NCT03158038

Study to Evaluate the Safety of 1 New 6:2 Influenza Virus Reassortant in Adults for the 2017-2018 Season

A Phase 4 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety of 1 New 6:2 Influenza Virus Reassortant in Adults

• 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

This prospective annual release study is designed to evaluate the safety of 1 new influenza virus vaccine strain to be included in FluMist Quadrivalent for the 2017-2018 influenza season.

Detailed description

This prospective, randomized, double-blind, placebo-controlled release study will enroll approximately 300 healthy adults 18 to 49 years of age (not yet reached their 50th birthday). Eligible participants will be randomly assigned in a 4:1 fashion to receive a single dose of monovalent vaccine or placebo by intranasal spray. Randomization will be stratified by site. This study will be conducted at 2 sites in the United States of America. Each participant will receive 1 dose of investigational product on Day 1. The duration of study participation for each participant is the time from study vaccination through 180 days after study vaccination.

Conditions

• Influenza
• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	Monovalent Influenza Vaccine	A single dose of monovalent influenza vaccine \[10\^7.0 +/- 0.5 FFU of each of 1 ca, att, ts 6:2 reassortant influenza strain\] will be administered as intranasal spray on Day 1.
OTHER	Placebo	A single dose of placebo matching with monovalent influenza vaccine will be administered as intranasal spray on Day 1.

Timeline

• Start date: 2017-05-30
• Primary completion: 2017-12-14
• Completion: 2017-12-14
• First posted: 2017-05-17
• Last updated: 2019-01-04
• Results posted: 2019-01-04

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study