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A Study to Evaluate the Immunogenicity of Quadrivalent LAIV (MEDI8662) in Adults 18 to 49 Years of Age

NCT00952705 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1800

Last updated 2018-05-03

Study results available
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Summary

The purpose of this study was to show that quadrivalent live attenuated influenza vaccine (Q/LAIV-BFS; MEDI8662) was at least as immunogenic as two different forms of the commercial vaccine, FluMist, by comparing the strain-specific antibody levels in the blood.

Conditions

  • Healthy or Stable Underlying Chronic Medical Condition

Interventions

BIOLOGICAL

Q/LAIV-BFS (MEDI8662)

A single dose of Q/LAIV-BFS delivered using the BFS delivery system (0.2 mL) on Day 0.

BIOLOGICAL

FluMist/B/Yamagata

FluMist/B/Yamagata - 0.2 mL dose at Day 0

BIOLOGICAL

FluMist/B/Victoria

FluMist/B/Victoria - 0.2 mL dose at Day 0

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • Joseph Sliman, M.D., MPH · 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
2009-08-31
Primary Completion
2010-01-31
Completion
2010-03-31

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 NCT00952705 on ClinicalTrials.gov