drugset / Trial / NCT02621164

Immunogenicity and Safety of Quadrivalent Influenza Vaccine in Children and Adolescents

NCT02621164

Phase 3 Completed 454 enrolled SK Chemicals Co., Ltd.
RandomizedParallel-groupQuadruple-blindPrevention

Summary

This study is a multi-center, randomized, double-blind Phase III clinical trial. The aim of the study is to describe the immunogenicity and safety of the quadrivalent cell culture-derived influenza vaccine compared to the trivalent egg-derived influenza vaccine among subjects.

Timeline

Start
2014-09
Primary completion
2015-02
Completion
2015-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Agrippal S1 Vaccine 0.25 ml Intramuscular
Comparator Agrippal S1 Vaccine 0.5 ml Intramuscular
Subject NBP607-QIV Vaccine 0.25 ml Intramuscular
Subject NBP607-QIV Vaccine 0.5 ml Intramuscular

Indications