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

Primary Purpose

Influenza

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Fluarix vaccine
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza vaccine, Prophylaxis Influenza vaccine

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

Primary Outcome Measures

occurrence of confirmed influenza

Secondary Outcome Measures

occurrence of influenza like illness
Occurrence of pneumonia
Immune response at days 0 and 21
Safety during 7 Months

Full Information

First Posted
August 10, 2006
Last Updated
March 21, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00363870
Brief Title
A Study to Demonstrate the Efficacy of GSK Biologicals' Influenza Vaccine in Adults
Official Title
A Study to Demonstrate the Efficacy of GSK Biologicals' Influenza Vaccine (Fluarix™) Administered Intramuscularly in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza vaccine, Prophylaxis Influenza vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
7632 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Fluarix vaccine
Primary Outcome Measure Information:
Title
occurrence of confirmed influenza
Secondary Outcome Measure Information:
Title
occurrence of influenza like illness
Title
Occurrence of pneumonia
Title
Immune response at days 0 and 21
Title
Safety during 7 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Hradec Kralove
ZIP/Postal Code
500 03
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Espoo
ZIP/Postal Code
02100
Country
Finland
Facility Name
GSK Investigational Site
City
Helsinki
ZIP/Postal Code
00100
Country
Finland
Facility Name
GSK Investigational Site
City
Helsinki
ZIP/Postal Code
00930
Country
Finland
Facility Name
GSK Investigational Site
City
Jarvenpaa
ZIP/Postal Code
04400
Country
Finland
Facility Name
GSK Investigational Site
City
Kotka
ZIP/Postal Code
48600
Country
Finland
Facility Name
GSK Investigational Site
City
Kuopio
ZIP/Postal Code
70100
Country
Finland
Facility Name
GSK Investigational Site
City
Lahti
ZIP/Postal Code
15140
Country
Finland
Facility Name
GSK Investigational Site
City
Oulu
ZIP/Postal Code
90100
Country
Finland
Facility Name
GSK Investigational Site
City
Pori
ZIP/Postal Code
28120
Country
Finland
Facility Name
GSK Investigational Site
City
Seinajoki
ZIP/Postal Code
60100
Country
Finland
Facility Name
GSK Investigational Site
City
Tampere
ZIP/Postal Code
33100
Country
Finland
Facility Name
GSK Investigational Site
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
GSK Investigational Site
City
Vantaa
ZIP/Postal Code
01300
Country
Finland
Facility Name
GSK Investigational Site
City
Vantaa
ZIP/Postal Code
01600
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Citations:
PubMed Identifier
22079305
Citation
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.
Results Reference
derived
PubMed Identifier
19909082
Citation
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.
Results Reference
derived
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
108134
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
108134
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
108134
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
108134
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
108134
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
108134
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
108134
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

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

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