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Study to Evaluate the Safety of 3 New 6:2 Influenza Virus Reassortants in Adults for the 2015-2016 Season

NCT02473510 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 301

Last updated 2016-11-28

Study results available
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Summary

This prospective annual release study is designed to evaluate the safety of 3 new influenza virus vaccine strains to be included in FluMist Quadrivalent for the 2015-2016 influenza season

Conditions

Interventions

BIOLOGICAL

Trivalent Influenza Vaccine

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

OTHER

Placebo

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

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • Ashwin Swami, MD · MedImmune LLC

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
2015-06-30
Primary Completion
2016-01-31
Completion
2016-01-31

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 NCT02473510 on ClinicalTrials.gov