A Study to Evaluate the Immunogenicity of Quadrivalent Live Attenuated Influenza Vaccine (LAIV) in Children

Phase 3 Completed 2312 enrolled MedImmune LLC

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The primary objective of this study is to demonstrate the immunologic noninferiority of Q/LAIV to FluMist in children 2 to 17 years of age.

Timeline

Start: 2010-03
Primary completion: 2010-07
Completion: 2010-12

Outcome

Met primary endpoint

registry analysis (non-inferiority or equivalence test); Q/LAIV (MEDI3250) vs All FluMist Group; Ratio of geometric mean 1.07 (95% CI 0.98 to 1.16); Bootstrapping NCT01091246 ↗

registry analysis (non-inferiority or equivalence test); Q/LAIV (MEDI3250) vs All FluMist Group; Ratio of geometric means 1.04 (95% CI 0.94 to 1.14); Bootstrapping NCT01091246 ↗

registry analysis (non-inferiority or equivalence test); Q/LAIV (MEDI3250) vs FluMist/B/Yamagata; Ratio of geometric mean 1.21 (95% CI 1.07 to 1.37) NCT01091246 ↗

registry analysis (non-inferiority or equivalence test); Q/LAIV (MEDI3250) vs FluMist/B/Victoria; Ratio of geometric mean 1.05 (95% CI 0.93 to 1.18) NCT01091246 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	FluMist/B/Victoria	Vaccine	1e+07 unknown	Intranasal
Subject	FluMist/B/Yamagata	Vaccine	1e+07 unknown	Intranasal
Subject	Q/LAIV	Vaccine	1e+07 unknown	Intranasal

Indications

No indication recorded.