Two doses vaccination in elderly subjects aged between 65 and 85 years old, in good general health and not previously immunized with the 23-valent pneumococcal polysaccharide vaccine (Pneumo 23).
Conditions
Interventions
Product Name: 11-valent Streptococcus pneumoniae conjugate vaccine reconstituted with AS adjuvant system
Product Code: 11Pn-PD-DiT/AS or 11PCV/AS
Pharmaceutical Form: Powder for suspension for injecti
TT:14-DT:9
Product Name: 10-valent Streptococcus pneumoniae conjugate vaccine
Product Code: 10Pn-PD-DiT or 10PCV
Pharmaceutical Form: Suspension for injection
Concentration unit: µg/ml microgram(s)/m
TT:9-
Trade Name: Pneumovax 23/Pneumo 23
Product Name: Pneumovax23/Pneumo23
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administrat
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To assess in healthy elderly subjects the safety and reactogenicity of the 11PCV adjuvanted either with AS01B or AS01E or AS02V, and of the 10-valent pneumococcal conjugate vaccine adjuvanted with AlPO4 (10PCV/AlPO4), given as a 2-dose vaccination 3 months apart, and of the licensed 23-valent pneumococcal polysaccharide vaccine (23PPV) given as a 1-dose vaccination. • To compare the antibody response of the 11PCV, adjuvanted either with AS01B, AS01E or AS02V, after 1 and 2 injections with the antibody response of the 23PPV. ;Secondary Objective: Month 12 objectives only in Belgium • To evaluate the safety as measured by haematological and biochemical parameters in each group. • To evaluate the humoral immune response elicited after 1 or 2 doses of 10PCV/AlPO4, injected at 3 months interval. • To evaluate the humoral immune response at month 12 in each group. • To evaluate the B-cell memory response to 4 polysaccharides in all subjects and to 11 polysaccharides in 10 subjects per group at Months 0, 1, 4 and 12. • To evaluate the humoral immune response to carrier proteins at Months 0, 1, 3, 4 and 12, in the PCV groups. • To evaluate the B-cell memory response to NTHi protein D at Months 0, 1, 4 and 12, in a subset of subjects (all subjects minus PS B-cell memory subset) of the PCV groups. • To evaluate the T-cell response to NTHi protein D at Months 0, 1, 4 and 12, in a subset of subjects (all subjects minus PS B-cell memory subset) of the 11PCV/AS01B, 11PCV/AS01E, 11PCV/AS02V and 10PCV/AlPO4 groups.;Primary end point(s): Safety and Reactogenicity • Occurrence, intensity and relationship to vaccination of any solicited local and general signs and symptoms during a 7-day follow up period (i.e. day of vaccination and 6 subsequent days) after each vaccine dose. • Occurrence, intensity and relationship to vaccination of unsolicited local and general signs and symptoms during a 31-day follow up period (i.e. day of vaccination and 30 subsequent days) af | — |
Countries
Finland, Sweden
Outcome results
None listed