Safety Study of S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine in Healthy Volunteers Aged Above 3 Months
NCT03561181 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 180
Last updated 2018-10-17
Summary
The purpose of this study is to evaluate safety of S.flexneriza-S.sonnei Bivalent Conjugate Vaccine in healthy volunteers aged above 3 Months.
Conditions
- Dysentery
- Dysentery, Bacillary
Interventions
- BIOLOGICAL
-
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.
- BIOLOGICAL
-
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.
Sponsors & Collaborators
-
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
lead INDUSTRY
Principal Investigators
-
Du lin, Master · Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 3 Months
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-07-18
- Primary Completion
- 2018-01-28
- Completion
- 2018-02-08
Countries
- China
Study Locations
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