{"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"0"}],"units":"Participants"}],"description":"An Enzyme-Linked Immunosorbent Spot (ELISPOT) assay was planned to be used to demonstrate a cell mediated immune response to V935 and/or V934 in vaccinated participants. Collection of Peripheral Blood Mononuclear Cells (PBMCs) and serum took place at baseline (Screening and pre-vaccination Day 1), and various time points post vaccination across the three distinct regimens to be tested. A positive immune response was to be defined by a minimum number of spot-forming cells per million PBMC (SFC/10\\^6 PBMCs) for the antigen well and a minimum n-fold increase in the antigen well over the control well.","groups":[{"description":"Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.","id":"OG000","title":"Part A: V935 LD"},{"description":"Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.","id":"OG001","title":"Part A: V934 LD(3)+V935 LD"},{"description":"Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.","id":"OG002","title":"Part A: V935 HD"},{"description":"Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.","id":"OG003","title":"Part A: V934 HD(3)+V935 HD"},{"description":"Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.","id":"OG004","title":"Part A: V934 HD(5)+V935 HD"},{"description":"Participants who completed Part A could enter Part B. Following a 12-week observation, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.","id":"OG005","title":"Part B: V935 LD/V934 Booster"},{"description":"Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.","id":"OG006","title":"Part B: V934 LD(3)+V935 LD/V934 Booster"},{"description":"Participants who completed Part A could enter Part B. Following a 12-week observation period, V934-EP booster was administered, 1 given every 2 weeks for 3 doses.","id":"OG007","title":"Part B: V935 HD/V934 Booster"},{"description":"Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.","id":"OG008","title":"Part B: V934 HD(3)+V935 HD/V934 Booster"},{"description":"Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.","id":"OG009","title":"Part B: V934 HD(5)+V935 HD/V934 Booster"}],"populationDescription":"Planned analysis for the secondary endpoint of Immunologic Response Rate was not performed due to study de-prioritization.","reportingStatus":"POSTED","timeFrame":"From pre-vaccination to Week 69","title":"Number of Participants With Immunologic Response to V934/V935 (Immunologic Response Rate)","type":"SECONDARY"}