 days;
• •With pathological jaundice confirmed by existing diagnosis;
• •History of thrombocytopenia or other coagulation disorders with definite diagnosis;
• •Known or suspected immunological deficiency (such as perianal abscess, which indicates that infants may have immune deficiency), and received long-term (≥14 days) immunosuppressive therapy (radiotherapy, chemotherapy, systemic glucocorticosteroids≥2 mg/kg/day, antimetabolic drugs and cytotoxic drugs) within half a year before vaccination, or confirmed that the parents were HIV infected;
• •Received immunoglobulin / blood products treatment within 3 months before vaccination;
• •Severe congenital malformations (functional impairment of important organs), severe malnutrition, developmental disorders and serious genetic diseases (such as severe thalassemia);
• •Subjects with the following diseases:
• •1. Serious liver and kidney diseases, cardiovascular diseases, malignant tumors and other chronic diseases;
• •2. Diagnosis with infectious diseases such as tuberculosis, viral hepatitis and so on;
• •3. Severe asthma;
• •4. Systemic rash, dermatophyte, skin suppuration or blister;
• •5. History or family history of convulsion, epilepsy, encephalopathy, mental illness;
• •Planning to participate or currently participating in clinical trials of other vaccines or drugs;
• •Any situation that the investigator believed may affect the study evaluation.