Status:
COMPLETED
Safety Study of Pandemic Candidate Influenza Vaccines in the Elderly Population
Lead Sponsor:
GlaxoSmithKline
Conditions:
Influenza
Influenza Vaccines
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief Summary
Influenza pandemics are caused by viruses that possess an Hemagglutinin molecule to which most of the population lacks immunity. If such virus is pathogenic to human and demonstrates the ability to tr...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol
- A male or female aged over 60 years at the time of vaccination.
- Written informed consent obtained from the subject.
- Exclusion criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
- Participation in an earlier study with a candidate pandemic H9N2 vaccine.
- Acute disease at the time of enrolment.
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Drug and/or alcohol dependency.
Exclusion
Key Trial Info
Start Date :
May 11 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 4 2006
Estimated Enrollment :
385 Patients enrolled
Trial Details
Trial ID
NCT00306995
Start Date
May 11 2005
End Date
July 4 2006
Last Update
February 10 2020
Active Locations (10)
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1
GSK Investigational Site
Finsterwalde, Brandenburg, Germany, 03238
2
GSK Investigational Site
Ketzin, Brandenburg, Germany, 14669
3
GSK Investigational Site
Tostedt, Lower Saxony, Germany, 21255
4
GSK Investigational Site
Dresden, Saxony, Germany, 01219