Conditions: Respiratory Synctial Virus Infections
Keywords: Reactogenicity Safety Respiratory syncytial virus (RSV) Vaccine Immunogenicity
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 73
Healthy volunteers: yes

Brief summary:
The purpose of this first time in human (FTiH) study is to assess the safety, reactogenicity and immunogenicity of 2 doses of the RSV investigational vaccine, when administered intramuscularly according to a 0, 1 month schedule, in healthy adults aged 18 to 45 years.

Detailed description:

Arms:
arm 1: Subjects in this group will receive 2 doses, one month apart of the GSK3389245A vaccine low dose arm 2: Subjects in this group will receive 2 doses, one month apart, of the GSK3389245A vaccine high dose arm 3: Subjects in this group will receive 2 doses, one month apart, of Bexsero arm 4: Subjects in this group will receive 2 doses, one month apart, of placebo

Interventions: intervention 1: GSK3389245A_LD GROUP intervention 2: GSK3389245A_HD GROUP intervention 3: Bexsero intervention 4: Placebo
Intervention descriptions: intervention 1: 2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm intervention 2: 2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm intervention 3: 2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm intervention 4: 2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm

Protocol document: