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The purpose of this study is to evaluate the efficacy, immunogenicity and safety of S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine in infants and children aged from 6 months to 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine, 0.5ml/dose, 2 doses with an interval of 30 days. |
|
| Placebo group | Placebo Comparator | Aluminium phosphate adjuvant, 0.5ml/dose, 2 doses with an interval of 30 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine | Biological | Single intramuscular dose contains 10 µg of S. flexneri 2a polysaccharide and S. sonnei polysaccharide respectively. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy study of S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine as assessed by protective rate | Evaluate the protective rate for bacillary dysentery | 30 day after each vaccination |
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Inclusion Criteria:
Exclusion Criteria:
Previous proven history of bacillary dysentery;
Subjects who are allergic to tetanus toxoid, and have any history of other vaccination or drug allergy, or a fever above 39.5 ℃ after previous vaccination;
Within 3 days before vaccination, suffering from acute diseases or in the acute episode of chronic disease or using antipyretic, analgesic and antiallergic drugs (such as acetaminophen, ibuprofen, etc.);
Had severe bowel disease, and had symptoms such as diarrhea, abdominal pain, pus and blood stool and other symptoms in the past 3 days;
With pathological jaundice confirmed by existing diagnosis;
History of thrombocytopenia or other coagulation disorders with definite diagnosis;
Known or suspected immunological deficiency (such as perianal abscess, which indicates that infants may have immune deficiency), and received long-term (≥14 days) immunosuppressive therapy (radiotherapy, chemotherapy, systemic glucocorticosteroids≥2 mg/kg/day, antimetabolic drugs and cytotoxic drugs) within half a year before vaccination, or confirmed that the parents were HIV infected;
Received immunoglobulin / blood products treatment within 3 months before vaccination;
Severe congenital malformations (functional impairment of important organs), severe malnutrition, developmental disorders and serious genetic diseases (such as severe thalassemia);
Subjects with the following diseases:
Planning to participate or currently participating in clinical trials of other vaccines or drugs;
Any situation that the investigator believed may affect the study evaluation.
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| Name | Affiliation | Role |
|---|---|---|
| Lin Du | Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hezhou Center for Disease Control and Prevention | Recruiting | Hezhou | Guangxi | 542899 | China |
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| Placebo | Biological | Single intramuscular dose contains 0.15~0.25 mg of aluminum ion |
|
| Luzhai Center for Disease Control and Prevention | Not yet recruiting | Luzhai | Guangxi | 545699 | China |
|
| Sanjiang Center for Disease Control and Prevention | Not yet recruiting | Sanjiang | Guangxi | 545500 | China |
|
| Zhongshan Center for Disease Control and Prevention | Recruiting | Zhongshan | Guangxi | 542600 | China |
|
| Yongnian Center for Disease Control and Prevention | Not yet recruiting | Handan | Hebei | 056011 | China |
|
| Yuanshi Center for Disease Control and Prevention | Not yet recruiting | Huaiyang | Hebei | 051130 | China |
|
| Panzhihua Center for Disease Control and Prevention | Not yet recruiting | Panzhihua | Sichuan | 617000 | China |
|
| Zigong Center for Disease Control and Prevention | Not yet recruiting | Zigong | Sichuan | 643000 | China |
|
| Fushun Center for Disease Control and Prevention | Not yet recruiting | Zigong | Sichuan | 643299 | China |
|
| 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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