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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose Group | Experimental | S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,10μg/dose |
|
| Low dose Group | Experimental | S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,5μg/dose |
|
| Adjuvant-free Group | Other | Adjuvant-free S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,10μg/dose |
|
| Control Group | Other | Haemophilus b Conjugate Vaccine,10μg/dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine | Biological | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Du lin, Master | Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quanzhou Center for Disease Control and Prevention | Quanzhou | Guangxi | 530000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35062694 | Result | Mo Y, Fang W, Li H, Chen J, Hu X, Wang B, Feng Z, Shi H, He Y, Huang D, Mo Z, Ye Q, Du L. Safety and Immunogenicity of a Shigella Bivalent Conjugate Vaccine (ZF0901) in 3-Month- to 5-Year-Old Children in China. Vaccines (Basel). 2021 Dec 28;10(1):33. doi: 10.3390/vaccines10010033. |
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| S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine | Biological | 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. |
|
| S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine | Biological | 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. |
|
| Haemophilus b Conjugate Vaccine | Biological | Group 1:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 10 µg Haemophilus b Conjugate Vaccine. |
|
| ID | Term |
|---|---|
| D004403 | Dysentery |
| D004405 | Dysentery, Bacillary |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D004756 | Enterobacteriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C061963 | HibTITER protein, Haemophilus influenzae |
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