The purpose of this first time in human (FTiH) study is to evaluate the safety, reactogenicity and immunogenicity of several formulations of Respiratory Syncytial Virus (RSV) investigational vaccines in healthy men.
This protocol posting has been updated following protocol amendment 3 to amend the respective exclusion criterion as to only exclude subjects with clinically significant hematological/ biochemical abnormalities as per opinion of the investigator.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
128
Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule
Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule
Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule
GSK Investigational Site
Halifax, Nova Scotia, Canada
GSK Investigational Site
Brampton, Ontario, Canada
GSK Investigational Site
Toronto, Ontario, Canada
Occurrence of each solicited local and general adverse event (AE)
Time frame: During the 7 days (Days 0-6) follow-up period after vaccination
Occurrence of any hematological (hemoglobin level, white blood cells [WBC], lymphocyte, neutrophil, eosinophil and platelet count) and biochemical (alanine amino-transferase [ALT], aspartate amino-transferase [AST] and creatinine) laboratory abnormality
Time frame: At Day 0
Occurrence of any hematological (hemoglobin level, white blood cells [WBC], lymphocyte, neutrophil, eosinophil and platelet count) and biochemical (alanine amino-transferase [ALT], aspartate amino-transferase [AST] and creatinine) laboratory abnormality
Time frame: At Day 7
Occurrence of any hematological (hemoglobin level, white blood cells [WBC], lymphocyte, neutrophil, eosinophil and platelet count) and biochemical (alanine amino-transferase [ALT], aspartate amino-transferase [AST] and creatinine) laboratory abnormality
Time frame: At Day 30
Occurrence of any hematological (hemoglobin level, WBC, lymphocyte, neutrophil, eosinophil and platelet count) and biochemical (alanine amino-transferase [ALT], aspartate amino-transferase [AST] and creatinine) laboratory abnormality
Time frame: At Day 60
Occurrence of any unsolicited AE
Time frame: During a 30-day (Days 0-29) follow-up period after vaccination
Occurrence of any Serious Adverse Events (SAEs)
Time frame: From Day 0 to Day 60
Humoral immune response in terms of neutralizing antibody titers to the investigational RSV vaccines, in all subjects, in all groups
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule
Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule
Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule
Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule
Time frame: At pre-vaccination (Day 0) and post-vaccination (Day 7, Day 30 and Day 60)
Persistence of the humoral immune response in terms of neutralizing antibody titers to the investigational RSV vaccines, in all subjects, in all groups
Time frame: At Day 180 and Day 360
Occurrence of any hematological (hemoglobin level, WBC, lymphocyte, neutrophil, eosinophil and platelet count) and biochemical (ALT, AST and creatinine) laboratory abnormality
Time frame: At Day 180 and Day 360
Occurrence of any SAE
Time frame: From Day 60 to the study conclusion (i.e. Day 360)