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

Beijing Zhifei Lvzhu Biopharmaceutical

Status and phase

Completed

Phase 1

Conditions

Dysentery

Dysentery, Bacillary

Treatments

Biological: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine

Study type

Interventional

Funder types

Industry

Identifiers

201619306

Details and patient eligibility

About

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

Enrollment

180 patients

Sex

All

Ages

3+ months old

Volunteers

Accepts Healthy Volunteers

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.