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Clinical Trial Summary

All participants received a single dose of their assigned vaccine on Day 0. They were followed up for immunogenicity and safety through Day 21 post-vaccination. Serious adverse events were collected for 6 months post-vaccination.


Clinical Trial Description

In a randomized controlled phase III trial undertaken in 10 university hospitals of South Korea, adults and elderly subjects were randomly assigned in a 2:1:1 ratio to NBP607-QIV versus cell culture-based trivalent inactivated influenza vaccine (TIV), NBP607-Y and NBP607-V. Immunogenicity was assessed 3 weeks after vaccination by hemagglutination inhibition (HI) assay. Safety was assessed for 6 months post-vaccination: solicited adverse events for 7 days, unsolicited adverse events (AEs) for 21 days and serious adverse events (SAE) for 6 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02467842
Study type Interventional
Source SK Chemicals Co., Ltd.
Contact
Status Completed
Phase Phase 3
Start date October 2014
Completion date May 2015

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