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

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Brief Summary

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To evaluate the antibody response to each influenza vaccine antigen when administering a single dose to subjects aged 18 years and over

Detailed Description

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Conditions

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Influenza

Keywords

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Influenza adult elderly vaccine

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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Surface Antigen, Inactivated, Influenza (form.2006-07)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older

Exclusion Criteria

* any serious disease such as cancer, autoimmune disease, advanced arteriosclerotic disease or complicated diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure and bleeding diathesis or conditions associated with prolonged bleeding time
* 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 (chronic antibiotic therapy for urinary tract prophylaxis was acceptable)
* fever within the past 3 days
* history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
* within the past 12 months have received more than one injection of influenza vaccine
* Women who are pregnant or women able to bear children but not willing to practice acceptable contraception for the duration of the trial (21 days)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Novartis Vaccines - Drug Information Services

Role: STUDY_CHAIR

Novartis Vaccines & Diagnostics

Locations

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Ufficio Igiene e Sanità Pubblica di Lanciano, ASL, Via S. Spaventa, 37

Lanciano, Lanciano, Italy

Site Status

Dipartimento di Medicina e Scienze dell'Invecchiamento Università G. D'AnnunzioVia dei Vestini

Chieti, , Italy

Site Status

Countries

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Italy

Other Identifiers

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Eudract no.2006-000609-43

Identifier Type: -

Identifier Source: secondary_id

V71P4S