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Fluarix Immunogenicity and Safety Trial

NCT00100399 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1050

Last updated 2010-08-27

No results posted yet for this study

Summary

The purpose of this study is to test the immune response caused by investigational Fluarix vaccine in healthy people aged between 18-64 years in the U.S.A. Up to 1050 volunteers at 4 centers will receive Fluarix or Placebo (saline), and their responses will then be compared. Subjects will be placed by age into 2 groups (18 to 49 years old and 50 to 64 years old), then randomly assigned to receive a dose of Fluarix or Placebo by injection into a muscle. There will be 2 phases in this study: (1) the active study phase (2 visits) for all subjects; and (2) the cross-over phase, only for subjects enrolled in the placebo group who accept to receive Fluarix. Blood samples will be obtained in order to measure immune response to the vaccine. On the day of vaccination, volunteers will receive a diary card to record information on symptoms experienced during the next 3 days. Subject participation in either group will be up to 2 months.

Conditions

Interventions

BIOLOGICAL

Fluarix

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2004-12-31
Completion
2004-12-31

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 NCT00100399 on ClinicalTrials.gov