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A Study to Evaluate the Immunogenicity of Quadrivalent Live Attenuated Influenza Vaccine (LAIV) in Children

NCT01091246 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2312

Last updated 2011-09-26

Study results available
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Summary

The primary objective of this study is to demonstrate the immunologic noninferiority of Q/LAIV to FluMist in children 2 to 17 years of age.

Conditions

  • Healthy or Stable Chronic Illness

Interventions

BIOLOGICAL

Q/LAIV (MEDI3250)

10 \^7.0 ± 0.5 FFU/dose of each of 4 influenza virus strains: A/H1N1, A/H3N2, B/Yamagata, and B/Victoria

BIOLOGICAL

FluMist/B/Yamagata

10 \^7.0 ± 0.5 FFU/dose of each of 3 influenza virus strains: A/H1N1, A/H3N2, and B/Yamagata

BIOLOGICAL

FluMist/B/Victoria

10 \^7.0 ± 0.5 FFU/dose of each of 3 influenza virus strains: A/H1N1, A/H3N2, and B/Victoria

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • Judith Falloon, M.D. · MedImmune LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2010-07-31
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 NCT01091246 on ClinicalTrials.gov