A Study to Evaluate the Safety of H1N1 Monovalent Vaccine (MEDI3414) in Healthy Adults

Summary

The purpose of this study was to determine the safety and descriptive immunogenicity of the H1N1 influenza vaccine in healthy adults.

Timeline

Start

2009-08

Primary completion

2009-09

Completion

2010-03

Outcome

Mixed primary results

registry The upper limit of the two-sided 95% CI was evaluated against the prespecified equivalence criterion of 10% NCT00945893 ↗

registry Rate difference 0.0 (95% CI -6.0 to 1.9); Score NCT00945893 ↗

registry rate difference 2.5 (95% CI -8.8 to 7.7); score NCT00945893 ↗

registry rate difference 6.1 (95% CI -5.6 to 12.6); score NCT00945893 ↗

registry rate difference 9.3 (95% CI -0.8 to 16.3); score NCT00945893 ↗

Publications

• Mallory RM, Malkin E, Ambrose CS, Bellamy T, Shi L, Yi T, Jones T, Kemble G, Dubovsky F. Safety and immunogenicity following administration of a live, attenuated monovalent 2009 H1N1 influenza vaccine to children and adults in two randomized controlled trials. PLoS One. 2010 Oct 29;5(10):e13755. doi: 10.1371/journal.pone.0013755.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MEDI3414	Vaccine	0.5 ml	Intranasal

Indications

No indication recorded.