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The aim of this study is to investigate the immunogenicity and safety of the inactivated split-virion vaccine in infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| split-virion, non-adjuvanted vaccine of 7.5 μg | Experimental | split-virion, non-adjuvanted H1N1 vaccine of 7.5 μg. |
|
| split-virion, non-adjuvanted vaccine of 15 μg | Experimental | split-virion, non-adjuvanted H1N1 vaccine of 15 μg. |
|
| split-virion, non-adjuvanted vaccine of seasonal influenza | Placebo Comparator | split-virion, non-adjuvanted H1N1 vaccine of seasonal influenza. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| split-virion, non-adjuvanted vaccine of 7.5 μg | Biological | 120 infants were assigned to receive 2 dose of 7.5μg split-virion, non-adjuvanted H1N1 vaccine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemagglutination inhibition antibody titer | Days 35 |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of solicited local and systemic adverse events after vaccination | Day0-42 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Provincial Center of Disease Prevention and Control Changsha, Hunan, China | Changsha | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25110632 | Derived | Wang S, Dong J, Chai W, Li F, Wang S, Sun B, Chen Z. Immunogenicity of a monovalent 2009 influenza A (H1N1) vaccine in infants: randomized, observer-masked, single-center clinical study. Springerplus. 2014 Jul 31;3:397. doi: 10.1186/2193-1801-3-397. eCollection 2014. |
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| split-virion, non-adjuvanted H1N1 vaccine of 15 μg | Biological | 120 infants were assigned to receive 2 dose of 15μg split-virion, non-adjuvanted H1N1 vaccine. |
|
| split-virion, non-adjuvanted vaccine of seasonal influenza | Biological | 120 infants were assigned to receive 2 dose of split-virion, non-adjuvanted seasonal influenza vaccine. |
|
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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