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Study to Evaluate the Safety of 1 New 6:2 Influenza Virus Reassortant in Adults for the 2016-2017 Season

NCT02743117 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 301

Last updated 2017-10-04

Study results available
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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 2016-2017 influenza season

Conditions

Interventions

BIOLOGICAL

Monovalent Influenza Vaccine

A single dose of 10\^(7.0 ± 0.5) FFU strain of monovalent influenza vaccine will be administered as intranasal spray on Day 1.

OTHER

Placebo

A single dose of placebo matched to monovalent influenza vaccine will be administered as intranasal spray on Day 1.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • MedImmune LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-05-02
Primary Completion
2016-11-30
Completion
2016-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02743117 on ClinicalTrials.gov