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

Study Overview
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Brief Summary
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The purpose of this study is to evaluate immunogenicity and safety of S.flexneriza-S.sonnei Bivalent Conjugate Vaccine in healthy volunteers aged from 3 months to 5 years old.

Official Title
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A Randomized, Blinded, Single-center, Parallel Controlled , Phase Ⅱ Clinical Trial to Evaluate Immunogenicity and Safety of S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine in Healthy Volunteers Aged From 3 Months to 5 Years Old

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
* Biological: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine
* Biological: Haemophilus b Conjugate Vaccine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 5 Years

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High dose Group<br>S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,10μg/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>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 adjuvant-free S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine.<br>Biological: Haemophilus b Conjugate Vaccine<br>* Group 1:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 10 µg Haemophilus b Conjugate Vaccine.<br>|
| Experimental: Low dose Group<br>S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,5μg/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>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 adjuvant-free S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine.<br>Biological: Haemophilus b Conjugate Vaccine<br>* Group 1:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 10 µg Haemophilus b Conjugate Vaccine.<br>|
| Other: Adjuvant-free Group<br>Adjuvant-free 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>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>Biological: Haemophilus b Conjugate Vaccine<br>* Group 1:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 10 µg Haemophilus b Conjugate Vaccine.<br>|
| Other: Control Group<br>Haemophilus b 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>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>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 adjuvant-free 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 |
| --- | --- | --- |
| incidence of adverse events during 30 days | Occurrence of adverse events during a 30 day follow-up period after each vaccination | 30 day after each vaccination | 
| Antibody positive rate | Percentage of participants with seroresponse to each vaccination | 30 day after each vaccination |