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Re-licensing Study to Assess Virosomal Influenza Vaccine Formulated With WHO Recommended Influenza Strains

NCT ID: NCT01631071

Last Updated: 2013-12-20

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

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2012-08-31

Brief Summary

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The study is to assess whether the virosomal influenza vaccine for season 2012/2013 fulfills the EMA 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 Virosomal influenza vaccine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Elderly subjects aged over 60 years

Group Type EXPERIMENTAL

Virosomal influenza vaccine

Intervention Type BIOLOGICAL

Intramuscular administration (M. deltoideus) of a single dose of 0.5 mL virosomal influenza vaccine

Adults from 18 to 60 years old inclusive

Group Type EXPERIMENTAL

Virosomal influenza vaccine

Intervention Type BIOLOGICAL

Intramuscular administration (M. deltoideus) of a single dose of 0.5 mL virosomal influenza vaccine

Interventions

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Virosomal influenza vaccine

Intramuscular administration (M. deltoideus) of a single dose of 0.5 mL virosomal influenza vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy female and male adults aged ≥18 on Day 1
* Written informed consent
* Female subjects of childbearing potential using and willing to continue using an acceptable method of contraception unless surgically sterilized/hysterectomized or post-menopausal for more than 2 years

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 the study vaccine, including oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent (inhaled or topical steroids are allowed)
* Known immunodeficiency (incl. leukemia, HIV seropositivity), cancer
* Investigational medicinal product received in the past 3 months (90 days) starting from the first day of the month following the last visit in a previous study
* 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 of the investigator
* Subjects who in the view of the investigator will not comply with study procedures and/or visit requirements as per protocol
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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Milko Radicioni, MD

Role: PRINCIPAL_INVESTIGATOR

CROSS-Research SA

Locations

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CROSS-Research SA

Arzo, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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ADD-V-A003

Identifier Type: -

Identifier Source: org_study_id