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Trial to Assess the Shedding,Immunogenicity, and Safety of FluMist Administered to Healthy Individuals 5-49 Years of Age

NCT00192140 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 345

Last updated 2007-12-28

No results posted yet for this study

Summary

* To describe the proportion of individuals 5-49 years of age who shed vaccine strain viruses.
* To describe the duration of shedding of vaccine viruses in individuals 5-49 years of age.
* To describe the genotypic and phenotypic stability of shed vaccine viruses.
* To describe the immune responses of FluMist in individuals 5-49 years of age.
* To describe the safety of FluMist in individuals 5-49 years of age in relation to shedding and the immune response

Conditions

Interventions

BIOLOGICAL

FluMist

A single intranasal dose of FluMist will be administered to approx. 300 subjects.

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • Robert Walker, MD · Sponsor GmbH

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2004-06-30
Primary Completion
2004-10-31
Completion
2005-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00192140 on ClinicalTrials.gov