A Study to Demonstrate the Efficacy of GSK Biologicals' Influenza Vaccine in Adults

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

PHASE4

Total Enrollment

7632 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-06-30

Brief Summary

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The purpose of this study is to demonstrate the efficacy of GSK Biologicals' influenza vaccine (Fluarix™) administered intramuscularly in adults.

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Detailed Description

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Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Fluarix vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* A male or female age between 18 and 64 years at the time of the first vaccination.
* non-childbearing female

Exclusion Criteria

* Use of non-registered products
* Pregnancy
* Hypersensitivity to a previous dose of influenza vaccine
* Acute disease at the time of enrolment/vaccination.
* History of allergy or reactions likely to be exacerbated by any component of the vaccine
* Administration of any other influenza vaccine for the season 2006-2007
* Chronic disorders of the pulmonary or cardiovascular system, including asthma.
* Administration of immune-modifying drugs
* Administration of immunoglobulins and/or any blood products
* History of requiring regular medical follow-up or hospitalization during the preceding year because of chronic metabolic diseases (including diabetes mellitus), renal dysfunction, hemoglobinopathies, asthma or immunosuppression (including immunosuppression caused by medications or by human immunodeficiency virus)

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Tampere, , Finland

Site Status

GSK Investigational Site

Turku, , Finland

Site Status

GSK Investigational Site

Vantaa, , Finland

Site Status

GSK Investigational Site

Vantaa, , Finland

Site Status

GSK Investigational Site

Hradec Králové, , Czechia

Site Status

GSK Investigational Site

Espoo, , Finland

Site Status

GSK Investigational Site

Helsinki, , Finland

Site Status

GSK Investigational Site

Helsinki, , Finland

Site Status

GSK Investigational Site

Järvenpää, , Finland

Site Status

GSK Investigational Site

Kotka, , Finland

Site Status

GSK Investigational Site

Kuopio, , Finland

Site Status

GSK Investigational Site

Lahti, , Finland

Site Status

GSK Investigational Site

Oulu, , Finland

Site Status

GSK Investigational Site

Pori, , Finland

Site Status

GSK Investigational Site

Seinäjoki, , Finland

Site Status

Countries

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Czechia Finland

References

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Vesikari T, Beran J, Durviaux S, Stainier I, El Idrissi M, Walravens K, Devaster JM. Use of real-time polymerase chain reaction (rtPCR) as a diagnostic tool for influenza infection in a vaccine efficacy trial. J Clin Virol. 2012 Jan;53(1):22-8. doi: 10.1016/j.jcv.2011.10.013. Epub 2011 Nov 11.

Reference Type DERIVED

PMID: 22079305 (View on PubMed)

Beran J, Vesikari T, Wertzova V, Karvonen A, Honegr K, Lindblad N, Van Belle P, Peeters M, Innis BL, Devaster JM. Efficacy of inactivated split-virus influenza vaccine against culture-confirmed influenza in healthy adults: a prospective, randomized, placebo-controlled trial. J Infect Dis. 2009 Dec 15;200(12):1861-9. doi: 10.1086/648406.

Reference Type DERIVED

PMID: 19909082 (View on PubMed)

Study Documents

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