Immunogenicity, Safety and Tolerability of Two Doses of FLUAD-H5N1 Influenza Vaccine in 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

PHASE3

Total Enrollment

4400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Brief Summary

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This study is designed to evaluate the immunogenicity, safety and tolerability of 2 doses of FLUAD-H5N1 vaccine compared to 2 doses of trivalent, interpandemic FLUAD, each administered 3 weeks apart.

Detailed Description

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Conditions

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Influenza

Keywords

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Influenza H5N1, pandemic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Interventions

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Pandemic influenza vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy Subjects 18 years of age who signed the informed consent

Exclusion Criteria

* Receipt of another investigational agent within 4 weeks
* Receipt of influenza vaccination for current season 2006/2007.
* any acute disease or infection, history of neurological symptoms or signs, known or suspected impairment of immune function, any serious disease, bleeding diathesis
* fever (defined as axillary temperature ³38.0°C) within 3 days (prior to Visit 1)
* Pregnant or breastfeeding or females of childbearing potential who refuse to use an acceptable method of birth control
* Surgery planned during the study period
* Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the study vaccine
* Receipt of another vaccine within 3 weeks prior to Visit 1 or planned vaccination within 3 weeks following the last study vaccination
* History of (or current) drug or alcohol abuse
* Any condition, which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Novartis Vaccines and Diagnostics GmbH & Co KG Novartis

Role: STUDY_CHAIR

Novartis Vaccines and Diagnostics GmbH & Co KG., Germany

Locations

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Centrum Badań Farmakologii Klinicznej monipol

Krakow, , Poland

Site Status

Countries

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Poland

Other Identifiers

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2006-005428-18

Identifier Type: -

Identifier Source: secondary_id

V87P4