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Immunogenicity and Safety Study to Assess Influenza Vaccine Formulated With Haemagglutinin (HA) Antigen From Two Different Suppliers

NCT ID: NCT01412281

Last Updated: 2013-09-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2011-12-31

Brief Summary

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The purpose of this study is to assess the humoral immune response and safety of the parenteral formulation of the 2010/2011-season virosomal subunit influenza vaccine Inflexal V using two different HA antigen suppliers (AdImmune and CSL), in groups of young and elderly adults, using the EMA (European Medicines Agency) regulation as a guideline.

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

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group A - Young adults

1 x 0.5 mL i.m. virosomal influenza vaccine (AdImmune HA Antigen) 2011/2012

Group Type EXPERIMENTAL

Virosomal influenza vaccine (AdImmune HA Antigen)

Intervention Type BIOLOGICAL

Virosomal influenza vaccine (surface antigen, inactivated, virosome, using AdImmune HA Antigen) 2011/2012, with intramuscular administration, containing per 0.5 mL dose: 15 μg HA antigen of A/California/7/2009 (H1N1)-like virus; 15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus; 15 μg HA antigen of B/Brisbane/60/2008-like virus

Group B - Young adults

1 x 0.5 mL i.m. virosomal influenza vaccine (CSL HA Antigen) 2011/2012

Group Type ACTIVE_COMPARATOR

Virosomal influenza vaccine (CSL HA Antigen)

Intervention Type BIOLOGICAL

Virosomal influenza vaccine (surface antigen, inactivated, virosome, using CSL HA antigen) 2011/2012 with intramuscular administration, containing per 0.5 mL dose: 15 μg HA antigen of A/California/7/2009 (H1N1)-like virus; 15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus; 15 μg HA antigen of B/Brisbane/60/2008-like virus

Group C - Elderly

1 x 0.5 mL i.m. virosomal influenza vaccine (AdImmune HA Antigen) 2011/2012

Group Type EXPERIMENTAL

Virosomal influenza vaccine (AdImmune HA Antigen)

Intervention Type BIOLOGICAL

Virosomal influenza vaccine (surface antigen, inactivated, virosome, using AdImmune HA Antigen) 2011/2012, with intramuscular administration, containing per 0.5 mL dose: 15 μg HA antigen of A/California/7/2009 (H1N1)-like virus; 15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus; 15 μg HA antigen of B/Brisbane/60/2008-like virus

Group D - Elderly

1 x 0.5 mL i.m. virosomal influenza vaccine (CSL HA Antigen) 2011/2012

Group Type ACTIVE_COMPARATOR

Virosomal influenza vaccine (CSL HA Antigen)

Intervention Type BIOLOGICAL

Virosomal influenza vaccine (surface antigen, inactivated, virosome, using CSL HA antigen) 2011/2012 with intramuscular administration, containing per 0.5 mL dose: 15 μg HA antigen of A/California/7/2009 (H1N1)-like virus; 15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus; 15 μg HA antigen of B/Brisbane/60/2008-like virus

Interventions

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Virosomal influenza vaccine (AdImmune HA Antigen)

Virosomal influenza vaccine (surface antigen, inactivated, virosome, using AdImmune HA Antigen) 2011/2012, with intramuscular administration, containing per 0.5 mL dose: 15 μg HA antigen of A/California/7/2009 (H1N1)-like virus; 15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus; 15 μg HA antigen of B/Brisbane/60/2008-like virus

Intervention Type BIOLOGICAL

Virosomal influenza vaccine (CSL HA Antigen)

Virosomal influenza vaccine (surface antigen, inactivated, virosome, using CSL HA antigen) 2011/2012 with intramuscular administration, containing per 0.5 mL dose: 15 μg HA antigen of A/California/7/2009 (H1N1)-like virus; 15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus; 15 μg HA antigen of B/Brisbane/60/2008-like virus

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy female and male adults
* Aged ≥18 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 (including the H1N1 pandemic swine flu 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 the 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 spouse and children of the investigator, or relative living in the same household as the investigator and/or are dependent on 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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ADD-V-A002

Identifier Type: -

Identifier Source: org_study_id