Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2006/2007) When Administered to Subjects 18 Years of Age or Older

NCT ID: NCT00342940

Last Updated: 2017-04-20

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

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Brief Summary

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The present study aims to evaluate safety and immunogenicity of one dose of a commercially available Surface Antigen, Inactivated Influenza Vaccine, Formulation 2006-2007, in non-elderly adult and elderly subjects.

Detailed Description

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Conditions

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Influenza

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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influenza surface antigen inactivated vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Male and female subjects 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
* known or suspected (or high risk of developing) impairment/alteration of immune function
* within the past 7 days any acute disease or infections requiring systemic antibiotic or antiviral therapy
* history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Vaccines

INDUSTRY

Sponsor Role collaborator

Novartis

INDUSTRY

Sponsor Role lead

Principal Investigators

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Novartis Vaccines Drug Information Services

Role: STUDY_CHAIR

Novartis

Locations

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Chiltern International Limited , Chiltern Place, Upton Road

Slough, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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Eudract number:2006-000787-88

Identifier Type: -

Identifier Source: secondary_id

V78P4S

Identifier Type: -

Identifier Source: org_study_id

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