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NCT00476307 Clinical Trial

Immunogenicity and Reactogenicity of Fluarix™ (Influsplit SSW®) 2007/2008 in People 18 Years Old or Above

Influenza Clinical Trial

Official title:
A Phase III Study for Evaluation of Immunogenicity and Reactogenicity of Fluarix™ (Influsplit SSW®) 2007/2008 in People Aged 18 Years or Above

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00476307
Other study ID # 110221
Secondary ID
Status Completed
Phase Phase 3
First received May 21, 2007
Last updated November 2, 2016
Start date June 2007
Est. completion date July 2007

Study information
Verified date November 2016
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority Germany: Paul-Ehrlich-Institut
Study type Interventional

Clinical Trial Summary

This study is designed to test the immunogenicity and reactogenicity of the Fluarix™/Influsplit SSW® containing the influenza strains recommended for the 2007-2008 season.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date July 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Healthy male or female aged 18 years or above;

- Non-childbearing or using adequate contraception;

- Written informed consent obtained from the subject.

Exclusion Criteria:

Subjects must not:

- Participate in a trial or using non-registered product;

- Use immunosuppressants, blood products, or another influenza vaccine during study;

- Have virologically confirmed influenza within 1 year;

- Have allergic or acute disease;

- Have unstabilized serious chronic disease;

- Be a lactating female.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Biological:
• Fluarix™/Influsplit SSW® 2007/2008

Locations
Country Name City State
Germany GSK Investigational Site Dresden Sachsen
Germany GSK Investigational Site Dresden Sachsen
Germany GSK Investigational Site Freital Sachsen

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Immune response 21 days post vaccination
Secondary Safety: solicited local and general symptoms, unsolicited symptoms, serious adverse events
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