NCT00363870

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,632

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_4

Geographic Reach
2 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 15, 2006

Completed
17 days until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

March 23, 2017

Status Verified

March 1, 2017

Enrollment Period

9 months

First QC Date

August 10, 2006

Last Update Submit

March 21, 2017

Conditions

Influenza

Keywords

Influenza vaccineProphylaxis Influenza vaccine

Outcome Measures

Primary Outcomes (1)

  • occurrence of confirmed influenza

Secondary Outcomes (4)

  • occurrence of influenza like illness

  • Occurrence of pneumonia

  • Immune response at days 0 and 21

  • Safety during 7 Months

Interventions

Fluarix vaccineBIOLOGICAL

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

GSK Investigational Site

Hradec Králové, 500 03, Czechia

Location

GSK Investigational Site

Espoo, 02100, Finland

Location

GSK Investigational Site

Helsinki, 00100, Finland

Location

GSK Investigational Site

Helsinki, 00930, Finland

Location

GSK Investigational Site

Jarvenpaa, 04400, Finland

Location

GSK Investigational Site

Kotka, 48600, Finland

Location

GSK Investigational Site

Kuopio, 70100, Finland

Location

GSK Investigational Site

Lahti, 15140, Finland

Location

GSK Investigational Site

Oulu, 90100, Finland

Location

GSK Investigational Site

Pori, 28120, Finland

Location

GSK Investigational Site

Seinäjoki, 60100, Finland

Location

GSK Investigational Site

Tampere, 33100, Finland

Location

GSK Investigational Site

Turku, 20520, Finland

Location

GSK Investigational Site

Vantaa, 01300, Finland

Location

GSK Investigational Site

Vantaa, 01600, Finland

Location

Related Publications (2)

  • 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.

    PMID: 22079305DERIVED

  • 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.

    PMID: 19909082DERIVED

Related Links

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2006

First Posted

August 15, 2006

Study Start

September 1, 2006

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

March 23, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will share

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Available IPD Datasets

Clinical Study Report (108134)Access
Individual Participant Data Set (108134)Access
Dataset Specification (108134)Access
Study Protocol (108134)Access
Annotated Case Report Form (108134)Access
Statistical Analysis Plan (108134)Access
Informed Consent Form (108134)Access

Locations

FI(14)CZ(1)