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

NCT03158038 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2019-01-04

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 2017-2018 influenza season.

Conditions

Interventions

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.

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
2017-05-30
Primary Completion
2017-12-14
Completion
2017-12-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03158038 on ClinicalTrials.gov