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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT02640989
Study type Interventional
Source Center for Disease Prevention and Control of Beijing Military Region
Contact
Status Completed
Phase Phase 4
Start date October 2014
Completion date April 2015

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