Clinical Trial of the S. Flexneri-S. Sonnei Bivalent Conjugate Vaccine

Exclusion Criteria

• •History of confirmed bacterial dysentery in the past 6 months.
• •Serious allergy to tetanus toxoid, history of severe allergies, fever above 39.5°C following previous vaccination with a prophylactic biological product.
• •Currently suffering from serious intestinal diseases, symptoms of diarrhea, abdominal pain, or bloody purulent stools in the past 15 days.
• •Diagnosed pathological jaundice currently.
• •Confirmed diagnosis of thrombocytopenia or other coagulation disorders.
• •Known or suspected immunological deficiencies (e.g., perianal abscesses indicating potential immune deficiency in infants and young children), long-term treatment (≥14 days) with immunosuppressants within half a year before vaccination (radiotherapy, chemotherapy, systemic corticosteroids ≥2 mg/kg/day, antimetabolites, cytotoxic drugs), or parents confirmed to have HIV infection.
• •Receipt of immunoglobulins/blood products (except hepatitis B immunoglobulin) within 3 months before vaccination.
• •Severe congenital anomalies (important organ function impairment), severe malnutrition, developmental disorders, severe hereditary diseases.
• •Currently suffering from the following diseases:
• •1. Severe liver or kidney diseases, cardiovascular diseases, malignant tumors, and other severe chronic diseases.
• •2. Diagnosed serious infectious diseases, such as tuberculosis, viral hepatitis, etc.
• •3. Severe asthma.
• •4. Generalized rashes, dermatophytosis, skin suppuration, or blistering.
• •5. Convulsions, epilepsy, encephalopathy, psychiatric disorders or family history of psychiatric disorders.
• •Planning to participate or currently participating in other vaccine or drug clinical trials.
• •Any condition that the investigators believe may affect the evaluation of the study.