Center for Disease Prevention and Control of Beijing Military Region
Beijing, Beijing Municipality, 100042, China
NCT Number: NCT02640989
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.
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Notify Me18 year–34 year
All sexes
Interventional
Phase 4
Beijing, Beijing Municipality, 100042, China
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Seasonal trivalent influenza vaccine manufactured by Sinovac Co., Ltd.
Other names: Anflu®
Seasonal trivalent influenza vaccine manufactured by PasteurSanofi Pasteur
Other names: VAXIGRIP
Seasonal trivalent influenza vaccine manufactured by GlaxoSmithKline Biologicals
Other names: Fluarix
Time frame: 21 days after vaccination
Hemagglutination inhibition (HI) titers were measured using the antigen and standard serum provided by the National Institute for Biological Standards and Control (NIBSC).
Time frame: 21 days after vaccination
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).
Time frame: 21 days after vaccination
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.
Time frame: 21 days after vaccination
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.
Time frame: 21 days after vaccination
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.
Center for Disease Prevention and Control of Beijing Military Region
Other
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