The purpose of this observer-blind study is to evaluate the safety, reactogenicity and immunogenicity of pneumococcal vaccines in elderly. Subjects will be vaccinated twice with an interval of two months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
168
Two doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2.
One dose of 0.5 ml will be administered intramuscularly at Month 0, and a placebo dose to keep the blinding at Month 2.
GSK Investigational Site
Malmö, Sweden
GSK Investigational Site
Örebro, Sweden
GSK Investigational Site
Uppsala, Sweden
Occurrence of any vaccine related and grade 3 solicited local and general adverse events
Time frame: During a 7-day follow up period after each vaccine dose
Occurrence of any vaccine related and grade 3 unsolicited adverse events
Time frame: During a 31-day follow up period after each vaccine dose
Occurrence of any vaccine related serious adverse events (SAE)
Time frame: From dose 1 to study conclusion
Occurrence of any grade 3 laboratory abnormalities
Time frame: At 1 and 7 days after each vaccine dose
Occurrence of any solicited local and general adverse events
Time frame: During a 7-day follow up period after each vaccine dose
Occurrence of any unsolicited adverse events
Time frame: During a 31-day follow up period after each vaccine dose
Occurrence of any laboratory abnormalities
Time frame: At 1 and 7 days after each vaccine dose
Occurrence of any medically significant conditions prompting emergency room visits or physician visits regardless of casual relationship to vaccination or intensity
Time frame: From dose 1 to study conclusion
Anti-pneumococcal and anti-NTHi candidate vaccine antigens
Time frame: At Days 0, 30 and 90
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