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To evaluate the safety and immunogenicity of the three consecutive lots of an seasonal split influenza vaccine Anflu in adults, a randomized, double-blind and controlled clinical trial was conducted in 560 subjects in Tianjin City of China.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1: Lot 1 | Experimental |
| |
| 2: Lot 2 | Experimental |
| |
| 3: Lot 3 | Experimental |
| |
| 4: control vaccine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| seasonal split influenza vaccine | Biological | 0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime |
|
| Measure | Description | Time Frame |
|---|---|---|
| Haemagglutination-inhibition (HI) antibody titer of influenza A H1N1, influenza A H3N2 and influenza B | 0, 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| local and systematic adverse reactions after vaccination | within 3 days after vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhilun Zhang | Tianjin centers for Disease Control and Prevention | Principal Investigator |
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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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| seasonal split influenza vaccine | Biological | 0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime |
|
| seasonal split influenza vaccine | Biological | 0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime |
|
| seasonal split influenza vaccine | Biological | 0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime |
|
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |