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A Clinical Study to Assess the Safety of a New Influenza Vaccine

NCT01104493 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2011-07-18

Study results available
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Summary

To assess the safety of a new influenza virus vaccine containing a new virus strain in healthy patients prior to the release of the vaccine.

Conditions

  • Healthy

Interventions

BIOLOGICAL

Monovalent Frozen FluMist®

Single dose of monovalent vaccine (240 subjects) by intranasal spray on Study Day 1.

OTHER

Placebo

Single dose of placebo (60 subjects) by intranasal spray on Study Day 1

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • Robert A. Gasser, Jr., M.D. · MedImmune LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2010-06-30
Completion
2010-12-31

Countries

  • United States

Study Locations

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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 NCT01104493 on ClinicalTrials.gov