search
Back to results

Study to Evaluate the Safety and Immunogenicity of Fluarix™ 2006/2007 in Adults Aged 18 Years or Above

Primary Purpose

Influenza

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Fluarix
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 of influenza

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: A male or female aged 18 years or above at the time of the vaccination; Healthy subjects or with well-controlled chronic diseases; If the subject is female, she must be of non-childbearing potential Exclusion Criteria: Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study. Administration of an influenza vaccine within 6 months preceding the study start. Administration of an influenza vaccine other than the study vaccine during the entire study Clinically or virologically confirmed influenza infection within 6 months preceding the study start History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Acute disease at the time of enrolment. Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. Not stabilized or clinically serious chronic underlying disease Lactating female. History of chronic alcohol consumption and/or drug abuse. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.

Sites / Locations

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

Outcomes

Primary Outcome Measures

to evaluate the humoral immune response in terms of anti-Haemmagglutinin antibodies 21 days post-vaccination

Secondary Outcome Measures

To evaluate the safety and reactogenicity of the vaccine in term of solicited local and general adverse events, unsolicited adverse events and serious adverse events

Full Information

First Posted
June 28, 2006
Last Updated
September 27, 2016
Sponsor
GlaxoSmithKline
search

1. Study Identification

Unique Protocol Identification Number
NCT00345904
Brief Title
Study to Evaluate the Safety and Immunogenicity of Fluarix™ 2006/2007 in Adults Aged 18 Years or Above
Official Title
A Phase III Study for Evaluation of Immunogenicity and Reactogenicity of Fluarix™ (Influsplit SSW®) 2006/2007 in People Aged 18 Years or Above
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
Vaccination is currently the most effective mean of controlling influenza and preventing its complications and mortality in persons at risk. Because of the variable nature of influenza viruses, the composition of influenza vaccines changes almost every year, to target the 3 main circulating strains. Each year the influenza vaccine formulation may thus be different and clinical studies are mandated to ensure that the immunogenicity and safety of the vaccine formulated from the three annual circulating strains are similar to what was observed during the previous years. This study is designed to test the immunogenicity and reactogenicity of the Fluarix™ vaccine containing the influenza strains recommended for the 2006-2007 season.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Fluarix
Primary Outcome Measure Information:
Title
to evaluate the humoral immune response in terms of anti-Haemmagglutinin antibodies 21 days post-vaccination
Secondary Outcome Measure Information:
Title
To evaluate the safety and reactogenicity of the vaccine in term of solicited local and general adverse events, unsolicited adverse events and serious adverse events

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: A male or female aged 18 years or above at the time of the vaccination; Healthy subjects or with well-controlled chronic diseases; If the subject is female, she must be of non-childbearing potential Exclusion Criteria: Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study. Administration of an influenza vaccine within 6 months preceding the study start. Administration of an influenza vaccine other than the study vaccine during the entire study Clinically or virologically confirmed influenza infection within 6 months preceding the study start History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Acute disease at the time of enrolment. Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. Not stabilized or clinically serious chronic underlying disease Lactating female. History of chronic alcohol consumption and/or drug abuse. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
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
Dresden
State/Province
Sachsen
ZIP/Postal Code
01097
Country
Germany
Facility Name
GSK Investigational Site
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01099
Country
Germany
Facility Name
GSK Investigational Site
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01277
Country
Germany
Facility Name
GSK Investigational Site
City
Freital
State/Province
Sachsen
ZIP/Postal Code
01705
Country
Germany

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.
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
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
107507
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
107507
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
107507
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
107507
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
107507
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

Study to Evaluate the Safety and Immunogenicity of Fluarix™ 2006/2007 in Adults Aged 18 Years or Above

We'll reach out to this number within 24 hrs