Safety and Immunogenicity of a Inactivated Influenza Vaccine When Administered to Non Elderly Adults 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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Brief Summary

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The purpose of this study is to evaluate safety and immunogenicity of a single intramuscular (IM) injection of a Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2005-2006, when Administered to Non-Elderly Adults and Elderly Subjects

Detailed Description

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Conditions

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Influenza Disease

Keywords

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influenza non elderly adult and 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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influenza vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* subjects 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
* 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
* known or suspected (or high risk of developing) impairment/alteration of immune function

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

Locations

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G. D'Annunzio University

Chieti, , Italy

Site Status

Office of Hygiene and Public Health, ASL Lanciano

Lanciano, , Italy

Site Status

Countries

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Italy

Other Identifiers

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Eudract number: 2005-000622-23

Identifier Type: -

Identifier Source: secondary_id

V71P3S