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

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

Official Title
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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

Conditions
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Dysentery, Dysentery, Bacillary

Intervention / Treatment
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* Biological: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine
* Biological: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High dose Group<br>Received Vaccine: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,10μg/dose | Biological: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine<br>* Group 1:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 10 µg S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine.<br>|
| Experimental: low dose Group<br>Received Vaccine: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,5μg/dose | Biological: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine<br>* Group 2:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 5 µg S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse events during a 30 day follow-up period after each vaccination |  | 30 day after each vaccination |