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NCT00363870 Clinical Trial

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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00363870
Other study ID # 108134
Secondary ID
Status Completed
Phase Phase 4
First received August 10, 2006
Last updated March 21, 2017
Start date September 2006
Est. completion date June 2007

Study information
Verified date March 2017
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 7632
Est. completion date June 2007
Est. primary completion date June 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 64 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Biological:
• Fluarix vaccine

Locations
Country Name City State
Czech Republic GSK Investigational Site Hradec Kralove
Finland GSK Investigational Site Espoo
Finland GSK Investigational Site Helsinki
Finland GSK Investigational Site Helsinki
Finland GSK Investigational Site Jarvenpaa
Finland GSK Investigational Site Kotka
Finland GSK Investigational Site Kuopio
Finland GSK Investigational Site Lahti
Finland GSK Investigational Site Oulu
Finland GSK Investigational Site Pori
Finland GSK Investigational Site Seinajoki
Finland GSK Investigational Site Tampere
Finland GSK Investigational Site Turku
Finland GSK Investigational Site Vantaa
Finland GSK Investigational Site Vantaa

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Czech Republic,  Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary occurrence of confirmed influenza
Secondary occurrence of influenza like illness
Secondary Occurrence of pneumonia
Secondary Immune response at days 0 and 21
Secondary Safety during 7 Months
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