drugset / Trial / NCT02212106

A Study to Evaluate the Safety and Tolerability of Trivalent Influenza Virus Vaccine in Children Aged 5 Years to < 9 Years

NCT02212106

Phase 4 Completed 402 enrolled Seqirus
RandomizedParallel-groupTriple-blindPrevention

Summary

This is a study to assess the safety of a bioCSL split virion, inactivated Trivalent Influenza Virus vaccine containing the 2014/2015 Northern Hemisphere strains of vaccine in children aged 5 years to less than 9 years. Comparison will be made to a licensed Quadrivalent Influenza Virus vaccine that complies with the FDA recommendations for the 2014/2015 influenza season in the US.

Timeline

Start
2014-09
Primary completion
2014-12
Completion
2014-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Influenza Virus Vaccine Vaccine Intramuscular
Subject bioCSL Trivalent Influenza Virus Vaccine (CSL TIV) Vaccine 45 ug Intramuscular

Indications