669
Participants
Start Date
July 6, 2018
Primary Completion Date
May 16, 2022
Study Completion Date
May 16, 2022
Placebo
Placebo for Ad26.RSV.preF, RSV preF protein, Ad26.RSV.preF/RSV preF protein mixture and selected regimen will be administered as sterile saline for intramuscular injection.
RSV preF Protein 50 mcg
RSV preF will be administered as a solution for intramuscular injection at a dose of 50 mcg.
RSV preF Protein 150 mcg
RSV preF will be administered as a solution for intramuscular injection at a dose of 150 mcg.
Ad26.RSV.preF 1*10^11 vp
Ad26.RSV.preF will be administered as a solution for intramuscular injection at a dose of 1\*10\^11 vp.
Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 50 mcg
Mixture of Ad26.RSV.preF (5\*10\^10 vp) and RSV preF protein (50 mcg) will be administered as a solution for intramuscular injection.
Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 150 mcg
Mixture of Ad26.RSV.preF (5\*10\^10 vp) and RSV preF protein (150 mcg) will be administered as a solution for intramuscular injection.
Mixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 50 mcg
Mixture of Ad26.RSV.preF (1\*10\^11 vp) and RSV preF protein (50 mcg) will be administered as a solution for intramuscular injection.
Mixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 150 mcg
Mixture of Ad26.RSV.preF (1\*10\^11 vp) and RSV preF protein (150 mcg) will be administered as a solution for intramuscular injection.
Selected Regimen
A regimen from Cohort 1 or Cohort 2 will be selected and administered as a solution for intramuscular injection at the selected dose.
Optimal Research, Rockville
Optimal Research, Melbourne
Optimal Research, Huntsville
Optimal Research, Peoria
Optimal Research, Austin
Optimal Research, San Diego
Janssen Vaccines & Prevention B.V.
INDUSTRY