Safety and Immunogenicity of Three Seasonal Trivalent Influenza Vaccines in China Military

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Safety and Immunogenicity of Three Seasonal Trivalent Influenza Vaccines in China Military

Conditions
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Influenza

Intervention / Treatment
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* Biological: Seasonal trivalent influenza vaccine, Anflu®
* Biological: Seasonal trivalent influenza vaccine, VAXIGRIP
* Biological: Seasonal trivalent influenza vaccine, Fluarix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy servicemen aged between 18-34 years ,who had not received any influenza vaccine during recent three years; Proven legal identity; Written informed consent; Complying with the requirement of the study protocol; Exclusion Criteria: Pregnant, breast feeding women; History of allergy to any vaccine or vaccine ingredient; Receipt of any immunosuppressant within 6 month prior to study entry; Congenital malformation, developmental disorders, serious chronic diseases, autoimmune disease, immunodeficiency, serious cardiovascular disease, diabetes, Guillain-Barré syndrome, hypertension that cannot be stabilized by medication, liver or kidney disease, or malignant tumor; Acute disease or acute stage of chronic disease within 7 days prior to study entry; Axillaty temperature > 37.0 °C; Any other factor that in the opinion of the investigator suggesting the volunteer is unsuitable for this study;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 34 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0 Seasonal trivalent influenza vaccine, Anflu® | Biological: Seasonal trivalent influenza vaccine, Anflu®<br>* Seasonal trivalent influenza vaccine manufactured by Sinovac Co., Ltd.<br>* Other names: Anflu®;|
| Experimental: Group 2<br>Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0 Seasonal trivalent influenza vaccine, VAXIGRIP | Biological: Seasonal trivalent influenza vaccine, VAXIGRIP<br>* Seasonal trivalent influenza vaccine manufactured by PasteurSanofi Pasteur<br>* Other names: VAXIGRIP;|
| Active Comparator: Group 3<br>Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0 Seasonal trivalent influenza vaccine, Fluarix | Biological: Seasonal trivalent influenza vaccine, Fluarix<br>* Seasonal trivalent influenza vaccine manufactured by GlaxoSmithKline Biologicals<br>* Other names: Fluarix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza Vaccine, Safety, Immunogenicity