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