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A Re-licensing Study to Assess the Efficacy of Inflexal V Formulated With WHO Recommended 2009/2010 Influenza Virus Strains for the Northern Hemisphere

NCT ID: NCT01306253

Last Updated: 2013-09-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2009-06-30

Brief Summary

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This study is to assess whether the Northern Hemisphere 2009/2010 season influenza vaccine Inflexal V fulfills the EMEA requirements for re-registration of influenza vaccines.

Detailed Description

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Conditions

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Influenza

Keywords

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Influenza Virus Vaccination Immunisation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Elderly

Elderly subjects aged over 60 years

Group Type EXPERIMENTAL

Inflexal V

Intervention Type BIOLOGICAL

Inflexal V influenza vaccine, formulated for the WHO requirements of the 2009-2010 season, containing per 0.5 mL dose:

* 15 µg hemagglutinin (HA) antigen of A/Brisbane/59/2007 (H1N1)-like virus
* 15 µg HA antigen of A/Brisbane/10/2007 (H3N2)-like virus
* 15 µg HA antigen of B/Brisbane/60/2008-like virus

Dose: intramuscular administration (M. deltoides) of a single dose of 0.5 mL on Day 1

Adults

Adults from 18 to 60 years old inclusive

Group Type EXPERIMENTAL

Inflexal V

Intervention Type BIOLOGICAL

Inflexal V influenza vaccine, formulated for the WHO requirements of the 2009-2010 season, containing per 0.5 mL dose:

* 15 µg hemagglutinin (HA) antigen of A/Brisbane/59/2007 (H1N1)-like virus
* 15 µg HA antigen of A/Brisbane/10/2007 (H3N2)-like virus
* 15 µg HA antigen of B/Brisbane/60/2008-like virus

Dose: intramuscular administration (M. deltoides) of a single dose of 0.5 mL on Day 1

Interventions

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Inflexal V

Inflexal V influenza vaccine, formulated for the WHO requirements of the 2009-2010 season, containing per 0.5 mL dose:

* 15 µg hemagglutinin (HA) antigen of A/Brisbane/59/2007 (H1N1)-like virus
* 15 µg HA antigen of A/Brisbane/10/2007 (H3N2)-like virus
* 15 µg HA antigen of B/Brisbane/60/2008-like virus

Dose: intramuscular administration (M. deltoides) of a single dose of 0.5 mL on Day 1

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy female and male adults
* Aged ≥18 to ≤60 years or \>60 years on Day 1
* Written informed consent

Exclusion Criteria

* Acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or other acute disease
* Acute febrile illness (≥38.0 °C)
* Prior vaccination with an influenza vaccine in the past 330 days
* Known hypersensitivity to any vaccine component
* Previous history of a serious adverse reaction to influenza vaccine
* History of egg protein allergy or severe atopy
* Known blood coagulation disorder
* Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of study vaccine, incl. oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent (inhaled or topical steroids are allowed)
* Known immunodeficiency (incl. leukemia, cancer, HIV seropositivity)
* Investigational medicinal product received in the past 3 months (90 days)
* Treatment with immunoglobulins or blood transfusion(s) received in the past 3 months (90 days)
* Pregnancy or lactation
* Participation in another clinical trial
* Employee at the investigational site, or relative or spouse of the investigator
* Suspected non-compliance
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Crucell Holland BV

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Seiberling, MD

Role: PRINCIPAL_INVESTIGATOR

Covance Clinical Research Unit AG

Locations

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Covance Clinical Research Unit AG

Allschwil, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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INF-V-A003

Identifier Type: -

Identifier Source: org_study_id