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Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2007/2008) When Administered to NON Elderly AND Elderly Subjects

NCT ID: NCT00518726

Last Updated: 2016-12-01

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

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2007-07-31

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

Detailed Description

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Conditions

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Influenza

Keywords

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Adjuvanted Influenza Vaccine

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Surface Antigen, Inactivated, Adjuvanted, Influenza Vaccine, Formulation 2007-2008

Intervention Type BIOLOGICAL

seasonal influenza vaccine 15ug

Interventions

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Surface Antigen, Inactivated, Adjuvanted, Influenza Vaccine, Formulation 2007-2008

seasonal influenza vaccine 15ug

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 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 within the past 7 days, any acute disease or infections requiring systemic antibiotic or antiviral therapy fever within the past 3 days.No women in breast feeding.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Vaccines

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Vaccines

Role: STUDY_CHAIR

Novartis Vaccines

Locations

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Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio

Via Dei Vestini, Chieti, Italy

Site Status

Ufficio Igiene e Sanità Pubblica di Lanciano, ASL Lanciano - Vasto sede legale

Via S. Spaventa, 37, Lanciano, Chieti, Italy

Site Status

Presidio Distrettuale No. 8 Azienda Sanitaria USL 7 di Siena

Siena, , Italy

Site Status

Countries

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Italy

Other Identifiers

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2007-000963-28

Identifier Type: -

Identifier Source: secondary_id

V71P5S

Identifier Type: -

Identifier Source: org_study_id