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Immunogenicity and Safety of an Adjuvanted Inactivated Subunit Influenza Vaccine to Those of a Non-adjuvanted Inactivated Subunit Influenza Vaccine, When Administered to Adults Affected by Chronic Diseases

NCT ID: NCT00519064

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

PHASE3

Total Enrollment

361 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-05-31

Brief Summary

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This phase III is designed to confirm the previous trial results evaluating the safety, clinical tolerability and immunogenicity of the 2006-2007 formulation of Novartis Vaccines' adjuvanted influenza vaccine and subunit influenza vaccine in adults with underlying chronic diseases.

Detailed Description

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Conditions

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Influenza Disease

Keywords

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influenza influenza vaccine adjuvanted influenza vaccine H5N1 influenza antigen

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Study Groups

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Arm 1

Group Type ACTIVE_COMPARATOR

Adjuvanted influenza vaccine

Intervention Type BIOLOGICAL

Arm 2

Group Type ACTIVE_COMPARATOR

Adjuvanted influenza vaccine

Intervention Type BIOLOGICAL

Interventions

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Adjuvanted influenza vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 18 to 60 years of age adult volunteers, mentally competent, willing and able to give written informed consent prior to study entry, suffering from at least one of these chronic diseases:moderate to severe hypertension, moderate to severe congestive heart failure, chronic obstructive pulmonary disease (COPD) or moderate to severe asthma, moderate to severe hepatic or renal insufficiency, arteriosclerotic disease or insulin dependent diabetes mellitus

Exclusion Criteria

* Hypersensitivity to ovalbumin, 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 impairment/ alteration of immune function;
* Any condition which might interfere with the evaluation of the study objectives
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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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Azienda ULSS 13 di Mirano

Mira, Via Nazionale 48, Venezia, Italy

Site Status

Countries

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Italy

References

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Black S, Della Cioppa G, Malfroot A, Nacci P, Nicolay U, Pellegrini M, Sokal E, Vertruyen A. Safety of MF59-adjuvanted versus non-adjuvanted influenza vaccines in children and adolescents: an integrated analysis. Vaccine. 2010 Oct 21;28(45):7331-6. doi: 10.1016/j.vaccine.2010.08.075. Epub 2010 Sep 15.

Reference Type RESULT
PMID: 20813217 (View on PubMed)

Other Identifiers

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2006-005558-63

Identifier Type: -

Identifier Source: secondary_id

V70P3

Identifier Type: -

Identifier Source: org_study_id