Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, of Two(Surface Antigen Adjuvanted With MF59C.1) Influenza Vaccines in Non-Elderly Adult and Elderly Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

520 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Brief Summary

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The present study aims to evaluate safety and immunogenicity of two doses, administered three weeks apart, of two influenza vaccines containing 7.5 micrograms or 15 micrograms of H5N1 influenza antigen, in non-elderly adult and elderly subjects.

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Detailed Description

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Conditions

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Pandemic Influenza Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Influenza vaccine surface antigen adjuvanted with MF59

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Male and female volunteers 18 years of age or older

Exclusion Criteria

* any auto-immune disease or other serious acute, chronic or progressive disease
* hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine.
* history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine.
* within the past 7 days, they have experienced: any acute disease, infections requiring systemic antibiotic or antiviral therapy.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No