drugset

drugset / Trial / NCT00946101

A Study to Evaluate the Safety of HIN1 Monovalent Vaccine (MEDI3414) in Children 2 to 17 Years of Age

NCT00946101 ↗

Phase 4 Completed 326 enrolled MedImmune LLC Department of Health and Human Services · collab

RandomizedParallel-groupQuadruple-blindPrevention

Summary

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

Timeline

Start: 2009-08
Primary completion: 2009-09
Completion: 2010-03

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
Comparator	MEDI3414	Vaccine	0.5 ml	Intranasal

Indications