Safety Study of S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine in Healthy Volunteers Aged Above 3 Months

A Single-center, Open, Phase I Clinical Trial to Evaluate Safety of S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine in Healthy Volunteers Aged Above 3 Months

The purpose of this study is to evaluate safety of S.flexneriza-S.sonnei Bivalent Conjugate Vaccine in healthy volunteers aged above 3 Months.

Inclusion Criteria:

• 3 months old and above healthy people.
• 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.
• Axillary temperature ≤37.0 ℃.

Exclusion Criteria:

• Febrile illness (temperature ≥ 38°C) in the 3 days.
• Subject who are allergic to tetanus toxoid.
• Allergic history after vaccination.
• Immunodeficiency diseases patients who administered with immunosuppressive agents.
• In pregnancy or lactation or pregnant women.
• Subject who are suffering from serious chronic diseases, infectious diseases, active infection, cardiovascular disease,liver or kidney disease.
• Subject who have symptoms such as diarrhea, abdominal pain, and pus and bloody stools in the past 3 days.
• History of allergy，eclampsia, epilepsy,brain trauma,encephalopathy and mental disease or family disease.
• 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,congenital malformations or developmental disorders(Only applicable to 3-5 months old group)
• Blood routine, blood chemistry and urinalysis laboratory collection abnormalities and the severity of grade 2 and above before immunization.
• 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.