This observer-blind study is designed to evaluate the immune response and safety of pandemic influenza vaccine in the elderly population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
GSK Investigational Site
Curitiba/Paraná, Paraná, Brazil
Serum HI antibody titres
Time frame: Day -30, Day 42
Serum HI antibody titres
Time frame: Day -30, Day 42, Month 6, Month 12
Serum neutralising antibody titres
Time frame: Day -30, Day 42, Month 6, Month 12
Occurrence, intensity, and relationship to vaccination of solicited local and general signs and symptoms
Time frame: Day 0 - Day 6 after each vaccination
Occurrence, intensity and relationship to vaccination of unsolicited adverse events
Time frame: Day 0 - Day 29 after vaccination, Day 0 - Day 20 after investigational vaccination
Occurrence and relationship to vaccination of serious adverse events
Time frame: Day 0 - Month 6
Occurrence of adverse events of specific interest
Time frame: Day 0 - Month 12
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