Trial Outcomes & Findings for RSV-MVA-BN Vaccine Phase II Trial in ≥ 55 Year Old Adults (NCT NCT02873286)

NCT ID: NCT02873286

Last Updated: 2020-09-22

Results Overview

Geometric Mean Titers (GMTs) based on RSV-specific Plaque Reduction Neutralization Test (PRNT; against subtype A). Titers below the detection limit (DL) are included with a value of '10' (i.e. 1/2 DL)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 420 participants
• Primary outcome timeframe: Week 6 (Main Study) i.e., 2 weeks following the second vaccination
• Results posted on: 2020-09-22

Participant Flow

Participant milestones

Measure	Group 1 - Single Low Dose / Booster First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 3 - Single High Dose / Booster First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
Main Study STARTED	78	89	80	90	83
Main Study COMPLETED	76	84	78	89	81
Main Study NOT COMPLETED	2	5	2	1	2
Booster Substudy STARTED	43	0	45	0	0
Booster Substudy COMPLETED	43	0	45	0	0
Booster Substudy NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

RSV-MVA-BN Vaccine Phase II Trial in ≥ 55 Year Old Adults

Baseline characteristics by cohort

Measure	Group 1 - Single Low Dose / Booster n=78 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses n=89 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 3 - Single High Dose / Booster n=80 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses n=90 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo n=83 Participants First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)	Total n=420 Participants Total of all reporting groups
Age, Continuous	65.1 years STANDARD_DEVIATION 8.09 • n=5 Participants	64.8 years STANDARD_DEVIATION 7.78 • n=7 Participants	65.3 years STANDARD_DEVIATION 7.18 • n=5 Participants	65.0 years STANDARD_DEVIATION 7.93 • n=4 Participants	65.6 years STANDARD_DEVIATION 7.20 • n=21 Participants	65.2 years STANDARD_DEVIATION 7.62 • n=8 Participants
Age, Customized 55 to 69 years	53 Participants n=5 Participants	61 Participants n=7 Participants	56 Participants n=5 Participants	63 Participants n=4 Participants	56 Participants n=21 Participants	289 Participants n=8 Participants
Age, Customized >=70 years	25 Participants n=5 Participants	28 Participants n=7 Participants	24 Participants n=5 Participants	27 Participants n=4 Participants	27 Participants n=21 Participants	131 Participants n=8 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	56 Participants n=7 Participants	49 Participants n=5 Participants	59 Participants n=4 Participants	48 Participants n=21 Participants	259 Participants n=8 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	33 Participants n=7 Participants	31 Participants n=5 Participants	31 Participants n=4 Participants	35 Participants n=21 Participants	161 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	7 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants	1 Participants n=21 Participants	16 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	75 Participants n=5 Participants	82 Participants n=7 Participants	79 Participants n=5 Participants	86 Participants n=4 Participants	82 Participants n=21 Participants	404 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	15 Participants n=7 Participants	14 Participants n=5 Participants	21 Participants n=4 Participants	11 Participants n=21 Participants	70 Participants n=8 Participants
Race (NIH/OMB) White	69 Participants n=5 Participants	69 Participants n=7 Participants	66 Participants n=5 Participants	69 Participants n=4 Participants	71 Participants n=21 Participants	344 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Region of Enrollment United States	78 participants n=5 Participants	89 participants n=7 Participants	80 participants n=5 Participants	90 participants n=4 Participants	83 participants n=21 Participants	420 participants n=8 Participants

PRIMARY outcome

Timeframe: Week 6 (Main Study) i.e., 2 weeks following the second vaccination

Population: Full Analysis Set i.e. all participants who received at least one vaccination in the main study. Calculations based on participants with data available for this outcome.

Geometric Mean Titers (GMTs) based on RSV-specific Plaque Reduction Neutralization Test (PRNT; against subtype A). Titers below the detection limit (DL) are included with a value of '10' (i.e. 1/2 DL)

Outcome measures

Measure	Group 3 - Single High Dose / Booster n=78 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses n=90 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo n=81 Participants First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)	Group 1 - Single Low Dose / Booster n=76 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses n=84 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
PRNT (Subtype A) GMT	311.9 Titer Interval 261.7 to 371.7	373.3 Titer Interval 320.9 to 434.2	229.3 Titer Interval 195.2 to 269.4	300.5 Titer Interval 251.7 to 358.6	278.9 Titer Interval 239.2 to 325.2

SECONDARY outcome

Timeframe: within 108 weeks

Population: Full Analysis Set i.e. all participants who received at least one vaccination in the main study. A subset of participants from groups 1 and 3 entered the booster substudy.

Geometric Mean Titers (GMTs) based on RSV-specific Plaque Reduction Neutralization Test (PRNT; against subtype A). Individual peak is defined as the maximum post-Baseline antibody titer up to the end of the respective active trial phase i.e., within 8 weeks for the main study and within 4 weeks for the booster substudy. Titers below the detection limit (DL) are included with a value of '10' (i.e. 1/2 DL)

Outcome measures

Measure	Group 3 - Single High Dose / Booster n=80 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses n=90 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo n=83 Participants First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)	Group 1 - Single Low Dose / Booster n=78 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses n=89 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
PRNT (Subtype A) GMT Week 4 (Main Study)	342.5 Titer Interval 287.5 to 408.1	347.7 Titer Interval 296.9 to 407.2	252.7 Titer Interval 214.2 to 298.0	307.5 Titer Interval 259.0 to 365.2	258.2 Titer Interval 218.6 to 304.9
PRNT (Subtype A) GMT Week 6 (Main Study)	311.9 Titer Interval 261.7 to 371.7	373.3 Titer Interval 320.9 to 434.2	229.3 Titer Interval 195.2 to 269.4	300.5 Titer Interval 251.7 to 358.6	278.9 Titer Interval 239.2 to 325.2
PRNT (Subtype A) GMT Week 68 (Booster Follow-Up 1)	235.9 Titer Interval 195.6 to 284.5	—	—	287.9 Titer Interval 231.3 to 358.4	—
PRNT (Subtype A) GMT Week 0 (Main Study)	234.9 Titer Interval 200.4 to 275.3	276.4 Titer Interval 235.9 to 323.9	251.7 Titer Interval 213.7 to 296.6	256.4 Titer Interval 214.2 to 307.0	208.0 Titer Interval 180.0 to 240.3
PRNT (Subtype A) GMT Week 2 (Main Study)	356.9 Titer Interval 298.8 to 426.4	398.8 Titer Interval 340.8 to 466.6	235.0 Titer Interval 202.1 to 273.2	316.7 Titer Interval 266.3 to 376.6	259.8 Titer Interval 222.5 to 303.4
PRNT (Subtype A) GMT Week 82 (Booster Follow-Up 2)	333.9 Titer Interval 271.4 to 411.0	—	—	405.8 Titer Interval 312.0 to 527.7	—
PRNT (Subtype A) GMT Week 8 (Main Study)	304.0 Titer Interval 251.8 to 367.1	370.9 Titer Interval 316.3 to 434.9	231.5 Titer Interval 197.4 to 271.6	292.0 Titer Interval 246.6 to 345.7	263.9 Titer Interval 226.9 to 306.9
PRNT (Subtype A) GMT Individual Peak (Main Study)	450.1 Titer Interval 371.5 to 545.4	483.7 Titer Interval 412.5 to 567.2	309.9 Titer Interval 267.7 to 358.7	381.7 Titer Interval 321.0 to 453.8	334.8 Titer Interval 287.0 to 390.6
PRNT (Subtype A) GMT Week 16 (Follow-Up 1)	275.5 Titer Interval 231.1 to 328.6	336.5 Titer Interval 285.5 to 396.7	242.9 Titer Interval 204.9 to 287.8	288.7 Titer Interval 236.5 to 352.4	261.3 Titer Interval 222.9 to 306.4
PRNT (Subtype A) GMT Week 108 (Booster Follow-Up 3)	258.1 Titer Interval 210.6 to 316.4	—	—	296.2 Titer Interval 235.1 to 373.1	—
PRNT (Subtype A) GMT Week 30 (Follow-Up 2)	228.2 Titer Interval 193.8 to 268.5	266.7 Titer Interval 228.6 to 311.1	202.2 Titer Interval 172.4 to 237.1	244.0 Titer Interval 202.6 to 293.7	205.4 Titer Interval 175.5 to 240.5
PRNT (Subtype A) GMT Week 56 (Booster Substudy)	264.2 Titer Interval 218.9 to 318.9	—	—	285.6 Titer Interval 228.4 to 357.1	—
PRNT (Subtype A) GMT Week 58 (Booster Substudy)	286.0 Titer Interval 236.0 to 346.7	—	—	351.9 Titer Interval 275.4 to 449.7	—
PRNT (Subtype A) GMT Week 60 (Booster Substudy)	341.2 Titer Interval 281.0 to 414.3	—	—	402.1 Titer Interval 323.9 to 499.2	—
PRNT (Subtype A) GMT Individual Peak (Booster Substudy)	358.6 Titer Interval 296.9 to 433.1	—	—	424.3 Titer Interval 339.6 to 530.3	—

SECONDARY outcome

Timeframe: within 108 weeks

Population: Full Analysis Set i.e. all participants who received at least one vaccination in the main study. Percentages based on number of subjects with paired data available, i.e. number of subjects with results available for the respective time point and the corresponding Baseline. A subset of participants from groups 1 and 3 entered the booster substudy.

Response rate based on RSV-specific Plaque Reduction Neutralization Test (PRNT; against subtype A). Response is defined as the appearance of antibody titers ≥ detection limit (20) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Individual peak response rate is based on the maximum post-Baseline antibody titer up to the end of the respective active trial phase i.e., within 8 weeks for the main study and within 4 weeks for the booster substudy. Percentages based on number of subjects with data available.

Outcome measures

Measure	Group 3 - Single High Dose / Booster n=79 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses n=90 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo n=82 Participants First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)	Group 1 - Single Low Dose / Booster n=78 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses n=88 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
Percentage of Participants With Response by PRNT (Subtype A) Week 2 (Main Study)	27.8 percentage of subjects Interval 18.3 to 39.1	23.3 percentage of subjects Interval 15.1 to 33.4	3.7 percentage of subjects Interval 0.8 to 10.3	10.3 percentage of subjects Interval 4.5 to 19.2	9.2 percentage of subjects Interval 4.1 to 17.3
Percentage of Participants With Response by PRNT (Subtype A) Week 4 (Main Study)	25.6 percentage of subjects Interval 16.4 to 36.8	8.9 percentage of subjects Interval 3.9 to 16.8	1.2 percentage of subjects Interval 0.0 to 6.6	13.3 percentage of subjects Interval 6.6 to 23.2	11.9 percentage of subjects Interval 5.9 to 20.8
Percentage of Participants With Response by PRNT (Subtype A) Week 6 (Main Study)	19.2 percentage of subjects Interval 11.2 to 29.7	15.6 percentage of subjects Interval 8.8 to 24.7	4.9 percentage of subjects Interval 1.4 to 12.2	9.2 percentage of subjects Interval 3.8 to 18.1	15.5 percentage of subjects Interval 8.5 to 25.0
Percentage of Participants With Response by PRNT (Subtype A) Week 8 (Main Study)	15.2 percentage of subjects Interval 8.1 to 25.0	14.6 percentage of subjects Interval 8.0 to 23.7	1.2 percentage of subjects Interval 0.0 to 6.7	7.8 percentage of subjects Interval 2.9 to 16.2	10.6 percentage of subjects Interval 5.0 to 19.2
Percentage of Participants With Response by PRNT (Subtype A) Individual Peak (Main Study)	41.3 percentage of subjects Interval 30.4 to 52.8	34.4 percentage of subjects Interval 24.7 to 45.2	7.3 percentage of subjects Interval 2.7 to 15.2	23.1 percentage of subjects Interval 14.3 to 34.0	25.0 percentage of subjects Interval 16.4 to 35.4
Percentage of Participants With Response by PRNT (Subtype A) Week 16 (Follow-Up 1)	10.4 percentage of subjects Interval 4.6 to 19.4	10.1 percentage of subjects Interval 4.7 to 18.3	4.9 percentage of subjects Interval 1.4 to 12.2	9.1 percentage of subjects Interval 3.7 to 17.8	8.3 percentage of subjects Interval 3.4 to 16.4
Percentage of Participants With Response by PRNT (Subtype A) Week 30 (Follow-Up 2)	3.9 percentage of subjects Interval 0.8 to 11.1	2.3 percentage of subjects Interval 0.3 to 8.0	3.7 percentage of subjects Interval 0.8 to 10.3	1.3 percentage of subjects Interval 0.0 to 7.2	7.2 percentage of subjects Interval 2.7 to 15.1
Percentage of Participants With Response by PRNT (Subtype A) Week 58 (Booster Substudy)	4.4 percentage of subjects Interval 0.5 to 15.1	—	—	17.1 percentage of subjects Interval 7.2 to 32.1	—
Percentage of Participants With Response by PRNT (Subtype A) Week 60 (Booster Substudy)	11.1 percentage of subjects Interval 3.7 to 24.1	—	—	19.5 percentage of subjects Interval 8.8 to 34.9	—
Percentage of Participants With Response by PRNT (Subtype A) Individual Peak (Booster Substudy)	15.6 percentage of subjects Interval 6.5 to 29.5	—	—	22.0 percentage of subjects Interval 10.6 to 37.6	—
Percentage of Participants With Response by PRNT (Subtype A) Week 68 (Booster Follow-Up 1)	0.0 percentage of subjects Interval 0.0 to 7.9	—	—	2.4 percentage of subjects Interval 0.1 to 12.9	—
Percentage of Participants With Response by PRNT (Subtype A) Week 82 (Booster Follow-Up 2)	13.3 percentage of subjects Interval 5.1 to 26.8	—	—	22.0 percentage of subjects Interval 10.6 to 37.6	—
Percentage of Participants With Response by PRNT (Subtype A) Week 108 (Booster Follow-Up 3)	4.5 percentage of subjects Interval 0.6 to 15.5	—	—	2.4 percentage of subjects Interval 0.1 to 12.9	—

SECONDARY outcome

Timeframe: within 108 weeks

Population: Full Analysis Set i.e. all participants who received at least one vaccination in the main study. A subset of participants from groups 1 and 3 entered the booster substudy.

Geometric Mean Titers (GMTs) based on RSV-specific Plaque Reduction Neutralization Test (PRNT; against subtype B). Individual peak is defined as the maximum post-Baseline antibody titer up to the end of the respective active trial phase i.e., within 8 weeks for the main study and within 4 weeks for the booster substudy. Titers below the detection limit (DL) are included with a value of '10' (i.e. 1/2 DL)

Outcome measures

Measure	Group 3 - Single High Dose / Booster n=80 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses n=90 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo n=83 Participants First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)	Group 1 - Single Low Dose / Booster n=78 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses n=89 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
PRNT (Subtype B) GMT Week 2 (Main Study)	688.6 Titer Interval 528.6 to 896.9	638.2 Titer Interval 510.9 to 797.3	441.4 Titer Interval 331.6 to 587.6	517.7 Titer Interval 407.4 to 657.9	464.5 Titer Interval 363.7 to 593.3
PRNT (Subtype B) GMT Week 0 (Main Study)	426.9 Titer Interval 331.7 to 549.4	498.6 Titer Interval 395.6 to 628.5	477.5 Titer Interval 361.3 to 630.9	424.3 Titer Interval 332.0 to 542.2	364.9 Titer Interval 285.6 to 466.2
PRNT (Subtype B) GMT Week 4 (Main Study)	635.9 Titer Interval 490.6 to 824.1	570.0 Titer Interval 453.6 to 716.3	431.5 Titer Interval 325.3 to 572.4	485.8 Titer Interval 385.9 to 611.4	458.8 Titer Interval 355.3 to 592.6
PRNT (Subtype B) GMT Week 6 (Main Study)	615.1 Titer Interval 468.9 to 806.8	674.3 Titer Interval 544.9 to 834.4	454.0 Titer Interval 340.7 to 605.0	506.1 Titer Interval 395.0 to 648.4	507.4 Titer Interval 396.4 to 649.6
PRNT (Subtype B) GMT Week 8 (Main Study)	670.1 Titer Interval 505.4 to 888.5	610.2 Titer Interval 492.5 to 756.0	465.3 Titer Interval 351.8 to 615.5	509.0 Titer Interval 398.4 to 650.5	483.5 Titer Interval 379.5 to 615.9
PRNT (Subtype B) GMT Individual Peak (Main Study)	932.3 Titer Interval 702.7 to 1236.9	858.0 Titer Interval 689.2 to 1068.0	614.6 Titer Interval 462.0 to 817.8	672.2 Titer Interval 531.5 to 850.2	639.7 Titer Interval 503.1 to 813.3
PRNT (Subtype B) GMT Week 16 (Follow-Up 1)	639.0 Titer Interval 499.4 to 817.7	635.6 Titer Interval 517.1 to 781.1	515.6 Titer Interval 394.3 to 674.3	577.8 Titer Interval 457.1 to 730.5	505.7 Titer Interval 403.4 to 634.0
PRNT (Subtype B) GMT Week 30 (Follow-Up 2)	606.1 Titer Interval 479.9 to 765.3	583.2 Titer Interval 471.2 to 721.9	518.1 Titer Interval 398.7 to 673.3	570.6 Titer Interval 453.7 to 717.6	458.1 Titer Interval 361.9 to 579.8
PRNT (Subtype B) GMT Week 56 (Booster Substudy)	584.5 Titer Interval 423.4 to 806.9	—	—	561.0 Titer Interval 395.7 to 795.3	—
PRNT (Subtype B) GMT Week 58 (Booster Substudy)	954.8 Titer Interval 702.8 to 1297.0	—	—	894.1 Titer Interval 656.2 to 1218.2	—
PRNT (Subtype B) GMT Week 60 (Booster Substudy)	804.2 Titer Interval 585.9 to 1103.9	—	—	761.7 Titer Interval 561.4 to 1033.4	—
PRNT (Subtype B) GMT Individual Peak (Booster Substudy)	1031.2 Titer Interval 755.2 to 1407.9	—	—	992.5 Titer Interval 730.1 to 1349.2	—
PRNT (Subtype B) GMT Week 68 (Booster Follow-Up 1)	686.7 Titer Interval 509.1 to 926.4	—	—	632.2 Titer Interval 470.4 to 849.5	—
PRNT (Subtype B) GMT Week 82 (Booster Follow-Up 2)	782.3 Titer Interval 581.8 to 1051.9	—	—	759.0 Titer Interval 561.3 to 1026.5	—
PRNT (Subtype B) GMT Week 108 (Booster Follow-Up 3)	669.4 Titer Interval 493.7 to 907.6	—	—	599.7 Titer Interval 448.8 to 801.3	—

SECONDARY outcome

Timeframe: within 108 weeks

Population: Full Analysis Set i.e. all participants who received at least one vaccination in the main study. Percentages based on number of subjects with paired data available, i.e. number of subjects with results available for the respective time point and the corresponding Baseline. A subset of participants from groups 1 and 3 entered the booster substudy.

Response rate based on RSV-specific Plaque Reduction Neutralization Test (PRNT; against subtype B). Response is defined as the appearance of antibody titers ≥ detection limit (20) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Individual peak response rate is based on the maximum post-Baseline antibody titer up to the end of the respective active trial phase i.e., within 8 weeks for the main study and within 4 weeks for the booster substudy. Percentages based on number of subjects with data available.

Outcome measures

Measure	Group 3 - Single High Dose / Booster n=79 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses n=90 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo n=82 Participants First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)	Group 1 - Single Low Dose / Booster n=78 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses n=88 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
Percentage of Participants With Response by PRNT (Subtype B) Week 2 (Main Study)	26.6 percentage of subjects Interval 17.3 to 37.7	14.4 percentage of subjects Interval 7.9 to 23.4	2.4 percentage of subjects Interval 0.3 to 8.5	12.8 percentage of subjects Interval 6.3 to 22.3	18.4 percentage of subjects Interval 10.9 to 28.1
Percentage of Participants With Response by PRNT (Subtype B) Week 4 (Main Study)	29.5 percentage of subjects Interval 19.7 to 40.9	11.1 percentage of subjects Interval 5.5 to 19.5	2.4 percentage of subjects Interval 0.3 to 8.5	9.3 percentage of subjects Interval 3.8 to 18.3	14.3 percentage of subjects Interval 7.6 to 23.6
Percentage of Participants With Response by PRNT (Subtype B) Week 6 (Main Study)	24.4 percentage of subjects Interval 15.3 to 35.4	21.1 percentage of subjects Interval 13.2 to 31.0	4.9 percentage of subjects Interval 1.4 to 12.2	10.5 percentage of subjects Interval 4.7 to 19.7	21.4 percentage of subjects Interval 13.2 to 31.7
Percentage of Participants With Response by PRNT (Subtype B) Week 8 (Main Study)	26.6 percentage of subjects Interval 17.3 to 37.7	14.6 percentage of subjects Interval 8.0 to 23.7	2.5 percentage of subjects Interval 0.3 to 8.6	15.6 percentage of subjects Interval 8.3 to 25.6	11.8 percentage of subjects Interval 5.8 to 20.6
Percentage of Participants With Response by PRNT (Subtype B) Individual Peak (Main Study)	45.0 percentage of subjects Interval 33.8 to 56.5	34.4 percentage of subjects Interval 24.7 to 45.2	9.8 percentage of subjects Interval 4.3 to 18.3	25.6 percentage of subjects Interval 16.4 to 36.8	34.1 percentage of subjects Interval 24.3 to 45.0
Percentage of Participants With Response by PRNT (Subtype B) Week 16 (Follow-Up 1)	22.1 percentage of subjects Interval 13.4 to 33.0	13.5 percentage of subjects Interval 7.2 to 22.4	7.4 percentage of subjects Interval 2.8 to 15.4	11.7 percentage of subjects Interval 5.5 to 21.0	20.2 percentage of subjects Interval 12.3 to 30.4
Percentage of Participants With Response by PRNT (Subtype B) Week 30 (Follow-Up 2)	21.1 percentage of subjects Interval 12.5 to 31.9	11.4 percentage of subjects Interval 5.6 to 19.9	11.0 percentage of subjects Interval 5.1 to 19.8	20.0 percentage of subjects Interval 11.6 to 30.8	13.3 percentage of subjects Interval 6.8 to 22.5
Percentage of Participants With Response by PRNT (Subtype B) Week 58 (Booster Substudy)	33.3 percentage of subjects Interval 20.0 to 49.0	—	—	39.0 percentage of subjects Interval 24.2 to 55.5	—
Percentage of Participants With Response by PRNT (Subtype B) Week 60 (Booster Substudy)	20.0 percentage of subjects Interval 9.6 to 34.6	—	—	17.1 percentage of subjects Interval 7.2 to 32.1	—
Percentage of Participants With Response by PRNT (Subtype B) Individual Peak (Booster Substudy)	35.6 percentage of subjects Interval 21.9 to 51.2	—	—	39.0 percentage of subjects Interval 24.2 to 55.5	—
Percentage of Participants With Response by PRNT (Subtype B) Week 68 (Booster Follow-Up 1)	11.1 percentage of subjects Interval 3.7 to 24.1	—	—	14.6 percentage of subjects Interval 5.6 to 29.2	—
Percentage of Participants With Response by PRNT (Subtype B) Week 82 (Booster Follow-Up 2)	17.8 percentage of subjects Interval 8.0 to 32.1	—	—	19.5 percentage of subjects Interval 8.8 to 34.9	—
Percentage of Participants With Response by PRNT (Subtype B) Week 108 (Booster Follow-Up 3)	9.1 percentage of subjects Interval 2.5 to 21.7	—	—	4.9 percentage of subjects Interval 0.6 to 16.5	—

SECONDARY outcome

Timeframe: within 108 weeks

Population: Full Analysis Set i.e. all participants who received at least one vaccination in the main study. A subset of participants from groups 1 and 3 entered the booster substudy.

Geometric Mean Titers (GMTs) based on RSV-specific Immunoglobulin G (IgG) Enzyme-linked Immunosorbent Assay (ELISA). Individual peak is defined as the maximum post-Baseline antibody titer up to the end of the respective active trial phase i.e., within 8 weeks for the main study and within 4 weeks for the booster substudy. Titers below the detection limit (DL) are included with a value of '31.5' (i.e. 1/2 DL)

Outcome measures

Measure	Group 3 - Single High Dose / Booster n=80 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses n=90 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo n=83 Participants First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)	Group 1 - Single Low Dose / Booster n=78 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses n=89 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
ELISA (IgG) GMT Week 16 (Follow-Up 1)	3294.5 Titer Interval 2906.5 to 3734.2	3950.8 Titer Interval 3519.2 to 4435.3	2117.1 Titer Interval 1815.8 to 2468.3	2833.4 Titer Interval 2489.8 to 3224.3	2965.0 Titer Interval 2609.3 to 3369.3
ELISA (IgG) GMT Week 30 (Follow-Up 2)	2796.5 Titer Interval 2416.3 to 3236.6	3023.4 Titer Interval 2682.7 to 3407.3	1777.6 Titer Interval 1513.1 to 2088.4	2162.3 Titer Interval 1885.3 to 2480.2	2107.5 Titer Interval 1825.7 to 2432.7
ELISA (IgG) GMT Week 56 (Booster Substudy)	2816.4 Titer Interval 2406.9 to 3295.5	—	—	2501.8 Titer Interval 2145.8 to 2916.8	—
ELISA (IgG) GMT Week 58 (Booster Substudy)	4261.7 Titer Interval 3532.7 to 5141.1	—	—	3878.2 Titer Interval 3263.2 to 4609.1	—
ELISA (IgG) GMT Week 60 (Booster Substudy)	4368.3 Titer Interval 3622.1 to 5268.2	—	—	4139.6 Titer Interval 3466.7 to 4943.2	—
ELISA (IgG) GMT Individual Peak (Booster Substudy)	4788.9 Titer Interval 3970.0 to 5776.8	—	—	4445.5 Titer Interval 3730.1 to 5298.1	—
ELISA (IgG) GMT Week 68 (Booster Follow-Up 1)	3250.5 Titer Interval 2652.3 to 3983.6	—	—	3031.5 Titer Interval 2489.7 to 3691.2	—
ELISA (IgG) GMT Week 82 (Booster Follow-Up 2)	2754.0 Titer Interval 2335.0 to 3248.1	—	—	2568.9 Titer Interval 2169.2 to 3042.3	—
ELISA (IgG) GMT Week 108 (Booster Follow-Up 3)	2260.0 Titer Interval 1893.7 to 2697.0	—	—	2083.1 Titer Interval 1761.6 to 2463.4	—
ELISA (IgG) GMT Week 0 (Main Study)	1636.1 Titer Interval 1421.9 to 1882.6	1819.5 Titer Interval 1595.2 to 2075.2	1672.2 Titer Interval 1480.7 to 1888.4	1578.4 Titer Interval 1394.0 to 1787.3	1488.6 Titer Interval 1322.4 to 1675.8
ELISA (IgG) GMT Week 2 (Main Study)	3773.6 Titer Interval 3212.8 to 4432.4	3639.5 Titer Interval 3212.7 to 4122.9	1674.3 Titer Interval 1486.8 to 1885.5	2506.9 Titer Interval 2221.3 to 2829.3	2460.0 Titer Interval 2172.9 to 2785.0
ELISA (IgG) GMT Week 4 (Main Study)	3884.6 Titer Interval 3336.2 to 4523.2	3697.0 Titer Interval 3257.6 to 4195.7	1747.3 Titer Interval 1550.1 to 1969.6	2599.9 Titer Interval 2299.0 to 2940.2	2559.9 Titer Interval 2233.4 to 2934.2
ELISA (IgG) GMT Week 6 (Main Study)	3864.3 Titer Interval 3348.1 to 4460.2	4270.0 Titer Interval 3753.4 to 4857.7	1766.6 Titer Interval 1536.0 to 2031.8	2671.0 Titer Interval 2365.5 to 3015.9	2964.1 Titer Interval 2601.4 to 3377.2
ELISA (IgG) GMT Week 8 (Main Study)	3773.6 Titer Interval 3278.4 to 4343.6	4283.2 Titer Interval 3790.3 to 4840.2	1844.6 Titer Interval 1603.1 to 2122.5	2653.4 Titer Interval 2309.5 to 3048.5	2960.1 Titer Interval 2592.8 to 3379.4
ELISA (IgG) GMT Individual Peak (Main Study)	4824.0 Titer Interval 4161.9 to 5591.4	5061.4 Titer Interval 4493.0 to 5701.8	2207.2 Titer Interval 1926.4 to 2528.8	3266.2 Titer Interval 2878.5 to 3706.1	3412.2 Titer Interval 3001.8 to 3878.8

SECONDARY outcome

Timeframe: within 108 weeks

Population: Full Analysis Set i.e. all participants who received at least one vaccination in the main study. Percentages based on number of subjects with paired data available, i.e. number of subjects with results available for the respective time point and the corresponding Baseline. A subset of participants from groups 1 and 3 entered the booster substudy.

Response rate based on RSV-specific Immunoglobulin G (IgG) Enzyme-linked Immunosorbent Assay (ELISA). Response is defined as the appearance of antibody titers ≥ detection limit (63) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Individual peak response rate is based on the maximum post-Baseline antibody titer up to the end of the respective active trial phase i.e., within 8 weeks for the main study and within 4 weeks for the booster substudy. Percentages based on number of subjects with data available.

Outcome measures

Measure	Group 3 - Single High Dose / Booster n=79 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses n=90 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo n=82 Participants First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)	Group 1 - Single Low Dose / Booster n=78 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses n=88 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
Percentage of Participants With Response by IgG ELISA Week 2 (Main Study)	51.9 percentage of subjects Interval 40.4 to 63.3	44.4 percentage of subjects Interval 34.0 to 55.3	0.0 percentage of subjects Interval 0.0 to 4.4	21.8 percentage of subjects Interval 13.2 to 32.6	19.5 percentage of subjects Interval 11.8 to 29.4
Percentage of Participants With Response by IgG ELISA Week 4 (Main Study)	60.3 percentage of subjects Interval 48.5 to 71.2	46.7 percentage of subjects Interval 36.1 to 57.5	2.4 percentage of subjects Interval 0.3 to 8.5	24.0 percentage of subjects Interval 14.9 to 35.3	27.4 percentage of subjects Interval 18.2 to 38.2
Percentage of Participants With Response by IgG ELISA Week 6 (Main Study)	55.1 percentage of subjects Interval 43.4 to 66.4	58.9 percentage of subjects Interval 48.0 to 69.2	2.5 percentage of subjects Interval 0.3 to 8.6	28.9 percentage of subjects Interval 19.1 to 40.5	39.3 percentage of subjects Interval 28.8 to 50.5
Percentage of Participants With Response by IgG ELISA Week 8 (Main Study)	54.4 percentage of subjects Interval 42.8 to 65.7	59.6 percentage of subjects Interval 48.6 to 69.8	1.2 percentage of subjects Interval 0.0 to 6.7	29.9 percentage of subjects Interval 20.0 to 41.4	40.0 percentage of subjects Interval 29.5 to 51.2
Percentage of Participants With Response by IgG ELISA Individual Peak (Main Study)	70.0 percentage of subjects Interval 58.7 to 79.7	71.1 percentage of subjects Interval 60.6 to 80.2	4.9 percentage of subjects Interval 1.3 to 12.0	42.3 percentage of subjects Interval 31.2 to 54.0	53.4 percentage of subjects Interval 42.5 to 64.1
Percentage of Participants With Response by IgG ELISA Week 16 (Follow-Up 1)	45.5 percentage of subjects Interval 34.1 to 57.2	51.7 percentage of subjects Interval 40.8 to 62.4	7.4 percentage of subjects Interval 2.8 to 15.4	29.9 percentage of subjects Interval 20.0 to 41.4	44.0 percentage of subjects Interval 33.2 to 55.3
Percentage of Participants With Response by IgG ELISA Week 30 (Follow-Up 2)	28.9 percentage of subjects Interval 19.1 to 40.5	26.1 percentage of subjects Interval 17.3 to 36.6	7.3 percentage of subjects Interval 2.7 to 15.2	13.3 percentage of subjects Interval 6.6 to 23.2	14.5 percentage of subjects Interval 7.7 to 23.9
Percentage of Participants With Response by IgG ELISA Week 58 (Booster Substudy)	22.2 percentage of subjects Interval 11.2 to 37.1	—	—	22.0 percentage of subjects Interval 10.6 to 37.6	—
Percentage of Participants With Response by IgG ELISA Week 60 (Booster Substudy)	17.8 percentage of subjects Interval 8.0 to 32.1	—	—	19.5 percentage of subjects Interval 8.8 to 34.9	—
Percentage of Participants With Response by IgG ELISA Individual Peak (Booster Substudy)	28.9 percentage of subjects Interval 16.4 to 44.3	—	—	24.4 percentage of subjects Interval 12.4 to 40.3	—
Percentage of Participants With Response by IgG ELISA Week 68 (Booster Follow-Up 1)	13.3 percentage of subjects Interval 5.1 to 26.8	—	—	9.8 percentage of subjects Interval 2.7 to 23.1	—
Percentage of Participants With Response by IgG ELISA Week 82 (Booster Follow-Up 2)	4.4 percentage of subjects Interval 0.5 to 15.1	—	—	4.9 percentage of subjects Interval 0.6 to 16.5	—
Percentage of Participants With Response by IgG ELISA Week 108 (Booster Follow-Up 3)	4.5 percentage of subjects Interval 0.6 to 15.5	—	—	0.0 percentage of subjects Interval 0.0 to 8.6	—

SECONDARY outcome

Timeframe: within 108 weeks

Population: Full Analysis Set i.e. all participants who received at least one vaccination in the main study. A subset of participants from groups 1 and 3 entered the booster substudy.

Geometric Mean Titers (GMTs) based on RSV-specific Immunoglobulin A (IgA) Enzyme-linked Immunosorbent Assay (ELISA). Individual peak is defined as the maximum post-Baseline antibody titer up to the end of the respective active trial phase i.e., within 8 weeks for the main study and within 4 weeks for the booster substudy. Titers below the detection limit (DL) are included with a value of '50' (i.e. 1/2 DL)

Outcome measures

Measure	Group 3 - Single High Dose / Booster n=80 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses n=90 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo n=83 Participants First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)	Group 1 - Single Low Dose / Booster n=78 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses n=89 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
ELISA (IgA) GMT Individual Peak (Main Study)	2795.1 Titer Interval 2173.6 to 3594.1	2331.1 Titer Interval 1860.6 to 2920.8	777.0 Titer Interval 601.7 to 1003.5	1511.0 Titer Interval 1195.9 to 1909.1	1696.5 Titer Interval 1336.9 to 2152.8
ELISA (IgA) GMT Week 16 (Follow-Up 1)	1001.6 Titer Interval 786.2 to 1276.1	933.2 Titer Interval 754.0 to 1155.1	573.8 Titer Interval 439.6 to 748.9	745.3 Titer Interval 580.6 to 956.7	709.8 Titer Interval 550.2 to 915.5
ELISA (IgA) GMT Week 0 (Main Study)	776.3 Titer Interval 614.9 to 980.0	623.3 Titer Interval 494.9 to 785.0	585.4 Titer Interval 451.7 to 758.5	581.7 Titer Interval 453.0 to 747.1	591.1 Titer Interval 475.1 to 735.3
ELISA (IgA) GMT Week 2 (Main Study)	2593.6 Titer Interval 2017.9 to 3333.6	1922.8 Titer Interval 1515.9 to 2439.0	619.8 Titer Interval 487.6 to 787.8	1377.7 Titer Interval 1091.6 to 1738.7	1373.3 Titer Interval 1067.2 to 1767.1
ELISA (IgA) GMT Week 4 (Main Study)	1763.0 Titer Interval 1370.6 to 2267.7	1378.1 Titer Interval 1091.0 to 1740.7	614.9 Titer Interval 478.3 to 790.7	1061.3 Titer Interval 813.6 to 1384.5	1120.8 Titer Interval 858.2 to 1463.8
ELISA (IgA) GMT Week 6 (Main Study)	1538.8 Titer Interval 1205.5 to 1964.1	1592.9 Titer Interval 1279.9 to 1982.4	608.8 Titer Interval 462.1 to 802.0	1001.3 Titer Interval 778.6 to 1287.7	1248.3 Titer Interval 958.1 to 1626.4
ELISA (IgA) GMT Week 8 (Main Study)	1459.2 Titer Interval 1137.2 to 1872.4	1367.3 Titer Interval 1071.6 to 1744.6	590.8 Titer Interval 447.9 to 779.4	887.3 Titer Interval 687.6 to 1145.1	1045.1 Titer Interval 808.6 to 1350.9
ELISA (IgA) GMT Week 30 (Follow-Up 2)	1089.5 Titer Interval 887.7 to 1337.2	970.3 Titer Interval 796.6 to 1181.8	676.3 Titer Interval 534.5 to 855.7	675.3 Titer Interval 531.3 to 858.4	743.5 Titer Interval 568.8 to 971.9
ELISA (IgA) GMT Week 56 (Booster Substudy)	719.4 Titer Interval 540.8 to 957.0	—	—	627.3 Titer Interval 437.3 to 899.8	—
ELISA (IgA) GMT Week 58 (Booster Substudy)	1480.5 Titer Interval 1153.1 to 1900.8	—	—	1235.2 Titer Interval 864.0 to 1766.0	—
ELISA (IgA) GMT Week 60 (Booster Substudy)	1099.0 Titer Interval 829.3 to 1456.4	—	—	941.3 Titer Interval 658.9 to 1344.7	—
ELISA (IgA) GMT Individual Peak (Booster Substudy)	1511.0 Titer Interval 1175.0 to 1943.0	—	—	1261.3 Titer Interval 887.5 to 1792.5	—
ELISA (IgA) GMT Week 68 (Booster Follow-Up 1)	853.3 Titer Interval 629.1 to 1157.3	—	—	734.4 Titer Interval 513.4 to 1050.5	—
ELISA (IgA) GMT Week 82 (Booster Follow-Up 2)	838.1 Titer Interval 649.2 to 1081.9	—	—	711.0 Titer Interval 517.8 to 976.2	—
ELISA (IgA) GMT Week 108 (Booster Follow-Up 3)	716.7 Titer Interval 542.0 to 947.7	—	—	619.1 Titer Interval 448.7 to 854.3	—

SECONDARY outcome

Timeframe: within 108 weeks

Population: Full Analysis Set i.e. all participants who received at least one vaccination in the main study. Percentages based on number of subjects with paired data available, i.e. number of subjects with results available for the respective time point and the corresponding Baseline. A subset of participants from groups 1 and 3 entered the booster substudy.

Response rate based on RSV-specific Immunoglobulin A (IgA) Enzyme-linked Immunosorbent Assay (ELISA). Response is defined as the appearance of antibody titers ≥ detection limit (100) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Individual peak response rate is based on the maximum post-Baseline antibody titer up to the end of the respective active trial phase i.e., within 8 weeks for the main study and within 4 weeks for the booster substudy. Percentages based on number of subjects with data available.

Outcome measures

Measure	Group 3 - Single High Dose / Booster n=79 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses n=90 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo n=82 Participants First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)	Group 1 - Single Low Dose / Booster n=78 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses n=88 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
Percentage of Participants With Response by IgA ELISA Week 2 (Main Study)	68.4 percentage of subjects Interval 56.9 to 78.4	70.0 percentage of subjects Interval 59.4 to 79.2	7.3 percentage of subjects Interval 2.7 to 15.2	50.0 percentage of subjects Interval 38.5 to 61.5	51.7 percentage of subjects Interval 40.8 to 62.6
Percentage of Participants With Response by IgA ELISA Week 4 (Main Study)	48.7 percentage of subjects Interval 37.2 to 60.3	52.2 percentage of subjects Interval 41.4 to 62.9	7.3 percentage of subjects Interval 2.7 to 15.2	32.0 percentage of subjects Interval 21.7 to 43.8	36.9 percentage of subjects Interval 26.6 to 48.1
Percentage of Participants With Response by IgA ELISA Week 6 (Main Study)	44.9 percentage of subjects Interval 33.6 to 56.6	62.2 percentage of subjects Interval 51.4 to 72.2	3.7 percentage of subjects Interval 0.8 to 10.4	28.9 percentage of subjects Interval 19.1 to 40.5	46.4 percentage of subjects Interval 35.5 to 57.6
Percentage of Participants With Response by IgA ELISA Week 8 (Main Study)	36.7 percentage of subjects Interval 26.1 to 48.3	51.7 percentage of subjects Interval 40.8 to 62.4	4.9 percentage of subjects Interval 1.4 to 12.2	24.7 percentage of subjects Interval 15.6 to 35.8	37.6 percentage of subjects Interval 27.4 to 48.8
Percentage of Participants With Response by IgA ELISA Individual Peak (Main Study)	72.5 percentage of subjects Interval 61.4 to 81.9	77.8 percentage of subjects Interval 67.8 to 85.9	14.6 percentage of subjects Interval 7.8 to 24.2	53.8 percentage of subjects Interval 42.2 to 65.2	69.3 percentage of subjects Interval 58.6 to 78.7
Percentage of Participants With Response by IgA ELISA Week 16 (Follow-Up 1)	28.6 percentage of subjects Interval 18.8 to 40.0	22.5 percentage of subjects Interval 14.3 to 32.6	8.6 percentage of subjects Interval 3.5 to 17.0	14.3 percentage of subjects Interval 7.4 to 24.1	14.3 percentage of subjects Interval 7.6 to 23.6
Percentage of Participants With Response by IgA ELISA Week 30 (Follow-Up 2)	27.6 percentage of subjects Interval 18.0 to 39.1	30.7 percentage of subjects Interval 21.3 to 41.4	14.6 percentage of subjects Interval 7.8 to 24.2	9.3 percentage of subjects Interval 3.8 to 18.3	22.9 percentage of subjects Interval 14.4 to 33.4
Percentage of Participants With Response by IgA ELISA Week 58 (Booster Substudy)	44.4 percentage of subjects Interval 29.6 to 60.0	—	—	39.0 percentage of subjects Interval 24.2 to 55.5	—
Percentage of Participants With Response by IgA ELISA Week 60 (Booster Substudy)	24.4 percentage of subjects Interval 12.9 to 39.5	—	—	17.1 percentage of subjects Interval 7.2 to 32.1	—
Percentage of Participants With Response by IgA ELISA Individual Peak (Booster Substudy)	44.4 percentage of subjects Interval 29.6 to 60.0	—	—	39.0 percentage of subjects Interval 24.2 to 55.5	—
Percentage of Participants With Response by IgA ELISA Week 68 (Booster Follow-Up 1)	6.7 percentage of subjects Interval 1.4 to 18.3	—	—	7.3 percentage of subjects Interval 1.5 to 19.9	—
Percentage of Participants With Response by IgA ELISA Week 82 (Booster Follow-Up 2)	2.2 percentage of subjects Interval 0.1 to 11.8	—	—	7.3 percentage of subjects Interval 1.5 to 19.9	—
Percentage of Participants With Response by IgA ELISA Week 108 (Booster Follow-Up 3)	0.0 percentage of subjects Interval 0.0 to 8.0	—	—	2.4 percentage of subjects Interval 0.1 to 12.9	—

SECONDARY outcome

Timeframe: within 82 weeks

Population: Full Analysis Set i.e. all participants who received at least one vaccination in the main study. A subset of participants from groups 1 and 3 entered the booster substudy.

Geometric Mean Titers (GMTs) based on mucosal RSV-specific Immunoglobulin A (IgA) Enzyme-linked Immunosorbent Assay (ELISA). Individual peak is defined as the maximum post-Baseline antibody titer up to the end of the respective active trial phase i.e., within 8 weeks for the main study and within 4 weeks for the booster substudy. Titers below the detection limit (DL) are included with a value of '1' (i.e. 1/2 DL)

Outcome measures

Measure	Group 3 - Single High Dose / Booster n=80 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses n=90 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo n=83 Participants First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)	Group 1 - Single Low Dose / Booster n=77 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses n=89 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
ELISA (Mucosal IgA) GMT Week 0 (Main Study)	11.9 Titer Interval 9.7 to 14.6	13.7 Titer Interval 11.4 to 16.6	12.3 Titer Interval 10.1 to 14.8	12.0 Titer Interval 9.8 to 14.6	10.9 Titer Interval 9.4 to 12.5
ELISA (Mucosal IgA) GMT Week 2 (Main Study)	15.7 Titer Interval 13.3 to 18.5	15.2 Titer Interval 12.6 to 18.3	12.0 Titer Interval 9.9 to 14.7	14.1 Titer Interval 11.7 to 17.0	12.1 Titer Interval 10.3 to 14.3
ELISA (Mucosal IgA) GMT Week 4 (Main Study)	14.1 Titer Interval 11.9 to 16.7	15.0 Titer Interval 12.6 to 17.8	12.2 Titer Interval 10.2 to 14.7	13.6 Titer Interval 11.4 to 16.1	13.1 Titer Interval 11.2 to 15.3
ELISA (Mucosal IgA) GMT Week 6 (Main Study)	13.2 Titer Interval 11.0 to 15.7	15.1 Titer Interval 12.7 to 18.1	12.4 Titer Interval 10.1 to 15.2	13.1 Titer Interval 10.9 to 15.7	13.4 Titer Interval 11.3 to 15.8
ELISA (Mucosal IgA) GMT Week 8 (Main Study)	13.1 Titer Interval 10.8 to 15.7	14.6 Titer Interval 12.1 to 17.5	11.2 Titer Interval 9.1 to 13.8	13.5 Titer Interval 11.4 to 15.9	12.6 Titer Interval 10.9 to 14.6
ELISA (Mucosal IgA) GMT Individual Peak (Main Study)	20.5 Titer Interval 17.5 to 24.0	21.4 Titer Interval 18.0 to 25.4	17.3 Titer Interval 14.4 to 20.8	18.6 Titer Interval 15.8 to 21.9	18.0 Titer Interval 15.3 to 21.1
ELISA (Mucosal IgA) GMT Week 16 (Follow-Up 1)	13.2 Titer Interval 10.9 to 16.2	13.0 Titer Interval 10.7 to 15.8	11.7 Titer Interval 9.7 to 14.1	13.0 Titer Interval 10.7 to 15.8	11.9 Titer Interval 10.0 to 14.0
ELISA (Mucosal IgA) GMT Week 30 (Follow-Up 2)	13.4 Titer Interval 11.0 to 16.2	13.6 Titer Interval 11.4 to 16.2	13.1 Titer Interval 10.6 to 16.1	13.1 Titer Interval 11.2 to 15.3	12.1 Titer Interval 10.3 to 14.2
ELISA (Mucosal IgA) GMT Week 56 (Booster Substudy)	11.9 Titer Interval 9.5 to 14.9	—	—	15.6 Titer Interval 12.8 to 19.0	—
ELISA (Mucosal IgA) GMT Week 58 (Booster Substudy)	14.6 Titer Interval 11.6 to 18.3	—	—	15.0 Titer Interval 12.0 to 18.8	—
ELISA (Mucosal IgA) GMT Week 60 (Booster Substudy)	13.8 Titer Interval 11.1 to 17.2	—	—	16.4 Titer Interval 13.4 to 20.1	—
ELISA (Mucosal IgA) GMT Individual Peak (Booster Substudy)	16.5 Titer Interval 13.4 to 20.4	—	—	18.2 Titer Interval 15.1 to 21.9	—
ELISA (Mucosal IgA) GMT Week 68 (Booster Follow-Up 1)	13.3 Titer Interval 10.5 to 16.8	—	—	16.9 Titer Interval 13.8 to 20.6	—
ELISA (Mucosal IgA) GMT Week 82 (Booster Follow-Up 2)	8.4 Titer Interval 6.5 to 11.0	—	—	12.7 Titer Interval 9.6 to 16.6	—

SECONDARY outcome

Timeframe: within 82 weeks

Population: Full Analysis Set i.e. all participants who received at least one vaccination in the main study. Percentages based on number of subjects with paired data available, i.e. number of subjects with results available for the respective time point and the corresponding Baseline. A subset of participants from groups 1 and 3 entered the booster substudy.

Response rate based on mucosal RSV-specific Immunoglobulin A (IgA) Enzyme-linked Immunosorbent Assay (ELISA). Response is defined as the appearance of antibody titers ≥ detection limit (2) for initially negative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially positive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Individual peak response rate is based on the maximum post-Baseline antibody titer up to the end of the respective active trial phase i.e., within 8 weeks for the main study and within 4 weeks for the booster substudy. Percentages based on number of subjects with data available.

Outcome measures

Measure	Group 3 - Single High Dose / Booster n=78 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses n=88 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo n=78 Participants First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)	Group 1 - Single Low Dose / Booster n=76 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses n=87 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
Percentage of Participants With Response by Mucosal IgA ELISA Week 2 (Main Study)	22.4 percentage of subjects Interval 13.6 to 33.4	12.5 percentage of subjects Interval 6.4 to 21.3	5.1 percentage of subjects Interval 1.4 to 12.6	12.2 percentage of subjects Interval 5.7 to 21.8	14.5 percentage of subjects Interval 7.7 to 23.9
Percentage of Participants With Response by Mucosal IgA ELISA Week 4 (Main Study)	13.5 percentage of subjects Interval 6.7 to 23.5	14.0 percentage of subjects Interval 7.4 to 23.1	10.4 percentage of subjects Interval 4.6 to 19.4	14.9 percentage of subjects Interval 7.7 to 25.0	12.7 percentage of subjects Interval 6.2 to 22.0
Percentage of Participants With Response by Mucosal IgA ELISA Week 6 (Main Study)	17.6 percentage of subjects Interval 9.7 to 28.2	16.5 percentage of subjects Interval 9.3 to 26.1	8.1 percentage of subjects Interval 3.0 to 16.8	12.5 percentage of subjects Interval 5.9 to 22.4	17.7 percentage of subjects Interval 10.0 to 27.9
Percentage of Participants With Response by Mucosal IgA ELISA Week 8 (Main Study)	20.0 percentage of subjects Interval 11.6 to 30.8	11.9 percentage of subjects Interval 5.9 to 20.8	6.7 percentage of subjects Interval 2.2 to 14.9	13.3 percentage of subjects Interval 6.6 to 23.2	16.5 percentage of subjects Interval 9.1 to 26.5
Percentage of Participants With Response by Mucosal IgA ELISA Individual Peak (Main Study)	33.3 percentage of subjects Interval 23.1 to 44.9	28.4 percentage of subjects Interval 19.3 to 39.0	17.9 percentage of subjects Interval 10.2 to 28.3	25.0 percentage of subjects Interval 15.8 to 36.3	34.5 percentage of subjects Interval 24.6 to 45.4
Percentage of Participants With Response by Mucosal IgA ELISA Week 16 (Follow-Up 1)	18.7 percentage of subjects Interval 10.6 to 29.3	11.9 percentage of subjects Interval 5.9 to 20.8	7.7 percentage of subjects Interval 2.9 to 16.0	12.3 percentage of subjects Interval 5.8 to 22.1	15.9 percentage of subjects Interval 8.7 to 25.6
Percentage of Participants With Response by Mucosal IgA ELISA Week 30 (Follow-Up 2)	20.0 percentage of subjects Interval 11.6 to 30.8	10.7 percentage of subjects Interval 5.0 to 19.4	11.5 percentage of subjects Interval 5.4 to 20.8	12.5 percentage of subjects Interval 5.9 to 22.4	12.5 percentage of subjects Interval 6.2 to 21.8
Percentage of Participants With Response by Mucosal IgA ELISA Week 58 (Booster Substudy)	7.1 percentage of subjects Interval 1.5 to 19.5	—	—	12.2 percentage of subjects Interval 4.1 to 26.2	—
Percentage of Participants With Response by Mucosal IgA ELISA Week 60 (Booster Substudy)	2.5 percentage of subjects Interval 0.1 to 13.2	—	—	12.2 percentage of subjects Interval 4.1 to 26.2	—
Percentage of Participants With Response by Mucosal IgA ELISA Individual Peak (Booster Substudy)	9.5 percentage of subjects Interval 2.7 to 22.6	—	—	14.3 percentage of subjects Interval 5.4 to 28.5	—
Percentage of Participants With Response by Mucosal IgA ELISA Week 68 (Booster Follow-Up 1)	9.5 percentage of subjects Interval 2.7 to 22.6	—	—	7.3 percentage of subjects Interval 1.5 to 19.9	—
Percentage of Participants With Response by Mucosal IgA ELISA Week 82 (Booster Follow-Up 2)	0.0 percentage of subjects Interval 0.0 to 8.4	—	—	15.0 percentage of subjects Interval 5.7 to 29.8	—

SECONDARY outcome

Timeframe: within 58 weeks

Population: Immunogenicity Analysis Set i.e. all participants who received at least one vaccination in the main study and were assigned to the subgroup for Peripheral Blood Mononuclear Cells (PBMC) collection. A subset of participants from groups 1 and 3 entered the booster substudy.

Geometric Mean Spot Forming Units (GMSFUs) based on RSV-specific Interferon-gamma (IFN-g) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool F. Values below the detection limit (DL) are included with a value of '25' (i.e. 1/2 DL)

Outcome measures

Measure	Group 3 - Single High Dose / Booster n=20 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses n=23 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo n=24 Participants First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)	Group 1 - Single Low Dose / Booster n=21 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses n=22 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
ELISPOT (IFN-g, Peptide Pool: F) GMSFU Week 0 (Main Study)	142.6 Spot Forming Units / 10^6 PBMC Interval 85.4 to 238.3	245.8 Spot Forming Units / 10^6 PBMC Interval 162.2 to 372.2	138.9 Spot Forming Units / 10^6 PBMC Interval 83.8 to 230.2	283.2 Spot Forming Units / 10^6 PBMC Interval 210.1 to 381.7	141.3 Spot Forming Units / 10^6 PBMC Interval 88.9 to 224.6
ELISPOT (IFN-g, Peptide Pool: F) GMSFU Week 1 (Main Study)	940.4 Spot Forming Units / 10^6 PBMC Interval 719.8 to 1228.7	810.2 Spot Forming Units / 10^6 PBMC Interval 592.9 to 1107.1	117.1 Spot Forming Units / 10^6 PBMC Interval 70.6 to 194.1	683.3 Spot Forming Units / 10^6 PBMC Interval 511.3 to 913.2	662.9 Spot Forming Units / 10^6 PBMC Interval 475.7 to 923.8
ELISPOT (IFN-g, Peptide Pool: F) GMSFU Week 2 (Main Study)	591.0 Spot Forming Units / 10^6 PBMC Interval 438.7 to 796.2	598.2 Spot Forming Units / 10^6 PBMC Interval 446.1 to 802.1	144.3 Spot Forming Units / 10^6 PBMC Interval 94.6 to 220.1	589.5 Spot Forming Units / 10^6 PBMC Interval 447.2 to 777.3	384.9 Spot Forming Units / 10^6 PBMC Interval 218.7 to 677.2
ELISPOT (IFN-g, Peptide Pool: F) GMSFU Week 5 (Main Study)	496.4 Spot Forming Units / 10^6 PBMC Interval 353.1 to 697.7	608.6 Spot Forming Units / 10^6 PBMC Interval 459.2 to 806.5	140.9 Spot Forming Units / 10^6 PBMC Interval 84.0 to 236.3	420.1 Spot Forming Units / 10^6 PBMC Interval 291.0 to 606.4	353.4 Spot Forming Units / 10^6 PBMC Interval 253.1 to 493.5
ELISPOT (IFN-g, Peptide Pool: F) GMSFU Week 6 (Main Study)	502.8 Spot Forming Units / 10^6 PBMC Interval 346.8 to 728.9	553.1 Spot Forming Units / 10^6 PBMC Interval 428.5 to 713.9	122.9 Spot Forming Units / 10^6 PBMC Interval 76.3 to 197.9	392.5 Spot Forming Units / 10^6 PBMC Interval 258.6 to 595.8	348.9 Spot Forming Units / 10^6 PBMC Interval 218.3 to 557.7
ELISPOT (IFN-g, Peptide Pool: F) GMSFU Week 56 (Booster Substudy)	378.8 Spot Forming Units / 10^6 PBMC Interval 185.6 to 773.4	—	—	282.6 Spot Forming Units / 10^6 PBMC Interval 190.6 to 418.9	—
ELISPOT (IFN-g, Peptide Pool: F) GMSFU Week 57 (Booster Substudy)	566.2 Spot Forming Units / 10^6 PBMC Interval 349.4 to 917.5	—	—	628.7 Spot Forming Units / 10^6 PBMC Interval 432.7 to 913.6	—
ELISPOT (IFN-g, Peptide Pool: F) GMSFU Week 58 (Booster Substudy)	539.7 Spot Forming Units / 10^6 PBMC Interval 325.5 to 894.7	—	—	514.4 Spot Forming Units / 10^6 PBMC Interval 365.5 to 723.9	—

SECONDARY outcome

Timeframe: within 58 weeks

Population: Immunogenicity Analysis Set i.e. all participants who received at least one vaccination in the main study and were assigned to the subgroup for Peripheral Blood Mononuclear Cells (PBMC) collection. A subset of participants from groups 1 and 3 entered the booster substudy.

Geometric Mean Spot Forming Units (GMSFUs) based on RSV-specific Interferon-gamma (IFN-g) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool G(A). Values below the detection limit (DL) are included with a value of '25' (i.e. 1/2 DL)

Outcome measures

Measure	Group 3 - Single High Dose / Booster n=20 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses n=23 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo n=24 Participants First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)	Group 1 - Single Low Dose / Booster n=21 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses n=22 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
ELISPOT (IFN-g, Peptide Pool: G(A)) GMSFU Week 0 (Main Study)	66.2 Spot Forming Units / 10^6 PBMC Interval 43.0 to 101.9	150.7 Spot Forming Units / 10^6 PBMC Interval 101.1 to 224.6	88.1 Spot Forming Units / 10^6 PBMC Interval 54.5 to 142.5	124.2 Spot Forming Units / 10^6 PBMC Interval 75.3 to 205.0	70.2 Spot Forming Units / 10^6 PBMC Interval 44.6 to 110.4
ELISPOT (IFN-g, Peptide Pool: G(A)) GMSFU Week 1 (Main Study)	564.7 Spot Forming Units / 10^6 PBMC Interval 395.2 to 807.1	659.7 Spot Forming Units / 10^6 PBMC Interval 436.3 to 997.5	68.2 Spot Forming Units / 10^6 PBMC Interval 40.9 to 113.8	517.9 Spot Forming Units / 10^6 PBMC Interval 369.1 to 726.8	370.9 Spot Forming Units / 10^6 PBMC Interval 219.2 to 627.6
ELISPOT (IFN-g, Peptide Pool: G(A)) GMSFU Week 2 (Main Study)	290.0 Spot Forming Units / 10^6 PBMC Interval 169.5 to 496.1	432.7 Spot Forming Units / 10^6 PBMC Interval 337.0 to 555.5	71.2 Spot Forming Units / 10^6 PBMC Interval 41.3 to 122.7	369.3 Spot Forming Units / 10^6 PBMC Interval 245.8 to 555.0	190.5 Spot Forming Units / 10^6 PBMC Interval 100.6 to 360.7
ELISPOT (IFN-g, Peptide Pool: G(A)) GMSFU Week 5 (Main Study)	209.6 Spot Forming Units / 10^6 PBMC Interval 132.1 to 332.5	415.7 Spot Forming Units / 10^6 PBMC Interval 298.9 to 578.1	68.9 Spot Forming Units / 10^6 PBMC Interval 38.3 to 124.0	271.1 Spot Forming Units / 10^6 PBMC Interval 192.2 to 382.5	180.9 Spot Forming Units / 10^6 PBMC Interval 104.5 to 313.0
ELISPOT (IFN-g, Peptide Pool: G(A)) GMSFU Week 6 (Main Study)	226.6 Spot Forming Units / 10^6 PBMC Interval 152.7 to 336.4	373.6 Spot Forming Units / 10^6 PBMC Interval 266.6 to 523.6	70.4 Spot Forming Units / 10^6 PBMC Interval 42.8 to 115.8	216.8 Spot Forming Units / 10^6 PBMC Interval 139.0 to 338.1	185.0 Spot Forming Units / 10^6 PBMC Interval 104.3 to 328.3
ELISPOT (IFN-g, Peptide Pool: G(A)) GMSFU Week 56 (Booster Substudy)	116.1 Spot Forming Units / 10^6 PBMC Interval 58.8 to 229.1	—	—	126.5 Spot Forming Units / 10^6 PBMC Interval 65.0 to 246.0	—
ELISPOT (IFN-g, Peptide Pool: G(A)) GMSFU Week 57 (Booster Substudy)	217.4 Spot Forming Units / 10^6 PBMC Interval 99.4 to 475.1	—	—	413.6 Spot Forming Units / 10^6 PBMC Interval 221.2 to 773.4	—
ELISPOT (IFN-g, Peptide Pool: G(A)) GMSFU Week 58 (Booster Substudy)	251.7 Spot Forming Units / 10^6 PBMC Interval 150.7 to 420.3	—	—	384.4 Spot Forming Units / 10^6 PBMC Interval 250.5 to 589.8	—

SECONDARY outcome

Timeframe: within 58 weeks

Population: Immunogenicity Analysis Set i.e. all participants who received at least one vaccination in the main study and were assigned to the subgroup for Peripheral Blood Mononuclear Cells (PBMC) collection. A subset of participants from groups 1 and 3 entered the booster substudy.

Geometric Mean Spot Forming Units (GMSFUs) based on RSV-specific Interferon-gamma (IFN-g) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool G(B). Values below the detection limit (DL) are included with a value of '25' (i.e. 1/2 DL)

Outcome measures

Measure	Group 3 - Single High Dose / Booster n=20 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses n=23 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo n=24 Participants First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)	Group 1 - Single Low Dose / Booster n=21 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses n=22 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
ELISPOT (IFN-g, Peptide Pool: G(B)) GMSFU Week 0 (Main Study)	56.8 Spot Forming Units / 10^6 PBMC Interval 31.5 to 102.6	135.5 Spot Forming Units / 10^6 PBMC Interval 83.2 to 220.7	73.6 Spot Forming Units / 10^6 PBMC Interval 43.6 to 124.1	111.3 Spot Forming Units / 10^6 PBMC Interval 64.6 to 191.7	63.4 Spot Forming Units / 10^6 PBMC Interval 35.4 to 113.3
ELISPOT (IFN-g, Peptide Pool: G(B)) GMSFU Week 1 (Main Study)	305.6 Spot Forming Units / 10^6 PBMC Interval 165.5 to 564.2	613.0 Spot Forming Units / 10^6 PBMC Interval 428.7 to 876.5	65.6 Spot Forming Units / 10^6 PBMC Interval 40.4 to 106.6	399.6 Spot Forming Units / 10^6 PBMC Interval 243.4 to 656.1	306.0 Spot Forming Units / 10^6 PBMC Interval 165.9 to 564.4
ELISPOT (IFN-g, Peptide Pool: G(B)) GMSFU Week 2 (Main Study)	181.2 Spot Forming Units / 10^6 PBMC Interval 93.2 to 352.4	371.5 Spot Forming Units / 10^6 PBMC Interval 269.7 to 511.7	71.6 Spot Forming Units / 10^6 PBMC Interval 43.8 to 117.2	247.9 Spot Forming Units / 10^6 PBMC Interval 136.5 to 450.1	141.4 Spot Forming Units / 10^6 PBMC Interval 73.9 to 270.7
ELISPOT (IFN-g, Peptide Pool: G(B)) GMSFU Week 5 (Main Study)	138.8 Spot Forming Units / 10^6 PBMC Interval 73.7 to 261.6	406.8 Spot Forming Units / 10^6 PBMC Interval 287.9 to 574.9	86.6 Spot Forming Units / 10^6 PBMC Interval 47.4 to 158.3	196.9 Spot Forming Units / 10^6 PBMC Interval 115.3 to 336.2	184.0 Spot Forming Units / 10^6 PBMC Interval 102.6 to 330.0
ELISPOT (IFN-g, Peptide Pool: G(B)) GMSFU Week 6 (Main Study)	128.1 Spot Forming Units / 10^6 PBMC Interval 66.4 to 247.3	359.7 Spot Forming Units / 10^6 PBMC Interval 257.9 to 501.5	77.0 Spot Forming Units / 10^6 PBMC Interval 43.2 to 137.5	177.8 Spot Forming Units / 10^6 PBMC Interval 102.9 to 307.0	219.0 Spot Forming Units / 10^6 PBMC Interval 114.2 to 419.8
ELISPOT (IFN-g, Peptide Pool: G(B)) GMSFU Week 56 (Booster Substudy)	57.5 Spot Forming Units / 10^6 PBMC Interval 28.6 to 115.5	—	—	87.8 Spot Forming Units / 10^6 PBMC Interval 44.5 to 173.3	—
ELISPOT (IFN-g, Peptide Pool: G(B)) GMSFU Week 57 (Booster Substudy)	101.2 Spot Forming Units / 10^6 PBMC Interval 44.6 to 229.5	—	—	300.6 Spot Forming Units / 10^6 PBMC Interval 140.3 to 644.0	—
ELISPOT (IFN-g, Peptide Pool: G(B)) GMSFU Week 58 (Booster Substudy)	132.2 Spot Forming Units / 10^6 PBMC Interval 64.0 to 272.8	—	—	246.7 Spot Forming Units / 10^6 PBMC Interval 120.0 to 507.3	—

SECONDARY outcome

Timeframe: within 58 weeks

Population: Immunogenicity Analysis Set i.e. all participants who received at least one vaccination in the main study and were assigned to the subgroup for Peripheral Blood Mononuclear Cells (PBMC) collection. A subset of participants from groups 1 and 3 entered the booster substudy.

Geometric Mean Spot Forming Units (GMSFUs) based on RSV-specific Interferon-gamma (IFN-g) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool M2. Values below the detection limit (DL) are included with a value of '25' (i.e. 1/2 DL)

Outcome measures

Measure	Group 3 - Single High Dose / Booster n=20 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses n=23 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo n=24 Participants First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)	Group 1 - Single Low Dose / Booster n=21 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses n=22 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
ELISPOT (IFN-g, Peptide Pool: M2) GMSFU Week 0 (Main Study)	54.9 Spot Forming Units / 10^6 PBMC Interval 34.2 to 88.3	86.6 Spot Forming Units / 10^6 PBMC Interval 51.4 to 145.9	60.5 Spot Forming Units / 10^6 PBMC Interval 38.9 to 94.0	84.1 Spot Forming Units / 10^6 PBMC Interval 52.2 to 135.6	41.2 Spot Forming Units / 10^6 PBMC Interval 29.1 to 58.4
ELISPOT (IFN-g, Peptide Pool: M2) GMSFU Week 1 (Main Study)	418.8 Spot Forming Units / 10^6 PBMC Interval 245.4 to 714.8	352.5 Spot Forming Units / 10^6 PBMC Interval 213.9 to 580.8	49.3 Spot Forming Units / 10^6 PBMC Interval 33.0 to 73.9	353.2 Spot Forming Units / 10^6 PBMC Interval 250.9 to 497.0	247.9 Spot Forming Units / 10^6 PBMC Interval 146.6 to 419.0
ELISPOT (IFN-g, Peptide Pool: M2) GMSFU Week 2 (Main Study)	284.7 Spot Forming Units / 10^6 PBMC Interval 157.1 to 515.7	317.9 Spot Forming Units / 10^6 PBMC Interval 217.1 to 465.4	42.4 Spot Forming Units / 10^6 PBMC Interval 31.1 to 58.0	281.9 Spot Forming Units / 10^6 PBMC Interval 197.2 to 403.0	136.9 Spot Forming Units / 10^6 PBMC Interval 76.5 to 245.1
ELISPOT (IFN-g, Peptide Pool: M2) GMSFU Week 5 (Main Study)	208.8 Spot Forming Units / 10^6 PBMC Interval 121.9 to 357.6	345.5 Spot Forming Units / 10^6 PBMC Interval 211.2 to 565.2	60.4 Spot Forming Units / 10^6 PBMC Interval 36.7 to 99.6	185.9 Spot Forming Units / 10^6 PBMC Interval 114.8 to 300.8	140.5 Spot Forming Units / 10^6 PBMC Interval 80.8 to 244.3
ELISPOT (IFN-g, Peptide Pool: M2) GMSFU Week 6 (Main Study)	169.6 Spot Forming Units / 10^6 PBMC Interval 94.3 to 305.1	333.4 Spot Forming Units / 10^6 PBMC Interval 198.3 to 560.4	54.6 Spot Forming Units / 10^6 PBMC Interval 34.2 to 87.2	208.2 Spot Forming Units / 10^6 PBMC Interval 118.8 to 364.8	161.1 Spot Forming Units / 10^6 PBMC Interval 90.9 to 285.6
ELISPOT (IFN-g, Peptide Pool: M2) GMSFU Week 56 (Booster Substudy)	56.3 Spot Forming Units / 10^6 PBMC Interval 30.2 to 104.9	—	—	86.8 Spot Forming Units / 10^6 PBMC Interval 44.4 to 169.4	—
ELISPOT (IFN-g, Peptide Pool: M2) GMSFU Week 57 (Booster Substudy)	181.3 Spot Forming Units / 10^6 PBMC Interval 75.9 to 433.1	—	—	242.0 Spot Forming Units / 10^6 PBMC Interval 126.3 to 463.7	—
ELISPOT (IFN-g, Peptide Pool: M2) GMSFU Week 58 (Booster Substudy)	216.5 Spot Forming Units / 10^6 PBMC Interval 101.0 to 464.2	—	—	237.0 Spot Forming Units / 10^6 PBMC Interval 122.5 to 458.5	—

SECONDARY outcome

Timeframe: within 58 weeks

Population: Immunogenicity Analysis Set i.e. all participants who received at least one vaccination in the main study and were assigned to the subgroup for Peripheral Blood Mononuclear Cells (PBMC) collection. A subset of participants from groups 1 and 3 entered the booster substudy.

Geometric Mean Spot Forming Units (GMSFUs) based on RSV-specific Interferon-gamma (IFN-g) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool N. Values below the detection limit (DL) are included with a value of '25' (i.e. 1/2 DL)

Outcome measures

Measure	Group 3 - Single High Dose / Booster n=20 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses n=23 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo n=24 Participants First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)	Group 1 - Single Low Dose / Booster n=21 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses n=22 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
ELISPOT (IFN-g, Peptide Pool: N) GMSFU Week 0 (Main Study)	85.1 Spot Forming Units / 10^6 PBMC Interval 53.1 to 136.3	169.4 Spot Forming Units / 10^6 PBMC Interval 107.9 to 266.2	82.7 Spot Forming Units / 10^6 PBMC Interval 51.4 to 132.8	179.2 Spot Forming Units / 10^6 PBMC Interval 114.8 to 279.7	97.1 Spot Forming Units / 10^6 PBMC Interval 62.7 to 150.3
ELISPOT (IFN-g, Peptide Pool: N) GMSFU Week 1 (Main Study)	825.9 Spot Forming Units / 10^6 PBMC Interval 591.6 to 1153.0	624.2 Spot Forming Units / 10^6 PBMC Interval 421.5 to 924.5	86.8 Spot Forming Units / 10^6 PBMC Interval 58.3 to 129.3	652.1 Spot Forming Units / 10^6 PBMC Interval 495.6 to 857.9	534.9 Spot Forming Units / 10^6 PBMC Interval 355.4 to 805.1
ELISPOT (IFN-g, Peptide Pool: N) GMSFU Week 2 (Main Study)	521.3 Spot Forming Units / 10^6 PBMC Interval 363.9 to 746.7	523.4 Spot Forming Units / 10^6 PBMC Interval 377.4 to 726.0	86.5 Spot Forming Units / 10^6 PBMC Interval 57.3 to 130.4	567.7 Spot Forming Units / 10^6 PBMC Interval 416.2 to 774.4	377.2 Spot Forming Units / 10^6 PBMC Interval 223.3 to 637.2
ELISPOT (IFN-g, Peptide Pool: N) GMSFU Week 5 (Main Study)	399.7 Spot Forming Units / 10^6 PBMC Interval 292.9 to 545.6	513.4 Spot Forming Units / 10^6 PBMC Interval 359.4 to 733.4	93.7 Spot Forming Units / 10^6 PBMC Interval 58.0 to 151.3	452.8 Spot Forming Units / 10^6 PBMC Interval 353.8 to 579.6	407.7 Spot Forming Units / 10^6 PBMC Interval 259.4 to 640.9
ELISPOT (IFN-g, Peptide Pool: N) GMSFU Week 6 (Main Study)	386.5 Spot Forming Units / 10^6 PBMC Interval 255.7 to 584.0	544.0 Spot Forming Units / 10^6 PBMC Interval 401.7 to 736.7	78.1 Spot Forming Units / 10^6 PBMC Interval 48.9 to 124.9	401.3 Spot Forming Units / 10^6 PBMC Interval 306.8 to 524.9	401.8 Spot Forming Units / 10^6 PBMC Interval 229.4 to 704.0
ELISPOT (IFN-g, Peptide Pool: N) GMSFU Week 56 (Booster Substudy)	166.2 Spot Forming Units / 10^6 PBMC Interval 92.6 to 298.2	—	—	164.3 Spot Forming Units / 10^6 PBMC Interval 88.4 to 305.6	—
ELISPOT (IFN-g, Peptide Pool: N) GMSFU Week 57 (Booster Substudy)	385.4 Spot Forming Units / 10^6 PBMC Interval 230.1 to 645.6	—	—	475.6 Spot Forming Units / 10^6 PBMC Interval 260.9 to 866.8	—
ELISPOT (IFN-g, Peptide Pool: N) GMSFU Week 58 (Booster Substudy)	436.6 Spot Forming Units / 10^6 PBMC Interval 268.5 to 710.0	—	—	471.1 Spot Forming Units / 10^6 PBMC Interval 325.7 to 681.4	—

SECONDARY outcome

Timeframe: within 58 weeks

Population: Immunogenicity Analysis Set i.e. all participants who received at least one vaccination in the main study and were assigned to the subgroup for Peripheral Blood Mononuclear Cells (PBMC) collection. A subset of participants from groups 1 and 3 entered the booster substudy.

Geometric Mean Spot Forming Units (GMSFUs) based on RSV-specific Interleukin 4 (IL-4) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool F. Values below the detection limit (DL) are included with a value of '25' (i.e. 1/2 DL)

Outcome measures

Measure	Group 3 - Single High Dose / Booster n=20 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses n=23 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo n=24 Participants First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)	Group 1 - Single Low Dose / Booster n=21 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses n=22 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
ELISPOT (IL-4, Peptide Pool: F) GMSFU Week 0 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0
ELISPOT (IL-4, Peptide Pool: F) GMSFU Week 1 (Main Study)	44.3 Spot Forming Units / 10^6 PBMC Interval 28.5 to 68.7	49.6 Spot Forming Units / 10^6 PBMC Interval 33.8 to 72.6	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	33.5 Spot Forming Units / 10^6 PBMC Interval 25.0 to 44.9	29.2 Spot Forming Units / 10^6 PBMC Interval 24.1 to 35.3
ELISPOT (IL-4, Peptide Pool: F) GMSFU Week 2 (Main Study)	34.1 Spot Forming Units / 10^6 PBMC Interval 24.8 to 46.8	34.8 Spot Forming Units / 10^6 PBMC Interval 25.7 to 47.2	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	28.0 Spot Forming Units / 10^6 PBMC Interval 23.8 to 32.9	29.0 Spot Forming Units / 10^6 PBMC Interval 24.4 to 34.4
ELISPOT (IL-4, Peptide Pool: F) GMSFU Week 5 (Main Study)	32.8 Spot Forming Units / 10^6 PBMC Interval 24.9 to 43.2	35.5 Spot Forming Units / 10^6 PBMC Interval 27.9 to 45.2	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0
ELISPOT (IL-4, Peptide Pool: F) GMSFU Week 6 (Main Study)	30.6 Spot Forming Units / 10^6 PBMC Interval 23.9 to 39.2	29.1 Spot Forming Units / 10^6 PBMC Interval 24.0 to 35.4	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	26.6 Spot Forming Units / 10^6 PBMC Interval 23.3 to 30.4	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0
ELISPOT (IL-4, Peptide Pool: F) GMSFU Week 56 (Booster Substudy)	26.5 Spot Forming Units / 10^6 PBMC Interval 23.3 to 30.1	—	—	26.7 Spot Forming Units / 10^6 PBMC Interval 23.2 to 30.7	—
ELISPOT (IL-4, Peptide Pool: F) GMSFU Week 57 (Booster Substudy)	28.5 Spot Forming Units / 10^6 PBMC Interval 21.5 to 37.7	—	—	34.7 Spot Forming Units / 10^6 PBMC Interval 23.6 to 51.1	—
ELISPOT (IL-4, Peptide Pool: F) GMSFU Week 58 (Booster Substudy)	27.9 Spot Forming Units / 10^6 PBMC Interval 23.8 to 32.7	—	—	27.4 Spot Forming Units / 10^6 PBMC Interval 22.5 to 33.4	—

SECONDARY outcome

Timeframe: within 58 weeks

Population: Immunogenicity Analysis Set i.e. all participants who received at least one vaccination in the main study and were assigned to the subgroup for Peripheral Blood Mononuclear Cells (PBMC) collection. A subset of participants from groups 1 and 3 entered the booster substudy.

Geometric Mean Spot Forming Units (GMSFUs) based on RSV-specific Interleukin 4 (IL-4) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool G(A). Values below the detection limit (DL) are included with a value of '25' (i.e. 1/2 DL)

Outcome measures

Measure	Group 3 - Single High Dose / Booster n=20 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses n=23 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo n=24 Participants First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)	Group 1 - Single Low Dose / Booster n=21 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses n=22 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
ELISPOT (IL-4, Peptide Pool: G(A)) GMSFU Week 0 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0
ELISPOT (IL-4, Peptide Pool: G(A)) GMSFU Week 1 (Main Study)	33.7 Spot Forming Units / 10^6 PBMC Interval 23.2 to 49.0	48.2 Spot Forming Units / 10^6 PBMC Interval 33.5 to 69.5	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	32.0 Spot Forming Units / 10^6 PBMC Interval 23.7 to 43.1	27.7 Spot Forming Units / 10^6 PBMC Interval 23.8 to 32.2
ELISPOT (IL-4, Peptide Pool: G(A)) GMSFU Week 2 (Main Study)	31.5 Spot Forming Units / 10^6 PBMC Interval 24.8 to 40.0	31.1 Spot Forming Units / 10^6 PBMC Interval 25.0 to 38.7	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	30.4 Spot Forming Units / 10^6 PBMC Interval 23.9 to 38.7	26.6 Spot Forming Units / 10^6 PBMC Interval 23.4 to 30.2
ELISPOT (IL-4, Peptide Pool: G(A)) GMSFU Week 5 (Main Study)	26.0 Spot Forming Units / 10^6 PBMC Interval 24.0 to 28.1	33.4 Spot Forming Units / 10^6 PBMC Interval 25.1 to 44.4	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	26.0 Spot Forming Units / 10^6 PBMC Interval 23.9 to 28.3	26.5 Spot Forming Units / 10^6 PBMC Interval 23.5 to 29.8
ELISPOT (IL-4, Peptide Pool: G(A)) GMSFU Week 6 (Main Study)	27.3 Spot Forming Units / 10^6 PBMC Interval 22.7 to 32.9	31.4 Spot Forming Units / 10^6 PBMC Interval 24.8 to 39.8	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0
ELISPOT (IL-4, Peptide Pool: G(A)) GMSFU Week 56 (Booster Substudy)	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	—	—	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	—
ELISPOT (IL-4, Peptide Pool: G(A)) GMSFU Week 57 (Booster Substudy)	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	—	—	40.4 Spot Forming Units / 10^6 PBMC Interval 23.0 to 70.9	—
ELISPOT (IL-4, Peptide Pool: G(A)) GMSFU Week 58 (Booster Substudy)	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	—	—	33.0 Spot Forming Units / 10^6 PBMC Interval 23.4 to 46.5	—

SECONDARY outcome

Timeframe: within 58 weeks

Population: Immunogenicity Analysis Set i.e. all participants who received at least one vaccination in the main study and were assigned to the subgroup for Peripheral Blood Mononuclear Cells (PBMC) collection. A subset of participants from groups 1 and 3 entered the booster substudy.

Geometric Mean Spot Forming Units (GMSFUs) based on RSV-specific Interleukin 4 (IL-4) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool G(B). Values below the detection limit (DL) are included with a value of '25' (i.e. 1/2 DL)

Outcome measures

Measure	Group 3 - Single High Dose / Booster n=20 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses n=23 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo n=24 Participants First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)	Group 1 - Single Low Dose / Booster n=21 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses n=22 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
ELISPOT (IL-4, Peptide Pool: G(B)) GMSFU Week 0 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0
ELISPOT (IL-4, Peptide Pool: G(B)) GMSFU Week 1 (Main Study)	34.2 Spot Forming Units / 10^6 PBMC Interval 23.3 to 50.2	43.4 Spot Forming Units / 10^6 PBMC Interval 31.0 to 60.6	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	30.1 Spot Forming Units / 10^6 PBMC Interval 22.9 to 39.5	27.4 Spot Forming Units / 10^6 PBMC Interval 23.9 to 31.5
ELISPOT (IL-4, Peptide Pool: G(B)) GMSFU Week 2 (Main Study)	29.1 Spot Forming Units / 10^6 PBMC Interval 22.9 to 36.8	29.5 Spot Forming Units / 10^6 PBMC Interval 24.3 to 35.7	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	28.1 Spot Forming Units / 10^6 PBMC Interval 21.9 to 36.1	27.9 Spot Forming Units / 10^6 PBMC Interval 23.8 to 32.7
ELISPOT (IL-4, Peptide Pool: G(B)) GMSFU Week 5 (Main Study)	26.9 Spot Forming Units / 10^6 PBMC Interval 23.1 to 31.3	32.8 Spot Forming Units / 10^6 PBMC Interval 25.8 to 41.7	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	26.4 Spot Forming Units / 10^6 PBMC Interval 23.5 to 29.7	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0
ELISPOT (IL-4, Peptide Pool: G(B)) GMSFU Week 6 (Main Study)	27.2 Spot Forming Units / 10^6 PBMC Interval 22.7 to 32.6	31.3 Spot Forming Units / 10^6 PBMC Interval 25.0 to 39.3	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0
ELISPOT (IL-4, Peptide Pool: G(B)) GMSFU Week 56 (Booster Substudy)	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	—	—	26.2 Spot Forming Units / 10^6 PBMC Interval 23.7 to 28.9	—
ELISPOT (IL-4, Peptide Pool: G(B)) GMSFU Week 57 (Booster Substudy)	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	—	—	38.1 Spot Forming Units / 10^6 PBMC Interval 23.2 to 62.4	—
ELISPOT (IL-4, Peptide Pool: G(B)) GMSFU Week 58 (Booster Substudy)	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	—	—	29.8 Spot Forming Units / 10^6 PBMC Interval 23.1 to 38.4	—

SECONDARY outcome

Timeframe: within 58 weeks

Population: Immunogenicity Analysis Set i.e. all participants who received at least one vaccination in the main study and were assigned to the subgroup for Peripheral Blood Mononuclear Cells (PBMC) collection. A subset of participants from groups 1 and 3 entered the booster substudy.

Geometric Mean Spot Forming Units (GMSFUs) based on RSV-specific Interleukin 4 (IL-4) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool M2. Values below the detection limit (DL) are included with a value of '25' (i.e. 1/2 DL)

Outcome measures

Measure	Group 3 - Single High Dose / Booster n=20 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses n=23 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo n=24 Participants First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)	Group 1 - Single Low Dose / Booster n=21 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses n=22 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
ELISPOT (IL-4, Peptide Pool: M2) GMSFU Week 0 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0
ELISPOT (IL-4, Peptide Pool: M2) GMSFU Week 1 (Main Study)	39.1 Spot Forming Units / 10^6 PBMC Interval 26.3 to 58.0	28.8 Spot Forming Units / 10^6 PBMC Interval 24.3 to 34.1	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	28.1 Spot Forming Units / 10^6 PBMC Interval 23.8 to 33.2	25.9 Spot Forming Units / 10^6 PBMC Interval 24.1 to 27.8
ELISPOT (IL-4, Peptide Pool: M2) GMSFU Week 2 (Main Study)	30.8 Spot Forming Units / 10^6 PBMC Interval 22.3 to 42.7	27.0 Spot Forming Units / 10^6 PBMC Interval 24.1 to 30.4	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	28.0 Spot Forming Units / 10^6 PBMC Interval 23.6 to 33.3	26.7 Spot Forming Units / 10^6 PBMC Interval 23.2 to 30.7
ELISPOT (IL-4, Peptide Pool: M2) GMSFU Week 5 (Main Study)	30.6 Spot Forming Units / 10^6 PBMC Interval 23.6 to 39.6	30.0 Spot Forming Units / 10^6 PBMC Interval 24.2 to 37.1	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	26.0 Spot Forming Units / 10^6 PBMC Interval 24.0 to 28.1
ELISPOT (IL-4, Peptide Pool: M2) GMSFU Week 6 (Main Study)	28.1 Spot Forming Units / 10^6 PBMC Interval 22.0 to 36.0	29.5 Spot Forming Units / 10^6 PBMC Interval 23.2 to 37.4	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	27.4 Spot Forming Units / 10^6 PBMC Interval 24.0 to 31.2	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0
ELISPOT (IL-4, Peptide Pool: M2) GMSFU Week 56 (Booster Substudy)	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	—	—	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	—
ELISPOT (IL-4, Peptide Pool: M2) GMSFU Week 57 (Booster Substudy)	28.1 Spot Forming Units / 10^6 PBMC Interval 21.8 to 36.3	—	—	28.9 Spot Forming Units / 10^6 PBMC Interval 21.2 to 39.4	—
ELISPOT (IL-4, Peptide Pool: M2) GMSFU Week 58 (Booster Substudy)	26.7 Spot Forming Units / 10^6 PBMC Interval 23.2 to 30.7	—	—	26.6 Spot Forming Units / 10^6 PBMC Interval 23.2 to 30.5	—

SECONDARY outcome

Timeframe: within 58 weeks

Population: Immunogenicity Analysis Set i.e. all participants who received at least one vaccination in the main study and were assigned to the subgroup for Peripheral Blood Mononuclear Cells (PBMC) collection. A subset of participants from groups 1 and 3 entered the booster substudy.

Geometric Mean Spot Forming Units (GMSFUs) based on RSV-specific Interleukin 4 (IL-4) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool N. Values below the detection limit (DL) are included with a value of '25' (i.e. 1/2 DL)

Outcome measures

Measure	Group 3 - Single High Dose / Booster n=20 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses n=23 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo n=24 Participants First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)	Group 1 - Single Low Dose / Booster n=21 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses n=22 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
ELISPOT (IL-4, Peptide Pool: N) GMSFU Week 0 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0
ELISPOT (IL-4, Peptide Pool: N) GMSFU Week 1 (Main Study)	41.4 Spot Forming Units / 10^6 PBMC Interval 30.8 to 55.5	35.3 Spot Forming Units / 10^6 PBMC Interval 26.1 to 47.9	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	28.7 Spot Forming Units / 10^6 PBMC Interval 22.9 to 36.0	32.9 Spot Forming Units / 10^6 PBMC Interval 25.9 to 41.7
ELISPOT (IL-4, Peptide Pool: N) GMSFU Week 2 (Main Study)	27.9 Spot Forming Units / 10^6 PBMC Interval 23.8 to 32.7	30.2 Spot Forming Units / 10^6 PBMC Interval 23.7 to 38.4	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	26.5 Spot Forming Units / 10^6 PBMC Interval 23.5 to 29.8	29.1 Spot Forming Units / 10^6 PBMC Interval 23.4 to 36.3
ELISPOT (IL-4, Peptide Pool: N) GMSFU Week 5 (Main Study)	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	28.0 Spot Forming Units / 10^6 PBMC Interval 23.7 to 33.0	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	30.1 Spot Forming Units / 10^6 PBMC Interval 23.9 to 37.9
ELISPOT (IL-4, Peptide Pool: N) GMSFU Week 6 (Main Study)	27.3 Spot Forming Units / 10^6 PBMC Interval 24.0 to 31.1	28.1 Spot Forming Units / 10^6 PBMC Interval 23.6 to 33.5	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	31.3 Spot Forming Units / 10^6 PBMC Interval 24.2 to 40.5
ELISPOT (IL-4, Peptide Pool: N) GMSFU Week 56 (Booster Substudy)	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	—	—	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	—
ELISPOT (IL-4, Peptide Pool: N) GMSFU Week 57 (Booster Substudy)	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	—	—	28.9 Spot Forming Units / 10^6 PBMC Interval 21.1 to 39.6	—
ELISPOT (IL-4, Peptide Pool: N) GMSFU Week 58 (Booster Substudy)	25.0 Spot Forming Units / 10^6 PBMC Interval 25.0 to 25.0	—	—	27.3 Spot Forming Units / 10^6 PBMC Interval 22.6 to 33.1	—

SECONDARY outcome

Timeframe: within 58 weeks

Population: Immunogenicity Analysis Set i.e. all participants who received at least one vaccination in the main study and were assigned to the subgroup for Peripheral Blood Mononuclear Cells (PBMC) collection. A subset of participants from groups 1 and 3 entered the booster substudy.

Response rate based on RSV-specific Interferon-gamma (IFN-g) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool F. Response is defined as the appearance of spot forming units ≥ detection limit (50) for initially negative subjects, or a doubling or more of the spot forming units compared to Baseline for initially positive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Percentages based on number of subjects with paired data available, i.e. number of subjects with results available for the respective time point and the corresponding Baseline.

Outcome measures

Measure	Group 3 - Single High Dose / Booster n=20 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses n=23 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo n=24 Participants First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)	Group 1 - Single Low Dose / Booster n=21 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses n=22 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: F) Week 1 (Main Study)	100.0 percentage of subjects Interval 83.2 to 100.0	73.9 percentage of subjects Interval 51.6 to 89.8	8.3 percentage of subjects Interval 1.0 to 27.0	57.1 percentage of subjects Interval 34.0 to 78.2	95.2 percentage of subjects Interval 76.2 to 99.9
Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: F) Week 2 (Main Study)	95.0 percentage of subjects Interval 75.1 to 99.9	56.5 percentage of subjects Interval 34.5 to 76.8	19.0 percentage of subjects Interval 5.4 to 41.9	61.1 percentage of subjects Interval 35.7 to 82.7	70.0 percentage of subjects Interval 45.7 to 88.1
Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: F) Week 5 (Main Study)	65.0 percentage of subjects Interval 40.8 to 84.6	56.5 percentage of subjects Interval 34.5 to 76.8	20.0 percentage of subjects Interval 5.7 to 43.7	23.8 percentage of subjects Interval 8.2 to 47.2	63.2 percentage of subjects Interval 38.4 to 83.7
Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: F) Week 6 (Main Study)	68.4 percentage of subjects Interval 43.4 to 87.4	63.6 percentage of subjects Interval 40.7 to 82.8	10.0 percentage of subjects Interval 1.2 to 31.7	41.2 percentage of subjects Interval 18.4 to 67.1	61.1 percentage of subjects Interval 35.7 to 82.7
Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: F) Week 57 (Booster Substudy)	21.4 percentage of subjects Interval 4.7 to 50.8	—	—	53.3 percentage of subjects Interval 26.6 to 78.7	—
Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: F) Week 58 (Booster Substudy)	14.3 percentage of subjects Interval 1.8 to 42.8	—	—	40.0 percentage of subjects Interval 16.3 to 67.7	—

SECONDARY outcome

Timeframe: within 58 weeks

Population: Immunogenicity Analysis Set i.e. all participants who received at least one vaccination in the main study and were assigned to the subgroup for Peripheral Blood Mononuclear Cells (PBMC) collection. A subset of participants from groups 1 and 3 entered the booster substudy.

Response rate based on RSV-specific Interferon-gamma (IFN-g) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool G(A). Response is defined as the appearance of spot forming units ≥ detection limit (50) for initially negative subjects, or a doubling or more of the spot forming units compared to Baseline for initially positive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Percentages based on number of subjects with paired data available, i.e. number of subjects with results available for the respective time point and the corresponding Baseline.

Outcome measures

Measure	Group 3 - Single High Dose / Booster n=20 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses n=23 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo n=24 Participants First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)	Group 1 - Single Low Dose / Booster n=21 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses n=22 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(A)) Week 1 (Main Study)	95.0 percentage of subjects Interval 75.1 to 99.9	82.6 percentage of subjects Interval 61.2 to 95.0	8.3 percentage of subjects Interval 1.0 to 27.0	81.0 percentage of subjects Interval 58.1 to 94.6	81.0 percentage of subjects Interval 58.1 to 94.6
Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(A)) Week 2 (Main Study)	85.0 percentage of subjects Interval 62.1 to 96.8	69.6 percentage of subjects Interval 47.1 to 86.8	9.5 percentage of subjects Interval 1.2 to 30.4	72.2 percentage of subjects Interval 46.5 to 90.3	65.0 percentage of subjects Interval 40.8 to 84.6
Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(A)) Week 5 (Main Study)	70.0 percentage of subjects Interval 45.7 to 88.1	65.2 percentage of subjects Interval 42.7 to 83.6	5.0 percentage of subjects Interval 0.1 to 24.9	38.1 percentage of subjects Interval 18.1 to 61.6	68.4 percentage of subjects Interval 43.4 to 87.4
Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(A)) Week 6 (Main Study)	68.4 percentage of subjects Interval 43.4 to 87.4	63.6 percentage of subjects Interval 40.7 to 82.8	5.0 percentage of subjects Interval 0.1 to 24.9	58.8 percentage of subjects Interval 32.9 to 81.6	66.7 percentage of subjects Interval 41.0 to 86.7
Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(A)) Week 57 (Booster Substudy)	50.0 percentage of subjects Interval 23.0 to 77.0	—	—	60.0 percentage of subjects Interval 32.3 to 83.7	—
Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(A)) Week 58 (Booster Substudy)	57.1 percentage of subjects Interval 28.9 to 82.3	—	—	60.0 percentage of subjects Interval 32.3 to 83.7	—

SECONDARY outcome

Timeframe: within 58 weeks

Population: Immunogenicity Analysis Set i.e. all participants who received at least one vaccination in the main study and were assigned to the subgroup for Peripheral Blood Mononuclear Cells (PBMC) collection. A subset of participants from groups 1 and 3 entered the booster substudy.

Response rate based on RSV-specific Interferon-gamma (IFN-g) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool G(B). Response is defined as the appearance of spot forming units ≥ detection limit (50) for initially negative subjects, or a doubling or more of the spot forming units compared to Baseline for initially positive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Percentages based on number of subjects with paired data available, i.e. number of subjects with results available for the respective time point and the corresponding Baseline.

Outcome measures

Measure	Group 3 - Single High Dose / Booster n=20 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses n=23 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo n=24 Participants First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)	Group 1 - Single Low Dose / Booster n=21 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses n=22 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(B)) Week 1 (Main Study)	85.0 percentage of subjects Interval 62.1 to 96.8	78.3 percentage of subjects Interval 56.3 to 92.5	12.5 percentage of subjects Interval 2.7 to 32.4	71.4 percentage of subjects Interval 47.8 to 88.7	76.2 percentage of subjects Interval 52.8 to 91.8
Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(B)) Week 2 (Main Study)	70.0 percentage of subjects Interval 45.7 to 88.1	60.9 percentage of subjects Interval 38.5 to 80.3	14.3 percentage of subjects Interval 3.0 to 36.3	55.6 percentage of subjects Interval 30.8 to 78.5	55.0 percentage of subjects Interval 31.5 to 76.9
Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(B)) Week 5 (Main Study)	60.0 percentage of subjects Interval 36.1 to 80.9	65.2 percentage of subjects Interval 42.7 to 83.6	10.0 percentage of subjects Interval 1.2 to 31.7	42.9 percentage of subjects Interval 21.8 to 66.0	63.2 percentage of subjects Interval 38.4 to 83.7
Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(B)) Week 6 (Main Study)	42.1 percentage of subjects Interval 20.3 to 66.5	68.2 percentage of subjects Interval 45.1 to 86.1	5.0 percentage of subjects Interval 0.1 to 24.9	35.3 percentage of subjects Interval 14.2 to 61.7	61.1 percentage of subjects Interval 35.7 to 82.7
Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(B)) Week 57 (Booster Substudy)	57.1 percentage of subjects Interval 28.9 to 82.3	—	—	60.0 percentage of subjects Interval 32.3 to 83.7	—
Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(B)) Week 58 (Booster Substudy)	42.9 percentage of subjects Interval 17.7 to 71.1	—	—	60.0 percentage of subjects Interval 32.3 to 83.7	—

SECONDARY outcome

Timeframe: within 58 weeks

Population: Immunogenicity Analysis Set i.e. all participants who received at least one vaccination in the main study and were assigned to the subgroup for Peripheral Blood Mononuclear Cells (PBMC) collection. A subset of participants from groups 1 and 3 entered the booster substudy.

Response rate based on RSV-specific Interferon-gamma (IFN-g) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool M2. Response is defined as the appearance of spot forming units ≥ detection limit (50) for initially negative subjects, or a doubling or more of the spot forming units compared to Baseline for initially positive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Percentages based on number of subjects with paired data available, i.e. number of subjects with results available for the respective time point and the corresponding Baseline.

Outcome measures

Measure	Group 3 - Single High Dose / Booster n=20 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses n=23 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo n=24 Participants First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)	Group 1 - Single Low Dose / Booster n=21 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses n=22 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: M2) Week 1 (Main Study)	95.0 percentage of subjects Interval 75.1 to 99.9	87.0 percentage of subjects Interval 66.4 to 97.2	8.3 percentage of subjects Interval 1.0 to 27.0	81.0 percentage of subjects Interval 58.1 to 94.6	71.4 percentage of subjects Interval 47.8 to 88.7
Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: M2) Week 2 (Main Study)	90.0 percentage of subjects Interval 68.3 to 98.8	65.2 percentage of subjects Interval 42.7 to 83.6	9.5 percentage of subjects Interval 1.2 to 30.4	72.2 percentage of subjects Interval 46.5 to 90.3	65.0 percentage of subjects Interval 40.8 to 84.6
Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: M2) Week 5 (Main Study)	85.0 percentage of subjects Interval 62.1 to 96.8	78.3 percentage of subjects Interval 56.3 to 92.5	15.0 percentage of subjects Interval 3.2 to 37.9	57.1 percentage of subjects Interval 34.0 to 78.2	78.9 percentage of subjects Interval 54.4 to 93.9
Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: M2) Week 6 (Main Study)	68.4 percentage of subjects Interval 43.4 to 87.4	72.7 percentage of subjects Interval 49.8 to 89.3	0.0 percentage of subjects Interval 0.0 to 16.8	58.8 percentage of subjects Interval 32.9 to 81.6	66.7 percentage of subjects Interval 41.0 to 86.7
Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: M2) Week 57 (Booster Substudy)	76.9 percentage of subjects Interval 46.2 to 95.0	—	—	66.7 percentage of subjects Interval 38.4 to 88.2	—
Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: M2) Week 58 (Booster Substudy)	76.9 percentage of subjects Interval 46.2 to 95.0	—	—	60.0 percentage of subjects Interval 32.3 to 83.7	—

SECONDARY outcome

Timeframe: within 58 weeks

Population: Immunogenicity Analysis Set i.e. all participants who received at least one vaccination in the main study and were assigned to the subgroup for Peripheral Blood Mononuclear Cells (PBMC) collection. A subset of participants from groups 1 and 3 entered the booster substudy.

Response rate based on RSV-specific Interferon-gamma (IFN-g) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool N. Response is defined as the appearance of spot forming units ≥ detection limit (50) for initially negative subjects, or a doubling or more of the spot forming units compared to Baseline for initially positive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Percentages based on number of subjects with paired data available, i.e. number of subjects with results available for the respective time point and the corresponding Baseline.

Outcome measures

Measure	Group 3 - Single High Dose / Booster n=20 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses n=23 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo n=24 Participants First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)	Group 1 - Single Low Dose / Booster n=21 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses n=22 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: N) Week 1 (Main Study)	100.0 percentage of subjects Interval 83.2 to 100.0	78.3 percentage of subjects Interval 56.3 to 92.5	16.7 percentage of subjects Interval 4.7 to 37.4	76.2 percentage of subjects Interval 52.8 to 91.8	85.7 percentage of subjects Interval 63.7 to 97.0
Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: N) Week 2 (Main Study)	95.0 percentage of subjects Interval 75.1 to 99.9	60.9 percentage of subjects Interval 38.5 to 80.3	19.0 percentage of subjects Interval 5.4 to 41.9	72.2 percentage of subjects Interval 46.5 to 90.3	75.0 percentage of subjects Interval 50.9 to 91.3
Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: N) Week 5 (Main Study)	95.0 percentage of subjects Interval 75.1 to 99.9	65.2 percentage of subjects Interval 42.7 to 83.6	20.0 percentage of subjects Interval 5.7 to 43.7	57.1 percentage of subjects Interval 34.0 to 78.2	84.2 percentage of subjects Interval 60.4 to 96.6
Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: N) Week 6 (Main Study)	73.7 percentage of subjects Interval 48.8 to 90.9	72.7 percentage of subjects Interval 49.8 to 89.3	15.0 percentage of subjects Interval 3.2 to 37.9	64.7 percentage of subjects Interval 38.3 to 85.8	72.2 percentage of subjects Interval 46.5 to 90.3
Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: N) Week 57 (Booster Substudy)	78.6 percentage of subjects Interval 49.2 to 95.3	—	—	60.0 percentage of subjects Interval 32.3 to 83.7	—
Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: N) Week 58 (Booster Substudy)	64.3 percentage of subjects Interval 35.1 to 87.2	—	—	80.0 percentage of subjects Interval 51.9 to 95.7	—

SECONDARY outcome

Timeframe: within 58 weeks

Population: Immunogenicity Analysis Set i.e. all participants who received at least one vaccination in the main study and were assigned to the subgroup for Peripheral Blood Mononuclear Cells (PBMC) collection. A subset of participants from groups 1 and 3 entered the booster substudy.

Response rate based on RSV-specific Interleukin 4 (IL-4) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool F. Response is defined as the appearance of spot forming units ≥ detection limit (50) for initially negative subjects, or a doubling or more of the spot forming units compared to Baseline for initially positive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Percentages based on number of subjects with paired data available, i.e. number of subjects with results available for the respective time point and the corresponding Baseline.

Outcome measures

Measure	Group 3 - Single High Dose / Booster n=20 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses n=23 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo n=24 Participants First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)	Group 1 - Single Low Dose / Booster n=21 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses n=22 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: F) Week 1 (Main Study)	30.0 percentage of subjects Interval 11.9 to 54.3	47.8 percentage of subjects Interval 26.8 to 69.4	0.0 percentage of subjects Interval 0.0 to 14.2	19.0 percentage of subjects Interval 5.4 to 41.9	14.3 percentage of subjects Interval 3.0 to 36.3
Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: F) Week 2 (Main Study)	20.0 percentage of subjects Interval 5.7 to 43.7	21.7 percentage of subjects Interval 7.5 to 43.7	0.0 percentage of subjects Interval 0.0 to 16.1	11.1 percentage of subjects Interval 1.4 to 34.7	15.0 percentage of subjects Interval 3.2 to 37.9
Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: F) Week 5 (Main Study)	20.0 percentage of subjects Interval 5.7 to 43.7	34.8 percentage of subjects Interval 16.4 to 57.3	0.0 percentage of subjects Interval 0.0 to 16.8	0.0 percentage of subjects Interval 0.0 to 16.1	0.0 percentage of subjects Interval 0.0 to 17.6
Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: F) Week 6 (Main Study)	15.8 percentage of subjects Interval 3.4 to 39.6	13.6 percentage of subjects Interval 2.9 to 34.9	0.0 percentage of subjects Interval 0.0 to 16.8	5.9 percentage of subjects Interval 0.1 to 28.7	0.0 percentage of subjects Interval 0.0 to 18.5
Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: F) Week 57 (Booster Substudy)	7.1 percentage of subjects Interval 0.2 to 33.9	—	—	20.0 percentage of subjects Interval 4.3 to 48.1	—
Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: F) Week 58 (Booster Substudy)	7.1 percentage of subjects Interval 0.2 to 33.9	—	—	6.7 percentage of subjects Interval 0.2 to 31.9	—

SECONDARY outcome

Timeframe: within 58 weeks

Population: Immunogenicity Analysis Set i.e. all participants who received at least one vaccination in the main study and were assigned to the subgroup for Peripheral Blood Mononuclear Cells (PBMC) collection. A subset of participants from groups 1 and 3 entered the booster substudy.

Response rate based on RSV-specific Interleukin 4 (IL-4) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool G(A). Response is defined as the appearance of spot forming units ≥ detection limit (50) for initially negative subjects, or a doubling or more of the spot forming units compared to Baseline for initially positive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Percentages based on number of subjects with paired data available, i.e. number of subjects with results available for the respective time point and the corresponding Baseline.

Outcome measures

Measure	Group 3 - Single High Dose / Booster n=20 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses n=23 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo n=24 Participants First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)	Group 1 - Single Low Dose / Booster n=21 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses n=22 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(A)) Week 1 (Main Study)	15.0 percentage of subjects Interval 3.2 to 37.9	43.5 percentage of subjects Interval 23.2 to 65.5	0.0 percentage of subjects Interval 0.0 to 14.2	14.3 percentage of subjects Interval 3.0 to 36.3	9.5 percentage of subjects Interval 1.2 to 30.4
Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(A)) Week 2 (Main Study)	20.0 percentage of subjects Interval 5.7 to 43.7	17.4 percentage of subjects Interval 5.0 to 38.8	0.0 percentage of subjects Interval 0.0 to 16.1	16.7 percentage of subjects Interval 3.6 to 41.4	5.0 percentage of subjects Interval 0.1 to 24.9
Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(A)) Week 5 (Main Study)	5.0 percentage of subjects Interval 0.1 to 24.9	17.4 percentage of subjects Interval 5.0 to 38.8	0.0 percentage of subjects Interval 0.0 to 16.8	4.8 percentage of subjects Interval 0.1 to 23.8	5.3 percentage of subjects Interval 0.1 to 26.0
Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(A)) Week 6 (Main Study)	5.3 percentage of subjects Interval 0.1 to 26.0	18.2 percentage of subjects Interval 5.2 to 40.3	0.0 percentage of subjects Interval 0.0 to 16.8	0.0 percentage of subjects Interval 0.0 to 19.5	0.0 percentage of subjects Interval 0.0 to 18.5
Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(A)) Week 57 (Booster Substudy)	0.0 percentage of subjects Interval 0.0 to 23.2	—	—	20.0 percentage of subjects Interval 4.3 to 48.1	—
Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(A)) Week 58 (Booster Substudy)	0.0 percentage of subjects Interval 0.0 to 23.2	—	—	20.0 percentage of subjects Interval 4.3 to 48.1	—

SECONDARY outcome

Timeframe: within 58 weeks

Population: Immunogenicity Analysis Set i.e. all participants who received at least one vaccination in the main study and were assigned to the subgroup for Peripheral Blood Mononuclear Cells (PBMC) collection. A subset of participants from groups 1 and 3 entered the booster substudy.

Response rate based on RSV-specific Interleukin 4 (IL-4) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool G(B). Response is defined as the appearance of spot forming units ≥ detection limit (50) for initially negative subjects, or a doubling or more of the spot forming units compared to Baseline for initially positive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Percentages based on number of subjects with paired data available, i.e. number of subjects with results available for the respective time point and the corresponding Baseline.

Outcome measures

Measure	Group 3 - Single High Dose / Booster n=20 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses n=23 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo n=24 Participants First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)	Group 1 - Single Low Dose / Booster n=21 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses n=22 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(B)) Week 1 (Main Study)	15.0 percentage of subjects Interval 3.2 to 37.9	39.1 percentage of subjects Interval 19.7 to 61.5	0.0 percentage of subjects Interval 0.0 to 14.2	9.5 percentage of subjects Interval 1.2 to 30.4	9.5 percentage of subjects Interval 1.2 to 30.4
Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(B)) Week 2 (Main Study)	10.0 percentage of subjects Interval 1.2 to 31.7	13.0 percentage of subjects Interval 2.8 to 33.6	0.0 percentage of subjects Interval 0.0 to 16.1	5.6 percentage of subjects Interval 0.1 to 27.3	10.0 percentage of subjects Interval 1.2 to 31.7
Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(B)) Week 5 (Main Study)	5.0 percentage of subjects Interval 0.1 to 24.9	21.7 percentage of subjects Interval 7.5 to 43.7	0.0 percentage of subjects Interval 0.0 to 16.8	4.8 percentage of subjects Interval 0.1 to 23.8	0.0 percentage of subjects Interval 0.0 to 17.6
Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(B)) Week 6 (Main Study)	5.3 percentage of subjects Interval 0.1 to 26.0	18.2 percentage of subjects Interval 5.2 to 40.3	0.0 percentage of subjects Interval 0.0 to 16.8	0.0 percentage of subjects Interval 0.0 to 19.5	0.0 percentage of subjects Interval 0.0 to 18.5
Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(B)) Week 57 (Booster Substudy)	0.0 percentage of subjects Interval 0.0 to 23.2	—	—	20.0 percentage of subjects Interval 4.3 to 48.1	—
Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(B)) Week 58 (Booster Substudy)	0.0 percentage of subjects Interval 0.0 to 23.2	—	—	13.3 percentage of subjects Interval 1.7 to 40.5	—

SECONDARY outcome

Timeframe: within 58 weeks

Population: Immunogenicity Analysis Set i.e. all participants who received at least one vaccination in the main study and were assigned to the subgroup for Peripheral Blood Mononuclear Cells (PBMC) collection. A subset of participants from groups 1 and 3 entered the booster substudy.

Response rate based on RSV-specific Interleukin 4 (IL-4) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool M2. Response is defined as the appearance of spot forming units ≥ detection limit (50) for initially negative subjects, or a doubling or more of the spot forming units compared to Baseline for initially positive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Percentages based on number of subjects with paired data available, i.e. number of subjects with results available for the respective time point and the corresponding Baseline.

Outcome measures

Measure	Group 3 - Single High Dose / Booster n=20 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses n=23 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo n=24 Participants First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)	Group 1 - Single Low Dose / Booster n=21 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses n=22 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: M2) Week 1 (Main Study)	25.0 percentage of subjects Interval 8.7 to 49.1	13.0 percentage of subjects Interval 2.8 to 33.6	0.0 percentage of subjects Interval 0.0 to 14.2	9.5 percentage of subjects Interval 1.2 to 30.4	4.8 percentage of subjects Interval 0.1 to 23.8
Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: M2) Week 2 (Main Study)	10.0 percentage of subjects Interval 1.2 to 31.7	8.7 percentage of subjects Interval 1.1 to 28.0	0.0 percentage of subjects Interval 0.0 to 16.1	11.1 percentage of subjects Interval 1.4 to 34.7	5.0 percentage of subjects Interval 0.1 to 24.9
Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: M2) Week 5 (Main Study)	15.0 percentage of subjects Interval 3.2 to 37.9	13.0 percentage of subjects Interval 2.8 to 33.6	0.0 percentage of subjects Interval 0.0 to 16.8	0.0 percentage of subjects Interval 0.0 to 16.1	5.3 percentage of subjects Interval 0.1 to 26.0
Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: M2) Week 6 (Main Study)	5.3 percentage of subjects Interval 0.1 to 26.0	9.1 percentage of subjects Interval 1.1 to 29.2	0.0 percentage of subjects Interval 0.0 to 16.8	11.8 percentage of subjects Interval 1.5 to 36.4	0.0 percentage of subjects Interval 0.0 to 18.5
Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: M2) Week 57 (Booster Substudy)	7.1 percentage of subjects Interval 0.2 to 33.9	—	—	6.7 percentage of subjects Interval 0.2 to 31.9	—
Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: M2) Week 58 (Booster Substudy)	7.1 percentage of subjects Interval 0.2 to 33.9	—	—	6.7 percentage of subjects Interval 0.2 to 31.9	—

SECONDARY outcome

Timeframe: within 58 weeks

Population: Immunogenicity Analysis Set i.e. all participants who received at least one vaccination in the main study and were assigned to the subgroup for Peripheral Blood Mononuclear Cells (PBMC) collection. A subset of participants from groups 1 and 3 entered the booster substudy.

Response rate based on RSV-specific Interleukin 4 (IL-4) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool N. Response is defined as the appearance of spot forming units ≥ detection limit (50) for initially negative subjects, or a doubling or more of the spot forming units compared to Baseline for initially positive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Percentages based on number of subjects with paired data available, i.e. number of subjects with results available for the respective time point and the corresponding Baseline.

Outcome measures

Measure	Group 3 - Single High Dose / Booster n=20 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses n=23 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo n=24 Participants First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)	Group 1 - Single Low Dose / Booster n=21 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses n=22 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: N) Week 1 (Main Study)	45.0 percentage of subjects Interval 23.1 to 68.5	21.7 percentage of subjects Interval 7.5 to 43.7	0.0 percentage of subjects Interval 0.0 to 14.2	9.5 percentage of subjects Interval 1.2 to 30.4	23.8 percentage of subjects Interval 8.2 to 47.2
Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: N) Week 2 (Main Study)	10.0 percentage of subjects Interval 1.2 to 31.7	13.0 percentage of subjects Interval 2.8 to 33.6	0.0 percentage of subjects Interval 0.0 to 16.1	5.6 percentage of subjects Interval 0.1 to 27.3	10.0 percentage of subjects Interval 1.2 to 31.7
Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: N) Week 5 (Main Study)	0.0 percentage of subjects Interval 0.0 to 16.8	8.7 percentage of subjects Interval 1.1 to 28.0	0.0 percentage of subjects Interval 0.0 to 16.8	0.0 percentage of subjects Interval 0.0 to 16.1	15.8 percentage of subjects Interval 3.4 to 39.6
Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: N) Week 6 (Main Study)	10.5 percentage of subjects Interval 1.3 to 33.1	9.1 percentage of subjects Interval 1.1 to 29.2	0.0 percentage of subjects Interval 0.0 to 16.8	0.0 percentage of subjects Interval 0.0 to 19.5	16.7 percentage of subjects Interval 3.6 to 41.4
Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: N) Week 57 (Booster Substudy)	0.0 percentage of subjects Interval 0.0 to 23.2	—	—	6.7 percentage of subjects Interval 0.2 to 31.9	—
Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: N) Week 58 (Booster Substudy)	0.0 percentage of subjects Interval 0.0 to 23.2	—	—	6.7 percentage of subjects Interval 0.2 to 31.9	—

SECONDARY outcome

Timeframe: within 82 weeks

Population: Immunogenicity Analysis Set i.e. all participants who received at least one vaccination in the main study and were assigned to the subgroup for Peripheral Blood Mononuclear Cells (PBMC) collection. A subset of participants from groups 1 and 3 entered the booster substudy.

Geometric Mean Spot Forming Units (GMSFUs) based on RSV-specific Immunoglobulin G (IgG)-producing memory B cells. Negative results (i.e. results below 0.01) are included with a value of '0.005'

Outcome measures

Measure	Group 3 - Single High Dose / Booster n=15 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses n=18 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo n=17 Participants First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)	Group 1 - Single Low Dose / Booster n=13 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses n=16 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
Memory B Cells (IgG) GMSFU Week 0 (Main Study)	0.068 Spot Forming Units / 10^6 PBMC Interval 0.034 to 0.134	0.129 Spot Forming Units / 10^6 PBMC Interval 0.073 to 0.228	0.117 Spot Forming Units / 10^6 PBMC Interval 0.061 to 0.225	0.091 Spot Forming Units / 10^6 PBMC Interval 0.051 to 0.163	0.083 Spot Forming Units / 10^6 PBMC Interval 0.046 to 0.151
Memory B Cells (IgG) GMSFU Week 16 (Follow-Up 1)	0.173 Spot Forming Units / 10^6 PBMC Interval 0.087 to 0.344	0.210 Spot Forming Units / 10^6 PBMC Interval 0.11 to 0.399	0.130 Spot Forming Units / 10^6 PBMC Interval 0.067 to 0.252	0.171 Spot Forming Units / 10^6 PBMC Interval 0.116 to 0.251	0.099 Spot Forming Units / 10^6 PBMC Interval 0.047 to 0.21
Memory B Cells (IgG) GMSFU Week 30 (Follow-Up 2)	0.123 Spot Forming Units / 10^6 PBMC Interval 0.051 to 0.297	0.100 Spot Forming Units / 10^6 PBMC Interval 0.053 to 0.189	0.079 Spot Forming Units / 10^6 PBMC Interval 0.042 to 0.148	0.148 Spot Forming Units / 10^6 PBMC Interval 0.093 to 0.237	0.068 Spot Forming Units / 10^6 PBMC Interval 0.034 to 0.137
Memory B Cells (IgG) GMSFU Week 56 (Booster Substudy)	0.138 Spot Forming Units / 10^6 PBMC Interval 0.072 to 0.266	—	—	0.127 Spot Forming Units / 10^6 PBMC Interval 0.066 to 0.245	—
Memory B Cells (IgG) GMSFU Week 68 (Booster Follow-Up 1)	0.231 Spot Forming Units / 10^6 PBMC Interval 0.111 to 0.48	—	—	0.104 Spot Forming Units / 10^6 PBMC Interval 0.041 to 0.265	—
Memory B Cells (IgG) GMSFU Week 82 (Booster Follow-Up 2)	0.167 Spot Forming Units / 10^6 PBMC Interval 0.088 to 0.318	—	—	0.103 Spot Forming Units / 10^6 PBMC Interval 0.053 to 0.202	—

SECONDARY outcome

Timeframe: within 108 weeks (Main Study + Booster Substudy)

Population: Full Analysis Set i.e. all participants who received at least one vaccination in the main study. A subset of participants from groups 1 and 3 entered the booster substudy.

Number of participants reporting Serious Adverse Events per period: Between 1st and 2nd vaccination (Vaccination Period 1, Main Study, duration: 4 weeks), between 2nd vaccination and end of active phase of the Main Study (Vaccination Period 2, Main Study, duration: 4 weeks), during the follow-up phase of the Main Study (Follow-Up, Main Study, duration: 22 weeks), after the Main Study and before the booster vaccination (Between Study Parts [retrospectively collected in booster substudy], duration: 26 weeks), between booster vaccination and end of active phase of the Booster Substudy (Booster Vaccination Period, Booster Substudy, duration: 4 weeks), and during the follow-up phase of the Booster Substudy (Follow-Up, Booster Substudy, duration: 48 weeks). Percentages based on number of subjects still in the study at the start of the respective period.

Outcome measures

Measure	Group 3 - Single High Dose / Booster n=80 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses n=90 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo n=83 Participants First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)	Group 1 - Single Low Dose / Booster n=78 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses n=89 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
Serious Adverse Events Vaccination Period 1, Main Study	2 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Serious Adverse Events Vaccination Period 2, Main Study	1 Participants	0 Participants	2 Participants	1 Participants	0 Participants
Serious Adverse Events Follow-Up, Main Study	0 Participants	1 Participants	3 Participants	1 Participants	3 Participants
Serious Adverse Events Between Study Parts	1 Participants	—	—	1 Participants	—
Serious Adverse Events Booster Vaccination Period, Booster Substudy	0 Participants	—	—	0 Participants	—
Serious Adverse Events Follow-Up, Booster Substudy	0 Participants	—	—	1 Participants	—

SECONDARY outcome

Timeframe: within 108 weeks (Main Study + Booster Substudy)

Population: Full Analysis Set i.e. all participants who received at least one vaccination in the main study. A subset of participants from groups 1 and 3 entered the booster substudy.

Number of participants reporting Serious Adverse Events possibly, probably or definitely related to the trial vaccine per period: Between 1st and 2nd vaccination (Vaccination Period 1, Main Study, duration: 4 weeks), between 2nd vaccination and end of active phase of the Main Study (Vaccination Period 2, Main Study, duration: 4 weeks), during the follow-up phase of the Main Study (Follow-Up, Main Study, duration: 22 weeks), after the Main Study and before the booster vaccination (Between Study Parts [retrospectively collected in booster substudy], duration: 26 weeks), between booster vaccination and end of active phase of the Booster Substudy (Booster Vaccination Period, Booster Substudy, duration: 4 weeks), and during the follow-up phase of the Booster Substudy (Follow-Up, Booster Substudy, duration: 48 weeks). Percentages based on number of subjects still in the study at the start of the respective period.

Outcome measures

Measure	Group 3 - Single High Dose / Booster n=80 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses n=90 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo n=83 Participants First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)	Group 1 - Single Low Dose / Booster n=78 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses n=89 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
Related Serious Adverse Events Vaccination Period 1, Main Study	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Related Serious Adverse Events Vaccination Period 2, Main Study	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Related Serious Adverse Events Follow-Up, Main Study	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Related Serious Adverse Events Between Study Parts	0 Participants	—	—	0 Participants	—
Related Serious Adverse Events Booster Vaccination Period, Booster Substudy	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Related Serious Adverse Events Follow-Up, Booster Substudy	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: within 108 weeks (Main Study + Booster Substudy)

Population: Full Analysis Set i.e. all participants who received at least one vaccination in the main study. A subset of participants from groups 1 and 3 entered the booster substudy.

Number of participants reporting Serious Adverse Events with intensity ≥ Grade 3 per period: Between 1st and 2nd vaccination (Vaccination Period 1, Main Study, duration: 4 weeks), between 2nd vaccination and end of active phase of the Main Study (Vaccination Period 2, Main Study, duration: 4 weeks), during the follow-up phase of the Main Study (Follow-Up, Main Study, duration: 22 weeks), after the Main Study and before the booster vaccination (Between Study Parts [retrospectively collected in booster substudy], duration: 26 weeks), between booster vaccination and end of active phase of the Booster Substudy (Booster Vaccination Period, Booster Substudy, duration: 4 weeks), and during the follow-up phase of the Booster Substudy (Follow-Up, Booster Substudy, duration: 48 weeks). Percentages based on number of subjects still in the study at the start of the respective period.

Outcome measures

Measure	Group 3 - Single High Dose / Booster n=80 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses n=90 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo n=83 Participants First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)	Group 1 - Single Low Dose / Booster n=78 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses n=89 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
Grade ≥ 3 Serious Adverse Events Vaccination Period 1, Main Study	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Grade ≥ 3 Serious Adverse Events Vaccination Period 2, Main Study	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Grade ≥ 3 Serious Adverse Events Follow-Up, Main Study	0 Participants	0 Participants	2 Participants	1 Participants	3 Participants
Grade ≥ 3 Serious Adverse Events Between Study Parts	1 Participants	—	—	1 Participants	—
Grade ≥ 3 Serious Adverse Events Booster Vaccination Period, Booster Substudy	0 Participants	—	—	0 Participants	—
Grade ≥ 3 Serious Adverse Events Follow-Up, Booster Substudy	0 Participants	—	—	1 Participants	—

SECONDARY outcome

Timeframe: within 29 days after vaccination

Population: Full Analysis Set i.e. all participants who received at least one vaccination in the main study. A subset of participants from groups 1 and 3 entered the booster substudy.

Number of participants reporting Adverse Events possibly, probably or definitely related to the trial vaccine with intensity ≥ Grade 3 per period: Following the 1st vaccination (Vaccination Period 1, Main Study), following the 2nd vaccination (Vaccination Period 2, Main Study), and following the booster vaccination (Booster Vaccination Period, Booster Substudy). Pooled solicited (general only) and unsolicited AEs. Percentages based on number of subjects still in the study at the start of the respective period.

Outcome measures

Measure	Group 3 - Single High Dose / Booster n=80 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses n=90 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo n=83 Participants First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)	Group 1 - Single Low Dose / Booster n=78 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses n=89 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
Related Grade ≥ 3 Adverse Events Vaccination Period 1, Main Study	6 Participants	6 Participants	0 Participants	0 Participants	3 Participants
Related Grade ≥ 3 Adverse Events Vaccination Period 2, Main Study	1 Participants	2 Participants	0 Participants	3 Participants	1 Participants
Related Grade ≥ 3 Adverse Events Booster Vaccination Period, Booster Substudy	2 Participants	—	—	3 Participants	—

SECONDARY outcome

Timeframe: within 8 days after vaccination

Population: Full Analysis Set i.e. all participants who received at least one vaccination in the main study. A subset of participants from groups 1 and 3 entered the booster substudy.

Incidence of injection site reactions (solicited via diary cards) after vaccination: Following the 1st vaccination (Vaccination Period 1, Main Study), following the 2nd vaccination (Vaccination Period 2, Main Study), and following the booster vaccination (Booster Vaccination Period, Booster Substudy). Percentages based on number of subjects with a completed diary card for the respective vaccination period.

Outcome measures

Measure	Group 3 - Single High Dose / Booster n=80 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses n=90 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo n=83 Participants First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)	Group 1 - Single Low Dose / Booster n=78 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses n=89 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
Solicited Local Adverse Events Pain - Vaccination Period 1	58 Participants	76 Participants	9 Participants	39 Participants	57 Participants
Solicited Local Adverse Events Pain - Vaccination Period 2	6 Participants	51 Participants	10 Participants	6 Participants	39 Participants
Solicited Local Adverse Events Pain - Booster Vaccination Period	39 Participants	—	—	24 Participants	—
Solicited Local Adverse Events Erythema - Vaccination Period 1	24 Participants	19 Participants	14 Participants	15 Participants	13 Participants
Solicited Local Adverse Events Erythema - Vaccination Period 2	6 Participants	17 Participants	8 Participants	5 Participants	13 Participants
Solicited Local Adverse Events Erythema - Booster Vaccination Period	15 Participants	—	—	9 Participants	—
Solicited Local Adverse Events Swelling - Vaccination Period 1	16 Participants	17 Participants	2 Participants	11 Participants	13 Participants
Solicited Local Adverse Events Swelling - Vaccination Period 2	1 Participants	16 Participants	1 Participants	1 Participants	8 Participants
Solicited Local Adverse Events Swelling - Booster Vaccination Period	15 Participants	—	—	9 Participants	—
Solicited Local Adverse Events Induration - Vaccination Period 1	13 Participants	13 Participants	3 Participants	9 Participants	5 Participants
Solicited Local Adverse Events Induration - Vaccination Period 2	3 Participants	11 Participants	3 Participants	0 Participants	2 Participants
Solicited Local Adverse Events Induration - Booster Vaccination Period	13 Participants	—	—	7 Participants	—
Solicited Local Adverse Events Pruritis - Vaccination Period 1	14 Participants	7 Participants	4 Participants	3 Participants	7 Participants
Solicited Local Adverse Events Pruritis - Vaccination Period 2	2 Participants	5 Participants	1 Participants	2 Participants	10 Participants
Solicited Local Adverse Events Pruritis - Booster Vaccination Period	11 Participants	—	—	3 Participants	—

SECONDARY outcome

Timeframe: within 8 days after vaccination

Population: Full Analysis Set i.e. all participants who received at least one vaccination in the main study. A subset of participants from groups 1 and 3 entered the booster substudy.

Incidence of injection site reactions (solicited via diary cards) with intensity ≥ Grade 3 after vaccination: Following the 1st vaccination (Vaccination Period 1, Main Study), following the 2nd vaccination (Vaccination Period 2, Main Study), and following the booster vaccination (Booster Vaccination Period, Booster Substudy). Percentages based on number of subjects with a completed diary card for the respective vaccination period.

Outcome measures

Measure	Group 3 - Single High Dose / Booster n=80 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses n=90 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo n=83 Participants First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)	Group 1 - Single Low Dose / Booster n=78 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses n=89 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
Grade ≥ 3 Solicited Local Adverse Events Grade ≥ 3 Pain - Vaccination Period 2	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Grade ≥ 3 Solicited Local Adverse Events Grade ≥ 3 Pain - Booster Vaccination Period	4 Participants	—	—	2 Participants	—
Grade ≥ 3 Solicited Local Adverse Events Grade ≥ 3 Erythema - Vaccination Period 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Grade ≥ 3 Solicited Local Adverse Events Grade ≥ 3 Erythema - Vaccination Period 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Grade ≥ 3 Solicited Local Adverse Events Grade ≥ 3 Erythema - Booster Vaccination Period	0 Participants	—	—	0 Participants	—
Grade ≥ 3 Solicited Local Adverse Events Grade ≥ 3 Swelling - Vaccination Period 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Grade ≥ 3 Solicited Local Adverse Events Grade ≥ 3 Swelling - Vaccination Period 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Grade ≥ 3 Solicited Local Adverse Events Grade ≥ 3 Swelling - Booster Vaccination Period	0 Participants	—	—	0 Participants	—
Grade ≥ 3 Solicited Local Adverse Events Grade ≥ 3 Induration - Vaccination Period 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Grade ≥ 3 Solicited Local Adverse Events Grade ≥ 3 Induration - Vaccination Period 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Grade ≥ 3 Solicited Local Adverse Events Grade ≥ 3 Induration - Booster Vaccination Period	0 Participants	—	—	0 Participants	—
Grade ≥ 3 Solicited Local Adverse Events Grade ≥ 3 Pruritis - Vaccination Period 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Grade ≥ 3 Solicited Local Adverse Events Grade ≥ 3 Pruritis - Vaccination Period 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Grade ≥ 3 Solicited Local Adverse Events Grade ≥ 3 Pruritis - Booster Vaccination Period	1 Participants	—	—	0 Participants	—
Grade ≥ 3 Solicited Local Adverse Events Grade ≥ 3 Pain - Vaccination Period 1	2 Participants	7 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: within 8 days after vaccination

Population: Full Analysis Set i.e. all participants who received at least one vaccination in the main study. A subset of participants from groups 1 and 3 entered the booster substudy.

Incidence of systemic reactions (solicited via diary cards) after vaccination: Following the 1st vaccination (Vaccination Period 1, Main Study), following the 2nd vaccination (Vaccination Period 2, Main Study), and following the booster vaccination (Booster Vaccination Period, Booster Substudy). Percentages based on number of subjects with a completed diary card for the respective vaccination period.

Outcome measures

Measure	Group 3 - Single High Dose / Booster n=80 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses n=90 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo n=83 Participants First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)	Group 1 - Single Low Dose / Booster n=78 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses n=89 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
Solicited General Adverse Events Fever - Vaccination Period 1	8 Participants	6 Participants	1 Participants	2 Participants	4 Participants
Solicited General Adverse Events Fever - Vaccination Period 2	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Solicited General Adverse Events Fever - Booster Vaccination Period	3 Participants	—	—	0 Participants	—
Solicited General Adverse Events Headache - Vaccination Period 1	21 Participants	21 Participants	13 Participants	4 Participants	16 Participants
Solicited General Adverse Events Headache - Vaccination Period 2	8 Participants	16 Participants	9 Participants	7 Participants	14 Participants
Solicited General Adverse Events Headache - Booster Vaccination Period	13 Participants	—	—	9 Participants	—
Solicited General Adverse Events Myalgia - Vaccination Period 1	37 Participants	34 Participants	7 Participants	13 Participants	19 Participants
Solicited General Adverse Events Myalgia - Vaccination Period 2	5 Participants	21 Participants	8 Participants	5 Participants	14 Participants
Solicited General Adverse Events Myalgia - Booster Vaccination Period	24 Participants	—	—	10 Participants	—
Solicited General Adverse Events Chills - Vaccination Period 1	10 Participants	11 Participants	3 Participants	5 Participants	4 Participants
Solicited General Adverse Events Chills - Vaccination Period 2	5 Participants	10 Participants	7 Participants	3 Participants	2 Participants
Solicited General Adverse Events Chills - Booster Vaccination Period	4 Participants	—	—	3 Participants	—
Solicited General Adverse Events Nausea - Vaccination Period 1	4 Participants	6 Participants	4 Participants	2 Participants	6 Participants
Solicited General Adverse Events Nausea - Vaccination Period 2	2 Participants	6 Participants	1 Participants	7 Participants	3 Participants
Solicited General Adverse Events Nausea - Booster Vaccination Period	3 Participants	—	—	1 Participants	—
Solicited General Adverse Events Fatigue - Vaccination Period 1	22 Participants	26 Participants	5 Participants	7 Participants	15 Participants
Solicited General Adverse Events Fatigue - Vaccination Period 2	4 Participants	15 Participants	10 Participants	8 Participants	9 Participants
Solicited General Adverse Events Fatigue - Booster Vaccination Period	16 Participants	—	—	4 Participants	—

SECONDARY outcome

Timeframe: within 8 days after vaccination

Population: Full Analysis Set i.e. all participants who received at least one vaccination in the main study. A subset of participants from groups 1 and 3 entered the booster substudy.

Incidence of systemic reactions (solicited via diary cards) with intensity ≥ Grade 3 after vaccination: Following the 1st vaccination (Vaccination Period 1, Main Study), following the 2nd vaccination (Vaccination Period 2, Main Study), and following the booster vaccination (Booster Vaccination Period, Booster Substudy). Percentages based on number of subjects with a completed diary card for the respective vaccination period.

Outcome measures

Measure	Group 3 - Single High Dose / Booster n=80 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses n=90 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo n=83 Participants First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)	Group 1 - Single Low Dose / Booster n=78 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses n=89 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
Grade ≥ 3 Solicited General Adverse Events Grade ≥ 3 Fatigue - Vaccination Period 2	1 Participants	2 Participants	0 Participants	3 Participants	0 Participants
Grade ≥ 3 Solicited General Adverse Events Grade ≥ 3 Fatigue - Booster Vaccination Period	1 Participants	—	—	0 Participants	—
Grade ≥ 3 Solicited General Adverse Events Grade ≥ 3 Nausea - Vaccination Period 1	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Grade ≥ 3 Solicited General Adverse Events Grade ≥ 3 Nausea - Vaccination Period 2	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Grade ≥ 3 Solicited General Adverse Events Grade ≥ 3 Nausea - Booster Vaccination Period	0 Participants	—	—	0 Participants	—
Grade ≥ 3 Solicited General Adverse Events Grade ≥ 3 Fatigue - Vaccination Period 1	4 Participants	2 Participants	1 Participants	0 Participants	0 Participants
Grade ≥ 3 Solicited General Adverse Events Grade ≥ 3 Chills - Vaccination Period 1	3 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Grade ≥ 3 Solicited General Adverse Events Grade ≥ 3 Chills - Vaccination Period 2	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Grade ≥ 3 Solicited General Adverse Events Grade ≥ 3 Fever - Vaccination Period 1	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Grade ≥ 3 Solicited General Adverse Events Grade ≥ 3 Fever - Vaccination Period 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Grade ≥ 3 Solicited General Adverse Events Grade ≥ 3 Fever - Booster Vaccination Period	0 Participants	—	—	0 Participants	—
Grade ≥ 3 Solicited General Adverse Events Grade ≥ 3 Headache - Vaccination Period 1	2 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Grade ≥ 3 Solicited General Adverse Events Grade ≥ 3 Headache - Vaccination Period 2	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Grade ≥ 3 Solicited General Adverse Events Grade ≥ 3 Chills - Booster Vaccination Period	0 Participants	—	—	0 Participants	—
Grade ≥ 3 Solicited General Adverse Events Grade ≥ 3 Headache - Booster Vaccination Period	0 Participants	—	—	2 Participants	—
Grade ≥ 3 Solicited General Adverse Events Grade ≥ 3 Myalgia - Vaccination Period 1	4 Participants	3 Participants	0 Participants	0 Participants	1 Participants
Grade ≥ 3 Solicited General Adverse Events Grade ≥ 3 Myalgia - Vaccination Period 2	1 Participants	1 Participants	0 Participants	2 Participants	1 Participants
Grade ≥ 3 Solicited General Adverse Events Grade ≥ 3 Myalgia - Booster Vaccination Period	2 Participants	—	—	1 Participants	—

SECONDARY outcome

Timeframe: within 8 days after vaccination

Population: Full Analysis Set i.e. all participants who received at least one vaccination in the main study. A subset of participants from groups 1 and 3 entered the booster substudy.

Incidence of systemic reactions (solicited via diary cards) possibly, probably or definitely related to the trial vaccine after vaccination: Following the 1st vaccination (Vaccination Period 1, Main Study), following the 2nd vaccination (Vaccination Period 2, Main Study), and following the booster vaccination (Booster Vaccination Period, Booster Substudy). Percentages based on number of subjects with a completed diary card for the respective vaccination period.

Outcome measures

Measure	Group 3 - Single High Dose / Booster n=80 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses n=90 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo n=83 Participants First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)	Group 1 - Single Low Dose / Booster n=78 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses n=89 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
Related Solicited General Adverse Events Related Fever - Vaccination Period 1	7 Participants	3 Participants	1 Participants	2 Participants	4 Participants
Related Solicited General Adverse Events Related Fever - Vaccination Period 2	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Related Solicited General Adverse Events Related Fever - Booster Vaccination Period	2 Participants	—	—	0 Participants	—
Related Solicited General Adverse Events Related Headache - Vaccination Period 1	15 Participants	17 Participants	7 Participants	4 Participants	14 Participants
Related Solicited General Adverse Events Related Headache - Vaccination Period 2	4 Participants	12 Participants	6 Participants	5 Participants	12 Participants
Related Solicited General Adverse Events Related Headache - Booster Vaccination Period	12 Participants	—	—	7 Participants	—
Related Solicited General Adverse Events Related Myalgia - Vaccination Period 1	29 Participants	29 Participants	6 Participants	9 Participants	18 Participants
Related Solicited General Adverse Events Related Myalgia - Vaccination Period 2	3 Participants	18 Participants	6 Participants	5 Participants	12 Participants
Related Solicited General Adverse Events Related Myalgia - Booster Vaccination Period	23 Participants	—	—	10 Participants	—
Related Solicited General Adverse Events Related Chills - Vaccination Period 1	8 Participants	11 Participants	3 Participants	4 Participants	4 Participants
Related Solicited General Adverse Events Related Chills - Vaccination Period 2	5 Participants	8 Participants	4 Participants	3 Participants	2 Participants
Related Solicited General Adverse Events Related Chills - Booster Vaccination Period	4 Participants	—	—	3 Participants	—
Related Solicited General Adverse Events Related Nausea - Vaccination Period 1	4 Participants	5 Participants	3 Participants	1 Participants	5 Participants
Related Solicited General Adverse Events Related Nausea - Vaccination Period 2	2 Participants	5 Participants	1 Participants	6 Participants	2 Participants
Related Solicited General Adverse Events Related Nausea - Booster Vaccination Period	3 Participants	—	—	1 Participants	—
Related Solicited General Adverse Events Related Fatigue - Vaccination Period 1	18 Participants	23 Participants	3 Participants	7 Participants	12 Participants
Related Solicited General Adverse Events Related Fatigue - Vaccination Period 2	4 Participants	14 Participants	8 Participants	8 Participants	9 Participants
Related Solicited General Adverse Events Related Fatigue - Booster Vaccination Period	15 Participants	—	—	4 Participants	—

SECONDARY outcome

Timeframe: within 29 days after vaccination

Population: Full Analysis Set i.e. all participants who received at least one vaccination in the main study. A subset of participants from groups 1 and 3 entered the booster substudy.

Incidence of unsolicited non-serious adverse events by period: Following the 1st vaccination (Vaccination Period 1, Main Study), following the 2nd vaccination (Vaccination Period 2, Main Study), and following the booster vaccination (Booster Vaccination Period, Booster Substudy). Percentages based on number of subjects having received the respective vaccination.

Outcome measures

Measure	Group 3 - Single High Dose / Booster n=80 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses n=90 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo n=83 Participants First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)	Group 1 - Single Low Dose / Booster n=78 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses n=89 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
Unsolicited Non-serious Adverse Events Vaccination Period 1	23 Participants	22 Participants	21 Participants	14 Participants	23 Participants
Unsolicited Non-serious Adverse Events Vaccination Period 2	26 Participants	21 Participants	27 Participants	21 Participants	23 Participants
Unsolicited Non-serious Adverse Events Booster Vaccination Period	3 Participants	—	—	1 Participants	—

SECONDARY outcome

Timeframe: within 29 days after vaccination

Population: Full Analysis Set i.e. all participants who received at least one vaccination in the main study. A subset of participants from groups 1 and 3 entered the booster substudy.

Incidence of unsolicited non-serious adverse events possibly, probably or definitely related to the trial vaccine by period: Following the 1st vaccination (Vaccination Period 1, Main Study), following the 2nd vaccination (Vaccination Period 2, Main Study), and following the booster vaccination (Booster Vaccination Period, Booster Substudy). Percentages based on number of subjects having received the respective vaccination.

Outcome measures

Measure	Group 3 - Single High Dose / Booster n=80 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses n=90 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo n=83 Participants First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)	Group 1 - Single Low Dose / Booster n=78 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses n=89 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
Related Unsolicited Non-serious Adverse Events Vaccination Period 1	9 Participants	9 Participants	4 Participants	4 Participants	6 Participants
Related Unsolicited Non-serious Adverse Events Vaccination Period 2	5 Participants	6 Participants	9 Participants	4 Participants	2 Participants
Related Unsolicited Non-serious Adverse Events Booster Vaccination Period	3 Participants	—	—	0 Participants	—

SECONDARY outcome

Timeframe: within 29 days after vaccination

Population: Full Analysis Set i.e. all participants who received at least one vaccination in the main study. A subset of participants from groups 1 and 3 entered the booster substudy.

Incidence of unsolicited non-serious adverse events with intensity ≥ Grade 3 by period: Following the 1st vaccination (Vaccination Period 1, Main Study), following the 2nd vaccination (Vaccination Period 2, Main Study), and following the booster vaccination (Booster Vaccination Period, Booster Substudy). Percentages based on number of subjects having received the respective vaccination.

Outcome measures

Measure	Group 3 - Single High Dose / Booster n=80 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses n=90 Participants First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo n=83 Participants First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)	Group 1 - Single Low Dose / Booster n=78 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses n=89 Participants First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)
Grade ≥ 3 Unsolicited Non-serious Adverse Events Vaccination Period 1	3 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Grade ≥ 3 Unsolicited Non-serious Adverse Events Vaccination Period 2	1 Participants	0 Participants	2 Participants	2 Participants	0 Participants
Grade ≥ 3 Unsolicited Non-serious Adverse Events Booster Vaccination Period	0 Participants	—	—	0 Participants	—

Adverse Events

Group 1 - Single Low Dose / Booster

Serious events: 4 serious events

Other events: 15 other events

Deaths: 0 deaths

Group 2 - Two Low Doses

Serious events: 4 serious events

Other events: 23 other events

Deaths: 0 deaths

Group 3 - Single High Dose / Booster

Serious events: 4 serious events

Other events: 20 other events

Deaths: 0 deaths

Group 4 - Two High Doses

Serious events: 2 serious events

Other events: 28 other events

Deaths: 0 deaths

Group 5 - Placebo

Serious events: 5 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group 1 - Single Low Dose / Booster n=78 participants at risk First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses n=89 participants at risk First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 3 - Single High Dose / Booster n=80 participants at risk First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses n=90 participants at risk First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo n=83 participants at risk First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
Cardiac disorders Cardiac arrest	0.00% 0/78 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/89 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/80 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/90 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	1.2% 1/83 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.
Cardiac disorders Cardiac failure congestive	0.00% 0/78 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/89 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	1.2% 1/80 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/90 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/83 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.
Endocrine disorders Hyperparathyroidism	0.00% 0/78 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/89 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/80 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/90 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	1.2% 1/83 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.
Gastrointestinal disorders Colitis	0.00% 0/78 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	1.1% 1/89 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/80 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/90 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/83 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.
Gastrointestinal disorders Enterovesical fistula	0.00% 0/78 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/89 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	1.2% 1/80 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/90 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/83 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/78 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/89 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/80 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	1.1% 1/90 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/83 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/78 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/89 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	1.2% 1/80 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/90 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/83 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.
Gastrointestinal disorders Small intestinal obstruction	1.3% 1/78 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	1.1% 1/89 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/80 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/90 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/83 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.
General disorders Non-cardiac chest pain	0.00% 0/78 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/89 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/80 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/90 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	1.2% 1/83 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.
Infections and infestations Extradural abscess	0.00% 0/78 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/89 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/80 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/90 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	1.2% 1/83 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.
Infections and infestations Pneumonia	0.00% 0/78 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/89 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/80 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	1.1% 1/90 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/83 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.
Infections and infestations Sepsis	0.00% 0/78 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/89 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/80 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/90 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	1.2% 1/83 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.
Infections and infestations Urinary tract infection	0.00% 0/78 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	1.1% 1/89 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/80 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/90 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/83 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.
Injury, poisoning and procedural complications Pelvic fracture	1.3% 1/78 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/89 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/80 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/90 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/83 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.
Injury, poisoning and procedural complications Rib fracture	1.3% 1/78 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/89 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/80 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/90 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/83 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/78 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/89 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/80 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/90 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	1.2% 1/83 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	1.3% 1/78 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/89 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/80 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/90 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/83 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive papillary breast carcinoma	0.00% 0/78 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	1.1% 1/89 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/80 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/90 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/83 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/78 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/89 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	1.2% 1/80 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/90 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/83 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.
Nervous system disorders Thalamic infarction	1.3% 1/78 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/89 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/80 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/90 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/83 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.
Renal and urinary disorders Acute kidney injury	0.00% 0/78 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/89 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/80 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/90 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	1.2% 1/83 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.

Other adverse events

Measure	Group 1 - Single Low Dose / Booster n=78 participants at risk First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 2 - Two Low Doses n=89 participants at risk First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)	Group 3 - Single High Dose / Booster n=80 participants at risk First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 4 - Two High Doses n=90 participants at risk First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)	Group 5 - Placebo n=83 participants at risk First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
Investigations Blood sodium increased	0.00% 0/78 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	1.1% 1/89 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	1.2% 1/80 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	5.6% 5/90 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	2.4% 2/83 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.
Musculoskeletal and connective tissue disorders Myalgia	3.8% 3/78 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	1.1% 1/89 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	7.5% 6/80 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	2.2% 2/90 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/83 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.
Nervous system disorders Headache	1.3% 1/78 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	2.2% 2/89 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	5.0% 4/80 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	2.2% 2/90 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	2.4% 2/83 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.
General disorders Fatigue	2.6% 2/78 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/89 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	5.0% 4/80 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/90 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	1.2% 1/83 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.
General disorders Injection site pain	1.3% 1/78 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	2.2% 2/89 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	5.0% 4/80 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	5.6% 5/90 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/83 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.
General disorders Injection site swelling	1.3% 1/78 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/89 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	5.0% 4/80 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	1.1% 1/90 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/83 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.
Infections and infestations Pharyngitis	2.6% 2/78 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	6.7% 6/89 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	2.5% 2/80 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	0.00% 0/90 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	2.4% 2/83 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.
Infections and infestations Upper respiratory tract infection	6.4% 5/78 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	6.7% 6/89 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	7.5% 6/80 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	5.6% 5/90 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	12.0% 10/83 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.
Respiratory, thoracic and mediastinal disorders Cough	3.8% 3/78 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	7.9% 7/89 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	5.0% 4/80 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	8.9% 8/90 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	10.8% 9/83 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.
Respiratory, thoracic and mediastinal disorders Nasal congestion	1.3% 1/78 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	6.7% 6/89 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	5.0% 4/80 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	6.7% 6/90 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	10.8% 9/83 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	7.7% 6/78 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	11.2% 10/89 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	6.2% 5/80 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	7.8% 7/90 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.	10.8% 9/83 • 108 weeks for participants of both study parts and 30 weeks for participants of the main study only Serious adverse events were to be reported during the entire study, non-serious adverse events within 4 weeks after each vaccination. Percentages of participants are based on MedDRA Preferred Terms.

Additional Information

Program Lead, Clinical Operations

Bavarian Nordic A/S

Phone: +45 3326

Email: info@bavarian-nordic.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place