Status:
COMPLETED
Study to Evaluate the Response Rate to the Licensed Pneumovax 23™ in Elderly Population.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Streptococcus Pneumoniae Vaccines
Eligibility:
All Genders
65+ years
Phase:
PHASE2
Brief Summary
Streptococcus pneumoniae are bacteria which normally live in the upper respiratory tract of humans. However, these bacteria can also cause severe infectious diseases such as pneumonia, septicemia and ...
Detailed Description
Since influenza vaccination is recommended in the age range of the study population, Fluarix™ (GlaxoSmithKline Biologicals) vaccine will be offered free of charge for the study period (3 consecutive y...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Subjects who the investigator believes will comply with the requirements of the protocol.
- A male or female \>= 65 years at the time of the first 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 first dose of study vaccine, or planned use during the study period or participation to another pharmaceutical/vaccine study.
- Previous vaccination against Streptococcus pneumoniae.
- History of administration of an experimental vaccine containing MPL or QS21.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Planned administration of a vaccine not foreseen by the study protocol within 2 weeks before and after first dose of vaccines, excluding influenza vaccine which can be administered at any time, including co-administration with Pneumovax23™.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- Current serious neurologic or mental disorders.
- Inflammatory processes such as known chronic active infections (e.g.Hep B, C).
- All malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders diagnosed or treated actively during the past 5 years.
- Acute disease at the time of enrolment.
- Chronic disease that might preclude participation to the whole study.
Exclusion
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2005
Estimated Enrollment :
1198 Patients enrolled
Trial Details
Trial ID
NCT00307008
Start Date
October 1 2003
End Date
February 1 2005
Last Update
April 15 2013
Active Locations (5)
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1
GSK Investigational Site
Eskilstuna, Sweden, SE-631 88
2
GSK Investigational Site
Jönköping, Sweden, SE-551 85
3
GSK Investigational Site
Skövde, Sweden, SE-541 85
4
GSK Investigational Site
Uppsala, Sweden, SE-751 85