Trial Outcomes & Findings for Immunogenicity and Safety Study of a Vaccine Against Lyme Borreliosis, in Healthy Adults Aged 18 to 65 Years. Randomized, Controlled, Observer-blind Phase 2 Study. (NCT NCT03769194)
NCT ID: NCT03769194
Last Updated: 2023-01-10
Results Overview
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype ST1 to ST6, determined by ELISA at Day 85. GMTs are calculated based on the number of subjects with non-missing results.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
572 participants
Primary outcome timeframe
at Day 85 / Month 3
Results posted on
2023-01-10
Participant Flow
Participant milestones
| Measure |
VLA15 Low Dose
VLA15 low dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 Medium Dose
VLA15 medium dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 High Dose
VLA15 high dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
Placebo
Placebo: Placebo: PBS (Phosphate Buffered Saline)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
29
|
214
|
205
|
124
|
|
Overall Study
COMPLETED
|
25
|
196
|
197
|
115
|
|
Overall Study
NOT COMPLETED
|
4
|
18
|
8
|
9
|
Reasons for withdrawal
| Measure |
VLA15 Low Dose
VLA15 low dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 Medium Dose
VLA15 medium dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 High Dose
VLA15 high dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
Placebo
Placebo: Placebo: PBS (Phosphate Buffered Saline)
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
7
|
4
|
1
|
|
Overall Study
moved from study area
|
0
|
2
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
6
|
3
|
6
|
|
Overall Study
other
|
1
|
3
|
0
|
1
|
Baseline Characteristics
Immunogenicity and Safety Study of a Vaccine Against Lyme Borreliosis, in Healthy Adults Aged 18 to 65 Years. Randomized, Controlled, Observer-blind Phase 2 Study.
Baseline characteristics by cohort
| Measure |
VLA15 Low Dose
n=29 Participants
VLA15 low dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 Medium Dose
n=214 Participants
VLA15 medium dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 High Dose
n=205 Participants
VLA15 high dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
Placebo
n=124 Participants
Placebo: Placebo: PBS (Phosphate Buffered Saline)
|
Total
n=572 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
29.2 years
STANDARD_DEVIATION 6.13 • n=5 Participants
|
41.7 years
STANDARD_DEVIATION 13.26 • n=7 Participants
|
41.6 years
STANDARD_DEVIATION 12.56 • n=5 Participants
|
40.7 years
STANDARD_DEVIATION 12.80 • n=4 Participants
|
40.8 years
STANDARD_DEVIATION 12.90 • n=21 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
312 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
260 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 number of participants
n=5 Participants
|
1 number of participants
n=7 Participants
|
0 number of participants
n=5 Participants
|
0 number of participants
n=4 Participants
|
1 number of participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 number of participants
n=5 Participants
|
2 number of participants
n=7 Participants
|
0 number of participants
n=5 Participants
|
0 number of participants
n=4 Participants
|
2 number of participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 number of participants
n=5 Participants
|
3 number of participants
n=7 Participants
|
6 number of participants
n=5 Participants
|
4 number of participants
n=4 Participants
|
17 number of participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 number of participants
n=5 Participants
|
0 number of participants
n=7 Participants
|
0 number of participants
n=5 Participants
|
0 number of participants
n=4 Participants
|
0 number of participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
25 number of participants
n=5 Participants
|
208 number of participants
n=7 Participants
|
196 number of participants
n=5 Participants
|
120 number of participants
n=4 Participants
|
549 number of participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 number of participants
n=5 Participants
|
0 number of participants
n=7 Participants
|
3 number of participants
n=5 Participants
|
0 number of participants
n=4 Participants
|
3 number of participants
n=21 Participants
|
PRIMARY outcome
Timeframe: at Day 85 / Month 3Population: Overall Number of Participants Analyzed Per Protocol population
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype ST1 to ST6, determined by ELISA at Day 85. GMTs are calculated based on the number of subjects with non-missing results.
Outcome measures
| Measure |
VLA15 Low Dose
n=29 Participants
VLA15 low dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 Medium Dose
n=192 Participants
VLA15 medium dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 High Dose
n=194 Participants
VLA15 high dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
Placebo
n=121 Participants
Placebo: Placebo: PBS (Phosphate Buffered Saline)
|
|---|---|---|---|---|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype ST1 to ST6
ST1 Day 85
|
74.3 U/mL
Interval 46.4 to 119.0
|
101.9 U/mL
Interval 87.1 to 119.4
|
115.8 U/mL
Interval 98.8 to 135.7
|
21.7 U/mL
Interval 20.0 to 23.6
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype ST1 to ST6
ST2 Day 85
|
180.9 U/mL
Interval 124.8 to 262.3
|
279.3 U/mL
Interval 247.1 to 315.8
|
303.7 U/mL
Interval 266.5 to 346.1
|
21.1 U/mL
Interval 20.0 to 22.3
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype ST1 to ST6
ST4 Day 85
|
117.0 U/mL
Interval 76.6 to 178.7
|
170.9 U/mL
Interval 150.5 to 194.2
|
190.7 U/mL
Interval 165.9 to 219.2
|
21.8 U/mL
Interval 20.4 to 23.4
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype ST1 to ST6
ST5 Day 85
|
118.3 U/mL
Interval 78.3 to 178.9
|
176.0 U/mL
Interval 154.2 to 201.0
|
199.6 U/mL
Interval 172.5 to 230.9
|
21.4 U/mL
Interval 20.2 to 22.6
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype ST1 to ST6
ST3 Day 85
|
267.4 U/mL
Interval 194.8 to 367.1
|
283.2 U/mL
Interval 248.2 to 323.1
|
308.6 U/mL
Interval 266.8 to 356.8
|
20.8 U/mL
Interval 19.8 to 21.8
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype ST1 to ST6
ST6 Day 85
|
115.6 U/mL
Interval 76.5 to 174.7
|
183.6 U/mL
Interval 161.7 to 208.4
|
208.7 U/mL
Interval 181.8 to 239.6
|
21.8 U/mL
Interval 20.3 to 23.4
|
SECONDARY outcome
Timeframe: up to Day 365 / Month 12GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) (Outer Surface Protein A) serotype (ST1 to ST6), determined by ELISA. GMTs are calculated based on the number of subjects with non-missing results.
Outcome measures
| Measure |
VLA15 Low Dose
n=29 Participants
VLA15 low dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 Medium Dose
n=192 Participants
VLA15 medium dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 High Dose
n=194 Participants
VLA15 high dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
Placebo
n=121 Participants
Placebo: Placebo: PBS (Phosphate Buffered Saline)
|
|---|---|---|---|---|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST3 Day 1
|
21.9 U/mL
Interval 19.1 to 25.1
|
20.4 U/mL
Interval 20.0 to 20.8
|
20.1 U/mL
Interval 19.9 to 20.4
|
20.4 U/mL
Interval 19.6 to 21.2
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST1 Day 180
|
26.2 U/mL
Interval 19.9 to 34.5
|
32.8 U/mL
Interval 28.8 to 37.3
|
33.9 U/mL
Interval 30.0 to 38.3
|
21.0 U/mL
Interval 19.8 to 22.3
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST1 Day 236
|
22.2 U/mL
Interval 18.8 to 26.1
|
25.7 U/mL
Interval 22.8 to 28.8
|
26.2 U/mL
Interval 23.1 to 29.7
|
21.5 U/mL
Interval 19.6 to 23.6
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST2 Day 29
|
21.1 U/mL
Interval 18.9 to 23.7
|
21.1 U/mL
Interval 20.0 to 22.2
|
21.4 U/mL
Interval 20.5 to 22.4
|
21.0 U/mL
Interval 19.9 to 22.1
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST2 Day 57
|
69.0 U/mL
Interval 47.7 to 99.8
|
89.2 U/mL
Interval 75.9 to 104.9
|
107.8 U/mL
Interval 92.7 to 125.2
|
21.3 U/mL
Interval 20.0 to 22.6
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST2 Day 236
|
26.6 U/mL
Interval 21.2 to 33.4
|
36.8 U/mL
Interval 32.1 to 42.2
|
35.7 U/mL
Interval 30.9 to 41.2
|
20.5 U/mL
Interval 19.5 to 21.5
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST2 Day 365
|
21.8 U/mL
Interval 19.2 to 24.7
|
24.6 U/mL
Interval 22.8 to 26.6
|
24.8 U/mL
Interval 23.1 to 26.6
|
20.6 U/mL
Interval 19.7 to 21.5
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST3 Day 29
|
23.7 U/mL
Interval 20.0 to 28.0
|
21.7 U/mL
Interval 20.2 to 23.2
|
21.2 U/mL
Interval 20.3 to 22.1
|
20.8 U/mL
Interval 19.8 to 21.9
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST4 Day 29
|
22.1 U/mL
Interval 19.1 to 25.6
|
21.9 U/mL
Interval 20.4 to 23.6
|
21.4 U/mL
Interval 20.4 to 22.4
|
22.0 U/mL
Interval 20.4 to 23.6
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST4 Day 57
|
45.9 U/mL
Interval 32.8 to 64.2
|
57.4 U/mL
Interval 49.5 to 66.6
|
64.7 U/mL
Interval 55.5 to 75.5
|
22.0 U/mL
Interval 20.4 to 23.8
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST4 Day 180
|
32.8 U/mL
Interval 24.1 to 44.6
|
48.1 U/mL
Interval 42.5 to 54.5
|
49.3 U/mL
Interval 43.1 to 56.3
|
21.5 U/mL
Interval 20.2 to 22.9
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST4 Day 236
|
25.5 U/mL
Interval 20.6 to 31.5
|
32.8 U/mL
Interval 29.0 to 37.2
|
31.9 U/mL
Interval 27.7 to 36.6
|
21.7 U/mL
Interval 20.0 to 23.5
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST4 Day 365
|
21.8 U/mL
Interval 19.2 to 24.7
|
26.5 U/mL
Interval 24.2 to 28.9
|
25.5 U/mL
Interval 23.2 to 27.9
|
21.7 U/mL
Interval 20.3 to 23.2
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST5 Day 1
|
20.6 U/mL
Interval 19.4 to 21.8
|
20.7 U/mL
Interval 20.1 to 21.3
|
20.2 U/mL
Interval 19.8 to 20.5
|
21.4 U/mL
Interval 20.2 to 22.7
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST5 Day 29
|
20.7 U/mL
Interval 19.2 to 22.4
|
21.2 U/mL
Interval 20.0 to 22.5
|
21.0 U/mL
Interval 20.2 to 21.9
|
21.4 U/mL
Interval 20.1 to 22.7
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST5 Day 180
|
26.7 U/mL
Interval 20.7 to 34.3
|
44.0 U/mL
Interval 38.8 to 49.8
|
50.0 U/mL
Interval 43.5 to 57.4
|
21.1 U/mL
Interval 20.0 to 22.3
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST5 Day 236
|
23.0 U/mL
Interval 19.6 to 27.0
|
31.0 U/mL
Interval 27.5 to 35.0
|
32.4 U/mL
Interval 28.0 to 37.4
|
21.5 U/mL
Interval 20.0 to 23.1
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST6 Day 180
|
30.1 U/mL
Interval 22.6 to 40.2
|
48.4 U/mL
Interval 42.8 to 54.8
|
51.4 U/mL
Interval 44.7 to 59.0
|
21.4 U/mL
Interval 20.1 to 22.8
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST1 Day 1
|
20.8 U/mL
Interval 19.2 to 22.5
|
20.5 U/mL
Interval 19.8 to 21.3
|
20.2 U/mL
Interval 19.8 to 20.6
|
21.6 U/mL
Interval 19.9 to 23.5
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST1 Day 29
|
21.1 U/mL
Interval 18.9 to 23.5
|
21.8 U/mL
Interval 20.0 to 23.8
|
21.2 U/mL
Interval 20.1 to 22.4
|
21.7 U/mL
Interval 20.0 to 23.7
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST1 Day 57
|
32.7 U/mL
Interval 25.1 to 42.6
|
37.5 U/mL
Interval 32.4 to 43.3
|
41.2 U/mL
Interval 35.7 to 47.5
|
21.9 U/mL
Interval 20.1 to 23.8
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST1 Day 365
|
20.9 U/mL
Interval 19.1 to 22.9
|
23.4 U/mL
Interval 21.4 to 25.6
|
23.0 U/mL
Interval 21.3 to 24.9
|
21.4 U/mL
Interval 19.9 to 22.9
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST2 Day 1
|
21.3 U/mL
Interval 18.7 to 24.2
|
20.0 U/mL
Interval 20.0 to 20.0
|
20.1 U/mL
Interval 19.9 to 20.2
|
20.7 U/mL
Interval 19.7 to 21.8
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST2 Day 180
|
41.2 U/mL
Interval 29.3 to 57.9
|
62.5 U/mL
Interval 54.5 to 71.7
|
67.1 U/mL
Interval 58.3 to 77.1
|
20.6 U/mL
Interval 19.7 to 21.5
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST3 Day 57
|
110.2 U/mL
Interval 71.1 to 171.0
|
123.8 U/mL
Interval 104.4 to 146.9
|
145.8 U/mL
Interval 122.8 to 173.0
|
21.2 U/mL
Interval 20.0 to 22.6
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST3 Day 180
|
53.1 U/mL
Interval 35.6 to 79.1
|
63.1 U/mL
Interval 55.2 to 72.2
|
68.7 U/mL
Interval 59.5 to 79.2
|
20.5 U/mL
Interval 19.8 to 21.3
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST3 Day 236
|
35.3 U/mL
Interval 25.7 to 48.6
|
35.8 U/mL
Interval 31.2 to 41.1
|
39.0 U/mL
Interval 33.3 to 45.8
|
20.6 U/mL
Interval 19.7 to 21.7
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST3 Day 365
|
25.2 U/mL
Interval 19.9 to 31.8
|
25.6 U/mL
Interval 23.5 to 27.9
|
27.0 U/mL
Interval 24.5 to 29.8
|
20.5 U/mL
Interval 19.8 to 21.3
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST4 Day 1
|
21.4 U/mL
Interval 18.7 to 24.4
|
21.0 U/mL
Interval 20.3 to 21.7
|
20.2 U/mL
Interval 19.9 to 20.6
|
21.7 U/mL
Interval 20.3 to 23.2
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST5 Day 57
|
42.7 U/mL
Interval 29.8 to 61.3
|
57.9 U/mL
Interval 44.9 to 67.2
|
72.2 U/mL
Interval 61.6 to 84.7
|
21.5 U/mL
Interval 20.2 to 22.9
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST5 Day 365
|
21.7 U/mL
Interval 19.3 to 24.3
|
24.0 U/mL
Interval 22.3 to 25.8
|
24.9 U/mL
Interval 22.7 to 27.2
|
21.1 U/mL
Interval 20.0 to 22.2
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST6 Day 1
|
21.1 U/mL
Interval 18.9 to 23.5
|
21.3 U/mL
Interval 20.4 to 22.2
|
20.8 U/mL
Interval 20.1 to 21.6
|
21.6 U/mL
Interval 20.2 to 23.2
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST6 Day 29
|
21.1 U/mL
Interval 18.9 to 23.6
|
22.7 U/mL
Interval 21.2 to 24.3
|
22.0 U/mL
Interval 20.9 to 23.2
|
22.0 U/mL
Interval 20.4 to 23.7
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST6 Day 57
|
42.3 U/mL
Interval 29.8 to 60.1
|
55.5 U/mL
Interval 48.1 to 64.1
|
65.3 U/mL
Interval 55.6 to 76.7
|
22.1 U/mL
Interval 20.4 to 23.9
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST6 Day 236
|
25.6 U/mL
Interval 20.7 to 31.8
|
33.4 U/mL
Interval 29.5 to 37.8
|
33.2 U/mL
Interval 28.6 to 38.6
|
22.1 U/mL
Interval 20.2 to 24.3
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST6 Day 365
|
22.1 U/mL
Interval 19.2 to 25.5
|
25.7 U/mL
Interval 23.8 to 27.9
|
26.0 U/mL
Interval 23.6 to 28.7
|
21.8 U/mL
Interval 20.3 to 23.3
|
SECONDARY outcome
Timeframe: up to Day 365 / Month 12Seroconversion for ELISA is defined as: * for subjects that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive (i.e. antibody titer of ≥40 U/mL) at a certain time point. * for subjects that are seropositive at Visit 1 (baseline): a ≥ 4-fold rise in IgG antibody titer from Visit 1. Percentages are based on the number of subjects with non-missing observations.
Outcome measures
| Measure |
VLA15 Low Dose
n=29 Participants
VLA15 low dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 Medium Dose
n=192 Participants
VLA15 medium dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 High Dose
n=194 Participants
VLA15 high dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
Placebo
n=121 Participants
Placebo: Placebo: PBS (Phosphate Buffered Saline)
|
|---|---|---|---|---|
|
SCRs (Seroconversion Rate) for Each OspA (Outer Surface Protein A) Serotype Specific IgG (Immunoglobulin G) (ST1 to ST6),
ST1 Day 29
|
0.0 percentage of subjects
Interval 0.0 to 11.7
|
3.7 percentage of subjects
Interval 1.8 to 7.4
|
3.1 percentage of subjects
Interval 1.4 to 6.6
|
0.8 percentage of subjects
Interval 0.1 to 4.6
|
|
SCRs (Seroconversion Rate) for Each OspA (Outer Surface Protein A) Serotype Specific IgG (Immunoglobulin G) (ST1 to ST6),
ST1 Day 57
|
39.3 percentage of subjects
Interval 23.6 to 57.6
|
37.2 percentage of subjects
Interval 30.6 to 44.2
|
40.7 percentage of subjects
Interval 34.1 to 47.8
|
1.7 percentage of subjects
Interval 0.5 to 5.8
|
|
SCRs (Seroconversion Rate) for Each OspA (Outer Surface Protein A) Serotype Specific IgG (Immunoglobulin G) (ST1 to ST6),
ST1 Day 180
|
11.5 percentage of subjects
Interval 4.0 to 29.0
|
32.8 percentage of subjects
Interval 26.4 to 39.9
|
35.4 percentage of subjects
Interval 29.0 to 42.5
|
0.9 percentage of subjects
Interval 0.2 to 4.8
|
|
SCRs (Seroconversion Rate) for Each OspA (Outer Surface Protein A) Serotype Specific IgG (Immunoglobulin G) (ST1 to ST6),
ST1 Day 236
|
7.7 percentage of subjects
Interval 2.1 to 24.1
|
17.2 percentage of subjects
Interval 11.5 to 24.9
|
18.5 percentage of subjects
Interval 12.5 to 26.4
|
2.6 percentage of subjects
Interval 0.7 to 9.1
|
|
SCRs (Seroconversion Rate) for Each OspA (Outer Surface Protein A) Serotype Specific IgG (Immunoglobulin G) (ST1 to ST6),
ST1 Day 365
|
4.0 percentage of subjects
Interval 0.7 to 19.5
|
10.9 percentage of subjects
Interval 7.2 to 16.3
|
8.9 percentage of subjects
Interval 5.6 to 13.8
|
1.8 percentage of subjects
Interval 0.5 to 6.2
|
|
SCRs (Seroconversion Rate) for Each OspA (Outer Surface Protein A) Serotype Specific IgG (Immunoglobulin G) (ST1 to ST6),
ST2 Day 29
|
0.0 percentage of subjects
Interval 0.0 to 11.7
|
2.6 percentage of subjects
Interval 1.1 to 6.0
|
5.7 percentage of subjects
Interval 3.2 to 9.9
|
0.8 percentage of subjects
Interval 0.1 to 4.6
|
|
SCRs (Seroconversion Rate) for Each OspA (Outer Surface Protein A) Serotype Specific IgG (Immunoglobulin G) (ST1 to ST6),
ST2 Day 57
|
67.9 percentage of subjects
Interval 49.3 to 82.1
|
72.3 percentage of subjects
Interval 65.5 to 78.1
|
79.9 percentage of subjects
Interval 73.7 to 84.9
|
1.7 percentage of subjects
Interval 0.5 to 5.8
|
|
SCRs (Seroconversion Rate) for Each OspA (Outer Surface Protein A) Serotype Specific IgG (Immunoglobulin G) (ST1 to ST6),
ST2 Day 180
|
42.3 percentage of subjects
Interval 25.5 to 61.1
|
66.1 percentage of subjects
Interval 59.0 to 72.6
|
66.7 percentage of subjects
Interval 59.7 to 73.0
|
0.9 percentage of subjects
Interval 0.2 to 4.8
|
|
SCRs (Seroconversion Rate) for Each OspA (Outer Surface Protein A) Serotype Specific IgG (Immunoglobulin G) (ST1 to ST6),
ST2 Day 236
|
19.2 percentage of subjects
Interval 8.5 to 37.9
|
42.6 percentage of subjects
Interval 34.2 to 51.5
|
38.7 percentage of subjects
Interval 30.4 to 47.6
|
0.0 percentage of subjects
Interval 0.0 to 4.8
|
|
SCRs (Seroconversion Rate) for Each OspA (Outer Surface Protein A) Serotype Specific IgG (Immunoglobulin G) (ST1 to ST6),
ST2 Day 365
|
8.0 percentage of subjects
Interval 2.2 to 25.0
|
15.3 percentage of subjects
Interval 10.8 to 21.2
|
17.8 percentage of subjects
Interval 13.0 to 23.8
|
0.9 percentage of subjects
Interval 0.2 to 4.8
|
|
SCRs (Seroconversion Rate) for Each OspA (Outer Surface Protein A) Serotype Specific IgG (Immunoglobulin G) (ST1 to ST6),
ST3 Day 57
|
75.0 percentage of subjects
Interval 56.6 to 87.3
|
80.1 percentage of subjects
Interval 73.9 to 85.1
|
84.0 percentage of subjects
Interval 78.2 to 88.5
|
2.5 percentage of subjects
Interval 0.8 to 7.0
|
|
SCRs (Seroconversion Rate) for Each OspA (Outer Surface Protein A) Serotype Specific IgG (Immunoglobulin G) (ST1 to ST6),
ST4 Day 365
|
8.0 percentage of subjects
Interval 2.2 to 25.0
|
19.7 percentage of subjects
Interval 14.6 to 26.0
|
16.8 percentage of subjects
Interval 12.1 to 22.7
|
2.7 percentage of subjects
Interval 0.9 to 7.5
|
|
SCRs (Seroconversion Rate) for Each OspA (Outer Surface Protein A) Serotype Specific IgG (Immunoglobulin G) (ST1 to ST6),
ST6 Day 236
|
15.4 percentage of subjects
Interval 6.2 to 33.5
|
35.2 percentage of subjects
Interval 27.3 to 44.1
|
31.1 percentage of subjects
Interval 23.5 to 39.9
|
3.9 percentage of subjects
Interval 1.4 to 11.0
|
|
SCRs (Seroconversion Rate) for Each OspA (Outer Surface Protein A) Serotype Specific IgG (Immunoglobulin G) (ST1 to ST6),
ST6 Day 365
|
8.0 percentage of subjects
Interval 2.2 to 25.0
|
16.9 percentage of subjects
Interval 12.2 to 23.0
|
13.6 percentage of subjects
Interval 9.5 to 19.2
|
3.5 percentage of subjects
Interval 1.4 to 8.7
|
|
SCRs (Seroconversion Rate) for Each OspA (Outer Surface Protein A) Serotype Specific IgG (Immunoglobulin G) (ST1 to ST6),
ST3 Day 29
|
6.9 percentage of subjects
Interval 1.9 to 22.0
|
4.2 percentage of subjects
Interval 2.1 to 8.0
|
3.6 percentage of subjects
Interval 1.8 to 7.3
|
1.7 percentage of subjects
Interval 0.5 to 5.9
|
|
SCRs (Seroconversion Rate) for Each OspA (Outer Surface Protein A) Serotype Specific IgG (Immunoglobulin G) (ST1 to ST6),
ST3 Day 180
|
50.0 percentage of subjects
Interval 32.1 to 67.9
|
68.9 percentage of subjects
Interval 61.8 to 75.1
|
69.3 percentage of subjects
Interval 62.4 to 75.4
|
1.8 percentage of subjects
Interval 0.5 to 6.2
|
|
SCRs (Seroconversion Rate) for Each OspA (Outer Surface Protein A) Serotype Specific IgG (Immunoglobulin G) (ST1 to ST6),
ST3 Day 236
|
34.6 percentage of subjects
Interval 19.4 to 53.8
|
39.3 percentage of subjects
Interval 31.1 to 48.2
|
42.0 percentage of subjects
Interval 33.5 to 51.0
|
2.6 percentage of subjects
Interval 0.7 to 9.1
|
|
SCRs (Seroconversion Rate) for Each OspA (Outer Surface Protein A) Serotype Specific IgG (Immunoglobulin G) (ST1 to ST6),
ST3 Day 365
|
12.0 percentage of subjects
Interval 4.2 to 30.0
|
17.5 percentage of subjects
Interval 12.7 to 23.6
|
19.9 percentage of subjects
Interval 14.9 to 26.1
|
1.8 percentage of subjects
Interval 0.5 to 6.2
|
|
SCRs (Seroconversion Rate) for Each OspA (Outer Surface Protein A) Serotype Specific IgG (Immunoglobulin G) (ST1 to ST6),
ST4 Day 29
|
3.4 percentage of subjects
Interval 0.6 to 17.2
|
2.6 percentage of subjects
Interval 1.1 to 6.0
|
3.6 percentage of subjects
Interval 1.8 to 7.3
|
0.8 percentage of subjects
Interval 0.1 to 4.6
|
|
SCRs (Seroconversion Rate) for Each OspA (Outer Surface Protein A) Serotype Specific IgG (Immunoglobulin G) (ST1 to ST6),
ST4 Day 57
|
50.0 percentage of subjects
Interval 32.6 to 67.4
|
58.6 percentage of subjects
Interval 51.6 to 65.4
|
67.0 percentage of subjects
Interval 60.1 to 73.2
|
0.8 percentage of subjects
Interval 0.1 to 4.5
|
|
SCRs (Seroconversion Rate) for Each OspA (Outer Surface Protein A) Serotype Specific IgG (Immunoglobulin G) (ST1 to ST6),
ST4 Day 180
|
30.8 percentage of subjects
Interval 16.5 to 50.0
|
57.4 percentage of subjects
Interval 50.1 to 64.3
|
58.2 percentage of subjects
Interval 51.1 to 65.0
|
0.9 percentage of subjects
Interval 0.2 to 4.8
|
|
SCRs (Seroconversion Rate) for Each OspA (Outer Surface Protein A) Serotype Specific IgG (Immunoglobulin G) (ST1 to ST6),
ST4 Day 236
|
15.4 percentage of subjects
Interval 6.2 to 33.5
|
36.1 percentage of subjects
Interval 28.1 to 44.9
|
31.9 percentage of subjects
Interval 24.2 to 40.8
|
1.3 percentage of subjects
Interval 0.2 to 7.1
|
|
SCRs (Seroconversion Rate) for Each OspA (Outer Surface Protein A) Serotype Specific IgG (Immunoglobulin G) (ST1 to ST6),
ST5 Day 29
|
0.0 percentage of subjects
Interval 0.0 to 11.7
|
1.6 percentage of subjects
Interval 0.5 to 4.5
|
2.6 percentage of subjects
Interval 1.1 to 5.9
|
0.0 percentage of subjects
Interval 0.0 to 3.1
|
|
SCRs (Seroconversion Rate) for Each OspA (Outer Surface Protein A) Serotype Specific IgG (Immunoglobulin G) (ST1 to ST6),
ST5 Day 57
|
42.9 percentage of subjects
Interval 26.5 to 60.9
|
58.1 percentage of subjects
Interval 51.0 to 64.9
|
67.5 percentage of subjects
Interval 60.7 to 73.7
|
0.0 percentage of subjects
Interval 0.0 to 3.1
|
|
SCRs (Seroconversion Rate) for Each OspA (Outer Surface Protein A) Serotype Specific IgG (Immunoglobulin G) (ST1 to ST6),
ST5 Day 180
|
19.2 percentage of subjects
Interval 8.5 to 37.9
|
49.7 percentage of subjects
Interval 42.6 to 56.9
|
55.0 percentage of subjects
Interval 47.9 to 61.9
|
0.9 percentage of subjects
Interval 0.2 to 4.8
|
|
SCRs (Seroconversion Rate) for Each OspA (Outer Surface Protein A) Serotype Specific IgG (Immunoglobulin G) (ST1 to ST6),
ST5 Day 236
|
11.5 percentage of subjects
Interval 4.0 to 29.0
|
32.0 percentage of subjects
Interval 24.4 to 40.7
|
31.9 percentage of subjects
Interval 24.2 to 40.8
|
1.3 percentage of subjects
Interval 0.2 to 7.1
|
|
SCRs (Seroconversion Rate) for Each OspA (Outer Surface Protein A) Serotype Specific IgG (Immunoglobulin G) (ST1 to ST6),
ST5 Day 365
|
8.0 percentage of subjects
Interval 2.2 to 25.0
|
13.1 percentage of subjects
Interval 9.0 to 18.8
|
13.1 percentage of subjects
Interval 9.0 to 18.6
|
0.9 percentage of subjects
Interval 0.2 to 4.8
|
|
SCRs (Seroconversion Rate) for Each OspA (Outer Surface Protein A) Serotype Specific IgG (Immunoglobulin G) (ST1 to ST6),
ST6 Day 29
|
0.0 percentage of subjects
Interval 0.0 to 11.7
|
6.3 percentage of subjects
Interval 3.6 to 10.7
|
4.6 percentage of subjects
Interval 2.5 to 8.6
|
1.7 percentage of subjects
Interval 0.5 to 5.9
|
|
SCRs (Seroconversion Rate) for Each OspA (Outer Surface Protein A) Serotype Specific IgG (Immunoglobulin G) (ST1 to ST6),
ST6 Day 57
|
42.9 percentage of subjects
Interval 26.5 to 60.9
|
54.5 percentage of subjects
Interval 47.4 to 61.4
|
60.3 percentage of subjects
Interval 53.3 to 66.9
|
1.7 percentage of subjects
Interval 0.5 to 5.8
|
|
SCRs (Seroconversion Rate) for Each OspA (Outer Surface Protein A) Serotype Specific IgG (Immunoglobulin G) (ST1 to ST6),
ST6 Day 180
|
23.1 percentage of subjects
Interval 11.0 to 42.1
|
54.1 percentage of subjects
Interval 46.9 to 61.2
|
53.4 percentage of subjects
Interval 46.3 to 60.4
|
2.6 percentage of subjects
Interval 0.9 to 7.5
|
SECONDARY outcome
Timeframe: up to Day 365 / Month 12GMFR (Geometric Mean of the Fold Rise as compared to baseline) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (ST1 to ST6), determined by ELISA. Calculations are based on number of subjects with non-missing results.
Outcome measures
| Measure |
VLA15 Low Dose
n=29 Participants
VLA15 low dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 Medium Dose
n=192 Participants
VLA15 medium dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 High Dose
n=194 Participants
VLA15 high dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
Placebo
n=121 Participants
Placebo: Placebo: PBS (Phosphate Buffered Saline)
|
|---|---|---|---|---|
|
GMFR (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST2 Day 365
|
1.1 Geometric Mean of the Fold Rise
Interval 1.0 to 1.2
|
1.2 Geometric Mean of the Fold Rise
Interval 1.1 to 1.3
|
1.2 Geometric Mean of the Fold Rise
Interval 1.1 to 1.3
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFR (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST3 Day 29
|
1.1 Geometric Mean of the Fold Rise
Interval 1.0 to 1.2
|
1.1 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
1.1 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
|
GMFR (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST3 Day 57
|
5.0 Geometric Mean of the Fold Rise
Interval 3.2 to 7.8
|
6.1 Geometric Mean of the Fold Rise
Interval 5.1 to 7.2
|
7.2 Geometric Mean of the Fold Rise
Interval 6.1 to 8.6
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
|
GMFR (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST3 Day 236
|
1.6 Geometric Mean of the Fold Rise
Interval 1.2 to 2.2
|
1.8 Geometric Mean of the Fold Rise
Interval 1.5 to 2.0
|
1.9 Geometric Mean of the Fold Rise
Interval 1.6 to 2.3
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
|
GMFR (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST3 Day 365
|
1.2 Geometric Mean of the Fold Rise
Interval 1.0 to 1.4
|
1.3 Geometric Mean of the Fold Rise
Interval 1.2 to 1.4
|
1.3 Geometric Mean of the Fold Rise
Interval 1.2 to 1.5
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
|
GMFR (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST4 Day 29
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
1.1 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFR (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST1 Day 29
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
1.1 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
1.1 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFR (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST1 Day 57
|
1.6 Geometric Mean of the Fold Rise
Interval 1.2 to 2.1
|
1.8 Geometric Mean of the Fold Rise
Interval 1.6 to 2.1
|
2.0 Geometric Mean of the Fold Rise
Interval 1.8 to 2.4
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFR (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST1 Day 180
|
1.3 Geometric Mean of the Fold Rise
Interval 1.0 to 1.6
|
1.6 Geometric Mean of the Fold Rise
Interval 1.4 to 1.8
|
1.7 Geometric Mean of the Fold Rise
Interval 1.5 to 1.9
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFR (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST1 Day 236
|
1.1 Geometric Mean of the Fold Rise
Interval 0.9 to 1.3
|
1.3 Geometric Mean of the Fold Rise
Interval 1.1 to 1.4
|
1.3 Geometric Mean of the Fold Rise
Interval 1.2 to 1.5
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
|
GMFR (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST1 Day 365
|
1.0 Geometric Mean of the Fold Rise
Interval 0.9 to 1.1
|
1.1 Geometric Mean of the Fold Rise
Interval 1.1 to 1.2
|
1.1 Geometric Mean of the Fold Rise
Interval 1.1 to 1.2
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
|
GMFR (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST2 Day 29
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
1.1 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
1.1 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFR (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST2 Day 57
|
3.2 Geometric Mean of the Fold Rise
Interval 2.2 to 4.7
|
4.5 Geometric Mean of the Fold Rise
Interval 3.8 to 5.2
|
5.4 Geometric Mean of the Fold Rise
Interval 4.6 to 6.2
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
|
GMFR (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST2 Day 180
|
1.9 Geometric Mean of the Fold Rise
Interval 1.4 to 2.7
|
3.1 Geometric Mean of the Fold Rise
Interval 2.7 to 3.6
|
3.3 Geometric Mean of the Fold Rise
Interval 2.9 to 3.8
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFR (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST2 Day 236
|
1.2 Geometric Mean of the Fold Rise
Interval 1.0 to 1.6
|
1.8 Geometric Mean of the Fold Rise
Interval 1.6 to 2.1
|
1.8 Geometric Mean of the Fold Rise
Interval 1.5 to 2.1
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFR (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST3 Day 180
|
2.4 Geometric Mean of the Fold Rise
Interval 1.6 to 3.6
|
3.1 Geometric Mean of the Fold Rise
Interval 2.7 to 3.5
|
3.4 Geometric Mean of the Fold Rise
Interval 3.0 to 3.9
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
|
GMFR (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST4 Day 57
|
2.1 Geometric Mean of the Fold Rise
Interval 1.5 to 3.0
|
2.7 Geometric Mean of the Fold Rise
Interval 2.4 to 3.2
|
3.2 Geometric Mean of the Fold Rise
Interval 2.7 to 3.7
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFR (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST6 Day 57
|
2.0 Geometric Mean of the Fold Rise
Interval 1.4 to 2.8
|
2.6 Geometric Mean of the Fold Rise
Interval 2.3 to 3.0
|
3.1 Geometric Mean of the Fold Rise
Interval 2.7 to 3.7
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFR (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST4 Day 180
|
1.5 Geometric Mean of the Fold Rise
Interval 1.1 to 2.1
|
2.3 Geometric Mean of the Fold Rise
Interval 2.0 to 2.6
|
2.4 Geometric Mean of the Fold Rise
Interval 2.1 to 2.8
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFR (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST4 Day 236
|
1.2 Geometric Mean of the Fold Rise
Interval 0.9 to 1.5
|
1.6 Geometric Mean of the Fold Rise
Interval 1.4 to 1.8
|
1.6 Geometric Mean of the Fold Rise
Interval 1.4 to 1.8
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
|
GMFR (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST4 Day 365
|
1.1 Geometric Mean of the Fold Rise
Interval 1.0 to 1.2
|
1.3 Geometric Mean of the Fold Rise
Interval 1.2 to 1.4
|
1.3 Geometric Mean of the Fold Rise
Interval 1.1 to 1.4
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
|
GMFR (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST5 Day 29
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFR (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST5 Day 57
|
2.1 Geometric Mean of the Fold Rise
Interval 1.5 to 3.0
|
2.8 Geometric Mean of the Fold Rise
Interval 2.4 to 3.2
|
3.6 Geometric Mean of the Fold Rise
Interval 3.1 to 4.2
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFR (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST5 Day 180
|
1.3 Geometric Mean of the Fold Rise
Interval 1.0 to 1.7
|
2.1 Geometric Mean of the Fold Rise
Interval 1.9 to 2.4
|
2.5 Geometric Mean of the Fold Rise
Interval 2.2 to 2.8
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFR (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST5 Day 236
|
1.1 Geometric Mean of the Fold Rise
Interval 0.9 to 1.3
|
1.5 Geometric Mean of the Fold Rise
Interval 1.4 to 1.7
|
1.6 Geometric Mean of the Fold Rise
Interval 1.4 to 1.8
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFR (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST5 Day 365
|
1.1 Geometric Mean of the Fold Rise
Interval 1.0 to 1.2
|
1.2 Geometric Mean of the Fold Rise
Interval 1.1 to 1.2
|
1.2 Geometric Mean of the Fold Rise
Interval 1.1 to 1.3
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFR (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST6 Day 29
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
1.1 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
1.1 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFR (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST6 Day 180
|
1.4 Geometric Mean of the Fold Rise
Interval 1.1 to 1.9
|
2.3 Geometric Mean of the Fold Rise
Interval 2.0 to 2.6
|
2.5 Geometric Mean of the Fold Rise
Interval 2.1 to 2.8
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
|
GMFR (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST6 Day 236
|
1.2 Geometric Mean of the Fold Rise
Interval 1.0 to 1.5
|
1.6 Geometric Mean of the Fold Rise
Interval 1.4 to 1.8
|
1.6 Geometric Mean of the Fold Rise
Interval 1.4 to 1.9
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
|
GMFR (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
ST6 Day 365
|
1.1 Geometric Mean of the Fold Rise
Interval 1.0 to 1.3
|
1.2 Geometric Mean of the Fold Rise
Interval 1.1 to 1.3
|
1.2 Geometric Mean of the Fold Rise
Interval 1.1 to 1.4
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
SECONDARY outcome
Timeframe: up to Day 365 / Month 12GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (ST1 to ST6), determined by ELISA, stratified by age group - Group 18 - 49 years. GMTs are calculated based on the number of subjects with non-missing results.
Outcome measures
| Measure |
VLA15 Low Dose
n=29 Participants
VLA15 low dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 Medium Dose
n=133 Participants
VLA15 medium dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 High Dose
n=136 Participants
VLA15 high dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
Placebo
n=88 Participants
Placebo: Placebo: PBS (Phosphate Buffered Saline)
|
|---|---|---|---|---|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST1 Day 365
|
20.9 U/mL
Interval 19.1 to 22.9
|
23.0 U/mL
Interval 21.1 to 25.1
|
23.8 U/mL
Interval 21.4 to 26.5
|
21.7 U/mL
Interval 19.7 to 23.9
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST4 Day 29
|
22.1 U/mL
Interval 19.1 to 25.6
|
21.5 U/mL
Interval 20.4 to 22.8
|
21.5 U/mL
Interval 20.3 to 22.8
|
22.3 U/mL
Interval 20.4 to 24.4
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST4 Day 365
|
21.8 U/mL
Interval 19.2 to 24.7
|
26.7 U/mL
Interval 24.2 to 29.5
|
26.7 U/mL
Interval 23.5 to 30.3
|
21.4 U/mL
Interval 19.9 to 23.0
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST5 Day 1
|
20.6 U/mL
Interval 19.4 to 21.8
|
20.4 U/mL
Interval 19.9 to 20.9
|
20.2 U/mL
Interval 19.8 to 20.8
|
21.5 U/mL
Interval 20.0 to 23.1
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST5 Day 85
|
118.3 U/mL
Interval 78.3 to 178.9
|
180.7 U/mL
Interval 156.8 to 208.2
|
218.3 U/mL
Interval 183.6 to 259.7
|
21.4 U/mL
Interval 20.0 to 22.9
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST5 Day 365
|
21.7 U/mL
Interval 19.3 to 24.3
|
24.0 U/mL
Interval 22.2 to 26.0
|
26.0 U/mL
Interval 23.0 to 29.5
|
20.8 U/mL
Interval 19.7 to 21.9
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST6 Day 57
|
42.3 U/mL
Interval 29.8 to 60.1
|
54.5 U/mL
Interval 46.2 to 64.3
|
72.3 U/mL
Interval 59.2 to 88.3
|
22.3 U/mL
Interval 20.3 to 24.4
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST1 Day 1
|
20.8 U/mL
Interval 19.2 to 22.5
|
20.3 U/mL
Interval 19.7 to 21.0
|
20.3 U/mL
Interval 19.7 to 20.8
|
22.0 U/mL
Interval 19.6 to 24.6
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST1 Day 29
|
21.1 U/mL
Interval 18.9 to 23.5
|
20.9 U/mL
Interval 19.7 to 22.1
|
21.4 U/mL
Interval 19.9 to 23.0
|
22.0 U/mL
Interval 19.6 to 24.6
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST1 Day 57
|
32.7 U/mL
Interval 25.1 to 42.6
|
34.8 U/mL
Interval 30.0 to 40.3
|
43.6 U/mL
Interval 36.5 to 52.0
|
22.4 U/mL
Interval 19.9 to 25.2
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST1 Day 85
|
74.3 U/mL
Interval 46.4 to 119.0
|
105.2 U/mL
Interval 88.8 to 124.5
|
129.6 U/mL
Interval 107.6 to 156.2
|
21.9 U/mL
Interval 19.6 to 24.5
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST1 Day 180
|
26.2 U/mL
Interval 19.9 to 34.5
|
31.7 U/mL
Interval 27.5 to 36.4
|
34.7 U/mL
Interval 29.7 to 40.5
|
21.0 U/mL
Interval 19.5 to 22.7
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST1 Day 236
|
22.2 U/mL
Interval 18.8 to 26.1
|
26.1 U/mL
Interval 22.5 to 30.3
|
26.4 U/mL
Interval 22.4 to 31.2
|
21.7 U/mL
Interval 19.3 to 24.4
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST2 Day 1
|
21.3 U/mL
Interval 18.7 to 24.2
|
20.0 U/mL
Interval 20.0 to 20.0
|
20.1 U/mL
Interval 19.9 to 20.3
|
21.0 U/mL
Interval 19.6 to 22.5
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST2 Day 29
|
21.1 U/mL
Interval 18.9 to 23.7
|
20.7 U/mL
Interval 19.9 to 21.5
|
21.4 U/mL
Interval 20.5 to 22.3
|
21.0 U/mL
Interval 19.6 to 22.4
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST2 Day 57
|
69.0 U/mL
Interval 47.7 to 99.8
|
89.5 U/mL
Interval 74.2 to 107.9
|
121.4 U/mL
Interval 102.4 to 143.9
|
21.4 U/mL
Interval 19.8 to 23.2
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST2 Day 85
|
180.9 U/mL
Interval 124.8 to 262.3
|
296.5 U/mL
Interval 258.6 to 339.9
|
322.1 U/mL
Interval 277.1 to 374.4
|
21.2 U/mL
Interval 19.8 to 22.7
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST2 Day 180
|
41.2 U/mL
Interval 29.3 to 57.9
|
64.5 U/mL
Interval 54.7 to 76.0
|
71.8 U/mL
Interval 60.8 to 84.7
|
20.5 U/mL
Interval 19.5 to 21.6
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST2 Day 236
|
26.6 U/mL
Interval 21.2 to 33.4
|
39.6 U/mL
Interval 33.5 to 46.8
|
37.0 U/mL
Interval 31.2 to 43.9
|
20.6 U/mL
Interval 19.4 to 22.0
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST2 Day 365
|
21.8 U/mL
Interval 19.2 to 24.7
|
24.5 U/mL
Interval 22.4 to 26.8
|
25.1 U/mL
Interval 23.0 to 27.4
|
20.5 U/mL
Interval 19.5 to 21.6
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST3 Day 1
|
21.9 U/mL
Interval 19.1 to 25.1
|
20.3 U/mL
Interval 19.9 to 20.7
|
20.2 U/mL
Interval 19.8 to 20.5
|
20.6 U/mL
Interval 19.5 to 21.7
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST3 Day 29
|
23.7 U/mL
Interval 20.0 to 28.0
|
21.0 U/mL
Interval 20.1 to 21.9
|
21.7 U/mL
Interval 20.5 to 23.0
|
20.7 U/mL
Interval 19.6 to 21.9
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST3 Day 57
|
110.2 U/mL
Interval 71.1 to 171.0
|
122.6 U/mL
Interval 101.3 to 148.3
|
159.4 U/mL
Interval 130.1 to 195.2
|
21.3 U/mL
Interval 19.7 to 22.9
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST3 Day 85
|
267.4 U/mL
Interval 194.8 to 367.1
|
295.1 U/mL
Interval 255.6 to 340.8
|
334.2 U/mL
Interval 282.1 to 395.9
|
20.7 U/mL
Interval 19.6 to 21.8
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST3 Day 180
|
53.1 U/mL
Interval 35.6 to 79.1
|
60.7 U/mL
Interval 51.7 to 71.2
|
73.0 U/mL
Interval 61.3 to 86.9
|
20.0 U/mL
Interval 20.0 to 20.0
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST3 Day 236
|
35.3 U/mL
Interval 25.7 to 48.6
|
35.8 U/mL
Interval 30.4 to 42.2
|
39.9 U/mL
Interval 33.0 to 48.3
|
20.2 U/mL
Interval 19.8 to 20.7
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST3 Day 365
|
25.2 U/mL
Interval 19.9 to 31.8
|
25.4 U/mL
Interval 23.2 to 27.8
|
28.0 U/mL
Interval 24.7 to 31.8
|
20.2 U/mL
Interval 19.8 to 20.7
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST4 Day 1
|
21.4 U/mL
Interval 18.7 to 24.4
|
20.8 U/mL
Interval 20.0 to 21.6
|
20.3 U/mL
Interval 19.9 to 20.8
|
22.0 U/mL
Interval 20.2 to 24.0
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST4 Day 57
|
45.9 U/mL
Interval 32.8 to 64.2
|
56.9 U/mL
Interval 48.3 to 67.1
|
71.4 U/mL
Interval 59.1 to 86.3
|
22.4 U/mL
Interval 20.4 to 24.6
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST4 Day 85
|
117.0 U/mL
Interval 76.6 to 178.7
|
177.1 U/mL
Interval 154.5 to 203.1
|
206.8 U/mL
Interval 175.0 to 244.3
|
22.1 U/mL
Interval 20.3 to 24.1
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST4 Day 180
|
32.8 U/mL
Interval 24.1 to 44.6
|
48.2 U/mL
Interval 41.8 to 55.6
|
53.2 U/mL
Interval 44.9 to 63.0
|
21.7 U/mL
Interval 20.0 to 23.5
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST4 Day 236
|
25.5 U/mL
Interval 20.6 to 31.5
|
34.9 U/mL
Interval 29.9 to 40.8
|
33.6 U/mL
Interval 28.1 to 40.1
|
21.2 U/mL
Interval 19.5 to 23.2
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST5 Day 29
|
20.7 U/mL
Interval 19.2 to 22.4
|
20.6 U/mL
Interval 19.9 to 21.3
|
21.1 U/mL
Interval 20.1 to 22.1
|
21.4 U/mL
Interval 20.0 to 22.9
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST5 Day 57
|
42.7 U/mL
Interval 29.8 to 61.3
|
56.6 U/mL
Interval 47.8 to 67.0
|
80.7 U/mL
Interval 66.3 to 98.1
|
21.6 U/mL
Interval 20.0 to 23.3
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST5 Day 180
|
26.7 U/mL
Interval 20.7 to 34.3
|
42.5 U/mL
Interval 36.7 to 49.1
|
54.6 U/mL
Interval 45.9 to 64.8
|
20.8 U/mL
Interval 19.7 to 21.9
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST5 Day 236
|
23.0 U/mL
Interval 19.6 to 27.0
|
31.9 U/mL
Interval 27.5 to 37.1
|
33.4 U/mL
Interval 27.7 to 40.2
|
21.0 U/mL
Interval 19.6 to 22.6
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST6 Day 1
|
21.1 U/mL
Interval 18.9 to 23.5
|
20.8 U/mL
Interval 20.0 to 21.5
|
21.2 U/mL
Interval 20.1 to 22.4
|
21.7 U/mL
Interval 20.0 to 23.6
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST6 Day 29
|
21.1 U/mL
Interval 18.9 to 23.6
|
22.3 U/mL
Interval 21.0 to 23.7
|
22.2 U/mL
Interval 20.8 to 23.7
|
22.1 U/mL
Interval 20.3 to 24.0
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST6 Day 85
|
115.6 U/mL
Interval 76.5 to 174.7
|
185.8 U/mL
Interval 162.2 to 213.0
|
225.6 U/mL
Interval 191.9 to 265.3
|
21.8 U/mL
Interval 20.1 to 23.7
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST6 Day 180
|
30.1 U/mL
Interval 22.6 to 40.2
|
46.7 U/mL
Interval 40.4 to 53.9
|
54.2 U/mL
Interval 45.5 to 64.4
|
20.6 U/mL
Interval 19.7 to 21.4
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST6 Day 236
|
25.6 U/mL
Interval 20.7 to 31.8
|
34.6 U/mL
Interval 29.8 to 40.2
|
34.6 U/mL
Interval 28.7 to 41.9
|
21.4 U/mL
Interval 19.7 to 23.2
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST6 Day 365
|
22.1 U/mL
Interval 19.2 to 25.5
|
25.5 U/mL
Interval 23.3 to 27.9
|
27.7 U/mL
Interval 24.3 to 31.6
|
21.4 U/mL
Interval 20.1 to 22.7
|
SECONDARY outcome
Timeframe: up to Day 365 / Month 12Population: In the elderly age group no participants were included in the VLA15 low dose, that's the reason why the number of participants is zero.
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6), determined by ELISA, stratified by age group - Group 50 - 65 years. GMTs are calculated based on the number of subjects with non-missing results.
Outcome measures
| Measure |
VLA15 Low Dose
VLA15 low dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 Medium Dose
n=59 Participants
VLA15 medium dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 High Dose
n=58 Participants
VLA15 high dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
Placebo
n=33 Participants
Placebo: Placebo: PBS (Phosphate Buffered Saline)
|
|---|---|---|---|---|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST1 Day 236
|
—
|
24.5 U/mL
Interval 20.4 to 29.4
|
25.6 U/mL
Interval 21.4 to 30.5
|
20.9 U/mL
Interval 19.1 to 22.9
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST1 Day 1
|
—
|
21.0 U/mL
Interval 19.0 to 23.3
|
20.0 U/mL
Interval 20.0 to 20.0
|
20.6 U/mL
Interval 19.4 to 22.0
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST1 Day 29
|
—
|
24.2 U/mL
Interval 18.7 to 31.4
|
20.9 U/mL
Interval 19.5 to 22.5
|
21.0 U/mL
Interval 19.6 to 22.6
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST1 Day 57
|
—
|
44.5 U/mL
Interval 31.7 to 62.3
|
36.2 U/mL
Interval 28.6 to 45.8
|
20.5 U/mL
Interval 19.5 to 21.6
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST1 Day 85
|
—
|
95.3 U/mL
Interval 67.2 to 135.1
|
89.2 U/mL
Interval 66.0 to 120.4
|
21.2 U/mL
Interval 19.5 to 23.1
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST1 Day 180
|
—
|
35.4 U/mL
Interval 26.8 to 46.9
|
32.1 U/mL
Interval 26.4 to 39.0
|
21.0 U/mL
Interval 19.6 to 22.5
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST1 Day 365
|
—
|
24.3 U/mL
Interval 19.6 to 30.1
|
21.4 U/mL
Interval 19.6 to 23.2
|
20.5 U/mL
Interval 19.4 to 21.7
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST2 Day 1
|
—
|
20.0 U/mL
Interval 20.0 to 20.0
|
20.0 U/mL
Interval 20.0 to 20.0
|
20.0 U/mL
Interval 20.0 to 20.0
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST2 Day 29
|
—
|
22.0 U/mL
Interval 18.9 to 25.7
|
21.6 U/mL
Interval 19.4 to 24.0
|
20.9 U/mL
Interval 19.1 to 22.8
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST2 Day 57
|
—
|
88.7 U/mL
Interval 64.1 to 122.5
|
81.5 U/mL
Interval 60.4 to 110.2
|
20.9 U/mL
Interval 19.1 to 22.8
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST2 Day 85
|
—
|
245.5 U/mL
Interval 190.3 to 316.6
|
265.0 U/mL
Interval 204.2 to 344.0
|
20.8 U/mL
Interval 19.2 to 22.4
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST2 Day 180
|
—
|
58.5 U/mL
Interval 45.4 to 75.3
|
57.4 U/mL
Interval 44.1 to 74.5
|
20.8 U/mL
Interval 19.2 to 22.4
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST2 Day 236
|
—
|
30.5 U/mL
Interval 24.1 to 38.7
|
32.7 U/mL
Interval 24.8 to 43.1
|
20.0 U/mL
Interval 20.0 to 20.0
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST2 Day 365
|
—
|
24.9 U/mL
Interval 21.3 to 29.2
|
24.1 U/mL
Interval 21.3 to 27.3
|
20.9 U/mL
Interval 19.1 to 22.7
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST3 Day 1
|
—
|
20.7 U/mL
Interval 19.7 to 21.7
|
20.0 U/mL
Interval 20.0 to 20.0
|
20.0 U/mL
Interval 20.0 to 20.0
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST3 Day 29
|
—
|
23.3 U/mL
Interval 18.9 to 28.7
|
20.0 U/mL
Interval 20.0 to 20.0
|
21.2 U/mL
Interval 18.8 to 23.8
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST3 Day 57
|
—
|
126.7 U/mL
Interval 88.0 to 182.4
|
118.3 U/mL
Interval 85.7 to 163.1
|
21.1 U/mL
Interval 18.9 to 23.6
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST3 Day 85
|
—
|
258.9 U/mL
Interval 194.9 to 343.8
|
256.5 U/mL
Interval 193.5 to 340.0
|
21.1 U/mL
Interval 19.0 to 23.4
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST3 Day 180
|
—
|
68.8 U/mL
Interval 53.5 to 88.4
|
59.7 U/mL
Interval 46.4 to 76.7
|
21.9 U/mL
Interval 19.1 to 25.0
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST3 Day 236
|
—
|
35.7 U/mL
Interval 27.3 to 46.8
|
36.9 U/mL
Interval 27.2 to 50.1
|
22.0 U/mL
Interval 18.0 to 26.9
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST3 Day 365
|
—
|
26.0 U/mL
Interval 21.5 to 31.5
|
24.8 U/mL
Interval 21.6 to 28.4
|
21.3 U/mL
Interval 18.7 to 24.2
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST4 Day 1
|
—
|
21.3 U/mL
Interval 19.8 to 23.0
|
20.0 U/mL
Interval 20.0 to 20.0
|
20.9 U/mL
Interval 19.1 to 22.9
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST4 Day 29
|
—
|
22.9 U/mL
Interval 18.7 to 28.0
|
21.0 U/mL
Interval 19.4 to 22.8
|
21.2 U/mL
Interval 18.8 to 23.8
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST4 Day 57
|
—
|
58.6 U/mL
Interval 42.6 to 80.6
|
51.4 U/mL
Interval 39.8 to 66.4
|
21.2 U/mL
Interval 18.8 to 23.9
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST4 Day 85
|
—
|
158.2 U/mL
Interval 119.5 to 209.4
|
158.1 U/mL
Interval 122.5 to 203.9
|
21.1 U/mL
Interval 18.9 to 23.4
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST4 Day 180
|
—
|
48.0 U/mL
Interval 37.5 to 61.5
|
41.3 U/mL
Interval 33.6 to 50.9
|
21.1 U/mL
Interval 18.9 to 23.6
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST4 Day 236
|
—
|
28.0 U/mL
Interval 23.1 to 33.8
|
28.0 U/mL
Interval 22.7 to 34.7
|
23.1 U/mL
Interval 18.7 to 28.5
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST4 Day 365
|
—
|
26.0 U/mL
Interval 21.7 to 31.1
|
22.9 U/mL
Interval 20.9 to 25.1
|
22.5 U/mL
Interval 19.4 to 26.1
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST5 Day 1
|
—
|
21.4 U/mL
Interval 19.8 to 23.0
|
20.0 U/mL
Interval 20.0 to 20.0
|
21.0 U/mL
Interval 19.0 to 23.4
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST5 Day 29
|
—
|
22.7 U/mL
Interval 19.0 to 27.1
|
20.8 U/mL
Interval 19.2 to 22.6
|
21.3 U/mL
Interval 18.7 to 24.3
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST5 Day 57
|
—
|
61.0 U/mL
Interval 44.9 to 82.9
|
55.7 U/mL
Interval 42.5 to 72.8
|
21.3 U/mL
Interval 18.7 to 24.2
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST5 Day 85
|
—
|
166.4 U/mL
Interval 124.1 to 223.0
|
162.1 U/mL
Interval 124.0 to 211.9
|
21.2 U/mL
Interval 18.8 to 23.9
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST5 Day 180
|
—
|
47.4 U/mL
Interval 37.2 to 60.5
|
40.8 U/mL
Interval 32.6 to 51.1
|
21.9 U/mL
Interval 19.1 to 25.2
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST5 Day 236
|
—
|
28.8 U/mL
Interval 23.4 to 35.6
|
30.2 U/mL
Interval 24.1 to 37.7
|
23.1 U/mL
Interval 18.6 to 28.7
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST5 Day 365
|
—
|
23.9 U/mL
Interval 20.5 to 27.8
|
22.4 U/mL
Interval 20.2 to 24.7
|
21.9 U/mL
Interval 19.1 to 25.2
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST6 Day 1
|
—
|
22.6 U/mL
Interval 20.3 to 25.1
|
20.0 U/mL
Interval 20.0 to 20.0
|
21.4 U/mL
Interval 18.7 to 24.4
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST6 Day 29
|
—
|
23.6 U/mL
Interval 19.9 to 28.1
|
21.6 U/mL
Interval 19.6 to 23.9
|
21.7 U/mL
Interval 18.3 to 25.8
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST6 Day 57
|
—
|
58.0 U/mL
Interval 43.2 to 77.7
|
51.4 U/mL
Interval 39.3 to 67.1
|
21.7 U/mL
Interval 18.4 to 25.6
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST6 Day 85
|
—
|
178.7 U/mL
Interval 136.2 to 236.3
|
174.3 U/mL
Interval 133.9 to 226.9
|
21.6 U/mL
Interval 18.5 to 25.3
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST6 Day 180
|
—
|
52.3 U/mL
Interval 41.1 to 66.5
|
45.5 U/mL
Interval 36.1 to 57.3
|
23.6 U/mL
Interval 19.2 to 28.8
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST6 Day 236
|
—
|
30.3 U/mL
Interval 24.1 to 38.1
|
30.1 U/mL
Interval 23.6 to 38.3
|
24.6 U/mL
Interval 18.0 to 33.6
|
|
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST6 Day 365
|
—
|
26.2 U/mL
Interval 22.2 to 30.9
|
22.5 U/mL
Interval 20.2 to 25.0
|
22.8 U/mL
Interval 18.7 to 27.8
|
SECONDARY outcome
Timeframe: up to Day 365 / Month 12SCRs (Seroconversion Rate) for Seroconversion for ELISA is defined as: * for subjects that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive (i.e. antibody titer of ≥40 U/mL) at a vertain time point. * for subjects that are seropositive at Visit 1 (baseline): a ≥ 4-fold rise in IgG antibody titer from Visit 1. Percentages are based on the number of subjects with non-missing observations.
Outcome measures
| Measure |
VLA15 Low Dose
n=29 Participants
VLA15 low dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 Medium Dose
n=133 Participants
VLA15 medium dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 High Dose
n=136 Participants
VLA15 high dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
Placebo
n=88 Participants
Placebo: Placebo: PBS (Phosphate Buffered Saline)
|
|---|---|---|---|---|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST1 Day 29
|
0.0 percentage of subjects
Interval 0.0 to 11.7
|
2.3 percentage of subjects
Interval 0.8 to 6.4
|
2.9 percentage of subjects
Interval 1.1 to 7.3
|
0.0 percentage of subjects
Interval 0.0 to 4.2
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST1 Day 57
|
39.3 percentage of subjects
Interval 23.6 to 57.6
|
36.1 percentage of subjects
Interval 28.4 to 44.5
|
43.4 percentage of subjects
Interval 35.3 to 51.8
|
1.1 percentage of subjects
Interval 0.2 to 6.2
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST1 Day 85
|
65.4 percentage of subjects
Interval 46.2 to 80.6
|
85.9 percentage of subjects
Interval 78.9 to 90.9
|
85.6 percentage of subjects
Interval 78.6 to 90.6
|
0.0 percentage of subjects
Interval 0.0 to 4.3
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST1 Day 180
|
11.5 percentage of subjects
Interval 4.0 to 29.0
|
31.2 percentage of subjects
Interval 23.7 to 39.8
|
36.4 percentage of subjects
Interval 28.7 to 44.8
|
0.0 percentage of subjects
Interval 0.0 to 4.5
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST1 Day 236
|
7.7 percentage of subjects
Interval 2.1 to 24.1
|
18.2 percentage of subjects
Interval 11.5 to 27.5
|
17.9 percentage of subjects
Interval 11.1 to 27.4
|
1.7 percentage of subjects
Interval 0.3 to 9.1
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST1 Day 365
|
4.0 percentage of subjects
Interval 0.7 to 19.5
|
11.3 percentage of subjects
Interval 6.8 to 18.1
|
10.5 percentage of subjects
Interval 6.4 to 16.9
|
1.2 percentage of subjects
Interval 0.2 to 6.6
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST2 Day 29
|
0.0 percentage of subjects
Interval 0.0 to 11.7
|
2.3 percentage of subjects
Interval 0.8 to 6.4
|
6.6 percentage of subjects
Interval 3.5 to 12.1
|
0.0 percentage of subjects
Interval 0.0 to 4.2
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST2 Day 57
|
67.9 percentage of subjects
Interval 49.3 to 82.1
|
72.9 percentage of subjects
Interval 64.8 to 79.8
|
85.3 percentage of subjects
Interval 78.4 to 90.3
|
1.1 percentage of subjects
Interval 0.2 to 6.2
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST2 Day 85
|
88.5 percentage of subjects
Interval 71.0 to 96.0
|
100 percentage of subjects
Interval 97.1 to 100.0
|
96.2 percentage of subjects
Interval 91.4 to 98.4
|
1.2 percentage of subjects
Interval 0.2 to 6.4
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST2 Day 180
|
42.3 percentage of subjects
Interval 25.5 to 61.1
|
68.0 percentage of subjects
Interval 59.4 to 75.5
|
69.7 percentage of subjects
Interval 61.4 to 76.9
|
0.0 percentage of subjects
Interval 0.0 to 4.5
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST2 Day 236
|
19.2 percentage of subjects
Interval 8.5 to 37.9
|
47.7 percentage of subjects
Interval 37.6 to 58.0
|
41.7 percentage of subjects
Interval 31.7 to 52.3
|
0.0 percentage of subjects
Interval 0.0 to 6.2
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST2 Day 365
|
8.0 percentage of subjects
Interval 2.2 to 25.0
|
15.3 percentage of subjects
Interval 10.0 to 22.7
|
18.8 percentage of subjects
Interval 13.1 to 26.3
|
0.0 percentage of subjects
Interval 0.0 to 4.5
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST3 Day 29
|
6.9 percentage of subjects
Interval 1.9 to 22.0
|
3.0 percentage of subjects
Interval 1.2 to 7.5
|
5.1 percentage of subjects
Interval 2.5 to 10.2
|
1.1 percentage of subjects
Interval 0.2 to 6.2
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST3 Day 57
|
75.0 percentage of subjects
Interval 56.6 to 87.3
|
81.2 percentage of subjects
Interval 73.7 to 86.9
|
85.3 percentage of subjects
Interval 78.4 to 90.3
|
2.3 percentage of subjects
Interval 0.6 to 7.9
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST3 Day 85
|
96.2 percentage of subjects
Interval 81.1 to 99.3
|
98.4 percentage of subjects
Interval 94.5 to 99.6
|
97.0 percentage of subjects
Interval 92.5 to 98.8
|
1.2 percentage of subjects
Interval 0.2 to 6.4
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST3 Day 180
|
50.0 percentage of subjects
Interval 32.1 to 67.9
|
66.4 percentage of subjects
Interval 57.7 to 74.1
|
70.5 percentage of subjects
Interval 62.2 to 77.6
|
0.0 percentage of subjects
Interval 0.0 to 4.5
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST3 Day 236
|
34.6 percentage of subjects
Interval 19.4 to 53.8
|
39.8 percentage of subjects
Interval 30.2 to 50.2
|
44.0 percentage of subjects
Interval 33.9 to 54.7
|
1.7 percentage of subjects
Interval 0.3 to 9.1
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST3 Day 365
|
12.0 percentage of subjects
Interval 4.2 to 30.0
|
19.4 percentage of subjects
Interval 13.4 to 27.2
|
21.8 percentage of subjects
Interval 15.6 to 29.6
|
1.2 percentage of subjects
Interval 0.2 to 6.6
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST4 Day 29
|
3.4 percentage of subjects
Interval 0.6 to 17.2
|
2.3 percentage of subjects
Interval 0.8 to 6.5
|
3.7 percentage of subjects
Interval 1.6 to 8.3
|
1.1 percentage of subjects
Interval 0.2 to 6.2
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST4 Day 57
|
50.0 percentage of subjects
Interval 32.6 to 67.4
|
60.2 percentage of subjects
Interval 51.7 to 68.1
|
71.3 percentage of subjects
Interval 63.2 to 78.3
|
1.1 percentage of subjects
Interval 0.2 to 6.2
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST4 Day 85
|
80.8 percentage of subjects
Interval 62.1 to 91.5
|
96.1 percentage of subjects
Interval 91.2 to 98.3
|
94.7 percentage of subjects
Interval 89.5 to 97.4
|
1.2 percentage of subjects
Interval 0.2 to 6.4
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST4 Day 180
|
30.8 percentage of subjects
Interval 16.5 to 50.0
|
58.4 percentage of subjects
Interval 49.6 to 66.7
|
60.6 percentage of subjects
Interval 52.1 to 68.5
|
1.2 percentage of subjects
Interval 0.2 to 6.6
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST4 Day 236
|
15.4 percentage of subjects
Interval 6.2 to 33.5
|
38.6 percentage of subjects
Interval 29.1 to 49.1
|
34.5 percentage of subjects
Interval 25.2 to 45.2
|
0.0 percentage of subjects
Interval 0.0 to 6.2
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST4 Day 365
|
8.0 percentage of subjects
Interval 2.2 to 25.0
|
21.0 percentage of subjects
Interval 14.7 to 29.0
|
18.0 percentage of subjects
Interval 12.4 to 25.4
|
1.2 percentage of subjects
Interval 0.2 to 6.6
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST5 Day 29
|
0.0 percentage of subjects
Interval 0.0 to 11.7
|
0.8 percentage of subjects
Interval 0.1 to 4.1
|
2.9 percentage of subjects
Interval 1.1 to 7.3
|
0.0 percentage of subjects
Interval 0.0 to 4.2
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST5 Day 57
|
42.9 percentage of subjects
Interval 26.5 to 60.9
|
59.4 percentage of subjects
Interval 50.9 to 67.4
|
72.8 percentage of subjects
Interval 64.8 to 79.6
|
0.0 percentage of subjects
Interval 0.0 to 4.2
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST5 Day 85
|
80.8 percentage of subjects
Interval 62.1 to 91.5
|
94.5 percentage of subjects
Interval 89.1 to 97.3
|
91.7 percentage of subjects
Interval 85.7 to 95.3
|
0.0 percentage of subjects
Interval 0.0 to 4.3
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST5 Day 180
|
19.2 percentage of subjects
Interval 8.5 to 37.9
|
48.8 percentage of subjects
Interval 40.2 to 57.5
|
59.1 percentage of subjects
Interval 50.6 to 67.1
|
0.0 percentage of subjects
Interval 0.0 to 4.5
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST5 Day 236
|
11.5 percentage of subjects
Interval 4.0 to 29.0
|
33.0 percentage of subjects
Interval 24.0 to 43.3
|
32.1 percentage of subjects
Interval 23.1 to 42.7
|
0.0 percentage of subjects
Interval 0.0 to 6.2
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST5 Day 365
|
8.0 percentage of subjects
Interval 2.2 to 25.0
|
15.3 percentage of subjects
Interval 10.0 to 22.7
|
15.0 percentage of subjects
Interval 10.0 to 22.1
|
0.0 percentage of subjects
Interval 0.0 to 4.5
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST6 Day 29
|
0.0 percentage of subjects
Interval 0.0 to 11.7
|
6.8 percentage of subjects
Interval 3.6 to 12.4
|
4.4 percentage of subjects
Interval 2.0 to 9.3
|
2.3 percentage of subjects
Interval 0.6 to 7.9
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST6 Day 57
|
42.9 percentage of subjects
Interval 26.5 to 60.9
|
55.6 percentage of subjects
Interval 47.2 to 63.8
|
64.0 percentage of subjects
Interval 55.6 to 71.6
|
2.3 percentage of subjects
Interval 0.6 to 7.9
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST6 Day 85
|
80.8 percentage of subjects
Interval 62.1 to 91.5
|
95.3 percentage of subjects
Interval 90.2 to 97.8
|
92.4 percentage of subjects
Interval 86.6 to 95.8
|
1.2 percentage of subjects
Interval 0.2 to 6.4
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST6 Day 180
|
23.1 percentage of subjects
Interval 11.0 to 42.1
|
54.4 percentage of subjects
Interval 45.7 to 62.9
|
53.8 percentage of subjects
Interval 45.3 to 62.1
|
1.2 percentage of subjects
Interval 0.2 to 6.6
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST6 Day 236
|
15.4 percentage of subjects
Interval 6.2 to 33.5
|
38.6 percentage of subjects
Interval 29.1 to 49.1
|
32.1 percentage of subjects
Interval 23.1 to 42.7
|
3.4 percentage of subjects
Interval 1.0 to 11.7
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST6 Day 365
|
8.0 percentage of subjects
Interval 2.2 to 25.0
|
17.7 percentage of subjects
Interval 12.0 to 25.4
|
15.8 percentage of subjects
Interval 10.6 to 22.9
|
3.7 percentage of subjects
Interval 1.3 to 10.2
|
SECONDARY outcome
Timeframe: up to Day 365 / Month 12Population: In the elderly age group no participants were included in the VLA15 low dose, that's the reason why the number of participants is zero.
Seroconversion for ELISA is defined as: * for subjects that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive (i.e. antibody titer of ≥40 U/mL) at a vertain time point. * for subjects that are seropositive at Visit 1 (baseline): a ≥ 4-fold rise in IgG antibody titer from Visit 1. Percentages are based on the number of subjects with non-missing observations.
Outcome measures
| Measure |
VLA15 Low Dose
VLA15 low dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 Medium Dose
n=59 Participants
VLA15 medium dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 High Dose
n=58 Participants
VLA15 high dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
Placebo
n=33 Participants
Placebo: Placebo: PBS (Phosphate Buffered Saline)
|
|---|---|---|---|---|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST2 Day 29
|
—
|
3.4 percentage of subjects
Interval 1.0 to 11.7
|
3.4 percentage of subjects
Interval 1.0 to 11.7
|
3.1 percentage of subjects
Interval 0.6 to 15.7
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST1 Day 236
|
—
|
14.7 percentage of subjects
Interval 6.4 to 30.1
|
20.0 percentage of subjects
Interval 10.0 to 35.9
|
5.6 percentage of subjects
Interval 1.0 to 25.8
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST1 Day 29
|
—
|
6.9 percentage of subjects
Interval 2.7 to 16.4
|
3.4 percentage of subjects
Interval 1.0 to 11.7
|
3.1 percentage of subjects
Interval 0.6 to 15.7
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST1 Day 57
|
—
|
39.7 percentage of subjects
Interval 28.1 to 52.5
|
34.5 percentage of subjects
Interval 23.6 to 47.3
|
3.0 percentage of subjects
Interval 0.5 to 15.3
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST1 Day 85
|
—
|
71.2 percentage of subjects
Interval 58.6 to 81.2
|
71.9 percentage of subjects
Interval 59.2 to 81.9
|
3.0 percentage of subjects
Interval 0.5 to 15.3
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST1 Day 180
|
—
|
36.2 percentage of subjects
Interval 25.1 to 49.1
|
33.3 percentage of subjects
Interval 22.5 to 46.3
|
3.1 percentage of subjects
Interval 0.6 to 15.7
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST1 Day 365
|
—
|
10.2 percentage of subjects
Interval 4.7 to 20.5
|
5.2 percentage of subjects
Interval 1.8 to 14.1
|
3.2 percentage of subjects
Interval 0.6 to 16.2
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST2 Day 57
|
—
|
70.7 percentage of subjects
Interval 58.0 to 80.8
|
67.2 percentage of subjects
Interval 54.4 to 77.9
|
3.0 percentage of subjects
Interval 0.5 to 15.3
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST2 Day 85
|
—
|
94.9 percentage of subjects
Interval 86.1 to 98.3
|
93.0 percentage of subjects
Interval 83.3 to 97.2
|
3.0 percentage of subjects
Interval 0.5 to 15.3
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST2 Day 180
|
—
|
62.1 percentage of subjects
Interval 49.2 to 73.4
|
59.6 percentage of subjects
Interval 46.7 to 71.4
|
3.1 percentage of subjects
Interval 0.6 to 15.7
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST2 Day 236
|
—
|
29.4 percentage of subjects
Interval 16.8 to 46.2
|
31.4 percentage of subjects
Interval 18.6 to 48.0
|
0.0 percentage of subjects
Interval 0.0 to 17.6
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST2 Day 365
|
—
|
15.3 percentage of subjects
Interval 8.2 to 26.5
|
15.5 percentage of subjects
Interval 8.4 to 26.9
|
3.2 percentage of subjects
Interval 0.6 to 16.2
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST3 Day 29
|
—
|
6.9 percentage of subjects
Interval 2.7 to 16.4
|
0.0 percentage of subjects
Interval 0.0 to 6.2
|
3.1 percentage of subjects
Interval 0.6 to 15.7
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST3 Day 57
|
—
|
77.6 percentage of subjects
Interval 65.3 to 86.4
|
81.0 percentage of subjects
Interval 69.1 to 89.1
|
3.0 percentage of subjects
Interval 0.5 to 15.3
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST3 Day 85
|
—
|
94.9 percentage of subjects
Interval 86.1 to 98.3
|
93.0 percentage of subjects
Interval 83.3 to 97.2
|
3.0 percentage of subjects
Interval 0.5 to 15.3
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST3 Day 180
|
—
|
74.1 percentage of subjects
Interval 61.6 to 83.7
|
66.7 percentage of subjects
Interval 53.7 to 77.5
|
6.3 percentage of subjects
Interval 1.7 to 20.1
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST3 Day 236
|
—
|
38.2 percentage of subjects
Interval 23.9 to 55.0
|
37.1 percentage of subjects
Interval 23.2 to 53.7
|
5.6 percentage of subjects
Interval 1.0 to 25.8
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST3 Day 365
|
—
|
13.6 percentage of subjects
Interval 7.0 to 24.5
|
15.5 percentage of subjects
Interval 8.4 to 26.9
|
3.2 percentage of subjects
Interval 0.6 to 16.2
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST4 Day 29
|
—
|
3.4 percentage of subjects
Interval 1.0 to 11.7
|
3.4 percentage of subjects
Interval 1.0 to 11.7
|
0.0 percentage of subjects
Interval 0.0 to 10.7
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST4 Day 57
|
—
|
55.2 percentage of subjects
Interval 42.5 to 67.3
|
56.9 percentage of subjects
Interval 44.1 to 68.8
|
0.0 percentage of subjects
Interval 0.0 to 10.4
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST4 Day 85
|
—
|
89.8 percentage of subjects
Interval 79.5 to 95.3
|
91.2 percentage of subjects
Interval 81.1 to 96.2
|
0.0 percentage of subjects
Interval 0.0 to 10.4
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST4 Day 180
|
—
|
55.2 percentage of subjects
Interval 42.5 to 67.3
|
52.6 percentage of subjects
Interval 39.9 to 65.0
|
0.0 percentage of subjects
Interval 0.0 to 10.7
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST4 Day 236
|
—
|
29.4 percentage of subjects
Interval 16.8 to 46.2
|
25.7 percentage of subjects
Interval 14.2 to 42.1
|
5.6 percentage of subjects
Interval 1.0 to 25.8
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST4 Day 365
|
—
|
16.9 percentage of subjects
Interval 9.5 to 28.5
|
13.8 percentage of subjects
Interval 7.2 to 24.9
|
6.5 percentage of subjects
Interval 1.8 to 20.7
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST5 Day 29
|
—
|
3.4 percentage of subjects
Interval 1.0 to 11.7
|
1.7 percentage of subjects
Interval 0.3 to 9.1
|
0.0 percentage of subjects
Interval 0.0 to 10.7
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST5 Day 57
|
—
|
55.2 percentage of subjects
Interval 42.5 to 67.3
|
55.2 percentage of subjects
Interval 42.5 to 67.3
|
0.0 percentage of subjects
Interval 0.0 to 10.4
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST5 Day 85
|
—
|
84.7 percentage of subjects
Interval 73.5 to 91.8
|
87.7 percentage of subjects
Interval 76.8 to 93.9
|
0.0 percentage of subjects
Interval 0.0 to 10.4
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST5 Day 180
|
—
|
51.7 percentage of subjects
Interval 39.2 to 64.1
|
45.6 percentage of subjects
Interval 33.4 to 58.4
|
3.1 percentage of subjects
Interval 0.6 to 15.7
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST5 Day 236
|
—
|
29.4 percentage of subjects
Interval 16.8 to 46.2
|
31.4 percentage of subjects
Interval 18.6 to 48.0
|
5.6 percentage of subjects
Interval 1.0 to 25.8
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST5 Day 365
|
—
|
8.5 percentage of subjects
Interval 3.7 to 18.4
|
8.6 percentage of subjects
Interval 3.7 to 18.6
|
3.2 percentage of subjects
Interval 0.6 to 16.2
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST6 Day 29
|
—
|
5.2 percentage of subjects
Interval 1.8 to 14.1
|
5.2 percentage of subjects
Interval 1.8 to 14.1
|
0.0 percentage of subjects
Interval 0.0 to 10.7
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST6 Day 57
|
—
|
51.7 percentage of subjects
Interval 39.2 to 64.1
|
51.7 percentage of subjects
Interval 39.2 to 64.1
|
0.0 percentage of subjects
Interval 0.0 to 10.4
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST6 Day 85
|
—
|
88.1 percentage of subjects
Interval 77.5 to 94.1
|
89.5 percentage of subjects
Interval 78.9 to 95.1
|
0.0 percentage of subjects
Interval 0.0 to 10.4
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST6 Day 180
|
—
|
53.4 percentage of subjects
Interval 40.8 to 65.7
|
52.6 percentage of subjects
Interval 39.9 to 65.0
|
6.3 percentage of subjects
Interval 1.7 to 20.1
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST6 Day 236
|
—
|
26.5 percentage of subjects
Interval 14.6 to 43.1
|
28.6 percentage of subjects
Interval 16.3 to 45.1
|
5.6 percentage of subjects
Interval 1.0 to 25.8
|
|
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST6 Day 365
|
—
|
15.3 percentage of subjects
Interval 8.2 to 26.5
|
8.6 percentage of subjects
Interval 3.7 to 18.6
|
3.2 percentage of subjects
Interval 0.6 to 16.2
|
SECONDARY outcome
Timeframe: up to Day 365 / Month 12GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6), stratified by age group - Group 18 - 49 years. Calculations are based on number of subjects with non-missing results.
Outcome measures
| Measure |
VLA15 Low Dose
n=29 Participants
VLA15 low dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 Medium Dose
n=133 Participants
VLA15 medium dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 High Dose
n=136 Participants
VLA15 high dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
Placebo
n=88 Participants
Placebo: Placebo: PBS (Phosphate Buffered Saline)
|
|---|---|---|---|---|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST5 Day 180
|
1.3 Geometric Mean of the Fold Rise
Interval 1.0 to 1.7
|
2.1 Geometric Mean of the Fold Rise
Interval 1.8 to 2.4
|
2.7 Geometric Mean of the Fold Rise
Interval 2.3 to 3.2
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST5 Day 236
|
1.1 Geometric Mean of the Fold Rise
Interval 0.9 to 1.3
|
1.6 Geometric Mean of the Fold Rise
Interval 1.4 to 1.8
|
1.6 Geometric Mean of the Fold Rise
Interval 1.4 to 2.0
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST5 Day 57
|
2.1 Geometric Mean of the Fold Rise
Interval 1.5 to 3.0
|
2.8 Geometric Mean of the Fold Rise
Interval 2.4 to 3.3
|
4.0 Geometric Mean of the Fold Rise
Interval 3.3 to 4.8
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST5 Day 85
|
5.7 Geometric Mean of the Fold Rise
Interval 3.8 to 8.7
|
9.0 Geometric Mean of the Fold Rise
Interval 7.8 to 10.3
|
10.8 Geometric Mean of the Fold Rise
Interval 9.1 to 12.8
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST5 Day 365
|
1.1 Geometric Mean of the Fold Rise
Interval 1.0 to 1.2
|
1.2 Geometric Mean of the Fold Rise
Interval 1.1 to 1.3
|
1.3 Geometric Mean of the Fold Rise
Interval 1.1 to 1.4
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST6 Day 29
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
1.1 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST6 Day 57
|
2.0 Geometric Mean of the Fold Rise
Interval 1.4 to 2.8
|
2.6 Geometric Mean of the Fold Rise
Interval 2.2 to 3.1
|
3.4 Geometric Mean of the Fold Rise
Interval 2.8 to 4.2
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST6 Day 85
|
5.4 Geometric Mean of the Fold Rise
Interval 3.6 to 8.3
|
9.1 Geometric Mean of the Fold Rise
Interval 7.9 to 10.4
|
10.6 Geometric Mean of the Fold Rise
Interval 9.0 to 12.5
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST6 Day 180
|
1.4 Geometric Mean of the Fold Rise
Interval 1.1 to 1.9
|
2.3 Geometric Mean of the Fold Rise
Interval 2.0 to 2.6
|
2.5 Geometric Mean of the Fold Rise
Interval 2.2 to 3.0
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST6 Day 236
|
1.2 Geometric Mean of the Fold Rise
Interval 1.0 to 1.5
|
1.7 Geometric Mean of the Fold Rise
Interval 1.5 to 2.0
|
1.7 Geometric Mean of the Fold Rise
Interval 1.4 to 2.0
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST6 Day 365
|
1.1 Geometric Mean of the Fold Rise
Interval 1.0 to 1.3
|
1.2 Geometric Mean of the Fold Rise
Interval 1.1 to 1.4
|
1.3 Geometric Mean of the Fold Rise
Interval 1.2 to 1.5
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST2 Day 29
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
1.1 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST1 Day 29
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
1.1 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST1 Day 57
|
1.6 Geometric Mean of the Fold Rise
Interval 1.2 to 2.1
|
1.7 Geometric Mean of the Fold Rise
Interval 1.5 to 2.0
|
2.2 Geometric Mean of the Fold Rise
Interval 1.8 to 2.6
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST1 Day 85
|
3.6 Geometric Mean of the Fold Rise
Interval 2.2 to 5.6
|
5.3 Geometric Mean of the Fold Rise
Interval 4.4 to 6.2
|
6.4 Geometric Mean of the Fold Rise
Interval 5.3 to 7.7
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST1 Day 180
|
1.3 Geometric Mean of the Fold Rise
Interval 1.0 to 1.6
|
1.6 Geometric Mean of the Fold Rise
Interval 1.4 to 1.8
|
1.7 Geometric Mean of the Fold Rise
Interval 1.5 to 2.0
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST1 Day 236
|
1.1 Geometric Mean of the Fold Rise
Interval 0.9 to 1.3
|
1.3 Geometric Mean of the Fold Rise
Interval 1.1 to 1.4
|
1.3 Geometric Mean of the Fold Rise
Interval 1.1 to 1.6
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST1 Day 365
|
1.0 Geometric Mean of the Fold Rise
Interval 0.9 to 1.1
|
1.1 Geometric Mean of the Fold Rise
Interval 1.1 to 1.2
|
1.2 Geometric Mean of the Fold Rise
Interval 1.1 to 1.3
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST2 Day 57
|
3.2 Geometric Mean of the Fold Rise
Interval 2.2 to 4.7
|
4.5 Geometric Mean of the Fold Rise
Interval 3.7 to 5.4
|
6.0 Geometric Mean of the Fold Rise
Interval 5.1 to 7.2
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST2 Day 85
|
8.4 Geometric Mean of the Fold Rise
Interval 5.7 to 12.4
|
14.8 Geometric Mean of the Fold Rise
Interval 12.9 to 17.0
|
16.0 Geometric Mean of the Fold Rise
Interval 13.8 to 18.6
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST2 Day 180
|
1.9 Geometric Mean of the Fold Rise
Interval 1.4 to 2.7
|
3.2 Geometric Mean of the Fold Rise
Interval 2.7 to 3.8
|
3.6 Geometric Mean of the Fold Rise
Interval 3.0 to 4.2
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST2 Day 236
|
1.2 Geometric Mean of the Fold Rise
Interval 1.0 to 1.6
|
2.0 Geometric Mean of the Fold Rise
Interval 1.7 to 2.3
|
1.8 Geometric Mean of the Fold Rise
Interval 1.5 to 2.2
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST2 Day 365
|
1.1 Geometric Mean of the Fold Rise
Interval 1.0 to 1.2
|
1.2 Geometric Mean of the Fold Rise
Interval 1.1 to 1.3
|
1.2 Geometric Mean of the Fold Rise
Interval 1.1 to 1.4
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST3 Day 29
|
1.1 Geometric Mean of the Fold Rise
Interval 1.0 to 1.2
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
1.1 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST3 Day 57
|
5.0 Geometric Mean of the Fold Rise
Interval 3.2 to 7.8
|
6.0 Geometric Mean of the Fold Rise
Interval 5.0 to 7.3
|
7.9 Geometric Mean of the Fold Rise
Interval 6.4 to 9.7
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST3 Day 85
|
12.1 Geometric Mean of the Fold Rise
Interval 8.6 to 17.0
|
14.7 Geometric Mean of the Fold Rise
Interval 12.7 to 16.9
|
16.6 Geometric Mean of the Fold Rise
Interval 14.0 to 19.6
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST3 Day 180
|
2.4 Geometric Mean of the Fold Rise
Interval 1.6 to 3.6
|
3.0 Geometric Mean of the Fold Rise
Interval 2.6 to 3.5
|
3.6 Geometric Mean of the Fold Rise
Interval 3.0 to 4.3
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST3 Day 236
|
1.6 Geometric Mean of the Fold Rise
Interval 1.2 to 2.2
|
1.8 Geometric Mean of the Fold Rise
Interval 1.5 to 2.1
|
2.0 Geometric Mean of the Fold Rise
Interval 1.6 to 2.4
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST3 Day 365
|
1.2 Geometric Mean of the Fold Rise
Interval 1.0 to 1.4
|
1.3 Geometric Mean of the Fold Rise
Interval 1.2 to 1.4
|
1.4 Geometric Mean of the Fold Rise
Interval 1.2 to 1.6
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST4 Day 29
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
1.1 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST4 Day 57
|
2.1 Geometric Mean of the Fold Rise
Interval 1.5 to 3.0
|
2.7 Geometric Mean of the Fold Rise
Interval 2.3 to 3.2
|
3.5 Geometric Mean of the Fold Rise
Interval 2.9 to 4.2
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST4 Day 85
|
5.4 Geometric Mean of the Fold Rise
Interval 3.5 to 8.5
|
8.6 Geometric Mean of the Fold Rise
Interval 7.5 to 9.8
|
10.2 Geometric Mean of the Fold Rise
Interval 8.6 to 12.0
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST4 Day 180
|
1.5 Geometric Mean of the Fold Rise
Interval 1.1 to 2.1
|
2.3 Geometric Mean of the Fold Rise
Interval 2.0 to 2.7
|
2.6 Geometric Mean of the Fold Rise
Interval 2.2 to 3.1
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST4 Day 236
|
1.2 Geometric Mean of the Fold Rise
Interval 0.9 to 1.5
|
1.7 Geometric Mean of the Fold Rise
Interval 1.4 to 2.0
|
1.7 Geometric Mean of the Fold Rise
Interval 1.4 to 2.0
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST4 Day 365
|
1.1 Geometric Mean of the Fold Rise
Interval 1.0 to 1.2
|
1.3 Geometric Mean of the Fold Rise
Interval 1.2 to 1.4
|
1.3 Geometric Mean of the Fold Rise
Interval 1.2 to 1.5
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
ST5 Day 29
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: up to Day 365 / Month 12Population: In the elderly age group no participants were included in the VLA15 low dose, that's the reason why the number of participants is zero.
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6), stratified by age group - Group 50 - 65 years. Calculations are based on number of subjects with non-missing results.
Outcome measures
| Measure |
VLA15 Low Dose
VLA15 low dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 Medium Dose
n=59 Participants
VLA15 medium dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 High Dose
n=58 Participants
VLA15 high dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
Placebo
n=33 Participants
Placebo: Placebo: PBS (Phosphate Buffered Saline)
|
|---|---|---|---|---|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST1 Day 29
|
—
|
1.2 Geometric Mean of the Fold Rise
Interval 1.0 to 1.4
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST1 Day 57
|
—
|
2.1 Geometric Mean of the Fold Rise
Interval 1.6 to 2.8
|
1.8 Geometric Mean of the Fold Rise
Interval 1.4 to 2.3
|
1.0 Geometric Mean of the Fold Rise
Interval 0.9 to 1.1
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST1 Day 85
|
—
|
4.5 Geometric Mean of the Fold Rise
Interval 3.3 to 6.1
|
4.5 Geometric Mean of the Fold Rise
Interval 3.3 to 6.0
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST1 Day 180
|
—
|
1.7 Geometric Mean of the Fold Rise
Interval 1.4 to 2.1
|
1.6 Geometric Mean of the Fold Rise
Interval 1.3 to 1.9
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST1 Day 236
|
—
|
1.2 Geometric Mean of the Fold Rise
Interval 1.0 to 1.5
|
1.3 Geometric Mean of the Fold Rise
Interval 1.1 to 1.5
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST1 Day 365
|
—
|
1.2 Geometric Mean of the Fold Rise
Interval 1.0 to 1.3
|
1.1 Geometric Mean of the Fold Rise
Interval 1.0 to 1.2
|
1.0 Geometric Mean of the Fold Rise
Interval 0.9 to 1.1
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST2 Day 29
|
—
|
1.1 Geometric Mean of the Fold Rise
Interval 0.9 to 1.3
|
1.1 Geometric Mean of the Fold Rise
Interval 1.0 to 1.2
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST2 Day 57
|
—
|
4.4 Geometric Mean of the Fold Rise
Interval 3.2 to 6.1
|
4.1 Geometric Mean of the Fold Rise
Interval 3.0 to 5.5
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST2 Day 85
|
—
|
12.3 Geometric Mean of the Fold Rise
Interval 9.5 to 15.8
|
13.3 Geometric Mean of the Fold Rise
Interval 10.2 to 17.2
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST2 Day 180
|
—
|
2.9 Geometric Mean of the Fold Rise
Interval 2.3 to 3.8
|
2.9 Geometric Mean of the Fold Rise
Interval 2.2 to 3.7
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST2 Day 236
|
—
|
1.5 Geometric Mean of the Fold Rise
Interval 1.2 to 1.9
|
1.6 Geometric Mean of the Fold Rise
Interval 1.2 to 2.2
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST2 Day 365
|
—
|
1.2 Geometric Mean of the Fold Rise
Interval 1.1 to 1.5
|
1.2 Geometric Mean of the Fold Rise
Interval 1.1 to 1.4
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST3 Day 29
|
—
|
1.1 Geometric Mean of the Fold Rise
Interval 1.0 to 1.4
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
1.1 Geometric Mean of the Fold Rise
Interval 0.9 to 1.2
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST3 Day 57
|
—
|
6.1 Geometric Mean of the Fold Rise
Interval 4.3 to 8.7
|
5.9 Geometric Mean of the Fold Rise
Interval 4.3 to 8.2
|
1.1 Geometric Mean of the Fold Rise
Interval 0.9 to 1.2
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST3 Day 85
|
—
|
12.5 Geometric Mean of the Fold Rise
Interval 9.6 to 16.4
|
12.8 Geometric Mean of the Fold Rise
Interval 9.7 to 17.0
|
1.1 Geometric Mean of the Fold Rise
Interval 0.9 to 1.2
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST3 Day 180
|
—
|
3.3 Geometric Mean of the Fold Rise
Interval 2.6 to 4.2
|
3.0 Geometric Mean of the Fold Rise
Interval 2.3 to 3.8
|
1.1 Geometric Mean of the Fold Rise
Interval 1.0 to 1.2
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST3 Day 236
|
—
|
1.7 Geometric Mean of the Fold Rise
Interval 1.3 to 2.2
|
1.8 Geometric Mean of the Fold Rise
Interval 1.4 to 2.5
|
1.1 Geometric Mean of the Fold Rise
Interval 0.9 to 1.3
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST3 Day 365
|
—
|
1.3 Geometric Mean of the Fold Rise
Interval 1.1 to 1.5
|
1.2 Geometric Mean of the Fold Rise
Interval 1.1 to 1.4
|
1.1 Geometric Mean of the Fold Rise
Interval 0.9 to 1.2
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST4 Day 29
|
—
|
1.1 Geometric Mean of the Fold Rise
Interval 0.9 to 1.3
|
1.1 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST4 Day 57
|
—
|
2.7 Geometric Mean of the Fold Rise
Interval 2.0 to 3.7
|
2.6 Geometric Mean of the Fold Rise
Interval 2.0 to 3.3
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST4 Day 85
|
—
|
7.4 Geometric Mean of the Fold Rise
Interval 5.7 to 9.7
|
7.9 Geometric Mean of the Fold Rise
Interval 6.1 to 10.2
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST4 Day 180
|
—
|
2.2 Geometric Mean of the Fold Rise
Interval 1.8 to 2.8
|
2.1 Geometric Mean of the Fold Rise
Interval 1.7 to 2.5
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST4 Day 236
|
—
|
1.4 Geometric Mean of the Fold Rise
Interval 1.2 to 1.7
|
1.4 Geometric Mean of the Fold Rise
Interval 1.1 to 1.7
|
1.1 Geometric Mean of the Fold Rise
Interval 0.9 to 1.2
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST4 Day 365
|
—
|
1.2 Geometric Mean of the Fold Rise
Interval 1.0 to 1.4
|
1.1 Geometric Mean of the Fold Rise
Interval 1.0 to 1.3
|
1.1 Geometric Mean of the Fold Rise
Interval 1.0 to 1.2
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST5 Day 29
|
—
|
1.1 Geometric Mean of the Fold Rise
Interval 0.9 to 1.2
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST5 Day 57
|
—
|
2.9 Geometric Mean of the Fold Rise
Interval 2.1 to 3.8
|
2.8 Geometric Mean of the Fold Rise
Interval 2.1 to 3.6
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST5 Day 85
|
—
|
7.8 Geometric Mean of the Fold Rise
Interval 5.9 to 10.3
|
8.1 Geometric Mean of the Fold Rise
Interval 6.2 to 10.6
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST5 Day 180
|
—
|
2.2 Geometric Mean of the Fold Rise
Interval 1.8 to 2.8
|
2.0 Geometric Mean of the Fold Rise
Interval 1.6 to 2.6
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST5 Day 236
|
—
|
1.4 Geometric Mean of the Fold Rise
Interval 1.2 to 1.8
|
1.5 Geometric Mean of the Fold Rise
Interval 1.2 to 1.9
|
1.1 Geometric Mean of the Fold Rise
Interval 0.9 to 1.2
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST5 Day 365
|
—
|
1.1 Geometric Mean of the Fold Rise
Interval 1.0 to 1.3
|
1.1 Geometric Mean of the Fold Rise
Interval 1.0 to 1.2
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.1
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST6 Day 29
|
—
|
1.1 Geometric Mean of the Fold Rise
Interval 0.9 to 1.2
|
1.1 Geometric Mean of the Fold Rise
Interval 1.0 to 1.2
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST6 Day 57
|
—
|
2.6 Geometric Mean of the Fold Rise
Interval 1.9 to 3.4
|
2.6 Geometric Mean of the Fold Rise
Interval 2.0 to 3.4
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST6 Day 85
|
—
|
7.9 Geometric Mean of the Fold Rise
Interval 6.1 to 10.4
|
8.7 Geometric Mean of the Fold Rise
Interval 6.7 to 11.3
|
1.0 Geometric Mean of the Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST6 Day 180
|
—
|
2.3 Geometric Mean of the Fold Rise
Interval 1.9 to 2.9
|
2.3 Geometric Mean of the Fold Rise
Interval 1.8 to 2.9
|
1.1 Geometric Mean of the Fold Rise
Interval 1.0 to 1.2
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST6 Day 236
|
—
|
1.4 Geometric Mean of the Fold Rise
Interval 1.1 to 1.7
|
1.5 Geometric Mean of the Fold Rise
Interval 1.2 to 1.9
|
1.1 Geometric Mean of the Fold Rise
Interval 0.9 to 1.3
|
|
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
ST6 Day 365
|
—
|
1.2 Geometric Mean of the Fold Rise
Interval 1.0 to 1.3
|
1.1 Geometric Mean of the Fold Rise
Interval 1.0 to 1.3
|
1.1 Geometric Mean of the Fold Rise
Interval 1.0 to 1.2
|
SECONDARY outcome
Timeframe: up to Day 365 / Month 12Frequency of SAEs (Serious Adverse Events) during the entire study; frequency is being assessed in terms of percentage of participants.
Outcome measures
| Measure |
VLA15 Low Dose
n=29 Participants
VLA15 low dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 Medium Dose
n=214 Participants
VLA15 medium dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 High Dose
n=205 Participants
VLA15 high dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
Placebo
n=124 Participants
Placebo: Placebo: PBS (Phosphate Buffered Saline)
|
|---|---|---|---|---|
|
Percentage of Participants With SAEs (Serious Adverse Events)
|
0.0 percentage of participants
Interval 0.0 to 11.7
|
1.9 percentage of participants
Interval 0.7 to 4.7
|
2.4 percentage of participants
Interval 1.0 to 5.6
|
2.4 percentage of participants
Interval 0.8 to 6.9
|
SECONDARY outcome
Timeframe: up to Day 365 / Month 12Frequency of related SAEs (Serious Adverse Events) during the entire study; frequency is being assessed in terms of percentage of participants.
Outcome measures
| Measure |
VLA15 Low Dose
n=29 Participants
VLA15 low dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 Medium Dose
n=214 Participants
VLA15 medium dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 High Dose
n=205 Participants
VLA15 high dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
Placebo
n=124 Participants
Placebo: Placebo: PBS (Phosphate Buffered Saline)
|
|---|---|---|---|---|
|
Percentage of Participants With Related SAEs (Serious Adverse Events)
|
0.0 percentage of participants
Interval 0.0 to 11.7
|
0.0 percentage of participants
Interval 0.0 to 1.8
|
0.0 percentage of participants
Interval 0.0 to 1.8
|
0.0 percentage of participants
Interval 0.0 to 3.0
|
SECONDARY outcome
Timeframe: up to Day 365 / Month 12Frequency of AESIs (Adverse Events of Special Interest) during the entire study; frequency is being assessed in terms of percentage of participants. AESIs are cases of Lyme Diseases, Lyme associated Events and the onset of potentially autoimmune or neuro-inflammatory disorders.
Outcome measures
| Measure |
VLA15 Low Dose
n=29 Participants
VLA15 low dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 Medium Dose
n=214 Participants
VLA15 medium dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 High Dose
n=205 Participants
VLA15 high dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
Placebo
n=124 Participants
Placebo: Placebo: PBS (Phosphate Buffered Saline)
|
|---|---|---|---|---|
|
Percentage of Participants With AESIs (Adverse Events of Special Interest)
|
0.0 percentage of participants
Interval 0.0 to 11.7
|
1.9 percentage of participants
Interval 0.7 to 4.7
|
0.5 percentage of participants
Interval 0.1 to 2.7
|
0.0 percentage of participants
Interval 0.0 to 3.0
|
SECONDARY outcome
Timeframe: up to Day 365 / Month 12Frequency of related AESIs (Adverse Events of Special Interest) during the entire study; frequency is being assessed in terms of percentage of participants. AESIs are cases of Lyme Diseases, Lyme associated Events and the onset of potentially autoimmune or neuro-inflammatory disorders.
Outcome measures
| Measure |
VLA15 Low Dose
n=29 Participants
VLA15 low dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 Medium Dose
n=214 Participants
VLA15 medium dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 High Dose
n=205 Participants
VLA15 high dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
Placebo
n=124 Participants
Placebo: Placebo: PBS (Phosphate Buffered Saline)
|
|---|---|---|---|---|
|
Percentage of Participants With Related AESIs (Adverse Events of Special Interest)
|
0.0 percentage of participants
Interval 0.0 to 11.7
|
0.5 percentage of participants
Interval 0.1 to 2.6
|
0.0 percentage of participants
Interval 0.0 to 1.8
|
0.0 percentage of participants
Interval 0.0 to 3.0
|
SECONDARY outcome
Timeframe: up to Day 365 / Month 12Frequency of unsolicited AEs (Adverse Events) during the entire study (incl. clinically relevant laboratory parameters); frequency is being assessed in terms of percentage of participants.
Outcome measures
| Measure |
VLA15 Low Dose
n=29 Participants
VLA15 low dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 Medium Dose
n=214 Participants
VLA15 medium dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 High Dose
n=205 Participants
VLA15 high dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
Placebo
n=124 Participants
Placebo: Placebo: PBS (Phosphate Buffered Saline)
|
|---|---|---|---|---|
|
Percentage of Participants With Unsolicited AEs (Adverse Events)
|
27.6 percentage of participants
Interval 14.7 to 45.7
|
51.9 percentage of participants
Interval 45.2 to 58.5
|
56.6 percentage of participants
Interval 49.7 to 63.2
|
51.6 percentage of participants
Interval 42.9 to 60.2
|
SECONDARY outcome
Timeframe: up to Day 365 / Month 12Frequency of related unsolicited AEs (Adverse Events) during the entire study (incl. clinically relevant laboratory parameters); frequency is being assessed in terms of percentage of participants.
Outcome measures
| Measure |
VLA15 Low Dose
n=29 Participants
VLA15 low dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 Medium Dose
n=214 Participants
VLA15 medium dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 High Dose
n=205 Participants
VLA15 high dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
Placebo
n=124 Participants
Placebo: Placebo: PBS (Phosphate Buffered Saline)
|
|---|---|---|---|---|
|
Percentage of Participants With Related Unsolicited AEs (Adverse Events)
|
6.9 percentage of participants
Interval 1.9 to 22.0
|
9.3 percentage of participants
Interval 6.1 to 14.0
|
14.6 percentage of participants
Interval 10.4 to 20.1
|
8.9 percentage of participants
Interval 5.0 to 15.2
|
SECONDARY outcome
Timeframe: Day 1 (day of first vaccination) through Day 7; Day 29 (day of second vaccination) through Day 35; Day 57 (day of third vaccination) through Day 63Frequency of solicited local and solicited systemic AEs (Adverse Events) within 7 days after each and after any vaccination; frequency is being assessed in terms of percentage of participants.
Outcome measures
| Measure |
VLA15 Low Dose
n=29 Participants
VLA15 low dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 Medium Dose
n=214 Participants
VLA15 medium dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 High Dose
n=205 Participants
VLA15 high dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
Placebo
n=124 Participants
Placebo: Placebo: PBS (Phosphate Buffered Saline)
|
|---|---|---|---|---|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs (Adverse Events)
Solicted Local AEs
|
89.7 percentage of participants
Interval 73.6 to 96.4
|
93.0 percentage of participants
Interval 88.8 to 95.7
|
96.1 percentage of participants
Interval 92.5 to 98.0
|
29.8 percentage of participants
Interval 22.5 to 38.4
|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs (Adverse Events)
Solicited Systemic AEs
|
62.1 percentage of participants
Interval 44.0 to 77.3
|
67.8 percentage of participants
Interval 61.2 to 73.7
|
71.7 percentage of participants
Interval 65.2 to 77.4
|
42.7 percentage of participants
Interval 34.4 to 51.5
|
SECONDARY outcome
Timeframe: up to Day 365 / Month 12Population: The overall number analyzed is for all participants. Below listed number of participants is for the different age groups.
Frequency of SAEs (Serious Adverse Events), AESIs (Adverse Events of Special Interest), solicited and unsolicited AEs (Adverse Events) during the entire study stratified by age group - Group 18-49; frequency is being assessed in terms of percentage of participants.
Outcome measures
| Measure |
VLA15 Low Dose
n=29 Participants
VLA15 low dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 Medium Dose
n=147 Participants
VLA15 medium dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 High Dose
n=145 Participants
VLA15 high dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
Placebo
n=91 Participants
Placebo: Placebo: PBS (Phosphate Buffered Saline)
|
|---|---|---|---|---|
|
Percentage of Participants With SAEs (Serious Adverse Events), AESIs (Adverse Events of Special Interest), Solicited and Unsolicited AEs (Adverse Events) - Group 18-49
SAEs
|
0.0 percentage of participants
Interval 0.0 to 11.7
|
2.0 percentage of participants
Interval 0.7 to 5.8
|
2.1 percentage of participants
Interval 0.7 to 5.9
|
1.1 percentage of participants
Interval 0.2 to 6.0
|
|
Percentage of Participants With SAEs (Serious Adverse Events), AESIs (Adverse Events of Special Interest), Solicited and Unsolicited AEs (Adverse Events) - Group 18-49
AESIs
|
0.0 percentage of participants
Interval 0.0 to 11.7
|
0.7 percentage of participants
Interval 0.1 to 3.8
|
0.0 percentage of participants
Interval 0.0 to 2.6
|
0.0 percentage of participants
Interval 0.0 to 4.1
|
|
Percentage of Participants With SAEs (Serious Adverse Events), AESIs (Adverse Events of Special Interest), Solicited and Unsolicited AEs (Adverse Events) - Group 18-49
solicited AEs
|
89.7 percentage of participants
Interval 73.6 to 96.4
|
93.9 percentage of participants
Interval 88.8 to 96.7
|
96.6 percentage of participants
Interval 92.2 to 98.5
|
56.0 percentage of participants
Interval 45.8 to 65.8
|
|
Percentage of Participants With SAEs (Serious Adverse Events), AESIs (Adverse Events of Special Interest), Solicited and Unsolicited AEs (Adverse Events) - Group 18-49
unsolicited AEs
|
27.6 percentage of participants
Interval 14.7 to 45.7
|
49.0 percentage of participants
Interval 41.0 to 57.0
|
55.2 percentage of participants
Interval 47.0 to 63.0
|
50.5 percentage of participants
Interval 40.5 to 60.6
|
SECONDARY outcome
Timeframe: up to Day 365 / Month 12Population: In the elderly age group no participants were included in the VLA15 low dose, that's the reason why the number of participants is zero.
Frequency of SAEs (Serious Adverse Events), AESIs (Adverse Events of Special Interest), Solicited and Unsolicited AEs (Adverse Events) during the entire study stratified by age group - Group 50-65 years; frequency is being assessed in terms of percentage of participants.
Outcome measures
| Measure |
VLA15 Low Dose
VLA15 low dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 Medium Dose
n=67 Participants
VLA15 medium dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 High Dose
n=60 Participants
VLA15 high dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
Placebo
n=33 Participants
Placebo: Placebo: PBS (Phosphate Buffered Saline)
|
|---|---|---|---|---|
|
Percentage of Participants With SAEs (Serious Adverse Events), AESIs (Adverse Events of Special Interest), Solicited and Unsolicited AEs (Adverse Events) - Group 50-65 Years
SAEs
|
—
|
1.5 percentage of participants
Interval 0.3 to 8.0
|
3.3 percentage of participants
Interval 0.9 to 11.4
|
6.1 percentage of participants
Interval 1.7 to 19.6
|
|
Percentage of Participants With SAEs (Serious Adverse Events), AESIs (Adverse Events of Special Interest), Solicited and Unsolicited AEs (Adverse Events) - Group 50-65 Years
AESIs
|
—
|
4.5 percentage of participants
Interval 1.5 to 12.4
|
1.7 percentage of participants
Interval 0.3 to 8.9
|
0.0 percentage of participants
Interval 0.0 to 10.4
|
|
Percentage of Participants With SAEs (Serious Adverse Events), AESIs (Adverse Events of Special Interest), Solicited and Unsolicited AEs (Adverse Events) - Group 50-65 Years
solicited AEs
|
—
|
92.5 percentage of participants
Interval 83.7 to 96.8
|
96.7 percentage of participants
Interval 88.6 to 99.1
|
51.5 percentage of participants
Interval 35.2 to 67.5
|
|
Percentage of Participants With SAEs (Serious Adverse Events), AESIs (Adverse Events of Special Interest), Solicited and Unsolicited AEs (Adverse Events) - Group 50-65 Years
unsolicited AEs
|
—
|
58.2 percentage of participants
Interval 46.3 to 69.3
|
60.0 percentage of participants
Interval 47.4 to 71.4
|
54.5 percentage of participants
Interval 38.0 to 70.2
|
SECONDARY outcome
Timeframe: up to Day 365 / Month 12Outcome measures
| Measure |
VLA15 Low Dose
n=29 Participants
VLA15 low dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 Medium Dose
n=214 Participants
VLA15 medium dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 High Dose
n=205 Participants
VLA15 high dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
Placebo
n=124 Participants
Placebo: Placebo: PBS (Phosphate Buffered Saline)
|
|---|---|---|---|---|
|
Number of Participants With AESIs (Adverse Events of Special Interest) up to Study End
Polyarthritis
|
0 Number of participants
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
|
Number of Participants With AESIs (Adverse Events of Special Interest) up to Study End
Any AE of Special Interest
|
0 Number of participants
|
4 Number of participants
|
1 Number of participants
|
0. Number of participants
|
|
Number of Participants With AESIs (Adverse Events of Special Interest) up to Study End
Lyme disease
|
0 Number of participants
|
2 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Number of Participants With AESIs (Adverse Events of Special Interest) up to Study End
Erythema migrans
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Number of Participants With AESIs (Adverse Events of Special Interest) up to Study End
Osteoarthritis
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
0 Number of participants
|
Adverse Events
VLA15 Low Dose
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
VLA15 Medium Dose
Serious events: 4 serious events
Other events: 203 other events
Deaths: 0 deaths
VLA15 High Dose
Serious events: 5 serious events
Other events: 202 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 85 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VLA15 Low Dose
n=29 participants at risk
VLA15 low dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 Medium Dose
n=214 participants at risk
VLA15 medium dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 High Dose
n=205 participants at risk
VLA15 high dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
Placebo
n=124 participants at risk
Placebo: Placebo: PBS (Phosphate Buffered Saline)
|
|---|---|---|---|---|
|
Infections and infestations
Cellulitis
|
0.00%
0/29 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
0.47%
1/214 • Number of events 1 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
0.00%
0/205 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
0.00%
0/124 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/29 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
0.00%
0/214 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
0.49%
1/205 • Number of events 1 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
0.00%
0/124 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/29 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
0.00%
0/214 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
0.49%
1/205 • Number of events 1 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
0.00%
0/124 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/29 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
0.47%
1/214 • Number of events 1 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
0.00%
0/205 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
0.00%
0/124 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/29 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
0.47%
1/214 • Number of events 1 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
0.00%
0/205 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
0.00%
0/124 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/29 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
0.00%
0/214 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
0.00%
0/205 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
0.81%
1/124 • Number of events 1 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
|
Infections and infestations
Neurosyphilis
|
0.00%
0/29 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
0.00%
0/214 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
0.00%
0/205 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
0.81%
1/124 • Number of events 1 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/29 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
0.00%
0/214 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
0.49%
1/205 • Number of events 1 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
0.00%
0/124 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/29 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
0.00%
0/214 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
0.00%
0/205 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
0.81%
1/124 • Number of events 1 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/29 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
0.00%
0/214 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
0.00%
0/205 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
0.81%
1/124 • Number of events 1 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
|
0.00%
0/29 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
0.00%
0/214 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
0.49%
1/205 • Number of events 1 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
0.00%
0/124 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/29 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
0.47%
1/214 • Number of events 1 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
0.00%
0/205 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
0.00%
0/124 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/29 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
0.00%
0/214 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
0.49%
1/205 • Number of events 1 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
0.00%
0/124 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
Other adverse events
| Measure |
VLA15 Low Dose
n=29 participants at risk
VLA15 low dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 Medium Dose
n=214 participants at risk
VLA15 medium dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
VLA15 High Dose
n=205 participants at risk
VLA15 high dose with Alum.
VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
|
Placebo
n=124 participants at risk
Placebo: Placebo: PBS (Phosphate Buffered Saline)
|
|---|---|---|---|---|
|
General disorders
Injection site pain
|
89.7%
26/29 • Number of events 111 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
92.5%
198/214 • Number of events 924 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
95.6%
196/205 • Number of events 941 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
24.2%
30/124 • Number of events 57 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
|
General disorders
Fatigue
|
27.6%
8/29 • Number of events 14 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
30.8%
66/214 • Number of events 111 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
39.5%
81/205 • Number of events 130 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
23.4%
29/124 • Number of events 40 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
|
General disorders
Injection site erythema
|
27.6%
8/29 • Number of events 10 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
31.8%
68/214 • Number of events 116 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
35.1%
72/205 • Number of events 123 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
9.7%
12/124 • Number of events 18 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
|
General disorders
Injection site induration
|
10.3%
3/29 • Number of events 6 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
29.9%
64/214 • Number of events 108 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
31.7%
65/205 • Number of events 108 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
1.6%
2/124 • Number of events 3 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
|
General disorders
Injection site swelling
|
13.8%
4/29 • Number of events 6 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
26.6%
57/214 • Number of events 84 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
33.2%
68/205 • Number of events 104 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
3.2%
4/124 • Number of events 6 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
|
General disorders
Influenza like illness
|
10.3%
3/29 • Number of events 3 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
15.0%
32/214 • Number of events 44 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
20.5%
42/205 • Number of events 49 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
16.1%
20/124 • Number of events 25 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
|
General disorders
Pyrexia
|
6.9%
2/29 • Number of events 2 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
4.2%
9/214 • Number of events 10 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
3.4%
7/205 • Number of events 7 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
2.4%
3/124 • Number of events 3 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
51.7%
15/29 • Number of events 22 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
49.5%
106/214 • Number of events 173 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
47.3%
97/205 • Number of events 156 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
16.9%
21/124 • Number of events 29 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.9%
2/29 • Number of events 4 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
19.6%
42/214 • Number of events 67 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
18.0%
37/205 • Number of events 55 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
9.7%
12/124 • Number of events 23 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
|
Nervous system disorders
Headache
|
34.5%
10/29 • Number of events 19 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
34.1%
73/214 • Number of events 115 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
41.0%
84/205 • Number of events 135 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
26.6%
33/124 • Number of events 46 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
|
Gastrointestinal disorders
Nausea
|
17.2%
5/29 • Number of events 5 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
10.7%
23/214 • Number of events 31 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
15.6%
32/205 • Number of events 36 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
8.9%
11/124 • Number of events 15 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.4%
1/29 • Number of events 1 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
6.5%
14/214 • Number of events 16 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
4.9%
10/205 • Number of events 12 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
5.6%
7/124 • Number of events 8 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/29 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
4.2%
9/214 • Number of events 10 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
4.9%
10/205 • Number of events 11 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
7.3%
9/124 • Number of events 10 • up to Day 365
Solicited AEs comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are collected by systematic assessment through subject diaries (up to 7 days after each vaccination) and unsolicited AEs, SAEs and AESIs are collected through non-systematic assessment up to Day 365.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place