A Study to Evaluate the Immunogenicity of Quadrivalent LAIV in Adults 18 to 49 Years of Age

Summary

The objective of this study was to show that quadrivalent live attenuated influenza vaccine (Q/LAIV; MEDI3250) produced antibody levels similar to those produced by the commercial vaccine, FluMist.

Timeline

Start

2009-03

Primary completion

2009-05

Completion

2009-10

Outcome

Met primary endpoint

registry analysis (non-inferiority or equivalence test); Q/LAIV (MEDI3250) vs All FluMist; Ratio of geometric mean 1.09 (95% CI 1.01 to 1.18); Bootstrapping NCT00860067 ↗

registry analysis (non-inferiority or equivalence test); Q/LAIV (MEDI3250) vs All FluMist; Ratio of geometric means 1.05 (95% CI 0.96 to 1.14); Bootstrapping NCT00860067 ↗

registry analysis (non-inferiority or equivalence test); Q/LAIV (MEDI3250) vs FluMist/B/Yamagata; Ratio of geometric mean 1.10 (95% CI 0.97 to 1.25); Bootstrapping NCT00860067 ↗

registry analysis (non-inferiority or equivalence test); Q/LAIV (MEDI3250) vs FluMist/B/Victoria; Ratio of geometric means 0.92 (95% CI 0.82 to 1.03); Bootstrapping NCT00860067 ↗

Publications

• Background Block SL, Yi T, Sheldon E, Dubovsky F, Falloon J. A randomized, double-blind noninferiority study of quadrivalent live attenuated influenza vaccine in adults. Vaccine. 2011 Nov 21;29(50):9391-7. doi: 10.1016/j.vaccine.2011.09.109. Epub 2011 Oct 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	FluMist/B/Victoria	Vaccine	0.2 ml	Intranasal
Comparator	FluMist/B/Yamagata	Vaccine	0.2 ml	Intranasal
Subject	MEDI3250	Vaccine	0.2 ml	Intranasal

Indications

No indication recorded.