NCT03564444

D2560C00015 FluMist Annual Safety Study 2018

A Phase 4, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Safety of 2 New of 6:2 Influenza Virus Reassortants 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 2 new influenza virus vaccine strains to be included in FluMist Quadrivalent for the 2018-2019 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 subjects will be randomly assigned in a 4:1 fashion to receive a single dose of bivalent 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 subject will receive 1 dose of investigational product on Day 1. The duration of study participation for each subject is the time from study vaccination through 180 days after study vaccination.

Conditions

• Influenza
• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	Bivalent influenza vaccine	A single dose of bivalent vaccine (10\^7±5 fluorescent focus unit of 2 cold-adapted, attenuated, temperature-sensitive, 6:2 reassortant influenza strain) will be administered as intranasal spray on Day 1.
OTHER	Placebo	A single dose of placebo matched to bivalent influenza vaccine will be administered as intranasal spray on Day 1.

Timeline

• Start date: 2018-06-06
• Primary completion: 2018-12-27
• Completion: 2018-12-27
• First posted: 2018-06-20
• Last updated: 2019-12-26
• Results posted: 2019-12-26

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study