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

NCT02640989 Phase 4 COMPLETED

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.

Details

Lead sponsor	Center for Disease Prevention and Control of Beijing Military Region
Phase	Phase 4
Status	COMPLETED
Enrolment	292
Start date	2014-10
Completion	2015-04

Conditions

• Influenza

Interventions

• Seasonal trivalent influenza vaccine, Anflu®
• Seasonal trivalent influenza vaccine, VAXIGRIP
• Seasonal trivalent influenza vaccine, Fluarix

Primary outcomes

• Hemagglutination inhibition (HI) titers of each strain which were recommended by WHO for the 2014 seasonal influenza vaccines — 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).

Countries

China