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The purpose of this study is to assess the safety and immunogenicity of three seasonal trivalent influenza vaccines (TIVs)manufactured by Glaxosmith Kline (GSK), Beijing Sinovac Biotech (Sinovac) and Shenzhen Sanofi Pasteur (Pasteur) in Chinese healthy servicemen. Using imported GSK's TIV as control, to compare it with other two domestic TIVs in Chinese healthy servicemen.
This study is a 1:1:1 randomized, double-blinded, controlled phase Ⅳ clinical trial in a military command in Beijing. Healthy individuals aged between 18~34 years who had not received any influenza vaccine during recent three years will be enrolled and administrated one dose TIV. Safety data will be collected for whole study (Day 0 to Day 30).Blood samples will be collected for immunogenicity assessments before injection and 21 days after vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental |
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| Group 2 | Experimental |
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| Group 3 | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seasonal trivalent influenza vaccine, Anflu® | Biological | Seasonal trivalent influenza vaccine manufactured by Sinovac Co., Ltd. |
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| Measure | Description | Time Frame |
|---|---|---|
| Hemagglutination inhibition (HI) titers of each strain which were recommended by WHO for the 2014 seasonal influenza vaccines | Hemagglutination inhibition (HI) titers were measured using the antigen and standard serum provided by the National Institute for Biological Standards and Control (NIBSC). | 21 days after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| The incidences of adverse events (AEs) | After vaccination, occurrences of AEs were collected till day 21. Each AE case was reviewed by the investigator to determine whether or not it was an adverse reaction (related to the vaccination). | 21 days after vaccination |
| The post-vaccination seroprotection rates of each of the influenza vaccines |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dongqi Gao, PhD | Center for Disease Prevention and Control of Beijing Military Region | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Disease Prevention and Control of Beijing Military Region | Beijing | Beijing Municipality | 100042 | China |
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| Seasonal trivalent influenza vaccine, VAXIGRIP | Biological | Seasonal trivalent influenza vaccine manufactured by PasteurSanofi Pasteur |
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| Seasonal trivalent influenza vaccine, Fluarix | Biological | Seasonal trivalent influenza vaccine manufactured by GlaxoSmithKline Biologicals |
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Hemagglutination inhibition (HI) titers were used to calculate post-vaccination seroprotection rates of each of the influenza vaccines. By European Committee(European criteria): in adults aged between 18 to 60, post-vaccination seroprotection rates should be ≥ 70% for all vaccine strains. |
| 21 days after vaccination |
| The post-vaccination seroconversion rates of each of the influenza vaccines | Hemagglutination inhibition (HI) titers were used to calculate post-vaccination seroconversion rates of each of the influenza vaccines. By European Committee(European criteria): in adults aged between 18 to 60, post-vaccination seroconversion rates should be > 40% for all vaccine strains. | 21 days after vaccination |
| The post-vaccination mean geometric increases (GMIs) of each of the influenza vaccines | Hemagglutination inhibition (HI) titers were used to calculate post-vaccination mean geometric increases (GMIs) of each of the influenza vaccines. By European Committee(European criteria): in adults aged between 18 to 60, post-vaccination mean geometric increases (GMIs) should be ≥ 2.5 for all vaccine strains. | 21 days after vaccination |
| 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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| ID | Term |
|---|---|
| C478242 | vaxigrip |
| C510903 | fluarix |
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