NCT00860067

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

A Randomized, Double-Blind, Active Controlled Study to Evaluate the Immunogenicity of MEDI3250 in Adults 18 to 49 Years of Age

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 1,800 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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.

Detailed description

This randomized, double-blind, active controlled, multicenter study enrolled 1,800 subjects who were 18 to 49 years of age. Subjects were randomized by site in a 4:1:1 fashion to receive a single dose of Q/LAIV, trivalent FluMist containing an influenza B strain from the Yamagata lineage (FluMist/B/Yamagata), or trivalent FluMist containing an influenza B strain from the Victoria lineage (FluMist/B/Victoria). The study was conducted at multiple sites in the USA in the influenza off-season.

Conditions

• Healthy or Stable Underlying Chronic Medical Condition

Interventions

Type	Name	Description
BIOLOGICAL	Q/LAIV (MEDI3250)	0.2 mL dose at Day 0
BIOLOGICAL	FluMist/B/Yamagata	0.2 mL dose at Day 0
BIOLOGICAL	FluMist/B/Victoria	0.2 mL dose at Day 0

Timeline

• Start date: 2009-03-01
• Primary completion: 2009-05-01
• Completion: 2009-10-01
• First posted: 2009-03-11
• Last updated: 2011-12-05
• Results posted: 2011-08-12

Locations

18 sites across 1 country: United States