Immunogenicity and Safety of S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine in Volunteers Aged From 3 Months to 5 Years Old

Launched by BEIJING ZHIFEI LVZHU BIOPHARMACEUTICAL CO., LTD · Apr 28, 2021

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Gender

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Eligibility criteria

• Inclusion Criteria:
• • Health infants and children aged from 3 months to 5 years old.
• • Subject or legal representative who consent and has signed written informed consent.
• • Subject and parent/guardian who is able to comply with all study procedures.
• • Subject who did't receive blood products within 30 days ,immune with any live vaccine within 14 days and inactivated vaccine within 7 days before vaccination.
• • Subject who haven't immuned with diarrhea vaccination,3-11 months health infants who haven't immuned with Haemophilus b Conjugate vaccination,or had a history of Hib vaccination before the age of 1 but no history of vaccination after 1 year of age,and the interval between the day of the enrollment and the previous dose is more than one month.
• • Axillary temperature ≤37.0 ℃.
• Exclusion Criteria:
• • Febrile illness (temperature ≥ 38°C) in the 3 days or in the acute phase of the disease / active period.
• • Subject who have symptoms such as diarrhea, abdominal pain, and pus and bloody stools in the past 3 days.
• • Subject who are allergic to tetanus toxoid.
• • Allergic history after vaccination.
• • Immunodeficiency diseases patients (such as perianal abscess suggests that there may be immunodeficiency in infants and young children) who administered with immunosuppressive agents (≥14 days).
• • Subject who are suffering from serious chronic diseases, cardiovascular disease,liver or kidney disease.
• • Subject with congenital malformations, drug allergies, convulsions, epilepsy, history of craniocerebral trauma, encephalopathy and psychosis, or family history.
• • Subject who diagnosis of thrombocytopenia or other history of coagulopathy may cause intramuscular contraindication.
• • Children with abnormal labor（pregnancy week\<37w,\>42w）,birth weight (\<2500g,\>4000g), asphyxia rescue history(Only applicable to 3-5 months old group).
• • Subject who plan to participate in or is in any other drug clinical trial.
• • Any condition that, in the judgment of investigator, may affect trial assessment.