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A Phase 2 Study to Evaluate Immune Responses of FluMist®

NCT00461981 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2021-10-06

Study results available
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Summary

The primary objective of this study is to describe the level of serum antibody and cellular immune responses conferred by FluMist and TIV against influenza virus strains.

Conditions

  • Influenza Vaccine

Interventions

BIOLOGICAL

TIV, Trivalent Inactivated Influenza Virus Vaccine

0.25 mL will be administered intramuscularly for each of two doses

BIOLOGICAL

FluMist, Influenza Virus Vaccine Live

0.5 mL will be administered intranasally (approximately 0.25 mL into each nostril) for each of two doses

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • Maria Allende, M.D. · MedImmune LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Months
Max Age
35 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2007-12-31
Completion
2008-02-29

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 NCT00461981 on ClinicalTrials.gov