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

March 21, 2017 updated by: GlaxoSmithKline

A Study to Demonstrate the Efficacy of GSK Biologicals' Influenza Vaccine (Fluarix™) Administered Intramuscularly in Adults

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

Study Overview

Status

Completed

Conditions

Influenza

Intervention / Treatment

Biological: Fluarix vaccine

Study Type

Interventional

Enrollment

7632

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Czech Republic
- - Hradec Kralove, Czech Republic, 500 03
    - GSK Investigational Site
Finland
- - Espoo, Finland, 02100
    - GSK Investigational Site
  - Helsinki, Finland, 00100
    - GSK Investigational Site
  - Helsinki, Finland, 00930
    - GSK Investigational Site
  - Jarvenpaa, Finland, 04400
    - GSK Investigational Site
  - Kotka, Finland, 48600
    - GSK Investigational Site
  - Kuopio, Finland, 70100
    - GSK Investigational Site
  - Lahti, Finland, 15140
    - GSK Investigational Site
  - Oulu, Finland, 90100
    - GSK Investigational Site
  - Pori, Finland, 28120
    - GSK Investigational Site
  - Seinajoki, Finland, 60100
    - GSK Investigational Site
  - Tampere, Finland, 33100
    - GSK Investigational Site
  - Turku, Finland, 20520
    - GSK Investigational Site
  - Vantaa, Finland, 01300
    - GSK Investigational Site
  - Vantaa, Finland, 01600
    - GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
occurrence of confirmed influenza

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

August 10, 2006

First Submitted That Met QC Criteria

August 10, 2006

First Posted (Estimate)

August 15, 2006

Study Record Updates

Last Update Posted (Actual)

March 23, 2017

Last Update Submitted That Met QC Criteria

March 21, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

108134

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Study Data/Documents

Clinical Study Report
Information identifier: 108134

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set
Information identifier: 108134

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification
Information identifier: 108134

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol
Information identifier: 108134

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form
Information identifier: 108134

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan
Information identifier: 108134

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form
Information identifier: 108134

Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.