The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of several formulations of an investigational Staphylococcal vaccine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
88
intramuscular vaccination according to protocol schedule
intramuscular vaccination according to protocol schedule
intramuscular vaccination according to protocol schedule
GSK Investigational Site
La Louvière, Belgium
Occurrence of solicited local and general adverse events (AEs) in all subjects, in all vaccine groups.
Time frame: During a 7-day (day 0-6) follow up period after each vaccine dose
Occurrence of unsolicited adverse events (AEs) in all subjects, in all vaccine groups.
Time frame: During a 30-day (day 0-29) follow up period after each vaccine dose
Occurrence of any Serious Adverse events (SAE) in all subjects, in all vaccine groups.
Time frame: From first vaccination (Day 0) to study conclusion (Day 540)
Occurrence of any adverse event (AE) of specific interest in all subjects, in all vaccine groups.
Time frame: From first vaccination (Day 0) to study conclusion (Day 540)
Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups.
Time frame: Prior to each vaccine dose
Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups.
Time frame: 1 day after each vaccine dose
Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups.
Time frame: 7 days after each vaccine dose
Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups.
Time frame: 29/30 days after each vaccine dose
Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups.
Time frame: 6 months after the last vaccine dose
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intramuscular vaccination according to protocol schedule
intramuscular vaccination according to protocol schedule
Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups.
Time frame: 12 months after the last vaccine dose
Immune response to components of the Staphylococcal vaccine formulations in all subjects, in all vaccine groups.
Time frame: Prior to each vaccine dose, 1, 7 and 29/30 days after each vaccine dose, and 6 and 12 months after the last vaccine dose.
Colonisation with Staphylococcus aureus in all subjects, in all vaccine groups.
Time frame: At Screening (pre-Day 0) and at Days 0, 30, 60, 180, 210 and 540.