A phase I/II, randomized, observer blinded study to evaluate and compare the safety, reactogenicity and immunogenicity of various formulations of the GlaxoSmithKline Biologicals’ adjuvanted 11-valent pneumococcal conjugate vaccine versus the licensed single-dose 23-valent pneumococcal polysaccharide vaccine and GlaxoSmithKline Biologicals’ aluminium-based 10-valent pneumococcal conjugate vaccine, in healthy elderly subjects. - STREP-ELD-010, STREP-ELD-011 EXT010 Y1

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

The cohort to be enrolled is a 23-valent pneumococcal polysaccharide vaccine naïve elderly subjects aged between 65 and 85 years old, in good general health at the time of the first vaccine dose.
All subjects must satisfy to the following criteria at study entry:
•Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits).
•A male or female between 65 and 85 years of age at the time of the first vaccination.
•Written informed consent obtained from the subject.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Previous vaccination against Streptococcus pneumoniae.
•Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests, in particular:
?Current or history of coronary artery disease or cardiac insufficiency
?Uncontrolled hypertension
?Clinically significant EKG abnormalities such as prior myocardial infarction, atrial fibrillation, heart block
?Creatinin level = 1.5 ULN
?ALT-AST levels = 1.5 ULN
?Type 2 diabetes
?Current or history of rheumatoid arthritis or temporal arteritis
?Current acute or chronic active pulmonary pathology diagnosed on chest X-ray
•Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature <37.5°C or Axillary temperature <37.5°C.
•History of documented radiologically confirmed pneumonia within 3 years prior to first vaccination.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
•Current or history of Parkinson disease, Alzheimer disease, stroke, dementia or any serious neurologic or mental disorders .
•All malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders diagnosed or treated actively during the past 5 years.
•Subjects with documented anaemia or iron-deficiency (Hemoglobin level more than 10% below lower limit of normal)
•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 3 months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, ? 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
•Planned administration/ administration of a vaccine not foreseen by the study protocol within 2 weeks of the first dose of vaccine(s) with the exception of a Flu vaccine which can be administered at least 1 week preceding the first dose of vaccine(s) or 1 month after the first dose of the vaccine(s).
•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.
•Administration of immunoglobulins and/or any blood products within three months preceding the first dose of study vaccine or planned administration during the study period.
•History of administration of an experimental/licensed vaccine containing MPL or QS21.
•History of chronic alcohol consumption and/or drug abuse.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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