The purpose of this study is to assess the safety, reactogenicity and immunogenicity of 8 different formulations of investigational NTHI vaccine in current and former smokers, 50-70 years of age.
This Protocol Posting has been updated following Protocol Amendment 1, dated 10 October 2012, leading to a change in an inclusion criterion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
272
Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
GSK Investigational Site
Antwerp, Belgium
GSK Investigational Site
Ghent, Belgium
GSK Investigational Site
Wilrijk, Belgium
Occurrence of each solicited local and general adverse event (AE), in all subjects, in all groups.
Time frame: During a 7-day follow-up period (from day 0 to day 6) after each vaccination.
Occurrence of any unsolicited AE, in all subjects, in all groups.
Time frame: During a 30-day follow-up period (from day 0 to day 29) after each vaccination.
Occurrence of haematological and biochemical laboratory abnormalities, in all subjects, in all groups.
Time frame: Prior to each vaccination.
Occurrence of haematological and biochemical laboratory abnormalities, in all subjects, in all groups.
Time frame: 7 days after each vaccination.
Occurrence of haematological and biochemical laboratory abnormalities, in all subjects, in all groups.
Time frame: At study conclusion (Day 420).
Occurrence of any serious adverse event (SAE), in all subjects, in all groups.
Time frame: From first vaccination (Day 0) to study conclusion (Day 420).
Occurrence of any potential immune-mediated disease (pIMD) in all subjects, in all groups.
Time frame: From first vaccination (Day 0) to study conclusion (Day 420).
Humoral immune response to the components of the NTHi vaccine formulations, in all subjects, in all groups, in terms of antibody concentrations.
Time frame: Prior to each vaccination, 30 days after each vaccination, and at study conclusion (Day 420).
Cell-mediated immune (CMI) responses to components of the NTHi vaccine formulations, in a sub-cohort of subjects, in all groups.
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Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
Time frame: Prior to each vaccination, 30 days after each vaccination, and at study conclusion (Day 420).