Status:
COMPLETED
Reacto & Immunogenicity of TF Formulation of Influsplit SSW® 2002/03 v/s Std Formulation of Influsplit SSW® 2002/03
Lead Sponsor:
GlaxoSmithKline
Conditions:
Influenza
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a comparative vaccination study of the reactogenicity and immunogenicity of a thiomersal-free formulation of Influsplit SSW® 2002/2003 versus the standard formulation of Influsplit SSW® 2002/2...
Eligibility Criteria
Inclusion
- Healthy subjects who are capable of being vaccinated and subjects with primary diseases (cardiovascular conditions, metabolic conditions such as diabetes mellitus, respiratory diseases) who are capable of being vaccinated and aged over 18 years who want to be vaccinated against influenza or for whom the doctor considers prophylactic influenza immunisation to be indicated.
- The inclusion of individuals who had not been immunised in the 2001/2002 season is preferred.
- Written consent to vaccination must be available after the subjects have been briefed on the study in understandable language.
Exclusion
- Use of study or unlicensed medication or administration of a vaccine other than the study vaccine within 30 days preceding vaccination and/or during the study period
- Acute disease at the beginning of the study
- Acute clinically significant changes in the lungs, cardiovascular system, liver or kidney function, identified by physical examination or laboratory tests
- Pregnancy
- Women who would like to fall pregnant during the period from the day of vaccination to 1 month thereafter
- Known allergic reactions that might have been caused by one or more ingredients of the vaccine
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
239 Patients enrolled
Trial Details
Trial ID
NCT00731029
Start Date
September 1 2002
Last Update
August 8 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Clinical Trials Call Center
Dresden, Germany