Evaluate the Shedding and Immunogencity of Different Formulations of FluMist in Children 24 to <48 Months of Age

Summary

This study is being conducted to compare the immunogenicity, safety, and viral shedding of a new A/H1N1 strain that will be incorporated into the FluMist quadrivalent formulation for the 2017-2018 influenza season with the previous A/H1N1 strain that was included in the vaccine in the 2015-2016 influenza season.

Timeline

Start

2017-05-08

Primary completion

2017-09-29

Completion

2017-09-29

Outcome

Met primary endpoint

registry analysis (superiority test); FluMist Quadrivalent (2015-2016) vs FluMist Quadrivalent (2017-2018); p = 0.006; Mean Difference (Net) 18.1 (95% CI 4.8 to 30.9) NCT03143101 ↗

registry analysis (superiority test); FluMist Quadrivalent (2015-2016) vs FluMist Quadrivalent (2017-2018); p <0.001; Mean Difference (Net) 32.7 (95% CI 14.4 to 47.8) NCT03143101 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	FluMist Quadrivalent (2015-2016)	Vaccine	0.2 ml	Intranasal
Subject	FluMist Quadrivalent (2017-2018)	Vaccine	0.2 ml	Intranasal
Subject	FluMist trivalent (2015-2016)	Vaccine	0.2 ml	Intranasal

Indications