The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals' NTHi candidate vaccine in adults, administered for the first time in humans.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
48
Administered intramuscularly (IM) in the deltoid region of non-dominant arm
2 doses administered IM in the deltoid region of non-dominant arm
2 doses administered IM in the deltoid region of non-dominant arm
GSK Investigational Site
Adelaide, South Australia, Australia
Occurrence of solicited local and general adverse event (AE), in all subjects, in all vaccine groups
Time frame: During a 7-day follow-up period (i.e. day of vaccination and 6 subsequent days) after each vaccination.
Occurrence of any unsolicited AE, in all subjects, in all vaccine groups
Time frame: During a 30-day follow-up period (i.e. day of vaccination and 29 subsequent days) after each vaccination.
Occurrence of haematological and biochemical laboratory abnormalities, in all subjects, in all vaccine groups
Time frame: At baseline (Screening visit) and after each vaccination.
Occurrence of any serious adverse event (SAE), in all subjects, in all vaccine groups
Time frame: From first vaccination to study conclusion (Day 420).
Occurrence of any potential Immune-Mediated Disease (pIMDs) in all subjects, in all vaccine groups
Time frame: From first vaccination to study conclusion (Day 420).
Humoral immune response to components of the NTHi vaccine formulations, in all subjects, in all vaccine groups
Time frame: Prior to each vaccination and 30 days post each vaccination.
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