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The purpose of this study is to evaluate the immunogenicity and safety of Northern hemisphere 2013-2014 seasonal trivalent inactivated influenza vaccine in 60 healthy infants aged 6-35 months old, 60 healthy adults aged 18-60 years old, and 60 healthy seniors aged > 60 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| trivalent seasonal influenza vaccine | Experimental | Northern hemisphere 2013-2014 trivalent seasonal influenza vaccine
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| trivalent seasonal influenza vaccine | Biological |
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| Measure | Description | Time Frame |
|---|---|---|
| The immunogenicity of 2013-2014 seasonal trivalent vaccine (TIV) in adults and seniors | To evaluate the immune responses to each antigen of the 2013-2014 seasonal TIV in adults and seniors by detection of hemagglutination inhibition (HI) antibody titer | 21 days after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| The incidences of adverse events (AEs) in infants, adults and seniors | After each injection, a 30-minute safety observation was conducted immediately, and the body temperature, occurrence of solicited local and general AEs within 72 hours were collected. Unsolicited AEs of adults and seniors were collected until day 21, and those of infants were collected until day 35. Each AE case was reviewed by the investigator to determine whether or not it was an adverse reaction (related to the vaccination). |
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For adults and seniors:
Inclusion Criteria:
Exclusion Criteria:
For infants:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yong-Gang Shen | Anhui Center for Diseases Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guzhen Center for Diseases Control and Prevention | Bengbu | Anhui | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26934750 | Derived | Shen Y, Hu Y, Meng F, Du W, Li W, Song Y, Ji X, Huo L, Fu Z, Yin W. Safety, immunogenicity and cross-reactivity of a Northern hemisphere 2013-2014 seasonal trivalent inactivated split influenza virus vaccine, Anflu(R). Hum Vaccin Immunother. 2016 May 3;12(5):1229-34. doi: 10.1080/21645515.2015.1123357. Epub 2016 Mar 2. |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| Day 0 - day 35 |
| The cross-reactivity of 2013-2014 seasonal TIV in adults and seniors against influenza B Victoria lineage virus and the avian influenza A(H7N9) virus | To evaluate the cross-reactivity of 2013-2014 seasonal TIV in adults and seniors against influenza B Victoria lineage virus (not in the vaccine formulation) and the avian influenza A(H7N9) virus by detection of HI antibody titer | 21 days after vaccination |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |