Safety and Immunogenicity of Three Influenza Vaccines in Children Aged 4 Years Old to Less Than 18 Years Old

Summary

Evaluate safety and immunogenicity of three influenza vaccines in children ages greater than 4 years old to less than 18 years old.

Timeline

Start

2013-11

Primary completion

2014-08

Completion

2014-08

Outcome

Met primary endpoint

paper QIVc met the non-inferiority criteria against all four vaccine strains and demonstrated superiority for both influenza B strains PMID 26585940 ↗

Publications

• Hartvickson R, Cruz M, Ervin J, Brandon D, Forleo-Neto E, Dagnew AF, Chandra R, Lindert K, Mateen AA. Non-inferiority of mammalian cell-derived quadrivalent subunit influenza virus vaccines compared to trivalent subunit influenza virus vaccines in healthy children: a phase III randomized, multicenter, double-blind clinical trial. Int J Infect Dis. 2015 Dec;41:65-72. doi: 10.1016/j.ijid.2015.11.004. Epub 2015 Nov 14.

Drugs

Indications