Safety Study of S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine in Healthy Volunteers Aged Above 3 Months
NCT ID: NCT03561181
Last Updated: 2018-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
180 participants
INTERVENTIONAL
2017-07-18
2018-02-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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High dose Group
Received Vaccine: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,10μg/dose
S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine
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.
low dose Group
Received Vaccine: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,5μg/dose
S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine
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.
Interventions
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S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine
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.
S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
3 Months
ALL
Yes
Sponsors
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Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Du lin, Master
Role: STUDY_CHAIR
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Locations
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Yizhou Center for Disease Control and Prevention
Yizhou, Guangxi, China
Countries
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Other Identifiers
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201619306
Identifier Type: -
Identifier Source: org_study_id
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