NCT01104493

A Clinical Study to Assess the Safety of a New Influenza Vaccine

A Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety of a New 6:2 Influenza Virus Reassortant

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

To assess the safety of a new influenza virus vaccine containing a new virus strain in healthy patients prior to the release of the vaccine.

Detailed description

This prospective, randomized, double-blind, placebo-controlled release study will enroll approximately 300 healthy adults 18-49 years of age. Eligible subjects will be randomly assigned in a 4:1 fashion to receive a single dose of monovalent vaccine or placebo by intranasal spray. This study will be conducted at multiple sites in the United States. Randomization will be stratified by site. Each subject will receive one dose of investigational product on Study Day 1. The duration of study participation for each subject is the time from receipt of investigational product through 180 days after receipt of investigational product. To summarize the primary safety phase data (Study Days 1-8), the study will be unblinded to the analysis team at MedImmune after all data through at least Study Day 8 are locked.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	Monovalent Frozen FluMist®	Single dose of monovalent vaccine (240 subjects) by intranasal spray on Study Day 1.
OTHER	Placebo	Single dose of placebo (60 subjects) by intranasal spray on Study Day 1

Timeline

• Start date: 2010-05-01
• Primary completion: 2010-06-01
• Completion: 2010-12-01
• First posted: 2010-04-15
• Last updated: 2011-07-18
• Results posted: 2011-07-14

Locations

3 sites across 1 country: United States