PhaseⅡClinical Trial of Oral Hexavalent Reassortant Rotavirus Attenuated Live Vaccine (Vero Cells)

Exclusion Criteria20

• Previous vaccination with any rotavirus vaccine.
• History of rotavirus infection.
• Gestational age <37 weeks or ≥42 weeks at birth.
• History of dystocia, neonatal asphyxia requiring resuscitation, or neurological impairment at birth.
• Known hypersensitivity to any vaccine component (e.g., urticaria, dyspnea, angioedema).
• Current diarrhea, vomiting, or other gastrointestinal disorders; gastroenteritis or any acute/chronic illness exacerbation within 7 days prior to vaccination; ongoing antibiotic/antiviral therapy.
• History of intussusception or chronic gastrointestinal diseases, including congenital malformations predisposing to intussusception (e.g., Meckel's diverticulum).
• Congenital malformations, developmental disorders, genetic defects, severe malnutrition, malignancies, or significant chronic conditions (e.g., Down syndrome, diabetes, sickle cell anemia, neurological disorders, Guillain-Barré syndrome).
• Autoimmune or immunodeficiency diseases (including but not limited to asplenia, functional asplenia, HIV infection).
• Household members with immunodeficiency/immunosuppression or undergoing/scheduled for immunosuppressive/cytotoxic therapy.
• Coagulation disorders (e.g., clotting factor deficiencies, platelet abnormalities).
• Immunosuppressive therapy for ≥14 days post-birth (prednisone ≥2mg/kg/day or equivalent), immunomodulatory/cytotoxic therapy, or planned use during the study.
• History of severe neurological/psychiatric disorders (e.g., epilepsy, non-febrile seizures, convulsions) or relevant family history.
• Postnatal administration of immunoglobulins/blood products (except hepatitis B immunoglobulin) or planned use during the study.
• Previous participation in other investigational drug/vaccine studies or planned use during this study.
• Receipt of live-attenuated vaccines within 14 days or subunit/inactivated vaccines within 7 days prior to enrollment.
• Axillary temperature ≥38.0°C within the past 3 days.
• Fever on scheduled vaccination day (axillary temperature >37.0°C; measured ≥30 minutes post-feeding).
• Currently or planning to participate in other vaccine or drug clinical trials.
• Any other factors that the investigator deems unsuitable for participation in the clinical trial.