NCT01579916

A Study to Evaluate the Safety of 3 New 6:2 Influenza Virus Reassortants in Adults

A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety of 3 New 6:2 Influenza Virus Reassortants in Adults

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 303 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

This prospective annual release study was designed to assess the safety of a trivalent influenza virus vaccine using two new strains recommended for the 2012-2013 influenza season not previously contained in the trivalent intranasal FluMist vaccine. Three hundred healthy adults will receive a single dose of vaccine or placebo and will be followed for 180 days after study vaccination.

Detailed description

This prospective, randomized, double-blind, placebo-controlled release study will enroll approximately 300 healthy adults 18 to 49 years of age. Eligible subjects will be randomly assigned in a 4:1 fashion to receive a single dose of trivalent vaccine or placebo by intranasal spray. Randomization will be stratified by site. This study will be conducted at 3 sites in the United States of America. 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 study vaccination through 180 days after study vaccination.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Trivalent Influenza Virus Vaccine	Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10\^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
OTHER	Placebo	Placebo is suppllied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.

Timeline

• Start date: 2012-05-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2012-04-18
• Last updated: 2014-02-03
• Results posted: 2014-02-03

Locations

3 sites across 1 country: United States