Status:
COMPLETED
Study to Evaluate the Safety and Immunogenicity of Pandemic Monovalent (H5N1) Influenza Vaccines (Whole Virus Formulation) in Adults 18 and 60 Years of Age
Lead Sponsor:
GlaxoSmithKline
Conditions:
Influenza
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
Today, the leading contender for the next pandemic of influenza is H5N1, a strain of avian virus. Prevention and control of a pandemic will depend on the rapid production and worldwide distribution of...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- A male or female between, and including, 18 and 60 years of age at the time of the first vaccination.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- If the subject is female, she must be of non-childbearing potential.
- Exclusion criteria:
- Administration of any vaccine during the period starting 15 days before the first administration of the study vaccine and ending 21 after the second one.
- Administration of an influenza vaccine other than the study vaccines during the entire study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first administration of the study vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- History of hypersensitivity to vaccines.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the study vaccine or during the study.
- lactating women
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to the first vaccination, or planned use during the study period.
Exclusion
Key Trial Info
Start Date :
March 29 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 16 2006
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00309647
Start Date
March 29 2006
End Date
November 16 2006
Last Update
May 8 2017
Active Locations (9)
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1
GSK Investigational Site
Finsterwalde, Brandenburg, Germany, 03238
2
GSK Investigational Site
Tostedt, Lower Saxony, Germany, 21255
3
GSK Investigational Site
Dresden, Saxony, Germany, 01129
4
GSK Investigational Site
Dresden, Saxony, Germany, 01307