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The objective of this study was to evaluate the safety and immunogenicity of one inactivated split influenza vaccine, a primarily Chinese-marketed trivalent vaccine.
A total of 3308 subjects were stratified equally into four age groups and receive either influenza vaccine or recombinant hepatitis b vaccine (seen as placebo). Systematic and local adverse reactions were reported for 28 d after the vaccination. Antibody levels were detected through hemagglutination inhibition assay before vaccination (Baseline) and 28d after the vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| recombinant hepatitis b vaccine | Placebo Comparator | 0.5ml intramuscular |
|
| Aleph influenza vaccine | Experimental | 0.5ml intramuscular |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| recombinant hepatitis b vaccine | Biological | 0.5ml intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of adverse events of the inactivated split influenza vaccine | two years |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody titre of the inactivated split influenza vaccine | two years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nianmin Shi, Master | Beijing Chaoyang District Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xinglong County Center for Disease Control and Prevention | Zhangjiakou | Hebei | China | |||
| Zhuolu County Center for Disease Control and Prevention |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26083828 | Derived | Bai Y, Shi N, Lu Q, Yang L, Wang Z, Li L, Han H, Zheng D, Luo F, Zhang Z, Ai X. Immunological persistence of a seasonal influenza vaccine in people more than 3 years old. Hum Vaccin Immunother. 2015;11(7):1648-53. doi: 10.1080/21645515.2015.1037998. | |
| 24301228 | Derived | Li S, Li L, Ai X, Yang L, Bai Y, Wang Z, Han H, Lu Q, Luo F, Zhang Z, Liu C, Xiao J, Shi N. A randomized, controlled, blinded study of the safety, immunogenicity and batch consistency of Aleph inactivated split influenza vaccine made in China in Chinese people. Hum Vaccin Immunother. 2014;10(3):557-65. doi: 10.4161/hv.27329. Epub 2013 Dec 3. |
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| ID | Term |
|---|---|
| D017325 | Hepatitis B Vaccines |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| Aleph influenza vaccine | Biological | 0.5ml intramuscular |
|
| Zhangjiakou |
| Hebei |
| China |
| D045424 |
| Complex Mixtures |