Trial Outcomes & Findings for Alternative Schedule Study For VLA15, a Vaccine Candidate Against Lyme Borreliosis (NCT NCT03970733)
NCT ID: NCT03970733
Last Updated: 2023-04-21
Results Overview
Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) against each Outer Surface Protein A (OspA) serotype ST1 to ST6, determined by Enzyme-Linked Immunosorbent Assay (ELISA) at Day 208 (Month 7)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
246 participants
Primary outcome timeframe
Day 208 (Month 7)
Results posted on
2023-04-21
Participant Flow
Participant milestones
| Measure |
VLA15 With Alum Lower Dose
Main Study Phase: VLA15 with Alum lower dose - Booster Phase: arm discontinued VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
VLA15 With Alum Higher Dose
Main Study Phase: VLA15 with Alum higher dose - Booster Phase: VLA15 higher dose or placebo VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
Placebo
Main Study Phase: placebo - Booster phase: arm discontinued Placebo: PBS (Phosphate Buffered Saline).
|
Booster Phase: VLA15 With Alum Higher Dose
Participants who received higher dose of VLA15 with alum in main study phase were randomized to receive a single booster dose of VLA15 with alum higher dose vaccine at Month 18 in booster phase.
|
Booster Phase: Placebo
Participants who received higher dose of VLA15 with alum in main study phase were randomized to receive a single dose of placebo at Month 18 in booster phase.
|
|---|---|---|---|---|---|
|
Main Study Phase (18 Months)
STARTED
|
97
|
98
|
51
|
0
|
0
|
|
Main Study Phase (18 Months)
COMPLETED
|
89
|
84
|
46
|
0
|
0
|
|
Main Study Phase (18 Months)
NOT COMPLETED
|
8
|
14
|
5
|
0
|
0
|
|
Booster Phase (Approx. 12 Months)
STARTED
|
0
|
0
|
0
|
39
|
19
|
|
Booster Phase (Approx. 12 Months)
COMPLETED
|
0
|
0
|
0
|
39
|
18
|
|
Booster Phase (Approx. 12 Months)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
VLA15 With Alum Lower Dose
Main Study Phase: VLA15 with Alum lower dose - Booster Phase: arm discontinued VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
VLA15 With Alum Higher Dose
Main Study Phase: VLA15 with Alum higher dose - Booster Phase: VLA15 higher dose or placebo VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
Placebo
Main Study Phase: placebo - Booster phase: arm discontinued Placebo: PBS (Phosphate Buffered Saline).
|
Booster Phase: VLA15 With Alum Higher Dose
Participants who received higher dose of VLA15 with alum in main study phase were randomized to receive a single booster dose of VLA15 with alum higher dose vaccine at Month 18 in booster phase.
|
Booster Phase: Placebo
Participants who received higher dose of VLA15 with alum in main study phase were randomized to receive a single dose of placebo at Month 18 in booster phase.
|
|---|---|---|---|---|---|
|
Main Study Phase (18 Months)
Withdrawal by Subject
|
0
|
7
|
2
|
0
|
0
|
|
Main Study Phase (18 Months)
Moved from study area
|
2
|
1
|
0
|
0
|
0
|
|
Main Study Phase (18 Months)
Lost to Follow-up
|
5
|
5
|
3
|
0
|
0
|
|
Main Study Phase (18 Months)
Other
|
1
|
1
|
0
|
0
|
0
|
|
Booster Phase (Approx. 12 Months)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Here, number analyzed signifies number of participants evaluable for specified rows.
Baseline characteristics by cohort
| Measure |
VLA15 With Alum Lower Dose
n=97 Participants
0.75 ml injection of VLA15 w/ alum applied at Days 1, 57, and 180 in the Main study phase. VLA15 is a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate. Participants of this arm did not enter booster phase.
|
VLA15 With Alum Higher Dose
n=98 Participants
1 ml injection of VLA15 w/ alum applied at Days 1, 57, and 180 in the Main study phase. VLA15 is a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate. Participants after completing main study, upon consent were randomized to receive either VLA15 with Alum higher dose arm or Placebo in booster phase.
|
Placebo
n=51 Participants
1 ml injection of placebo applied at Days 1, 57, and 180 in the Main study phase. Placebo: phosphate buffered saline (PBS) solution. Participants of this arm did not enter booster phase.
|
Total
n=246 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
Main Study Phase
|
43.5 years
STANDARD_DEVIATION 12.61 • n=97 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
43.0 years
STANDARD_DEVIATION 12.76 • n=98 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
45.0 years
STANDARD_DEVIATION 12.79 • n=51 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
43.6 years
STANDARD_DEVIATION 12.68 • n=246 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
|
Age, Continuous
Booster Phase: VLA15 with Alum higher dose
|
—
|
46.5 years
STANDARD_DEVIATION 13.15 • n=39 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
—
|
46.5 years
STANDARD_DEVIATION 13.15 • n=39 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
|
Age, Continuous
Booster Phase: Placebo
|
—
|
38.8 years
STANDARD_DEVIATION 13.50 • n=19 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
—
|
38.8 years
STANDARD_DEVIATION 13.50 • n=19 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
|
Sex: Female, Male
Main Study Phase · Female
|
49 Participants
n=97 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
50 Participants
n=98 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
34 Participants
n=51 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
133 Participants
n=246 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
|
Sex: Female, Male
Main Study Phase · Male
|
48 Participants
n=97 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
48 Participants
n=98 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
17 Participants
n=51 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
113 Participants
n=246 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
|
Sex: Female, Male
Booster Phase: VLA15 with Alum higher dose · Female
|
0 Participants
Here, number analyzed signifies number of participants evaluable for specified rows.
|
23 Participants
n=39 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
Here, number analyzed signifies number of participants evaluable for specified rows.
|
23 Participants
n=39 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
|
Sex: Female, Male
Booster Phase: VLA15 with Alum higher dose · Male
|
0 Participants
Here, number analyzed signifies number of participants evaluable for specified rows.
|
16 Participants
n=39 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
Here, number analyzed signifies number of participants evaluable for specified rows.
|
16 Participants
n=39 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
|
Sex: Female, Male
Booster Phase: Placebo · Female
|
0 Participants
Here, number analyzed signifies number of participants evaluable for specified rows.
|
7 Participants
n=19 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
Here, number analyzed signifies number of participants evaluable for specified rows.
|
7 Participants
n=19 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
|
Sex: Female, Male
Booster Phase: Placebo · Male
|
0 Participants
Here, number analyzed signifies number of participants evaluable for specified rows.
|
12 Participants
n=19 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
Here, number analyzed signifies number of participants evaluable for specified rows.
|
12 Participants
n=19 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
|
Race (NIH/OMB)
Main Study Phase · American Indian or Alaska Native
|
0 Participants
n=97 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
n=98 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
n=51 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
n=246 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
|
Race (NIH/OMB)
Main Study Phase · Asian
|
0 Participants
n=97 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
1 Participants
n=98 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
n=51 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
1 Participants
n=246 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
|
Race (NIH/OMB)
Main Study Phase · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=97 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
n=98 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
n=51 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
n=246 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
|
Race (NIH/OMB)
Main Study Phase · Black or African American
|
4 Participants
n=97 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
4 Participants
n=98 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
n=51 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
8 Participants
n=246 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
|
Race (NIH/OMB)
Main Study Phase · White
|
91 Participants
n=97 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
93 Participants
n=98 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
51 Participants
n=51 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
235 Participants
n=246 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
|
Race (NIH/OMB)
Main Study Phase · More than one race
|
0 Participants
n=97 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
n=98 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
n=51 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
n=246 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
|
Race (NIH/OMB)
Main Study Phase · Unknown or Not Reported
|
2 Participants
n=97 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
n=98 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
n=51 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
2 Participants
n=246 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
|
Race (NIH/OMB)
Booster Phase: VLA15 with Alum higher dose · American Indian or Alaska Native
|
0 Participants
Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
n=39 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
n=39 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
|
Race (NIH/OMB)
Booster Phase: VLA15 with Alum higher dose · Asian
|
0 Participants
Here, number analyzed signifies number of participants evaluable for specified rows.
|
1 Participants
n=39 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
Here, number analyzed signifies number of participants evaluable for specified rows.
|
1 Participants
n=39 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
|
Race (NIH/OMB)
Booster Phase: VLA15 with Alum higher dose · Native Hawaiian or Other Pacific Islander
|
0 Participants
Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
n=39 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
n=39 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
|
Race (NIH/OMB)
Booster Phase: VLA15 with Alum higher dose · Black or African American
|
0 Participants
Here, number analyzed signifies number of participants evaluable for specified rows.
|
4 Participants
n=39 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
Here, number analyzed signifies number of participants evaluable for specified rows.
|
4 Participants
n=39 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
|
Race (NIH/OMB)
Booster Phase: VLA15 with Alum higher dose · White
|
0 Participants
Here, number analyzed signifies number of participants evaluable for specified rows.
|
34 Participants
n=39 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
Here, number analyzed signifies number of participants evaluable for specified rows.
|
34 Participants
n=39 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
|
Race (NIH/OMB)
Booster Phase: VLA15 with Alum higher dose · More than one race
|
0 Participants
Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
n=39 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
n=39 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
|
Race (NIH/OMB)
Booster Phase: VLA15 with Alum higher dose · Unknown or Not Reported
|
0 Participants
Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
n=39 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
n=39 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
|
Race (NIH/OMB)
Booster Phase: Placebo · American Indian or Alaska Native
|
0 Participants
Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
n=19 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
n=19 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
|
Race (NIH/OMB)
Booster Phase: Placebo · Asian
|
0 Participants
Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
n=19 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
n=19 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
|
Race (NIH/OMB)
Booster Phase: Placebo · Native Hawaiian or Other Pacific Islander
|
0 Participants
Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
n=19 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
n=19 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
|
Race (NIH/OMB)
Booster Phase: Placebo · Black or African American
|
0 Participants
Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
n=19 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
n=19 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
|
Race (NIH/OMB)
Booster Phase: Placebo · White
|
0 Participants
Here, number analyzed signifies number of participants evaluable for specified rows.
|
19 Participants
n=19 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
Here, number analyzed signifies number of participants evaluable for specified rows.
|
19 Participants
n=19 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
|
Race (NIH/OMB)
Booster Phase: Placebo · More than one race
|
0 Participants
Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
n=19 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
n=19 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
|
Race (NIH/OMB)
Booster Phase: Placebo · Unknown or Not Reported
|
0 Participants
Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
n=19 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
Here, number analyzed signifies number of participants evaluable for specified rows.
|
0 Participants
n=19 Participants • Here, number analyzed signifies number of participants evaluable for specified rows.
|
PRIMARY outcome
Timeframe: Day 208 (Month 7)Population: Per-protocol population, excluded those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) against each Outer Surface Protein A (OspA) serotype ST1 to ST6, determined by Enzyme-Linked Immunosorbent Assay (ELISA) at Day 208 (Month 7)
Outcome measures
| Measure |
VLA15 With Alum Lower Dose
n=78 Participants
Main Study Phase: VLA15 with Alum lower dose - Booster Phase: arm discontinued VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
VLA15 With Alum Higher Dose
n=80 Participants
Main Study Phase: VLA15 with Alum higher dose - Booster Phase: VLA15 higher dose or placebo VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
Placebo
n=38 Participants
Main Study Phase: placebo - Booster Phase: arm discontinued Placebo: PBS (Phosphate Buffered Saline).
|
|---|---|---|---|
|
GMTs for IgG Against Each OspA Serotype
ST1 Day 208
|
278.5 Units per milliliter (U/mL)
Interval 214.9 to 361.0
|
274.7 Units per milliliter (U/mL)
Interval 209.4 to 360.4
|
21.0 Units per milliliter (U/mL)
Interval 19.6 to 22.5
|
|
GMTs for IgG Against Each OspA Serotype
ST2 Day 208
|
545.2 Units per milliliter (U/mL)
Interval 431.8 to 688.4
|
579.8 Units per milliliter (U/mL)
Interval 461.9 to 727.8
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype
ST3 Day 208
|
520.0 Units per milliliter (U/mL)
Interval 410.5 to 658.7
|
596.8 Units per milliliter (U/mL)
Interval 471.9 to 754.8
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype
ST4 Day 208
|
332.6 Units per milliliter (U/mL)
Interval 261.3 to 423.3
|
367.8 Units per milliliter (U/mL)
Interval 293.8 to 460.4
|
21.3 Units per milliliter (U/mL)
Interval 19.8 to 23.0
|
|
GMTs for IgG Against Each OspA Serotype
ST5 Day 208
|
332.8 Units per milliliter (U/mL)
Interval 262.9 to 421.3
|
358.8 Units per milliliter (U/mL)
Interval 283.7 to 453.7
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype
ST6 Day 208
|
339.9 Units per milliliter (U/mL)
Interval 267.3 to 432.3
|
345.7 Units per milliliter (U/mL)
Interval 273.7 to 436.6
|
21.4 Units per milliliter (U/mL)
Interval 19.4 to 23.5
|
SECONDARY outcome
Timeframe: At Day 1 (Month 0), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 365 (Month 12) and Day 545 (Month 18)Population: Per-protocol population, excluded those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity). Here, "Number Analyzed" signifies participants evaluable for this outcome measure at specified time points.
GMTs for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 1 (Month 0), 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 365 (Month 12) and 545 (Month 18).
Outcome measures
| Measure |
VLA15 With Alum Lower Dose
n=85 Participants
Main Study Phase: VLA15 with Alum lower dose - Booster Phase: arm discontinued VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
VLA15 With Alum Higher Dose
n=86 Participants
Main Study Phase: VLA15 with Alum higher dose - Booster Phase: VLA15 higher dose or placebo VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
Placebo
n=43 Participants
Main Study Phase: placebo - Booster Phase: arm discontinued Placebo: PBS (Phosphate Buffered Saline).
|
|---|---|---|---|
|
GMTs for IgG Against Each OspA Serotype During the Main Study Phase
ST2 Day 545
|
44.6 Units per milliliter (U/mL)
Interval 35.9 to 55.4
|
33.1 Units per milliliter (U/mL)
Interval 27.5 to 39.7
|
21.1 Units per milliliter (U/mL)
Interval 19.0 to 23.4
|
|
GMTs for IgG Against Each OspA Serotype During the Main Study Phase
ST1 Day 1
|
21.4 Units per milliliter (U/mL)
Interval 19.8 to 23.1
|
20.2 Units per milliliter (U/mL)
Interval 19.8 to 20.6
|
21.8 Units per milliliter (U/mL)
Interval 19.6 to 24.1
|
|
GMTs for IgG Against Each OspA Serotype During the Main Study Phase
ST1 Day 29
|
22.0 Units per milliliter (U/mL)
Interval 20.2 to 24.0
|
20.4 Units per milliliter (U/mL)
Interval 19.8 to 21.0
|
22.1 Units per milliliter (U/mL)
Interval 19.9 to 24.6
|
|
GMTs for IgG Against Each OspA Serotype During the Main Study Phase
ST1 Day 57
|
22.5 Units per milliliter (U/mL)
Interval 20.6 to 24.6
|
21.1 Units per milliliter (U/mL)
Interval 19.9 to 22.3
|
21.6 Units per milliliter (U/mL)
Interval 19.6 to 23.9
|
|
GMTs for IgG Against Each OspA Serotype During the Main Study Phase
ST1 Day 85
|
64.5 Units per milliliter (U/mL)
Interval 50.7 to 82.0
|
75.2 Units per milliliter (U/mL)
Interval 59.6 to 94.9
|
21.7 Units per milliliter (U/mL)
Interval 19.7 to 23.8
|
|
GMTs for IgG Against Each OspA Serotype During the Main Study Phase
ST1 Day 180
|
26.4 Units per milliliter (U/mL)
Interval 23.0 to 30.2
|
24.9 Units per milliliter (U/mL)
Interval 22.7 to 27.4
|
21.5 Units per milliliter (U/mL)
Interval 19.7 to 23.4
|
|
GMTs for IgG Against Each OspA Serotype During the Main Study Phase
ST1 Day 365
|
48.3 Units per milliliter (U/mL)
Interval 39.1 to 59.7
|
37.2 Units per milliliter (U/mL)
Interval 30.6 to 45.2
|
21.4 Units per milliliter (U/mL)
Interval 19.8 to 23.1
|
|
GMTs for IgG Against Each OspA Serotype During the Main Study Phase
ST1 Day 545
|
29.7 Units per milliliter (U/mL)
Interval 24.4 to 36.3
|
23.9 Units per milliliter (U/mL)
Interval 21.5 to 26.7
|
20.6 Units per milliliter (U/mL)
Interval 19.4 to 21.9
|
|
GMTs for IgG Against Each OspA Serotype During the Main Study Phase
ST2 Day 1
|
20.8 Units per milliliter (U/mL)
Interval 19.9 to 21.8
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype During the Main Study Phase
ST2 Day 29
|
21.5 Units per milliliter (U/mL)
Interval 20.2 to 23.0
|
21.9 Units per milliliter (U/mL)
Interval 20.2 to 23.6
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype During the Main Study Phase
ST2 Day 57
|
21.3 Units per milliliter (U/mL)
Interval 20.0 to 22.6
|
22.0 Units per milliliter (U/mL)
Interval 20.1 to 24.0
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype During the Main Study Phase
ST2 Day 85
|
162.6 Units per milliliter (U/mL)
Interval 127.0 to 208.2
|
183.5 Units per milliliter (U/mL)
Interval 144.9 to 232.4
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype During the Main Study Phase
ST2 Day 180
|
38.0 Units per milliliter (U/mL)
Interval 30.9 to 46.5
|
35.4 Units per milliliter (U/mL)
Interval 29.9 to 41.9
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype During the Main Study Phase
ST2 Day 365
|
87.2 Units per milliliter (U/mL)
Interval 69.0 to 110.2
|
71.1 Units per milliliter (U/mL)
Interval 57.0 to 88.8
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype During the Main Study Phase
ST3 Day 1
|
20.3 Units per milliliter (U/mL)
Interval 19.8 to 20.8
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype During the Main Study Phase
ST3 Day 29
|
21.3 Units per milliliter (U/mL)
Interval 20.0 to 22.7
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype During the Main Study Phase
ST3 Day 57
|
20.9 Units per milliliter (U/mL)
Interval 19.8 to 22.1
|
20.7 Units per milliliter (U/mL)
Interval 19.3 to 22.3
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype During the Main Study Phase
ST3 Day 85
|
166.3 Units per milliliter (U/mL)
Interval 128.6 to 215.0
|
217.7 Units per milliliter (U/mL)
Interval 171.7 to 275.9
|
20.7 Units per milliliter (U/mL)
Interval 19.3 to 22.2
|
|
GMTs for IgG Against Each OspA Serotype During the Main Study Phase
ST3 Day 180
|
38.2 Units per milliliter (U/mL)
Interval 31.6 to 46.1
|
41.0 Units per milliliter (U/mL)
Interval 34.7 to 48.5
|
20.4 Units per milliliter (U/mL)
Interval 19.6 to 21.4
|
|
GMTs for IgG Against Each OspA Serotype During the Main Study Phase
ST3 Day 365
|
78.5 Units per milliliter (U/mL)
Interval 62.7 to 98.3
|
74.6 Units per milliliter (U/mL)
Interval 59.6 to 93.3
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype During the Main Study Phase
ST3 Day 545
|
39.1 Units per milliliter (U/mL)
Interval 31.9 to 48.0
|
32.2 Units per milliliter (U/mL)
Interval 27.4 to 37.8
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype During the Main Study Phase
ST4 Day 1
|
20.7 Units per milliliter (U/mL)
Interval 19.7 to 21.7
|
20.3 Units per milliliter (U/mL)
Interval 19.7 to 21.0
|
20.5 Units per milliliter (U/mL)
Interval 19.5 to 21.7
|
|
GMTs for IgG Against Each OspA Serotype During the Main Study Phase
ST4 Day 29
|
20.8 Units per milliliter (U/mL)
Interval 19.7 to 21.9
|
20.5 Units per milliliter (U/mL)
Interval 19.8 to 21.3
|
20.8 Units per milliliter (U/mL)
Interval 19.7 to 22.0
|
|
GMTs for IgG Against Each OspA Serotype During the Main Study Phase
ST4 Day 57
|
21.0 Units per milliliter (U/mL)
Interval 20.0 to 22.1
|
20.9 Units per milliliter (U/mL)
Interval 19.8 to 22.1
|
21.2 Units per milliliter (U/mL)
Interval 19.8 to 22.8
|
|
GMTs for IgG Against Each OspA Serotype During the Main Study Phase
ST4 Day 85
|
79.3 Units per milliliter (U/mL)
Interval 63.2 to 99.6
|
100.8 Units per milliliter (U/mL)
Interval 81.2 to 125.0
|
21.6 Units per milliliter (U/mL)
Interval 20.0 to 23.3
|
|
GMTs for IgG Against Each OspA Serotype During the Main Study Phase
ST4 Day 180
|
28.0 Units per milliliter (U/mL)
Interval 24.6 to 31.9
|
27.1 Units per milliliter (U/mL)
Interval 24.1 to 30.4
|
21.3 Units per milliliter (U/mL)
Interval 19.8 to 22.8
|
|
GMTs for IgG Against Each OspA Serotype During the Main Study Phase
ST4 Day 365
|
53.9 Units per milliliter (U/mL)
Interval 44.1 to 65.9
|
43.2 Units per milliliter (U/mL)
Interval 35.5 to 52.5
|
21.0 Units per milliliter (U/mL)
Interval 19.6 to 22.5
|
|
GMTs for IgG Against Each OspA Serotype During the Main Study Phase
ST4 Day 545
|
35.5 Units per milliliter (U/mL)
Interval 29.7 to 42.5
|
27.3 Units per milliliter (U/mL)
Interval 24.0 to 31.1
|
22.4 Units per milliliter (U/mL)
Interval 19.3 to 26.1
|
|
GMTs for IgG Against Each OspA Serotype During the Main Study Phase
ST5 Day 1
|
21.0 Units per milliliter (U/mL)
Interval 19.9 to 22.2
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype During the Main Study Phase
ST5 Day 29
|
21.5 Units per milliliter (U/mL)
Interval 20.0 to 23.1
|
20.9 Units per milliliter (U/mL)
Interval 19.8 to 22.0
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype During the Main Study Phase
ST5 Day 57
|
21.3 Units per milliliter (U/mL)
Interval 20.0 to 22.7
|
21.3 Units per milliliter (U/mL)
Interval 19.9 to 22.9
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype During the Main Study Phase
ST5 Day 85
|
87.4 Units per milliliter (U/mL)
Interval 69.1 to 110.5
|
100.2 Units per milliliter (U/mL)
Interval 81.0 to 124.1
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype During the Main Study Phase
ST5 Day 180
|
29.0 Units per milliliter (U/mL)
Interval 24.9 to 33.8
|
27.0 Units per milliliter (U/mL)
Interval 24.1 to 30.3
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype During the Main Study Phase
ST5 Day 365
|
53.9 Units per milliliter (U/mL)
Interval 43.5 to 66.9
|
42.7 Units per milliliter (U/mL)
Interval 34.9 to 52.2
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype During the Main Study Phase
ST5 Day 545
|
35.0 Units per milliliter (U/mL)
Interval 28.9 to 42.4
|
27.1 Units per milliliter (U/mL)
Interval 23.8 to 30.9
|
20.4 Units per milliliter (U/mL)
Interval 19.6 to 21.2
|
|
GMTs for IgG Against Each OspA Serotype During the Main Study Phase
ST6 Day 1
|
22.6 Units per milliliter (U/mL)
Interval 20.6 to 24.8
|
20.7 Units per milliliter (U/mL)
Interval 19.7 to 21.6
|
21.2 Units per milliliter (U/mL)
Interval 19.5 to 23.1
|
|
GMTs for IgG Against Each OspA Serotype During the Main Study Phase
ST6 Day 29
|
23.3 Units per milliliter (U/mL)
Interval 20.9 to 25.9
|
21.2 Units per milliliter (U/mL)
Interval 20.0 to 22.4
|
21.0 Units per milliliter (U/mL)
Interval 19.6 to 22.5
|
|
GMTs for IgG Against Each OspA Serotype During the Main Study Phase
ST6 Day 57
|
23.2 Units per milliliter (U/mL)
Interval 21.0 to 25.6
|
22.2 Units per milliliter (U/mL)
Interval 20.5 to 24.2
|
21.6 Units per milliliter (U/mL)
Interval 19.8 to 23.6
|
|
GMTs for IgG Against Each OspA Serotype During the Main Study Phase
ST6 Day 85
|
79.9 Units per milliliter (U/mL)
Interval 62.9 to 101.5
|
84.3 Units per milliliter (U/mL)
Interval 67.4 to 105.4
|
20.7 Units per milliliter (U/mL)
Interval 19.3 to 22.1
|
|
GMTs for IgG Against Each OspA Serotype During the Main Study Phase
ST6 Day 180
|
32.7 Units per milliliter (U/mL)
Interval 27.8 to 38.4
|
28.8 Units per milliliter (U/mL)
Interval 25.3 to 32.7
|
21.7 Units per milliliter (U/mL)
Interval 19.7 to 23.9
|
|
GMTs for IgG Against Each OspA Serotype During the Main Study Phase
ST6 Day 365
|
61.1 Units per milliliter (U/mL)
Interval 48.9 to 76.3
|
46.7 Units per milliliter (U/mL)
Interval 37.9 to 57.5
|
21.5 Units per milliliter (U/mL)
Interval 19.8 to 23.4
|
|
GMTs for IgG Against Each OspA Serotype During the Main Study Phase
ST6 Day 545
|
36.8 Units per milliliter (U/mL)
Interval 30.0 to 45.3
|
27.1 Units per milliliter (U/mL)
Interval 23.6 to 31.1
|
20.7 Units per milliliter (U/mL)
Interval 19.3 to 22.1
|
SECONDARY outcome
Timeframe: Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18)Population: Per-protocol population, excluded those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity). Here, "Number Analyzed" signifies participants evaluable for this outcome measure at specified time points.
Seroconversion Rate (SCR) for each Outer Surface Protein A (OspA) serotype specific IgG ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12) and 545 (Month 18). Seroconversion for ELISA was defined as 1) for participants that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive at a certain time point or 2) for participants that are seropositive at Visit 1 (baseline): greater than or equal to (\>=) 4-fold rise in IgG antibody titer from Visit 1. SCR was reported as percentage of participants. Percentages are based on the number of participants with non-missing observations.
Outcome measures
| Measure |
VLA15 With Alum Lower Dose
n=85 Participants
Main Study Phase: VLA15 with Alum lower dose - Booster Phase: arm discontinued VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
VLA15 With Alum Higher Dose
n=86 Participants
Main Study Phase: VLA15 with Alum higher dose - Booster Phase: VLA15 higher dose or placebo VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
Placebo
n=43 Participants
Main Study Phase: placebo - Booster Phase: arm discontinued Placebo: PBS (Phosphate Buffered Saline).
|
|---|---|---|---|
|
SCRs for Each OspA Serotype Specific IgG During the Main Study Phase
ST4 Day 208
|
97.4 Percentage of Participants
Interval 91.1 to 99.3
|
98.8 Percentage of Participants
Interval 93.3 to 99.8
|
5.3 Percentage of Participants
Interval 1.5 to 17.3
|
|
SCRs for Each OspA Serotype Specific IgG During the Main Study Phase
ST4 Day 365
|
62.2 Percentage of Participants
Interval 51.4 to 71.9
|
51.9 Percentage of Participants
Interval 41.1 to 62.6
|
2.4 Percentage of Participants
Interval 0.4 to 12.3
|
|
SCRs for Each OspA Serotype Specific IgG During the Main Study Phase
ST4 Day 545
|
39.7 Percentage of Participants
Interval 29.3 to 51.2
|
27.7 Percentage of Participants
Interval 18.3 to 39.6
|
5.3 Percentage of Participants
Interval 1.5 to 17.3
|
|
SCRs for Each OspA Serotype Specific IgG During the Main Study Phase
ST5 Day 29
|
1.2 Percentage of Participants
Interval 0.2 to 6.5
|
3.5 Percentage of Participants
Interval 1.2 to 9.8
|
0.0 Percentage of Participants
Interval 0.0 to 8.2
|
|
SCRs for Each OspA Serotype Specific IgG During the Main Study Phase
ST5 Day 57
|
1.2 Percentage of Participants
Interval 0.2 to 6.4
|
4.7 Percentage of Participants
Interval 1.8 to 11.4
|
0.0 Percentage of Participants
Interval 0.0 to 8.2
|
|
SCRs for Each OspA Serotype Specific IgG During the Main Study Phase
ST1 Day 29
|
2.4 Percentage of Participants
Interval 0.7 to 8.4
|
1.2 Percentage of Participants
Interval 0.2 to 6.3
|
2.3 Percentage of Participants
Interval 0.4 to 12.1
|
|
SCRs for Each OspA Serotype Specific IgG During the Main Study Phase
ST1 Day 57
|
4.7 Percentage of Participants
Interval 1.8 to 11.5
|
3.5 Percentage of Participants
Interval 1.2 to 9.8
|
0.0 Percentage of Participants
Interval 0.0 to 8.2
|
|
SCRs for Each OspA Serotype Specific IgG During the Main Study Phase
ST1 Day 85
|
59.0 Percentage of Participants
Interval 48.3 to 69.0
|
69.0 Percentage of Participants
Interval 58.5 to 77.9
|
2.3 Percentage of Participants
Interval 0.4 to 12.1
|
|
SCRs for Each OspA Serotype Specific IgG During the Main Study Phase
ST1 Day 180
|
14.1 Percentage of Participants
Interval 8.3 to 23.1
|
19.8 Percentage of Participants
Interval 12.7 to 29.4
|
4.7 Percentage of Participants
Interval 1.3 to 15.5
|
|
SCRs for Each OspA Serotype Specific IgG During the Main Study Phase
ST1 Day 208
|
92.3 Percentage of Participants
Interval 84.2 to 96.4
|
93.8 Percentage of Participants
Interval 86.2 to 97.3
|
0.0 Percentage of Participants
Interval 0.0 to 9.2
|
|
SCRs for Each OspA Serotype Specific IgG During the Main Study Phase
ST1 Day 365
|
50.0 Percentage of Participants
Interval 39.4 to 60.6
|
38.0 Percentage of Participants
Interval 28.1 to 49.0
|
2.4 Percentage of Participants
Interval 0.4 to 12.3
|
|
SCRs for Each OspA Serotype Specific IgG During the Main Study Phase
ST1 Day 545
|
17.8 Percentage of Participants
Interval 10.7 to 28.1
|
13.8 Percentage of Participants
Interval 7.5 to 24.3
|
0.0 Percentage of Participants
Interval 0.0 to 9.2
|
|
SCRs for Each OspA Serotype Specific IgG During the Main Study Phase
ST2 Day 29
|
2.4 Percentage of Participants
Interval 0.7 to 8.4
|
5.8 Percentage of Participants
Interval 2.5 to 12.9
|
0.0 Percentage of Participants
Interval 0.0 to 8.2
|
|
SCRs for Each OspA Serotype Specific IgG During the Main Study Phase
ST2 Day 57
|
1.2 Percentage of Participants
Interval 0.2 to 6.4
|
5.8 Percentage of Participants
Interval 2.5 to 12.9
|
0.0 Percentage of Participants
Interval 0.0 to 8.2
|
|
SCRs for Each OspA Serotype Specific IgG During the Main Study Phase
ST2 Day 85
|
84.3 Percentage of Participants
Interval 75.0 to 90.6
|
89.3 Percentage of Participants
Interval 80.9 to 94.3
|
0.0 Percentage of Participants
Interval 0.0 to 8.2
|
|
SCRs for Each OspA Serotype Specific IgG During the Main Study Phase
ST2 Day 180
|
32.9 Percentage of Participants
Interval 23.9 to 43.5
|
38.4 Percentage of Participants
Interval 28.8 to 48.9
|
0.0 Percentage of Participants
Interval 0.0 to 8.2
|
|
SCRs for Each OspA Serotype Specific IgG During the Main Study Phase
ST2 Day 208
|
96.2 Percentage of Participants
Interval 89.3 to 98.7
|
98.8 Percentage of Participants
Interval 93.3 to 99.8
|
0.0 Percentage of Participants
Interval 0.0 to 9.2
|
|
SCRs for Each OspA Serotype Specific IgG During the Main Study Phase
ST2 Day 365
|
72.0 Percentage of Participants
Interval 61.4 to 80.5
|
70.9 Percentage of Participants
Interval 60.1 to 79.7
|
0.0 Percentage of Participants
Interval 0.0 to 8.4
|
|
SCRs for Each OspA Serotype Specific IgG During the Main Study Phase
ST2 Day 545
|
45.2 Percentage of Participants
Interval 34.3 to 56.6
|
35.4 Percentage of Participants
Interval 24.9 to 47.5
|
2.6 Percentage of Participants
Interval 0.5 to 13.5
|
|
SCRs for Each OspA Serotype Specific IgG During the Main Study Phase
ST3 Day 29
|
3.6 Percentage of Participants
Interval 1.2 to 10.1
|
0.0 Percentage of Participants
Interval 0.0 to 4.3
|
0.0 Percentage of Participants
Interval 0.0 to 8.2
|
|
SCRs for Each OspA Serotype Specific IgG During the Main Study Phase
ST3 Day 57
|
2.4 Percentage of Participants
Interval 0.6 to 8.2
|
1.2 Percentage of Participants
Interval 0.2 to 6.3
|
0.0 Percentage of Participants
Interval 0.0 to 8.2
|
|
SCRs for Each OspA Serotype Specific IgG During the Main Study Phase
ST3 Day 85
|
84.3 Percentage of Participants
Interval 75.0 to 90.6
|
91.7 Percentage of Participants
Interval 83.8 to 95.9
|
2.3 Percentage of Participants
Interval 0.4 to 12.1
|
|
SCRs for Each OspA Serotype Specific IgG During the Main Study Phase
ST3 Day 180
|
40.0 Percentage of Participants
Interval 30.2 to 50.6
|
50.0 Percentage of Participants
Interval 39.7 to 60.3
|
2.3 Percentage of Participants
Interval 0.4 to 12.1
|
|
SCRs for Each OspA Serotype Specific IgG During the Main Study Phase
ST3 Day 208
|
98.7 Percentage of Participants
Interval 93.1 to 99.8
|
97.5 Percentage of Participants
Interval 91.3 to 99.3
|
0.0 Percentage of Participants
Interval 0.0 to 9.2
|
|
SCRs for Each OspA Serotype Specific IgG During the Main Study Phase
ST3 Day 365
|
70.7 Percentage of Participants
Interval 60.1 to 79.5
|
70.9 Percentage of Participants
Interval 60.1 to 79.7
|
0.0 Percentage of Participants
Interval 0.0 to 8.4
|
|
SCRs for Each OspA Serotype Specific IgG During the Main Study Phase
ST3 Day 545
|
42.5 Percentage of Participants
Interval 31.8 to 53.9
|
36.9 Percentage of Participants
Interval 26.2 to 49.1
|
0.0 Percentage of Participants
Interval 0.0 to 9.2
|
|
SCRs for Each OspA Serotype Specific IgG During the Main Study Phase
ST4 Day 29
|
1.2 Percentage of Participants
Interval 0.2 to 6.5
|
1.2 Percentage of Participants
Interval 0.2 to 6.3
|
2.3 Percentage of Participants
Interval 0.4 to 12.1
|
|
SCRs for Each OspA Serotype Specific IgG During the Main Study Phase
ST4 Day 57
|
2.4 Percentage of Participants
Interval 0.6 to 8.2
|
2.3 Percentage of Participants
Interval 0.6 to 8.1
|
4.7 Percentage of Participants
Interval 1.3 to 15.5
|
|
SCRs for Each OspA Serotype Specific IgG During the Main Study Phase
ST4 Day 85
|
74.7 Percentage of Participants
Interval 64.4 to 82.8
|
83.3 Percentage of Participants
Interval 73.9 to 89.8
|
7.0 Percentage of Participants
Interval 2.4 to 18.6
|
|
SCRs for Each OspA Serotype Specific IgG During the Main Study Phase
ST4 Day 180
|
25.9 Percentage of Participants
Interval 17.8 to 36.1
|
24.4 Percentage of Participants
Interval 16.6 to 34.5
|
4.7 Percentage of Participants
Interval 1.3 to 15.5
|
|
SCRs for Each OspA Serotype Specific IgG During the Main Study Phase
ST5 Day 85
|
73.5 Percentage of Participants
Interval 63.1 to 81.8
|
81.0 Percentage of Participants
Interval 71.3 to 87.9
|
0.0 Percentage of Participants
Interval 0.0 to 8.2
|
|
SCRs for Each OspA Serotype Specific IgG During the Main Study Phase
ST5 Day 180
|
20.0 Percentage of Participants
Interval 12.9 to 29.7
|
25.6 Percentage of Participants
Interval 17.5 to 35.7
|
0.0 Percentage of Participants
Interval 0.0 to 8.2
|
|
SCRs for Each OspA Serotype Specific IgG During the Main Study Phase
ST5 Day 208
|
94.9 Percentage of Participants
Interval 87.5 to 98.0
|
96.3 Percentage of Participants
Interval 89.5 to 98.7
|
0.0 Percentage of Participants
Interval 0.0 to 9.2
|
|
SCRs for Each OspA Serotype Specific IgG During the Main Study Phase
ST5 Day 365
|
53.7 Percentage of Participants
Interval 42.9 to 64.0
|
48.1 Percentage of Participants
Interval 37.4 to 58.9
|
0.0 Percentage of Participants
Interval 0.0 to 8.4
|
|
SCRs for Each OspA Serotype Specific IgG During the Main Study Phase
ST5 Day 545
|
34.2 Percentage of Participants
Interval 24.4 to 45.7
|
27.7 Percentage of Participants
Interval 18.3 to 39.6
|
2.6 Percentage of Participants
Interval 0.5 to 13.5
|
|
SCRs for Each OspA Serotype Specific IgG During the Main Study Phase
ST6 Day 29
|
2.4 Percentage of Participants
Interval 0.7 to 8.4
|
2.3 Percentage of Participants
Interval 0.6 to 8.1
|
2.3 Percentage of Participants
Interval 0.4 to 12.1
|
|
SCRs for Each OspA Serotype Specific IgG During the Main Study Phase
ST6 Day 57
|
3.5 Percentage of Participants
Interval 1.2 to 9.9
|
5.8 Percentage of Participants
Interval 2.5 to 12.9
|
4.7 Percentage of Participants
Interval 1.3 to 15.5
|
|
SCRs for Each OspA Serotype Specific IgG During the Main Study Phase
ST6 Day 85
|
61.4 Percentage of Participants
Interval 50.7 to 71.2
|
71.4 Percentage of Participants
Interval 61.0 to 80.0
|
0.0 Percentage of Participants
Interval 0.0 to 8.2
|
|
SCRs for Each OspA Serotype Specific IgG During the Main Study Phase
ST6 Day 180
|
27.1 Percentage of Participants
Interval 18.8 to 37.3
|
26.7 Percentage of Participants
Interval 18.5 to 36.9
|
4.7 Percentage of Participants
Interval 1.3 to 15.5
|
|
SCRs for Each OspA Serotype Specific IgG During the Main Study Phase
ST6 Day 208
|
89.7 Percentage of Participants
Interval 81.0 to 94.7
|
96.3 Percentage of Participants
Interval 89.5 to 98.7
|
2.6 Percentage of Participants
Interval 0.5 to 13.5
|
|
SCRs for Each OspA Serotype Specific IgG During the Main Study Phase
ST6 Day 365
|
56.1 Percentage of Participants
Interval 45.3 to 66.3
|
49.4 Percentage of Participants
Interval 38.6 to 60.2
|
4.8 Percentage of Participants
Interval 1.3 to 15.8
|
|
SCRs for Each OspA Serotype Specific IgG During the Main Study Phase
ST6 Day 545
|
31.5 Percentage of Participants
Interval 22.0 to 42.9
|
21.5 Percentage of Participants
Interval 13.3 to 33.0
|
0.0 Percentage of Participants
Interval 0.0 to 9.2
|
SECONDARY outcome
Timeframe: Day 1 (baseline from where comparison was done), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18)Population: Per-protocol population, excluded those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity). Here, "Number Analyzed" signifies participants evaluable for this outcome measure at specified time points.
Geometric Mean Fold Rise (GMFR) as compared to baseline for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12) and 545 (Month 18).
Outcome measures
| Measure |
VLA15 With Alum Lower Dose
n=85 Participants
Main Study Phase: VLA15 with Alum lower dose - Booster Phase: arm discontinued VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
VLA15 With Alum Higher Dose
n=86 Participants
Main Study Phase: VLA15 with Alum higher dose - Booster Phase: VLA15 higher dose or placebo VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
Placebo
n=43 Participants
Main Study Phase: placebo - Booster Phase: arm discontinued Placebo: PBS (Phosphate Buffered Saline).
|
|---|---|---|---|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase
ST1 Day 29
|
1.0 Fold Rise
Interval 1.0 to 1.1
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
1.0 Fold Rise
Interval 1.0 to 1.1
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase
ST1 Day 57
|
1.1 Fold Rise
Interval 1.0 to 1.1
|
1.0 Fold Rise
Interval 1.0 to 1.1
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase
ST1 Day 85
|
3.0 Fold Rise
Interval 2.4 to 3.8
|
3.7 Fold Rise
Interval 3.0 to 4.7
|
1.0 Fold Rise
Interval 0.9 to 1.1
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase
ST1 Day 180
|
1.2 Fold Rise
Interval 1.1 to 1.4
|
1.2 Fold Rise
Interval 1.1 to 1.4
|
1.0 Fold Rise
Interval 0.9 to 1.1
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase
ST1 Day 208
|
12.9 Fold Rise
Interval 9.8 to 17.1
|
13.6 Fold Rise
Interval 10.4 to 17.8
|
1.0 Fold Rise
Interval 0.9 to 1.0
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase
ST1 Day 365
|
2.3 Fold Rise
Interval 1.8 to 2.8
|
1.8 Fold Rise
Interval 1.5 to 2.2
|
1.0 Fold Rise
Interval 0.9 to 1.1
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase
ST1 Day 545
|
1.4 Fold Rise
Interval 1.1 to 1.7
|
1.2 Fold Rise
Interval 1.1 to 1.3
|
0.9 Fold Rise
Interval 0.9 to 1.0
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase
ST2 Day 29
|
1.0 Fold Rise
Interval 1.0 to 1.1
|
1.1 Fold Rise
Interval 1.0 to 1.2
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase
ST2 Day 57
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
1.1 Fold Rise
Interval 1.0 to 1.2
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase
ST2 Day 85
|
7.8 Fold Rise
Interval 6.1 to 10.0
|
9.2 Fold Rise
Interval 7.2 to 11.6
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase
ST2 Day 180
|
1.8 Fold Rise
Interval 1.5 to 2.2
|
1.8 Fold Rise
Interval 1.5 to 2.1
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase
ST2 Day 208
|
26.1 Fold Rise
Interval 20.4 to 33.3
|
29.0 Fold Rise
Interval 23.1 to 36.4
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase
ST2 Day 365
|
4.2 Fold Rise
Interval 3.3 to 5.3
|
3.6 Fold Rise
Interval 2.8 to 4.4
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase
ST2 Day 545
|
2.1 Fold Rise
Interval 1.7 to 2.6
|
1.7 Fold Rise
Interval 1.4 to 2.0
|
1.1 Fold Rise
Interval 0.9 to 1.2
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase
ST3 Day 29
|
1.1 Fold Rise
Interval 1.0 to 1.1
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase
ST3 Day 57
|
1.0 Fold Rise
Interval 1.0 to 1.1
|
1.0 Fold Rise
Interval 1.0 to 1.1
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase
ST3 Day 85
|
8.2 Fold Rise
Interval 6.3 to 10.6
|
10.9 Fold Rise
Interval 8.6 to 13.8
|
1.0 Fold Rise
Interval 1.0 to 1.1
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase
ST3 Day 180
|
1.9 Fold Rise
Interval 1.6 to 2.3
|
2.1 Fold Rise
Interval 1.7 to 2.4
|
1.0 Fold Rise
Interval 1.0 to 1.1
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase
ST3 Day 208
|
25.6 Fold Rise
Interval 20.2 to 32.6
|
29.8 Fold Rise
Interval 23.6 to 37.7
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase
ST3 Day 365
|
3.9 Fold Rise
Interval 3.1 to 4.9
|
3.7 Fold Rise
Interval 3.0 to 4.7
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase
ST3 Day 545
|
2.0 Fold Rise
Interval 1.6 to 2.4
|
1.6 Fold Rise
Interval 1.4 to 1.9
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase
ST4 Day 29
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase
ST4 Day 57
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
1.0 Fold Rise
Interval 1.0 to 1.1
|
1.0 Fold Rise
Interval 1.0 to 1.1
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase
ST4 Day 85
|
3.8 Fold Rise
Interval 3.1 to 4.8
|
5.0 Fold Rise
Interval 4.0 to 6.1
|
1.1 Fold Rise
Interval 1.0 to 1.1
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase
ST4 Day 180
|
1.4 Fold Rise
Interval 1.2 to 1.5
|
1.3 Fold Rise
Interval 1.2 to 1.5
|
1.0 Fold Rise
Interval 1.0 to 1.1
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase
ST4 Day 208
|
16.0 Fold Rise
Interval 12.6 to 20.4
|
18.1 Fold Rise
Interval 14.5 to 22.6
|
1.0 Fold Rise
Interval 1.0 to 1.1
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase
ST4 Day 365
|
2.6 Fold Rise
Interval 2.1 to 3.2
|
2.1 Fold Rise
Interval 1.8 to 2.6
|
1.0 Fold Rise
Interval 1.0 to 1.1
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase
ST4 Day 545
|
1.7 Fold Rise
Interval 1.4 to 2.0
|
1.3 Fold Rise
Interval 1.2 to 1.5
|
1.1 Fold Rise
Interval 0.9 to 1.3
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase
ST5 Day 29
|
1.0 Fold Rise
Interval 1.0 to 1.1
|
1.0 Fold Rise
Interval 1.0 to 1.1
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase
ST5 Day 57
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
1.1 Fold Rise
Interval 1.0 to 1.1
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase
ST5 Day 85
|
4.2 Fold Rise
Interval 3.3 to 5.2
|
5.0 Fold Rise
Interval 4.0 to 6.2
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase
ST5 Day 180
|
1.4 Fold Rise
Interval 1.2 to 1.6
|
1.3 Fold Rise
Interval 1.2 to 1.5
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase
ST5 Day 208
|
15.8 Fold Rise
Interval 12.4 to 20.0
|
17.9 Fold Rise
Interval 14.2 to 22.7
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase
ST5 Day 365
|
2.6 Fold Rise
Interval 2.1 to 3.2
|
2.1 Fold Rise
Interval 1.7 to 2.6
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase
ST5 Day 545
|
1.7 Fold Rise
Interval 1.4 to 2.0
|
1.4 Fold Rise
Interval 1.2 to 1.5
|
1.0 Fold Rise
Interval 1.0 to 1.1
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase
ST6 Day 29
|
1.0 Fold Rise
Interval 1.0 to 1.1
|
1.0 Fold Rise
Interval 1.0 to 1.1
|
1.0 Fold Rise
Interval 0.9 to 1.1
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase
ST6 Day 57
|
1.0 Fold Rise
Interval 1.0 to 1.1
|
1.1 Fold Rise
Interval 1.0 to 1.2
|
1.0 Fold Rise
Interval 0.9 to 1.1
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase
ST6 Day 85
|
3.5 Fold Rise
Interval 2.8 to 4.5
|
4.1 Fold Rise
Interval 3.3 to 5.1
|
1.0 Fold Rise
Interval 0.9 to 1.0
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase
ST6 Day 180
|
1.4 Fold Rise
Interval 1.2 to 1.7
|
1.4 Fold Rise
Interval 1.2 to 1.6
|
1.0 Fold Rise
Interval 0.9 to 1.1
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase
ST6 Day 208
|
14.9 Fold Rise
Interval 11.4 to 19.3
|
16.7 Fold Rise
Interval 13.2 to 21.1
|
1.0 Fold Rise
Interval 0.9 to 1.1
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase
ST6 Day 365
|
2.7 Fold Rise
Interval 2.1 to 3.4
|
2.3 Fold Rise
Interval 1.8 to 2.8
|
1.0 Fold Rise
Interval 0.9 to 1.1
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype During the Main Study Phase
ST6 Day 545
|
1.6 Fold Rise
Interval 1.3 to 1.9
|
1.3 Fold Rise
Interval 1.1 to 1.5
|
1.0 Fold Rise
Interval 0.9 to 1.0
|
SECONDARY outcome
Timeframe: At Day 1 (Month 0), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18)Population: Per-protocol population, excluded those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for this outcome measure at specified time points.
GMTs for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 1 (Month 0), 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12) and 545 (Month 18) stratified by age group: 18 - 49 years.
Outcome measures
| Measure |
VLA15 With Alum Lower Dose
n=55 Participants
Main Study Phase: VLA15 with Alum lower dose - Booster Phase: arm discontinued VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
VLA15 With Alum Higher Dose
n=57 Participants
Main Study Phase: VLA15 with Alum higher dose - Booster Phase: VLA15 higher dose or placebo VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
Placebo
n=30 Participants
Main Study Phase: placebo - Booster Phase: arm discontinued Placebo: PBS (Phosphate Buffered Saline).
|
|---|---|---|---|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST1 Day 1
|
20.8 Units per milliliter (U/mL)
Interval 19.3 to 22.4
|
20.3 Units per milliliter (U/mL)
Interval 19.7 to 20.9
|
21.2 Units per milliliter (U/mL)
Interval 19.5 to 23.1
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST1 Day 29
|
21.3 Units per milliliter (U/mL)
Interval 19.5 to 23.4
|
20.6 Units per milliliter (U/mL)
Interval 19.8 to 21.5
|
21.2 Units per milliliter (U/mL)
Interval 19.5 to 23.1
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST1 Day 57
|
22.0 Units per milliliter (U/mL)
Interval 19.9 to 24.3
|
20.9 Units per milliliter (U/mL)
Interval 19.9 to 22.0
|
21.0 Units per milliliter (U/mL)
Interval 19.6 to 22.5
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST1 Day 85
|
60.8 Units per milliliter (U/mL)
Interval 43.6 to 84.8
|
83.6 Units per milliliter (U/mL)
Interval 61.7 to 113.2
|
21.3 Units per milliliter (U/mL)
Interval 19.5 to 23.2
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST1 Day 180
|
27.2 Units per milliliter (U/mL)
Interval 22.7 to 32.5
|
25.1 Units per milliliter (U/mL)
Interval 22.2 to 28.4
|
21.0 Units per milliliter (U/mL)
Interval 19.6 to 22.6
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST1 Day 208
|
284.1 Units per milliliter (U/mL)
Interval 203.4 to 396.9
|
291.2 Units per milliliter (U/mL)
Interval 211.6 to 400.8
|
20.6 Units per milliliter (U/mL)
Interval 19.4 to 21.9
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST1 Day 365
|
47.8 Units per milliliter (U/mL)
Interval 36.4 to 62.7
|
37.4 Units per milliliter (U/mL)
Interval 29.7 to 47.1
|
21.2 Units per milliliter (U/mL)
Interval 19.5 to 23.1
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST1 Day 545
|
30.9 Units per milliliter (U/mL)
Interval 23.3 to 41.0
|
23.5 Units per milliliter (U/mL)
Interval 20.6 to 26.6
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST2 Day 1
|
20.4 Units per milliliter (U/mL)
Interval 19.6 to 21.3
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST2 Day 29
|
21.5 Units per milliliter (U/mL)
Interval 19.8 to 23.3
|
21.7 Units per milliliter (U/mL)
Interval 19.8 to 23.9
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST2 Day 57
|
20.9 Units per milliliter (U/mL)
Interval 19.6 to 22.3
|
22.5 Units per milliliter (U/mL)
Interval 19.9 to 25.4
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST2 Day 85
|
155.9 Units per milliliter (U/mL)
Interval 113.0 to 215.0
|
195.1 Units per milliliter (U/mL)
Interval 145.0 to 262.6
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST2 Day 180
|
36.6 Units per milliliter (U/mL)
Interval 28.9 to 46.4
|
36.0 Units per milliliter (U/mL)
Interval 29.2 to 44.3
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST2 Day 208
|
551.9 Units per milliliter (U/mL)
Interval 419.0 to 727.0
|
581.3 Units per milliliter (U/mL)
Interval 465.3 to 726.2
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST2 Day 365
|
82.6 Units per milliliter (U/mL)
Interval 62.2 to 109.7
|
66.1 Units per milliliter (U/mL)
Interval 51.2 to 85.5
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST2 Day 545
|
46.3 Units per milliliter (U/mL)
Interval 35.3 to 60.8
|
32.3 Units per milliliter (U/mL)
Interval 26.1 to 39.8
|
21.6 Units per milliliter (U/mL)
Interval 18.5 to 25.2
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST3 Day 1
|
20.4 Units per milliliter (U/mL)
Interval 19.6 to 21.2
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST3 Day 29
|
21.7 Units per milliliter (U/mL)
Interval 19.7 to 23.8
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST3 Day 57
|
21.1 Units per milliliter (U/mL)
Interval 19.5 to 22.8
|
21.1 Units per milliliter (U/mL)
Interval 18.9 to 23.6
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST3 Day 85
|
178.3 Units per milliliter (U/mL)
Interval 127.9 to 248.5
|
233.5 Units per milliliter (U/mL)
Interval 172.9 to 315.2
|
21.0 Units per milliliter (U/mL)
Interval 19.0 to 23.3
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST3 Day 180
|
40.3 Units per milliliter (U/mL)
Interval 31.4 to 51.8
|
42.6 Units per milliliter (U/mL)
Interval 34.5 to 52.6
|
20.6 Units per milliliter (U/mL)
Interval 19.3 to 22.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST3 Day 208
|
573.5 Units per milliliter (U/mL)
Interval 434.9 to 756.2
|
633.4 Units per milliliter (U/mL)
Interval 507.5 to 790.6
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST3 Day 365
|
80.2 Units per milliliter (U/mL)
Interval 60.2 to 106.8
|
71.3 Units per milliliter (U/mL)
Interval 54.7 to 92.9
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST3 Day 545
|
40.8 Units per milliliter (U/mL)
Interval 30.8 to 54.0
|
33.5 Units per milliliter (U/mL)
Interval 27.1 to 41.3
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST4 Day 1
|
21.0 Units per milliliter (U/mL)
Interval 19.6 to 22.6
|
20.5 Units per milliliter (U/mL)
Interval 19.5 to 21.5
|
20.8 Units per milliliter (U/mL)
Interval 19.2 to 22.4
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST4 Day 29
|
21.2 Units per milliliter (U/mL)
Interval 19.5 to 23.0
|
20.8 Units per milliliter (U/mL)
Interval 19.7 to 21.9
|
20.7 Units per milliliter (U/mL)
Interval 19.3 to 22.1
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST4 Day 57
|
21.3 Units per milliliter (U/mL)
Interval 19.8 to 23.0
|
21.4 Units per milliliter (U/mL)
Interval 19.7 to 23.2
|
21.8 Units per milliliter (U/mL)
Interval 19.7 to 24.1
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST4 Day 85
|
84.4 Units per milliliter (U/mL)
Interval 62.1 to 114.5
|
111.9 Units per milliliter (U/mL)
Interval 85.1 to 147.2
|
21.7 Units per milliliter (U/mL)
Interval 19.8 to 23.9
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST4 Day 180
|
29.3 Units per milliliter (U/mL)
Interval 24.5 to 35.2
|
27.7 Units per milliliter (U/mL)
Interval 23.8 to 32.2
|
21.8 Units per milliliter (U/mL)
Interval 19.7 to 24.1
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST4 Day 208
|
365.2 Units per milliliter (U/mL)
Interval 275.1 to 484.8
|
393.3 Units per milliliter (U/mL)
Interval 311.9 to 495.8
|
22.0 Units per milliliter (U/mL)
Interval 19.7 to 24.5
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST4 Day 365
|
55.4 Units per milliliter (U/mL)
Interval 42.7 to 72.0
|
42.6 Units per milliliter (U/mL)
Interval 33.9 to 53.4
|
21.5 Units per milliliter (U/mL)
Interval 19.4 to 23.8
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST4 Day 545
|
40.9 Units per milliliter (U/mL)
Interval 31.8 to 52.6
|
28.0 Units per milliliter (U/mL)
Interval 23.7 to 33.0
|
23.6 Units per milliliter (U/mL)
Interval 18.9 to 29.5
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST5 Day 1
|
21.1 Units per milliliter (U/mL)
Interval 19.6 to 22.6
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST5 Day 29
|
21.9 Units per milliliter (U/mL)
Interval 19.7 to 24.2
|
20.4 Units per milliliter (U/mL)
Interval 19.6 to 21.1
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST5 Day 57
|
21.5 Units per milliliter (U/mL)
Interval 19.7 to 23.4
|
21.3 Units per milliliter (U/mL)
Interval 19.3 to 23.5
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST5 Day 85
|
91.0 Units per milliliter (U/mL)
Interval 66.9 to 123.7
|
106.4 Units per milliliter (U/mL)
Interval 81.0 to 139.6
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST5 Day 180
|
30.0 Units per milliliter (U/mL)
Interval 24.6 to 36.6
|
27.1 Units per milliliter (U/mL)
Interval 23.5 to 31.3
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST5 Day 208
|
358.8 Units per milliliter (U/mL)
Interval 269.7 to 477.4
|
371.0 Units per milliliter (U/mL)
Interval 287.6 to 478.4
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST5 Day 365
|
54.5 Units per milliliter (U/mL)
Interval 40.9 to 72.5
|
42.0 Units per milliliter (U/mL)
Interval 33.3 to 53.1
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST5 Day 545
|
37.7 Units per milliliter (U/mL)
Interval 28.8 to 49.4
|
26.8 Units per milliliter (U/mL)
Interval 22.8 to 31.6
|
20.6 Units per milliliter (U/mL)
Interval 19.4 to 21.8
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST6 Day 1
|
23.0 Units per milliliter (U/mL)
Interval 20.2 to 26.3
|
20.6 Units per milliliter (U/mL)
Interval 19.5 to 21.7
|
21.0 Units per milliliter (U/mL)
Interval 19.0 to 23.3
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST6 Day 29
|
24.1 Units per milliliter (U/mL)
Interval 20.6 to 28.0
|
21.0 Units per milliliter (U/mL)
Interval 19.6 to 22.5
|
20.9 Units per milliliter (U/mL)
Interval 19.1 to 22.8
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST6 Day 57
|
23.5 Units per milliliter (U/mL)
Interval 20.5 to 26.9
|
22.5 Units per milliliter (U/mL)
Interval 20.1 to 25.3
|
21.6 Units per milliliter (U/mL)
Interval 19.4 to 24.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST6 Day 85
|
86.8 Units per milliliter (U/mL)
Interval 63.6 to 118.4
|
85.4 Units per milliliter (U/mL)
Interval 64.0 to 114.1
|
21.0 Units per milliliter (U/mL)
Interval 19.0 to 23.1
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST6 Day 180
|
32.9 Units per milliliter (U/mL)
Interval 26.5 to 40.8
|
27.5 Units per milliliter (U/mL)
Interval 23.5 to 32.1
|
21.6 Units per milliliter (U/mL)
Interval 19.3 to 24.3
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST6 Day 208
|
362.4 Units per milliliter (U/mL)
Interval 277.1 to 473.9
|
337.5 Units per milliliter (U/mL)
Interval 258.2 to 441.1
|
21.2 Units per milliliter (U/mL)
Interval 18.8 to 23.8
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST6 Day 365
|
61.2 Units per milliliter (U/mL)
Interval 45.9 to 81.8
|
41.7 Units per milliliter (U/mL)
Interval 32.7 to 53.2
|
21.6 Units per milliliter (U/mL)
Interval 19.3 to 24.1
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST6 Day 545
|
41.1 Units per milliliter (U/mL)
Interval 30.7 to 55.0
|
24.7 Units per milliliter (U/mL)
Interval 21.2 to 28.9
|
21.0 Units per milliliter (U/mL)
Interval 19.0 to 23.1
|
SECONDARY outcome
Timeframe: At Day 1 (Month 0), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18)Population: Per-protocol population, excluded those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for this outcome measure at specified time points.
GMTs for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 1 (Month 0), 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12) and 545 (Month 18) stratified by age group: 50 - 65 years.
Outcome measures
| Measure |
VLA15 With Alum Lower Dose
n=30 Participants
Main Study Phase: VLA15 with Alum lower dose - Booster Phase: arm discontinued VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
VLA15 With Alum Higher Dose
n=29 Participants
Main Study Phase: VLA15 with Alum higher dose - Booster Phase: VLA15 higher dose or placebo VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
Placebo
n=13 Participants
Main Study Phase: placebo - Booster Phase: arm discontinued Placebo: PBS (Phosphate Buffered Saline).
|
|---|---|---|---|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST1 Day 180
|
24.9 Units per milliliter (U/mL)
Interval 20.1 to 30.9
|
24.5 Units per milliliter (U/mL)
Interval 20.9 to 28.6
|
22.5 Units per milliliter (U/mL)
Interval 17.4 to 29.1
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST1 Day 365
|
49.2 Units per milliliter (U/mL)
Interval 34.4 to 70.4
|
36.8 Units per milliliter (U/mL)
Interval 25.3 to 53.4
|
21.8 Units per milliliter (U/mL)
Interval 18.1 to 26.2
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST1 Day 1
|
22.6 Units per milliliter (U/mL)
Interval 19.0 to 26.8
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
23.1 Units per milliliter (U/mL)
Interval 16.9 to 31.5
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST1 Day 29
|
23.3 Units per milliliter (U/mL)
Interval 19.6 to 27.8
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
24.4 Units per milliliter (U/mL)
Interval 17.7 to 33.8
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST1 Day 57
|
23.5 Units per milliliter (U/mL)
Interval 19.5 to 28.3
|
21.4 Units per milliliter (U/mL)
Interval 18.6 to 24.6
|
23.2 Units per milliliter (U/mL)
Interval 16.8 to 31.9
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST1 Day 85
|
71.5 Units per milliliter (U/mL)
Interval 51.2 to 100.0
|
61.6 Units per milliliter (U/mL)
Interval 42.8 to 88.5
|
22.6 Units per milliliter (U/mL)
Interval 17.3 to 29.6
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST1 Day 208
|
269.3 Units per milliliter (U/mL)
Interval 174.1 to 416.5
|
246.6 Units per milliliter (U/mL)
Interval 145.6 to 417.5
|
21.9 Units per milliliter (U/mL)
Interval 18.0 to 26.6
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST1 Day 545
|
27.9 Units per milliliter (U/mL)
Interval 21.4 to 36.5
|
24.8 Units per milliliter (U/mL)
Interval 20.1 to 30.5
|
21.9 Units per milliliter (U/mL)
Interval 17.9 to 26.9
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST2 Day 1
|
21.6 Units per milliliter (U/mL)
Interval 19.3 to 24.2
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST2 Day 29
|
21.7 Units per milliliter (U/mL)
Interval 19.3 to 24.4
|
22.1 Units per milliliter (U/mL)
Interval 19.0 to 25.7
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST2 Day 57
|
21.9 Units per milliliter (U/mL)
Interval 19.2 to 25.0
|
21.1 Units per milliliter (U/mL)
Interval 18.9 to 23.5
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST2 Day 85
|
175.3 Units per milliliter (U/mL)
Interval 117.0 to 262.6
|
163.4 Units per milliliter (U/mL)
Interval 108.4 to 246.1
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST2 Day 180
|
40.5 Units per milliliter (U/mL)
Interval 27.2 to 60.4
|
34.3 Units per milliliter (U/mL)
Interval 25.4 to 46.3
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST2 Day 208
|
534.1 Units per milliliter (U/mL)
Interval 342.5 to 832.8
|
577.0 Units per milliliter (U/mL)
Interval 340.7 to 977.2
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST2 Day 365
|
95.9 Units per milliliter (U/mL)
Interval 62.4 to 147.5
|
80.6 Units per milliliter (U/mL)
Interval 52.4 to 124.2
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST2 Day 545
|
41.9 Units per milliliter (U/mL)
Interval 28.5 to 61.7
|
34.5 Units per milliliter (U/mL)
Interval 23.9 to 49.7
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST3 Day 1
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST3 Day 29
|
20.6 Units per milliliter (U/mL)
Interval 19.4 to 21.9
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST3 Day 57
|
20.6 Units per milliliter (U/mL)
Interval 19.4 to 21.8
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST3 Day 85
|
147.1 Units per milliliter (U/mL)
Interval 96.3 to 224.7
|
190.6 Units per milliliter (U/mL)
Interval 127.1 to 285.7
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST3 Day 180
|
34.5 Units per milliliter (U/mL)
Interval 25.8 to 46.2
|
38.1 Units per milliliter (U/mL)
Interval 28.4 to 51.0
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST3 Day 208
|
440.6 Units per milliliter (U/mL)
Interval 281.3 to 690.1
|
534.3 Units per milliliter (U/mL)
Interval 307.0 to 930.0
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST3 Day 365
|
75.7 Units per milliliter (U/mL)
Interval 51.5 to 111.2
|
80.6 Units per milliliter (U/mL)
Interval 52.7 to 123.4
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST3 Day 545
|
36.6 Units per milliliter (U/mL)
Interval 27.0 to 49.7
|
30.1 Units per milliliter (U/mL)
Interval 23.1 to 39.1
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST4 Day 1
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST4 Day 29
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
21.1 Units per milliliter (U/mL)
Interval 18.8 to 23.7
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST4 Day 57
|
20.5 Units per milliliter (U/mL)
Interval 19.5 to 21.7
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST4 Day 85
|
71.1 Units per milliliter (U/mL)
Interval 50.4 to 100.3
|
82.6 Units per milliliter (U/mL)
Interval 57.9 to 117.7
|
21.3 Units per milliliter (U/mL)
Interval 18.6 to 24.3
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST4 Day 180
|
25.7 Units per milliliter (U/mL)
Interval 21.8 to 30.3
|
25.9 Units per milliliter (U/mL)
Interval 21.6 to 31.0
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST4 Day 208
|
283.9 Units per milliliter (U/mL)
Interval 179.8 to 448.3
|
324.8 Units per milliliter (U/mL)
Interval 197.4 to 534.3
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST4 Day 365
|
51.4 Units per milliliter (U/mL)
Interval 37.0 to 71.4
|
44.3 Units per milliliter (U/mL)
Interval 30.2 to 64.8
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST4 Day 545
|
28.3 Units per milliliter (U/mL)
Interval 22.6 to 35.5
|
26.3 Units per milliliter (U/mL)
Interval 21.2 to 32.7
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST5 Day 1
|
20.9 Units per milliliter (U/mL)
Interval 19.1 to 22.8
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST5 Day 29
|
20.8 Units per milliliter (U/mL)
Interval 19.2 to 22.7
|
21.9 Units per milliliter (U/mL)
Interval 19.0 to 25.3
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST5 Day 57
|
20.9 Units per milliliter (U/mL)
Interval 19.1 to 23.0
|
21.4 Units per milliliter (U/mL)
Interval 19.4 to 23.7
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST5 Day 85
|
81.4 Units per milliliter (U/mL)
Interval 55.9 to 118.5
|
89.6 Units per milliliter (U/mL)
Interval 62.6 to 128.2
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST5 Day 180
|
27.3 Units per milliliter (U/mL)
Interval 21.3 to 34.9
|
26.7 Units per milliliter (U/mL)
Interval 21.8 to 32.8
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST5 Day 208
|
293.1 Units per milliliter (U/mL)
Interval 190.5 to 451.0
|
337.2 Units per milliliter (U/mL)
Interval 204.3 to 556.6
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST5 Day 365
|
52.9 Units per milliliter (U/mL)
Interval 37.7 to 74.4
|
43.8 Units per milliliter (U/mL)
Interval 29.7 to 64.6
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST5 Day 545
|
31.0 Units per milliliter (U/mL)
Interval 23.9 to 40.3
|
27.6 Units per milliliter (U/mL)
Interval 21.7 to 35.0
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST6 Day 1
|
21.8 Units per milliliter (U/mL)
Interval 19.3 to 24.8
|
20.9 Units per milliliter (U/mL)
Interval 19.1 to 22.8
|
21.7 Units per milliliter (U/mL)
Interval 18.1 to 26.1
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST6 Day 29
|
22.0 Units per milliliter (U/mL)
Interval 19.2 to 25.1
|
21.5 Units per milliliter (U/mL)
Interval 19.4 to 23.8
|
21.3 Units per milliliter (U/mL)
Interval 18.6 to 24.3
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST6 Day 57
|
22.7 Units per milliliter (U/mL)
Interval 19.6 to 26.4
|
21.7 Units per milliliter (U/mL)
Interval 19.3 to 24.3
|
21.7 Units per milliliter (U/mL)
Interval 18.2 to 25.9
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST6 Day 85
|
69.0 Units per milliliter (U/mL)
Interval 46.8 to 101.9
|
82.1 Units per milliliter (U/mL)
Interval 56.8 to 118.7
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST6 Day 180
|
32.3 Units per milliliter (U/mL)
Interval 25.2 to 41.4
|
31.6 Units per milliliter (U/mL)
Interval 25.0 to 39.9
|
21.9 Units per milliliter (U/mL)
Interval 18.0 to 26.7
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST6 Day 208
|
305.1 Units per milliliter (U/mL)
Interval 188.3 to 494.3
|
361.4 Units per milliliter (U/mL)
Interval 225.9 to 578.3
|
21.8 Units per milliliter (U/mL)
Interval 18.0 to 26.4
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST6 Day 365
|
60.7 Units per milliliter (U/mL)
Interval 42.0 to 87.9
|
56.6 Units per milliliter (U/mL)
Interval 38.3 to 83.7
|
21.4 Units per milliliter (U/mL)
Interval 18.5 to 24.6
|
|
GMTs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST6 Day 545
|
30.9 Units per milliliter (U/mL)
Interval 23.5 to 40.8
|
31.6 Units per milliliter (U/mL)
Interval 24.1 to 41.4
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
SECONDARY outcome
Timeframe: Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18)Population: Per-protocol population, excluded those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for this outcome measure at specified time points.
SCR for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12) and 545 (Month 18) stratified by age group: 18 - 49 years. Seroconversion for ELISA was defined as 1) for participants that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive at a certain time point or 2) for participants that are seropositive at Visit 1 (baseline): \>=4-fold rise in IgG antibody titer from Visit 1. SCR was reported as percentage of participants.
Outcome measures
| Measure |
VLA15 With Alum Lower Dose
n=55 Participants
Main Study Phase: VLA15 with Alum lower dose - Booster Phase: arm discontinued VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
VLA15 With Alum Higher Dose
n=57 Participants
Main Study Phase: VLA15 with Alum higher dose - Booster Phase: VLA15 higher dose or placebo VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
Placebo
n=30 Participants
Main Study Phase: placebo - Booster Phase: arm discontinued Placebo: PBS (Phosphate Buffered Saline).
|
|---|---|---|---|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST1 Day 365
|
51.9 Percentage of Participants
Interval 38.7 to 64.9
|
38.0 Percentage of Participants
Interval 25.9 to 51.8
|
3.4 Percentage of Participants
Interval 0.6 to 17.2
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST2 Day 545
|
53.3 Percentage of Participants
Interval 39.1 to 67.1
|
36.6 Percentage of Participants
Interval 23.6 to 51.9
|
3.8 Percentage of Participants
Interval 0.7 to 18.9
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST3 Day 57
|
1.8 Percentage of Participants
Interval 0.3 to 9.6
|
1.8 Percentage of Participants
Interval 0.3 to 9.3
|
0.0 Percentage of Participants
Interval 0.0 to 11.4
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST1 Day 545
|
20.0 Percentage of Participants
Interval 10.9 to 33.8
|
12.2 Percentage of Participants
Interval 5.3 to 25.5
|
0.0 Percentage of Participants
Interval 0.0 to 12.9
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST2 Day 29
|
3.8 Percentage of Participants
Interval 1.0 to 12.8
|
5.3 Percentage of Participants
Interval 1.8 to 14.4
|
0.0 Percentage of Participants
Interval 0.0 to 11.4
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST2 Day 57
|
1.8 Percentage of Participants
Interval 0.3 to 9.6
|
7.0 Percentage of Participants
Interval 2.8 to 16.7
|
0.0 Percentage of Participants
Interval 0.0 to 11.4
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST2 Day 85
|
84.9 Percentage of Participants
Interval 72.9 to 92.1
|
90.9 Percentage of Participants
Interval 80.4 to 96.1
|
0.0 Percentage of Participants
Interval 0.0 to 11.4
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST2 Day 180
|
34.5 Percentage of Participants
Interval 23.4 to 47.7
|
38.6 Percentage of Participants
Interval 27.1 to 51.6
|
0.0 Percentage of Participants
Interval 0.0 to 11.4
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST2 Day 208
|
100 Percentage of Participants
Interval 92.7 to 100.0
|
100 Percentage of Participants
Interval 93.1 to 100.0
|
0.0 Percentage of Participants
Interval 0.0 to 12.9
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST2 Day 365
|
73.1 Percentage of Participants
Interval 59.7 to 83.2
|
70.0 Percentage of Participants
Interval 56.2 to 80.9
|
0.0 Percentage of Participants
Interval 0.0 to 11.7
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST3 Day 29
|
3.8 Percentage of Participants
Interval 1.0 to 12.8
|
0.0 Percentage of Participants
Interval 0.0 to 6.3
|
0.0 Percentage of Participants
Interval 0.0 to 11.4
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST3 Day 85
|
84.9 Percentage of Participants
Interval 72.9 to 92.1
|
92.7 Percentage of Participants
Interval 82.7 to 97.1
|
3.3 Percentage of Participants
Interval 0.6 to 16.7
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST3 Day 180
|
41.8 Percentage of Participants
Interval 29.7 to 55.0
|
52.6 Percentage of Participants
Interval 39.9 to 65.0
|
3.3 Percentage of Participants
Interval 0.6 to 16.7
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST3 Day 208
|
100 Percentage of Participants
Interval 92.7 to 100.0
|
100 Percentage of Participants
Interval 93.1 to 100.0
|
0.0 Percentage of Participants
Interval 0.0 to 12.9
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST1 Day 29
|
1.9 Percentage of Participants
Interval 0.3 to 9.9
|
1.8 Percentage of Participants
Interval 0.3 to 9.3
|
0.0 Percentage of Participants
Interval 0.0 to 11.4
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST1 Day 57
|
5.5 Percentage of Participants
Interval 1.9 to 14.9
|
3.5 Percentage of Participants
Interval 1.0 to 11.9
|
0.0 Percentage of Participants
Interval 0.0 to 11.4
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST1 Day 85
|
54.7 Percentage of Participants
Interval 41.5 to 67.3
|
70.9 Percentage of Participants
Interval 57.9 to 81.2
|
3.3 Percentage of Participants
Interval 0.6 to 16.7
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST3 Day 365
|
69.2 Percentage of Participants
Interval 55.7 to 80.1
|
72.0 Percentage of Participants
Interval 58.3 to 82.5
|
0.0 Percentage of Participants
Interval 0.0 to 11.7
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST3 Day 545
|
42.2 Percentage of Participants
Interval 29.0 to 56.7
|
39.0 Percentage of Participants
Interval 25.7 to 54.3
|
0.0 Percentage of Participants
Interval 0.0 to 12.9
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST4 Day 29
|
1.9 Percentage of Participants
Interval 0.3 to 9.9
|
1.8 Percentage of Participants
Interval 0.3 to 9.3
|
0.0 Percentage of Participants
Interval 0.0 to 11.4
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST4 Day 57
|
1.8 Percentage of Participants
Interval 0.3 to 9.6
|
3.5 Percentage of Participants
Interval 1.0 to 11.9
|
6.7 Percentage of Participants
Interval 1.8 to 21.3
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST4 Day 85
|
75.5 Percentage of Participants
Interval 62.4 to 85.1
|
87.3 Percentage of Participants
Interval 76.0 to 93.7
|
6.7 Percentage of Participants
Interval 1.8 to 21.3
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST4 Day 180
|
25.5 Percentage of Participants
Interval 15.8 to 38.3
|
24.6 Percentage of Participants
Interval 15.2 to 37.1
|
6.7 Percentage of Participants
Interval 1.8 to 21.3
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST4 Day 208
|
100 Percentage of Participants
Interval 92.7 to 100.0
|
100 Percentage of Participants
Interval 93.1 to 100.0
|
7.7 Percentage of Participants
Interval 2.1 to 24.1
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST4 Day 365
|
61.5 Percentage of Participants
Interval 48.0 to 73.5
|
52.0 Percentage of Participants
Interval 38.5 to 65.2
|
3.4 Percentage of Participants
Interval 0.6 to 17.2
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST4 Day 545
|
46.7 Percentage of Participants
Interval 32.9 to 60.9
|
29.3 Percentage of Participants
Interval 17.6 to 44.5
|
7.7 Percentage of Participants
Interval 2.1 to 24.1
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST5 Day 29
|
1.9 Percentage of Participants
Interval 0.3 to 9.9
|
1.8 Percentage of Participants
Interval 0.3 to 9.3
|
0.0 Percentage of Participants
Interval 0.0 to 11.4
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST5 Day 57
|
1.8 Percentage of Participants
Interval 0.3 to 9.6
|
3.5 Percentage of Participants
Interval 1.0 to 11.9
|
0.0 Percentage of Participants
Interval 0.0 to 11.4
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST5 Day 85
|
73.6 Percentage of Participants
Interval 60.4 to 83.6
|
81.8 Percentage of Participants
Interval 69.7 to 89.8
|
0.0 Percentage of Participants
Interval 0.0 to 11.4
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST5 Day 180
|
21.8 Percentage of Participants
Interval 12.9 to 34.4
|
26.3 Percentage of Participants
Interval 16.6 to 39.0
|
0.0 Percentage of Participants
Interval 0.0 to 11.4
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST5 Day 208
|
95.9 Percentage of Participants
Interval 86.3 to 98.9
|
98.1 Percentage of Participants
Interval 89.9 to 99.7
|
0.0 Percentage of Participants
Interval 0.0 to 12.9
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST5 Day 365
|
51.9 Percentage of Participants
Interval 38.7 to 64.9
|
48.0 Percentage of Participants
Interval 34.8 to 61.5
|
0.0 Percentage of Participants
Interval 0.0 to 11.7
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST5 Day 545
|
37.8 Percentage of Participants
Interval 25.1 to 52.4
|
26.8 Percentage of Participants
Interval 15.7 to 41.9
|
3.8 Percentage of Participants
Interval 0.7 to 18.9
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST6 Day 29
|
3.8 Percentage of Participants
Interval 1.0 to 12.8
|
1.8 Percentage of Participants
Interval 0.3 to 9.3
|
0.0 Percentage of Participants
Interval 0.0 to 11.4
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST6 Day 57
|
3.6 Percentage of Participants
Interval 1.0 to 12.3
|
7.0 Percentage of Participants
Interval 2.8 to 16.7
|
3.3 Percentage of Participants
Interval 0.6 to 16.7
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST6 Day 85
|
62.3 Percentage of Participants
Interval 48.8 to 74.1
|
70.9 Percentage of Participants
Interval 57.9 to 81.2
|
0.0 Percentage of Participants
Interval 0.0 to 11.4
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST6 Day 180
|
25.5 Percentage of Participants
Interval 15.8 to 38.3
|
22.8 Percentage of Participants
Interval 13.8 to 35.2
|
3.3 Percentage of Participants
Interval 0.6 to 16.7
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST6 Day 208
|
89.8 Percentage of Participants
Interval 78.2 to 95.6
|
96.2 Percentage of Participants
Interval 87.0 to 98.9
|
0.0 Percentage of Participants
Interval 0.0 to 12.9
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST6 Day 365
|
55.8 Percentage of Participants
Interval 42.3 to 68.4
|
44.0 Percentage of Participants
Interval 31.2 to 57.7
|
3.4 Percentage of Participants
Interval 0.6 to 17.2
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST6 Day 545
|
37.8 Percentage of Participants
Interval 25.1 to 52.4
|
14.6 Percentage of Participants
Interval 6.9 to 28.4
|
0.0 Percentage of Participants
Interval 0.0 to 12.9
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST1 Day 180
|
18.2 Percentage of Participants
Interval 10.2 to 30.3
|
19.3 Percentage of Participants
Interval 11.1 to 31.3
|
6.7 Percentage of Participants
Interval 1.8 to 21.3
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST1 Day 208
|
93.9 Percentage of Participants
Interval 83.5 to 97.9
|
94.2 Percentage of Participants
Interval 84.4 to 98.0
|
0.0 Percentage of Participants
Interval 0.0 to 12.9
|
SECONDARY outcome
Timeframe: Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18)Population: Per-protocol population, excluded those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for this outcome measure at specified time points.
SCR for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12) and 545 (Month 18) stratified by age group: 50 - 65 years. Seroconversion for ELISA was defined as 1) for participants that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive at a certain time point or 2) for participants that are seropositive at Visit 1 (baseline): \>=4-fold rise in IgG antibody titer from Visit 1. SCR was reported as percentage of participants.
Outcome measures
| Measure |
VLA15 With Alum Lower Dose
n=30 Participants
Main Study Phase: VLA15 with Alum lower dose - Booster Phase: arm discontinued VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
VLA15 With Alum Higher Dose
n=29 Participants
Main Study Phase: VLA15 with Alum higher dose - Booster Phase: VLA15 higher dose or placebo VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
Placebo
n=13 Participants
Main Study Phase: placebo - Booster Phase: arm discontinued Placebo: PBS (Phosphate Buffered Saline).
|
|---|---|---|---|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST1 Day 29
|
3.3 Percentage of Participants
Interval 0.6 to 16.7
|
0.0 Percentage of Participants
Interval 0.0 to 11.7
|
7.7 Percentage of Participants
Interval 1.4 to 33.3
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST1 Day 57
|
3.3 Percentage of Participants
Interval 0.6 to 16.7
|
3.4 Percentage of Participants
Interval 0.6 to 17.2
|
0.0 Percentage of Participants
Interval 0.0 to 22.8
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST1 Day 85
|
66.7 Percentage of Participants
Interval 48.8 to 80.8
|
65.5 Percentage of Participants
Interval 47.3 to 80.1
|
0.0 Percentage of Participants
Interval 0.0 to 22.8
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST1 Day 180
|
6.7 Percentage of Participants
Interval 1.8 to 21.3
|
20.7 Percentage of Participants
Interval 9.8 to 38.4
|
0.0 Percentage of Participants
Interval 0.0 to 22.8
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST1 Day 208
|
89.7 Percentage of Participants
Interval 73.6 to 96.4
|
92.9 Percentage of Participants
Interval 77.4 to 98.0
|
0.0 Percentage of Participants
Interval 0.0 to 24.2
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST1 Day 365
|
46.7 Percentage of Participants
Interval 30.2 to 63.9
|
37.9 Percentage of Participants
Interval 22.7 to 56.0
|
0.0 Percentage of Participants
Interval 0.0 to 22.8
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST1 Day 545
|
14.3 Percentage of Participants
Interval 5.7 to 31.5
|
16.7 Percentage of Participants
Interval 6.7 to 35.9
|
0.0 Percentage of Participants
Interval 0.0 to 24.2
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST2 Day 29
|
0.0 Percentage of Participants
Interval 0.0 to 11.4
|
6.9 Percentage of Participants
Interval 1.9 to 22.0
|
0.0 Percentage of Participants
Interval 0.0 to 22.8
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST2 Day 57
|
0.0 Percentage of Participants
Interval 0.0 to 11.4
|
3.4 Percentage of Participants
Interval 0.6 to 17.2
|
0.0 Percentage of Participants
Interval 0.0 to 22.8
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST2 Day 85
|
83.3 Percentage of Participants
Interval 66.4 to 92.7
|
86.2 Percentage of Participants
Interval 69.4 to 94.5
|
0.0 Percentage of Participants
Interval 0.0 to 22.8
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST2 Day 180
|
30.0 Percentage of Participants
Interval 16.7 to 47.9
|
37.9 Percentage of Participants
Interval 22.7 to 56.0
|
0.0 Percentage of Participants
Interval 0.0 to 22.8
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST2 Day 208
|
89.7 Percentage of Participants
Interval 73.6 to 96.4
|
96.4 Percentage of Participants
Interval 82.3 to 99.4
|
0.0 Percentage of Participants
Interval 0.0 to 24.2
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST2 Day 365
|
70.0 Percentage of Participants
Interval 52.1 to 83.3
|
72.4 Percentage of Participants
Interval 54.3 to 85.3
|
0.0 Percentage of Participants
Interval 0.0 to 22.8
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST2 Day 545
|
32.1 Percentage of Participants
Interval 17.9 to 50.7
|
33.3 Percentage of Participants
Interval 18.0 to 53.3
|
0.0 Percentage of Participants
Interval 0.0 to 24.2
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST3 Day 29
|
3.3 Percentage of Participants
Interval 0.6 to 16.7
|
0.0 Percentage of Participants
Interval 0.0 to 11.7
|
0.0 Percentage of Participants
Interval 0.0 to 22.8
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST3 Day 57
|
3.3 Percentage of Participants
Interval 0.6 to 16.7
|
0.0 Percentage of Participants
Interval 0.0 to 11.7
|
0.0 Percentage of Participants
Interval 0.0 to 22.8
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST3 Day 85
|
83.3 Percentage of Participants
Interval 66.4 to 92.7
|
89.7 Percentage of Participants
Interval 73.6 to 96.4
|
0.0 Percentage of Participants
Interval 0.0 to 22.8
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST3 Day 180
|
36.7 Percentage of Participants
Interval 21.9 to 54.5
|
44.8 Percentage of Participants
Interval 28.4 to 62.5
|
0.0 Percentage of Participants
Interval 0.0 to 22.8
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST3 Day 208
|
96.6 Percentage of Participants
Interval 82.8 to 99.4
|
92.9 Percentage of Participants
Interval 77.4 to 98.0
|
0.0 Percentage of Participants
Interval 0.0 to 24.2
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST3 Day 365
|
73.3 Percentage of Participants
Interval 55.6 to 85.8
|
69.0 Percentage of Participants
Interval 50.8 to 82.7
|
0.0 Percentage of Participants
Interval 0.0 to 22.8
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST3 Day 545
|
42.9 Percentage of Participants
Interval 26.5 to 60.9
|
33.3 Percentage of Participants
Interval 18.0 to 53.3
|
0.0 Percentage of Participants
Interval 0.0 to 24.2
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST4 Day 29
|
0.0 Percentage of Participants
Interval 0.0 to 11.4
|
0.0 Percentage of Participants
Interval 0.0 to 11.7
|
7.7 Percentage of Participants
Interval 1.4 to 33.3
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST4 Day 57
|
3.3 Percentage of Participants
Interval 0.6 to 16.7
|
0.0 Percentage of Participants
Interval 0.0 to 11.7
|
0.0 Percentage of Participants
Interval 0.0 to 22.8
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST4 Day 85
|
73.3 Percentage of Participants
Interval 55.6 to 85.8
|
75.9 Percentage of Participants
Interval 57.9 to 87.8
|
7.7 Percentage of Participants
Interval 1.4 to 33.3
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST4 Day 180
|
26.7 Percentage of Participants
Interval 14.2 to 44.4
|
24.1 Percentage of Participants
Interval 12.2 to 42.1
|
0.0 Percentage of Participants
Interval 0.0 to 22.8
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST4 Day 208
|
93.1 Percentage of Participants
Interval 78.0 to 98.1
|
96.4 Percentage of Participants
Interval 82.3 to 99.4
|
0.0 Percentage of Participants
Interval 0.0 to 24.2
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST4 Day 365
|
63.3 Percentage of Participants
Interval 45.5 to 78.1
|
51.7 Percentage of Participants
Interval 34.4 to 68.6
|
0.0 Percentage of Participants
Interval 0.0 to 22.8
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST4 Day 545
|
28.6 Percentage of Participants
Interval 15.3 to 47.1
|
25.0 Percentage of Participants
Interval 12.0 to 44.9
|
0.0 Percentage of Participants
Interval 0.0 to 24.2
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST5 Day 29
|
0.0 Percentage of Participants
Interval 0.0 to 11.4
|
6.9 Percentage of Participants
Interval 1.9 to 22.0
|
0.0 Percentage of Participants
Interval 0.0 to 22.8
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST5 Day 57
|
0.0 Percentage of Participants
Interval 0.0 to 11.4
|
6.9 Percentage of Participants
Interval 1.9 to 22.0
|
0.0 Percentage of Participants
Interval 0.0 to 22.8
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST5 Day 85
|
73.3 Percentage of Participants
Interval 55.6 to 85.8
|
79.3 Percentage of Participants
Interval 61.6 to 90.2
|
0.0 Percentage of Participants
Interval 0.0 to 22.8
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST5 Day 180
|
16.7 Percentage of Participants
Interval 7.3 to 33.6
|
24.1 Percentage of Participants
Interval 12.2 to 42.1
|
0.0 Percentage of Participants
Interval 0.0 to 22.8
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST5 Day 208
|
93.1 Percentage of Participants
Interval 78.0 to 98.1
|
92.9 Percentage of Participants
Interval 77.4 to 98.0
|
0.0 Percentage of Participants
Interval 0.0 to 24.2
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST5 Day 365
|
56.7 Percentage of Participants
Interval 39.2 to 72.6
|
48.3 Percentage of Participants
Interval 31.4 to 65.6
|
0.0 Percentage of Participants
Interval 0.0 to 22.8
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST5 Day 545
|
28.6 Percentage of Participants
Interval 15.3 to 47.1
|
29.2 Percentage of Participants
Interval 14.9 to 49.2
|
0.0 Percentage of Participants
Interval 0.0 to 24.2
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST6 Day 29
|
0.0 Percentage of Participants
Interval 0.0 to 11.4
|
3.4 Percentage of Participants
Interval 0.6 to 17.2
|
7.7 Percentage of Participants
Interval 1.4 to 33.3
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST6 Day 57
|
3.3 Percentage of Participants
Interval 0.6 to 16.7
|
3.4 Percentage of Participants
Interval 0.6 to 17.2
|
7.7 Percentage of Participants
Interval 1.4 to 33.3
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST6 Day 85
|
60.0 Percentage of Participants
Interval 42.3 to 75.4
|
72.4 Percentage of Participants
Interval 54.3 to 85.3
|
0.0 Percentage of Participants
Interval 0.0 to 22.8
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST6 Day 180
|
30.0 Percentage of Participants
Interval 16.7 to 47.9
|
34.5 Percentage of Participants
Interval 19.9 to 52.7
|
7.7 Percentage of Participants
Interval 1.4 to 33.3
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST6 Day 208
|
89.7 Percentage of Participants
Interval 73.6 to 96.4
|
96.4 Percentage of Participants
Interval 82.3 to 99.4
|
8.3 Percentage of Participants
Interval 1.5 to 35.4
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST6 Day 365
|
56.7 Percentage of Participants
Interval 39.2 to 72.6
|
58.6 Percentage of Participants
Interval 40.7 to 74.5
|
7.7 Percentage of Participants
Interval 1.4 to 33.3
|
|
SCR for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST6 Day 545
|
21.4 Percentage of Participants
Interval 10.2 to 39.5
|
33.3 Percentage of Participants
Interval 18.0 to 53.3
|
0.0 Percentage of Participants
Interval 0.0 to 24.2
|
SECONDARY outcome
Timeframe: Day 1 (baseline), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18)Population: Per-protocol population, excluded those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for this outcome measure at specified time points.
GMFR for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12) and 545 (Month 18) stratified by age group: 18 - 49 years.
Outcome measures
| Measure |
VLA15 With Alum Lower Dose
n=55 Participants
Main Study Phase: VLA15 with Alum lower dose - Booster Phase: arm discontinued VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
VLA15 With Alum Higher Dose
n=57 Participants
Main Study Phase: VLA15 with Alum higher dose - Booster Phase: VLA15 higher dose or placebo VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
Placebo
n=30 Participants
Main Study Phase: placebo - Booster Phase: arm discontinued Placebo: PBS (Phosphate Buffered Saline).
|
|---|---|---|---|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST1 Day 29
|
1.0 Fold Rise
Interval 1.0 to 1.1
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST1 Day 57
|
1.1 Fold Rise
Interval 1.0 to 1.1
|
1.0 Fold Rise
Interval 1.0 to 1.1
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST1 Day 85
|
2.9 Fold Rise
Interval 2.1 to 4.1
|
4.1 Fold Rise
Interval 3.0 to 5.6
|
1.0 Fold Rise
Interval 0.9 to 1.1
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST1 Day 180
|
1.3 Fold Rise
Interval 1.1 to 1.6
|
1.2 Fold Rise
Interval 1.1 to 1.4
|
1.0 Fold Rise
Interval 0.9 to 1.1
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST1 Day 208
|
13.6 Fold Rise
Interval 9.7 to 19.2
|
14.3 Fold Rise
Interval 10.4 to 19.7
|
1.0 Fold Rise
Interval 0.9 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST1 Day 365
|
2.3 Fold Rise
Interval 1.8 to 3.0
|
1.8 Fold Rise
Interval 1.5 to 2.3
|
1.0 Fold Rise
Interval 0.9 to 1.1
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST1 Day 545
|
1.5 Fold Rise
Interval 1.1 to 1.9
|
1.1 Fold Rise
Interval 1.0 to 1.3
|
0.9 Fold Rise
Interval 0.8 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST2 Day 29
|
1.1 Fold Rise
Interval 1.0 to 1.1
|
1.1 Fold Rise
Interval 1.0 to 1.2
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST2 Day 57
|
1.0 Fold Rise
Interval 1.0 to 1.1
|
1.1 Fold Rise
Interval 1.0 to 1.3
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST2 Day 85
|
7.6 Fold Rise
Interval 5.5 to 10.5
|
9.8 Fold Rise
Interval 7.2 to 13.1
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST2 Day 180
|
1.8 Fold Rise
Interval 1.4 to 2.3
|
1.8 Fold Rise
Interval 1.5 to 2.2
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST2 Day 208
|
27.0 Fold Rise
Interval 20.5 to 35.5
|
29.1 Fold Rise
Interval 23.3 to 36.3
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST2 Day 365
|
4.0 Fold Rise
Interval 3.0 to 5.4
|
3.3 Fold Rise
Interval 2.6 to 4.3
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST2 Day 545
|
2.3 Fold Rise
Interval 1.7 to 2.9
|
1.6 Fold Rise
Interval 1.3 to 2.0
|
1.1 Fold Rise
Interval 0.9 to 1.3
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST3 Day 29
|
1.1 Fold Rise
Interval 1.0 to 1.1
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST3 Day 57
|
1.0 Fold Rise
Interval 1.0 to 1.1
|
1.1 Fold Rise
Interval 0.9 to 1.2
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST3 Day 85
|
8.7 Fold Rise
Interval 6.2 to 12.2
|
11.7 Fold Rise
Interval 8.6 to 15.8
|
1.1 Fold Rise
Interval 0.9 to 1.2
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST3 Day 180
|
2.0 Fold Rise
Interval 1.5 to 2.5
|
2.1 Fold Rise
Interval 1.7 to 2.6
|
1.0 Fold Rise
Interval 1.0 to 1.1
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST3 Day 208
|
28.1 Fold Rise
Interval 21.1 to 37.3
|
31.7 Fold Rise
Interval 25.4 to 39.5
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST3 Day 365
|
3.9 Fold Rise
Interval 2.9 to 5.2
|
3.6 Fold Rise
Interval 2.7 to 4.6
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST3 Day 545
|
2.0 Fold Rise
Interval 1.5 to 2.7
|
1.7 Fold Rise
Interval 1.4 to 2.1
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST4 Day 29
|
1.0 Fold Rise
Interval 0.9 to 1.1
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST4 Day 57
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
1.0 Fold Rise
Interval 1.0 to 1.1
|
1.0 Fold Rise
Interval 1.0 to 1.1
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST4 Day 85
|
4.0 Fold Rise
Interval 3.0 to 5.4
|
5.5 Fold Rise
Interval 4.2 to 7.1
|
1.0 Fold Rise
Interval 1.0 to 1.1
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST4 Day 180
|
1.4 Fold Rise
Interval 1.2 to 1.7
|
1.4 Fold Rise
Interval 1.2 to 1.6
|
1.1 Fold Rise
Interval 1.0 to 1.1
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST4 Day 208
|
17.2 Fold Rise
Interval 13.0 to 22.9
|
19.1 Fold Rise
Interval 15.3 to 24.0
|
1.1 Fold Rise
Interval 1.0 to 1.1
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST4 Day 365
|
2.6 Fold Rise
Interval 2.0 to 3.4
|
2.1 Fold Rise
Interval 1.7 to 2.6
|
1.0 Fold Rise
Interval 1.0 to 1.1
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST4 Day 545
|
1.9 Fold Rise
Interval 1.5 to 2.5
|
1.4 Fold Rise
Interval 1.2 to 1.6
|
1.1 Fold Rise
Interval 0.9 to 1.4
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST5 Day 29
|
1.0 Fold Rise
Interval 1.0 to 1.1
|
1.0 Fold Rise
Interval 1.0 to 1.1
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST5 Day 57
|
1.0 Fold Rise
Interval 1.0 to 1.1
|
1.1 Fold Rise
Interval 1.0 to 1.2
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST5 Day 85
|
4.3 Fold Rise
Interval 3.2 to 5.8
|
5.3 Fold Rise
Interval 4.1 to 7.0
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST5 Day 180
|
1.4 Fold Rise
Interval 1.2 to 1.7
|
1.4 Fold Rise
Interval 1.2 to 1.6
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST5 Day 208
|
16.9 Fold Rise
Interval 12.6 to 22.8
|
18.5 Fold Rise
Interval 14.4 to 23.9
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST5 Day 365
|
2.6 Fold Rise
Interval 1.9 to 3.4
|
2.1 Fold Rise
Interval 1.7 to 2.7
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST5 Day 545
|
1.8 Fold Rise
Interval 1.4 to 2.3
|
1.3 Fold Rise
Interval 1.1 to 1.6
|
1.0 Fold Rise
Interval 1.0 to 1.1
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST6 Day 29
|
1.0 Fold Rise
Interval 1.0 to 1.1
|
1.0 Fold Rise
Interval 1.0 to 1.1
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST6 Day 57
|
1.0 Fold Rise
Interval 1.0 to 1.1
|
1.1 Fold Rise
Interval 1.0 to 1.2
|
1.0 Fold Rise
Interval 1.0 to 1.1
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST6 Day 85
|
3.7 Fold Rise
Interval 2.7 to 5.1
|
4.2 Fold Rise
Interval 3.1 to 5.5
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST6 Day 180
|
1.4 Fold Rise
Interval 1.2 to 1.8
|
1.3 Fold Rise
Interval 1.2 to 1.5
|
1.0 Fold Rise
Interval 1.0 to 1.1
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST6 Day 208
|
15.5 Fold Rise
Interval 11.1 to 21.4
|
16.4 Fold Rise
Interval 12.5 to 21.4
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST6 Day 365
|
2.6 Fold Rise
Interval 1.9 to 3.6
|
2.0 Fold Rise
Interval 1.6 to 2.5
|
1.0 Fold Rise
Interval 1.0 to 1.1
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 18 - 49 Years
ST6 Day 545
|
1.7 Fold Rise
Interval 1.3 to 2.3
|
1.2 Fold Rise
Interval 1.0 to 1.4
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: Day 1 (baseline), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12) and Day 545 (Month 18)Population: Per-protocol population, excluded those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for this outcome measure at specified time points.
GMFR for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12) and 545 (Month 18) stratified by age group: 50 - 65 years.
Outcome measures
| Measure |
VLA15 With Alum Lower Dose
n=30 Participants
Main Study Phase: VLA15 with Alum lower dose - Booster Phase: arm discontinued VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
VLA15 With Alum Higher Dose
n=29 Participants
Main Study Phase: VLA15 with Alum higher dose - Booster Phase: VLA15 higher dose or placebo VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
Placebo
n=13 Participants
Main Study Phase: placebo - Booster Phase: arm discontinued Placebo: PBS (Phosphate Buffered Saline).
|
|---|---|---|---|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST3 Day 545
|
1.8 Fold Rise
Interval 1.4 to 2.5
|
1.5 Fold Rise
Interval 1.2 to 2.0
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST4 Day 57
|
1.0 Fold Rise
Interval 1.0 to 1.1
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST2 Day 208
|
24.6 Fold Rise
Interval 15.1 to 40.0
|
28.8 Fold Rise
Interval 17.0 to 48.9
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST2 Day 365
|
4.4 Fold Rise
Interval 2.9 to 6.9
|
4.0 Fold Rise
Interval 2.6 to 6.2
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST2 Day 545
|
1.9 Fold Rise
Interval 1.3 to 2.8
|
1.7 Fold Rise
Interval 1.2 to 2.5
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST3 Day 29
|
1.0 Fold Rise
Interval 1.0 to 1.1
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST3 Day 57
|
1.0 Fold Rise
Interval 1.0 to 1.1
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST3 Day 85
|
7.4 Fold Rise
Interval 4.8 to 11.2
|
9.5 Fold Rise
Interval 6.4 to 14.3
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST3 Day 180
|
1.7 Fold Rise
Interval 1.3 to 2.3
|
1.9 Fold Rise
Interval 1.4 to 2.6
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST3 Day 208
|
22.0 Fold Rise
Interval 14.1 to 34.5
|
26.7 Fold Rise
Interval 15.4 to 46.5
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST3 Day 365
|
3.8 Fold Rise
Interval 2.6 to 5.6
|
4.0 Fold Rise
Interval 2.6 to 6.2
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST4 Day 29
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
1.1 Fold Rise
Interval 0.9 to 1.2
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST4 Day 85
|
3.6 Fold Rise
Interval 2.5 to 5.0
|
4.1 Fold Rise
Interval 2.9 to 5.9
|
1.1 Fold Rise
Interval 0.9 to 1.2
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST4 Day 180
|
1.3 Fold Rise
Interval 1.1 to 1.5
|
1.3 Fold Rise
Interval 1.1 to 1.5
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST4 Day 208
|
14.2 Fold Rise
Interval 9.0 to 22.4
|
16.2 Fold Rise
Interval 9.9 to 26.7
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST4 Day 365
|
2.6 Fold Rise
Interval 1.8 to 3.6
|
2.2 Fold Rise
Interval 1.5 to 3.2
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST4 Day 545
|
1.4 Fold Rise
Interval 1.1 to 1.8
|
1.3 Fold Rise
Interval 1.1 to 1.6
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST5 Day 29
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
1.1 Fold Rise
Interval 0.9 to 1.3
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST5 Day 57
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
1.1 Fold Rise
Interval 1.0 to 1.2
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST5 Day 85
|
3.9 Fold Rise
Interval 2.7 to 5.6
|
4.5 Fold Rise
Interval 3.1 to 6.4
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST5 Day 180
|
1.3 Fold Rise
Interval 1.0 to 1.6
|
1.3 Fold Rise
Interval 1.1 to 1.6
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST5 Day 208
|
14.0 Fold Rise
Interval 9.3 to 21.2
|
16.9 Fold Rise
Interval 10.2 to 27.8
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST5 Day 365
|
2.5 Fold Rise
Interval 1.8 to 3.5
|
2.2 Fold Rise
Interval 1.5 to 3.2
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST5 Day 545
|
1.5 Fold Rise
Interval 1.2 to 1.9
|
1.4 Fold Rise
Interval 1.1 to 1.8
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST6 Day 29
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
1.0 Fold Rise
Interval 1.0 to 1.1
|
1.0 Fold Rise
Interval 0.8 to 1.2
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST6 Day 57
|
1.0 Fold Rise
Interval 1.0 to 1.1
|
1.0 Fold Rise
Interval 1.0 to 1.1
|
1.0 Fold Rise
Interval 0.8 to 1.3
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST6 Day 85
|
3.2 Fold Rise
Interval 2.2 to 4.5
|
3.9 Fold Rise
Interval 2.7 to 5.7
|
0.9 Fold Rise
Interval 0.8 to 1.1
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST6 Day 180
|
1.5 Fold Rise
Interval 1.2 to 1.8
|
1.5 Fold Rise
Interval 1.2 to 1.9
|
1.0 Fold Rise
Interval 0.8 to 1.3
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST6 Day 208
|
13.9 Fold Rise
Interval 8.7 to 22.2
|
17.3 Fold Rise
Interval 10.7 to 28.0
|
1.0 Fold Rise
Interval 0.7 to 1.3
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST6 Day 365
|
2.8 Fold Rise
Interval 1.9 to 4.0
|
2.7 Fold Rise
Interval 1.8 to 4.0
|
1.0 Fold Rise
Interval 0.8 to 1.2
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST6 Day 545
|
1.4 Fold Rise
Interval 1.1 to 1.8
|
1.5 Fold Rise
Interval 1.2 to 2.0
|
0.9 Fold Rise
Interval 0.7 to 1.1
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST1 Day 29
|
1.0 Fold Rise
Interval 0.9 to 1.1
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
1.1 Fold Rise
Interval 0.9 to 1.2
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST1 Day 57
|
1.0 Fold Rise
Interval 0.9 to 1.1
|
1.1 Fold Rise
Interval 0.9 to 1.2
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST1 Day 85
|
3.2 Fold Rise
Interval 2.3 to 4.5
|
3.1 Fold Rise
Interval 2.1 to 4.4
|
1.0 Fold Rise
Interval 0.9 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST1 Day 180
|
1.1 Fold Rise
Interval 1.0 to 1.3
|
1.2 Fold Rise
Interval 1.0 to 1.4
|
1.0 Fold Rise
Interval 0.9 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST1 Day 208
|
11.9 Fold Rise
Interval 7.2 to 19.5
|
12.3 Fold Rise
Interval 7.3 to 20.9
|
0.9 Fold Rise
Interval 0.8 to 1.1
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST1 Day 365
|
2.2 Fold Rise
Interval 1.5 to 3.1
|
1.8 Fold Rise
Interval 1.3 to 2.7
|
0.9 Fold Rise
Interval 0.8 to 1.1
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST1 Day 545
|
1.2 Fold Rise
Interval 1.0 to 1.5
|
1.2 Fold Rise
Interval 1.0 to 1.5
|
0.9 Fold Rise
Interval 0.8 to 1.1
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST2 Day 29
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
1.1 Fold Rise
Interval 1.0 to 1.3
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST2 Day 57
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
1.1 Fold Rise
Interval 0.9 to 1.2
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST2 Day 85
|
8.1 Fold Rise
Interval 5.3 to 12.5
|
8.2 Fold Rise
Interval 5.4 to 12.3
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
|
GMFRs for IgG Against Each OspA Serotype Stratified by Age Group During Main Study Phase: Group 50 - 65 Years
ST2 Day 180
|
1.9 Fold Rise
Interval 1.3 to 2.8
|
1.7 Fold Rise
Interval 1.3 to 2.3
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: From Day 1 of vaccination up to Day 545 (Month 18)Population: Safety population included all participants who entered into the study and received at least 1 dose of vaccination.
SAE was any untoward medical occurrence that at any dose resulted in any of the following outcomes or deemed significant for any other reason: death; required inpatient prolonged existing hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly/birth defect. Two-sided 95% confidence intervals were calculated according to Altman method.
Outcome measures
| Measure |
VLA15 With Alum Lower Dose
n=97 Participants
Main Study Phase: VLA15 with Alum lower dose - Booster Phase: arm discontinued VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
VLA15 With Alum Higher Dose
n=98 Participants
Main Study Phase: VLA15 with Alum higher dose - Booster Phase: VLA15 higher dose or placebo VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
Placebo
n=51 Participants
Main Study Phase: placebo - Booster Phase: arm discontinued Placebo: PBS (Phosphate Buffered Saline).
|
|---|---|---|---|
|
Percentage of Participants With Serious Adverse Events (SAEs) During the Main Study Phase
|
4.1 Percentage of Participants
Interval 1.6 to 10.1
|
4.1 Percentage of Participants
Interval 1.6 to 10.0
|
3.9 Percentage of Participants
Interval 1.1 to 13.2
|
SECONDARY outcome
Timeframe: From Day 1 of vaccination up to Day 545 (Month 18)Population: Safety population included all participants who entered into the study and received at least 1 dose of vaccination.
SAE was any untoward medical occurrence that at any dose resulted in any of the following outcomes or deemed significant for any other reason: death; required inpatient prolonged existing hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly/birth defect. Relatedness to study vaccine was assessed by the investigator. Two-sided 95% confidence intervals were calculated according to Altman method.
Outcome measures
| Measure |
VLA15 With Alum Lower Dose
n=97 Participants
Main Study Phase: VLA15 with Alum lower dose - Booster Phase: arm discontinued VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
VLA15 With Alum Higher Dose
n=98 Participants
Main Study Phase: VLA15 with Alum higher dose - Booster Phase: VLA15 higher dose or placebo VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
Placebo
n=51 Participants
Main Study Phase: placebo - Booster Phase: arm discontinued Placebo: PBS (Phosphate Buffered Saline).
|
|---|---|---|---|
|
Percentage of Participants With Related SAEs During the Main Study Phase
|
0.0 Percentage of Participants
Interval 0.0 to 3.8
|
0.0 Percentage of Participants
Interval 0.0 to 3.8
|
0.0 Percentage of Participants
Interval 0.0 to 7.0
|
SECONDARY outcome
Timeframe: From Day 1 of vaccination up to Day 545 (Month 18)Population: Safety population included all participants who entered into the study and received at least 1 dose of vaccination.
AESIs were defined as serious or non-serious AEs which were of scientific and medical concern specific to the investigational product. Two-sided 95% confidence intervals were calculated according to Altman method.
Outcome measures
| Measure |
VLA15 With Alum Lower Dose
n=97 Participants
Main Study Phase: VLA15 with Alum lower dose - Booster Phase: arm discontinued VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
VLA15 With Alum Higher Dose
n=98 Participants
Main Study Phase: VLA15 with Alum higher dose - Booster Phase: VLA15 higher dose or placebo VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
Placebo
n=51 Participants
Main Study Phase: placebo - Booster Phase: arm discontinued Placebo: PBS (Phosphate Buffered Saline).
|
|---|---|---|---|
|
Percentage of Participants Adverse Event of Special Interest (AESIs) During the Main Study Phase
|
2.1 Percentage of Participants
Interval 0.6 to 7.2
|
0.0 Percentage of Participants
Interval 0.0 to 3.8
|
0.0 Percentage of Participants
Interval 0.0 to 7.0
|
SECONDARY outcome
Timeframe: From Day 1 of vaccination up to Day 545 (Month 18)Population: Safety population included all participants who entered into the study and received at least 1 dose of vaccination.
AESIs were defined as serious or non-serious AEs which were of scientific and medical concern specific to the investigational product. Relatedness to study vaccine was assessed by the investigator. Two-sided 95% confidence intervals were calculated according to Altman method.
Outcome measures
| Measure |
VLA15 With Alum Lower Dose
n=97 Participants
Main Study Phase: VLA15 with Alum lower dose - Booster Phase: arm discontinued VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
VLA15 With Alum Higher Dose
n=98 Participants
Main Study Phase: VLA15 with Alum higher dose - Booster Phase: VLA15 higher dose or placebo VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
Placebo
n=51 Participants
Main Study Phase: placebo - Booster Phase: arm discontinued Placebo: PBS (Phosphate Buffered Saline).
|
|---|---|---|---|
|
Percentage of Participants With Related AESIs During the Main Study Phase
|
1.0 Percentage of Participants
Interval 0.2 to 5.6
|
0.0 Percentage of Participants
Interval 0.0 to 3.8
|
0.0 Percentage of Participants
Interval 0.0 to 7.0
|
SECONDARY outcome
Timeframe: From Day 1 of vaccination up to Day 545 (Month 18)Population: Safety population included all participants who entered into the study and received at least 1 dose of vaccination.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation participant temporally associated with the use of investigational product, whether or not related to investigational product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up (more than 6 days after vaccination) for solicited symptoms. Two-sided 95% confidence intervals were calculated according to Altman method.
Outcome measures
| Measure |
VLA15 With Alum Lower Dose
n=97 Participants
Main Study Phase: VLA15 with Alum lower dose - Booster Phase: arm discontinued VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
VLA15 With Alum Higher Dose
n=98 Participants
Main Study Phase: VLA15 with Alum higher dose - Booster Phase: VLA15 higher dose or placebo VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
Placebo
n=51 Participants
Main Study Phase: placebo - Booster Phase: arm discontinued Placebo: PBS (Phosphate Buffered Saline).
|
|---|---|---|---|
|
Percentage of Participants With Unsolicited AEs During the Main Study Phase
|
66.0 Percentage of Participants
Interval 56.1 to 74.6
|
64.3 Percentage of Participants
Interval 54.4 to 73.1
|
68.6 Percentage of Participants
Interval 55.0 to 79.7
|
SECONDARY outcome
Timeframe: From Day 1 of vaccination up to Day 545 (Month 18)Population: Safety population included all participants who entered into the study and received at least 1 dose of vaccination.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation participant temporally associated with the use of investigational product, whether or not related to investigational product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up (more than 6 days after vaccination) for solicited symptoms. Relatedness to study vaccine was assessed by the investigator. Two-sided 95% confidence intervals were calculated according to Altman method.
Outcome measures
| Measure |
VLA15 With Alum Lower Dose
n=97 Participants
Main Study Phase: VLA15 with Alum lower dose - Booster Phase: arm discontinued VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
VLA15 With Alum Higher Dose
n=98 Participants
Main Study Phase: VLA15 with Alum higher dose - Booster Phase: VLA15 higher dose or placebo VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
Placebo
n=51 Participants
Main Study Phase: placebo - Booster Phase: arm discontinued Placebo: PBS (Phosphate Buffered Saline).
|
|---|---|---|---|
|
Percentage of Participants With Related Unsolicited AEs During the Main Study Phase
|
18.6 Percentage of Participants
Interval 12.1 to 27.4
|
22.4 Percentage of Participants
Interval 15.3 to 31.7
|
7.8 Percentage of Participants
Interval 3.1 to 18.5
|
SECONDARY outcome
Timeframe: Up to 7 days after Vaccination 1, 2 and 3; Up to 7 days after any vaccinationPopulation: Safety population included all participants who entered into the study and received at least 1 dose of vaccination.
Solicited local AEs included pain, tenderness, induration (hardening), swelling and erythema (redness). Solicited systemic AEs included headache, myalgia (muscle pain), arthralgia (joint pain), fever (oral body temperature), flu-like symptoms, nausea, vomiting and fatigue. Two-sided 95% confidence intervals were calculated according to Altman method.
Outcome measures
| Measure |
VLA15 With Alum Lower Dose
n=97 Participants
Main Study Phase: VLA15 with Alum lower dose - Booster Phase: arm discontinued VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
VLA15 With Alum Higher Dose
n=98 Participants
Main Study Phase: VLA15 with Alum higher dose - Booster Phase: VLA15 higher dose or placebo VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
Placebo
n=51 Participants
Main Study Phase: placebo - Booster Phase: arm discontinued Placebo: PBS (Phosphate Buffered Saline).
|
|---|---|---|---|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Each and After Any Vaccination During the Main Study Phase
Solicited local AE: 3rd vaccination
|
78.4 Percentage of Participants
Interval 69.2 to 85.4
|
82.7 Percentage of Participants
Interval 74.0 to 88.9
|
17.6 Percentage of Participants
Interval 9.6 to 30.3
|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Each and After Any Vaccination During the Main Study Phase
Any solicited systemic AE: Any vaccination
|
78.4 Percentage of Participants
Interval 69.2 to 85.4
|
69.4 Percentage of Participants
Interval 59.7 to 77.6
|
51.0 Percentage of Participants
Interval 37.7 to 64.1
|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Each and After Any Vaccination During the Main Study Phase
Any solicited local AE: Any vaccination
|
95.9 Percentage of Participants
Interval 89.9 to 98.4
|
98.0 Percentage of Participants
Interval 92.9 to 99.4
|
45.1 Percentage of Participants
Interval 32.3 to 58.6
|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Each and After Any Vaccination During the Main Study Phase
Solicited local AE: 1st vaccination
|
94.8 Percentage of Participants
Interval 88.5 to 97.8
|
93.9 Percentage of Participants
Interval 87.3 to 97.2
|
25.5 Percentage of Participants
Interval 15.5 to 38.9
|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Each and After Any Vaccination During the Main Study Phase
Solicited local AE: 2nd vaccination
|
80.4 Percentage of Participants
Interval 71.4 to 87.1
|
83.7 Percentage of Participants
Interval 75.1 to 89.7
|
23.5 Percentage of Participants
Interval 14.0 to 36.8
|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Each and After Any Vaccination During the Main Study Phase
Solicited systemic AE: 1st vaccination
|
61.9 Percentage of Participants
Interval 51.9 to 70.9
|
56.1 Percentage of Participants
Interval 46.3 to 65.5
|
35.3 Percentage of Participants
Interval 23.6 to 49.0
|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Each and After Any Vaccination During the Main Study Phase
Solicited systemic AE: 2nd vaccination
|
47.4 Percentage of Participants
Interval 37.8 to 57.3
|
40.8 Percentage of Participants
Interval 31.6 to 50.7
|
21.6 Percentage of Participants
Interval 12.5 to 34.6
|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Each and After Any Vaccination During the Main Study Phase
Solicited systemic AE: 3rd vaccination
|
36.1 Percentage of Participants
Interval 27.2 to 46.0
|
40.8 Percentage of Participants
Interval 31.6 to 50.7
|
17.6 Percentage of Participants
Interval 9.6 to 30.3
|
SECONDARY outcome
Timeframe: From Day 1 of vaccination up to Day 545 (Month 18)Population: Safety population included all participants who entered into the study and received at least 1 dose of vaccination. Here "Number Analyzed" signifies participants evaluable for this outcome measure at specified rows.
Percentage of participants with SAEs, AESIs, solicited and unsolicited AEs during main study phase stratified by age group 18-49 years and 50-65 years were reported. SAE: any untoward medical occurrence that at any dose resulted in any of the following outcomes or deemed significant for any other reason: death; required inpatient prolonged existing hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly/birth defect. AESI: any AEs of scientific/medical concern specific to study vaccine. Solicited AE: predefined reactions at injection site or systemic reactions after each vaccination. Unsolicited AE: any untoward medical occurrence in participant associated with use of study vaccine, whether or not related to study vaccine, reported in addition to solicited and any solicited symptom with onset outside specified period of follow-up. Two-sided 95% confidence intervals were calculated according to Altman method.
Outcome measures
| Measure |
VLA15 With Alum Lower Dose
n=97 Participants
Main Study Phase: VLA15 with Alum lower dose - Booster Phase: arm discontinued VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
VLA15 With Alum Higher Dose
n=98 Participants
Main Study Phase: VLA15 with Alum higher dose - Booster Phase: VLA15 higher dose or placebo VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
Placebo
n=51 Participants
Main Study Phase: placebo - Booster Phase: arm discontinued Placebo: PBS (Phosphate Buffered Saline).
|
|---|---|---|---|
|
Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Main Study Phase
SAE: 18-49 Years
|
3.1 Percentage of Participants
Interval 0.9 to 10.7
|
3.1 Percentage of Participants
Interval 0.9 to 10.7
|
0.0 Percentage of Participants
Interval 0.0 to 10.7
|
|
Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Main Study Phase
AESI: 18-49 Years
|
3.1 Percentage of Participants
Interval 0.9 to 10.7
|
0.0 Percentage of Participants
Interval 0.0 to 5.7
|
0.0 Percentage of Participants
Interval 0.0 to 10.7
|
|
Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Main Study Phase
AESI: 50-65 Years
|
0.0 Percentage of Participants
Interval 0.0 to 10.4
|
0.0 Percentage of Participants
Interval 0.0 to 10.2
|
0.0 Percentage of Participants
Interval 0.0 to 16.8
|
|
Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Main Study Phase
Solicited AE: 18-49 Years
|
95.3 Percentage of Participants
Interval 87.1 to 98.4
|
96.9 Percentage of Participants
Interval 89.3 to 99.1
|
59.4 Percentage of Participants
Interval 42.3 to 74.5
|
|
Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Main Study Phase
Solicited AE: 50-65 Years
|
100 Percentage of Participants
Interval 89.6 to 100.0
|
100 Percentage of Participants
Interval 89.8 to 100.0
|
73.7 Percentage of Participants
Interval 51.2 to 88.2
|
|
Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Main Study Phase
Unsolicited AE: 18-49 Years
|
64.1 Percentage of Participants
Interval 51.8 to 74.7
|
65.6 Percentage of Participants
Interval 53.4 to 76.1
|
59.4 Percentage of Participants
Interval 42.3 to 74.5
|
|
Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Main Study Phase
SAE: 50-65 Years
|
6.1 Percentage of Participants
Interval 1.7 to 19.6
|
5.9 Percentage of Participants
Interval 1.6 to 19.1
|
10.5 Percentage of Participants
Interval 2.9 to 31.4
|
|
Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Main Study Phase
Unsolicited AE: 50-65 Years
|
69.7 Percentage of Participants
Interval 52.7 to 82.6
|
61.8 Percentage of Participants
Interval 45.0 to 76.1
|
84.2 Percentage of Participants
Interval 62.4 to 94.5
|
SECONDARY outcome
Timeframe: At Day 1 (Month 0), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30Population: Booster per-protocol (PP) population, excluded those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity) and who were enrolled into the booster phase despite exclusion from the PP population of main study phase. Here, "Number Analyzed" signifies participants evaluable for this outcome measure at specified time points.
GMTs for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 1 (Month 0), 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12), 545 (Month 18), Month 19, Month 24, and Month 30. The outcome measure was planned to be analyzed for Booster PP population from Day 1 to Day 545 of main study phase and from day of vaccination in Month 18 up to Month 30 of booster phase.
Outcome measures
| Measure |
VLA15 With Alum Lower Dose
n=37 Participants
Main Study Phase: VLA15 with Alum lower dose - Booster Phase: arm discontinued VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
VLA15 With Alum Higher Dose
n=18 Participants
Main Study Phase: VLA15 with Alum higher dose - Booster Phase: VLA15 higher dose or placebo VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
Placebo
Main Study Phase: placebo - Booster Phase: arm discontinued Placebo: PBS (Phosphate Buffered Saline).
|
|---|---|---|---|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST2 Month 24
|
258.6 Units per milliliter (U/mL)
Interval 197.4 to 338.8
|
26.0 Units per milliliter (U/mL)
Interval 19.9 to 34.1
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST5 Day 57
|
23.3 Units per milliliter (U/mL)
Interval 19.7 to 27.5
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST4 Day 365
|
47.5 Units per milliliter (U/mL)
Interval 35.8 to 62.9
|
46.5 Units per milliliter (U/mL)
Interval 26.7 to 80.9
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST1 Day 1
|
20.5 Units per milliliter (U/mL)
Interval 19.5 to 21.4
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST1 Day 29
|
20.9 Units per milliliter (U/mL)
Interval 19.6 to 22.3
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST1 Day 57
|
22.6 Units per milliliter (U/mL)
Interval 19.8 to 25.8
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST1 Day 85
|
78.9 Units per milliliter (U/mL)
Interval 53.2 to 117.1
|
67.2 Units per milliliter (U/mL)
Interval 41.2 to 109.6
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST1 Day 180
|
27.6 Units per milliliter (U/mL)
Interval 23.4 to 32.5
|
24.2 Units per milliliter (U/mL)
Interval 19.4 to 30.3
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST1 Day 208
|
292.0 Units per milliliter (U/mL)
Interval 198.1 to 430.3
|
349.5 Units per milliliter (U/mL)
Interval 184.4 to 662.4
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST1 Day 365
|
39.7 Units per milliliter (U/mL)
Interval 30.0 to 52.4
|
37.3 Units per milliliter (U/mL)
Interval 20.9 to 66.4
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST1 Day 545
|
24.9 Units per milliliter (U/mL)
Interval 21.2 to 29.2
|
24.0 Units per milliliter (U/mL)
Interval 17.9 to 32.3
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST1 Month 19
|
1277.0 Units per milliliter (U/mL)
Interval 861.8 to 1892.3
|
23.6 Units per milliliter (U/mL)
Interval 18.1 to 30.8
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST1 Month 24
|
137.4 Units per milliliter (U/mL)
Interval 95.8 to 196.9
|
22.3 Units per milliliter (U/mL)
Interval 17.7 to 28.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST1 Month 30
|
54.1 Units per milliliter (U/mL)
Interval 38.6 to 75.7
|
22.1 Units per milliliter (U/mL)
Interval 17.9 to 27.4
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST2 Day 1
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST2 Day 29
|
23.4 Units per milliliter (U/mL)
Interval 20.0 to 27.2
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST2 Day 57
|
23.2 Units per milliliter (U/mL)
Interval 19.3 to 27.8
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST2 Day 85
|
219.3 Units per milliliter (U/mL)
Interval 156.5 to 307.4
|
187.4 Units per milliliter (U/mL)
Interval 109.2 to 321.8
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST2 Day 180
|
41.0 Units per milliliter (U/mL)
Interval 31.1 to 54.1
|
33.5 Units per milliliter (U/mL)
Interval 22.9 to 48.8
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST2 Day 208
|
606.3 Units per milliliter (U/mL)
Interval 419.0 to 877.3
|
694.7 Units per milliliter (U/mL)
Interval 427.9 to 1127.9
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST2 Day 365
|
76.1 Units per milliliter (U/mL)
Interval 55.0 to 105.5
|
75.5 Units per milliliter (U/mL)
Interval 44.0 to 129.6
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST2 Day 545
|
31.8 Units per milliliter (U/mL)
Interval 25.2 to 40.1
|
35.9 Units per milliliter (U/mL)
Interval 25.2 to 51.2
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST2 Month 19
|
2194.5 Units per milliliter (U/mL)
Interval 1566.8 to 3073.7
|
36.8 Units per milliliter (U/mL)
Interval 26.4 to 51.3
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST2 Month 30
|
89.5 Units per milliliter (U/mL)
Interval 63.4 to 126.2
|
21.9 Units per milliliter (U/mL)
Interval 18.0 to 26.6
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST3 Day 1
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST3 Day 29
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST3 Day 57
|
21.8 Units per milliliter (U/mL)
Interval 18.3 to 25.9
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST3 Day 85
|
235.1 Units per milliliter (U/mL)
Interval 155.9 to 354.3
|
237.6 Units per milliliter (U/mL)
Interval 152.4 to 370.4
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST3 Day 180
|
47.6 Units per milliliter (U/mL)
Interval 36.7 to 61.7
|
43.9 Units per milliliter (U/mL)
Interval 28.0 to 68.8
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST3 Day 208
|
631.9 Units per milliliter (U/mL)
Interval 431.2 to 925.9
|
666.3 Units per milliliter (U/mL)
Interval 393.9 to 1127.3
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST3 Day 365
|
78.7 Units per milliliter (U/mL)
Interval 57.2 to 108.3
|
81.1 Units per milliliter (U/mL)
Interval 44.0 to 149.7
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST3 Day 545
|
31.1 Units per milliliter (U/mL)
Interval 24.8 to 38.8
|
39.5 Units per milliliter (U/mL)
Interval 25.9 to 60.4
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST3 Month 19
|
1916.2 Units per milliliter (U/mL)
Interval 1320.7 to 2780.2
|
35.8 Units per milliliter (U/mL)
Interval 24.9 to 51.7
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST3 Month 24
|
265.8 Units per milliliter (U/mL)
Interval 202.9 to 348.2
|
29.1 Units per milliliter (U/mL)
Interval 20.8 to 40.6
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST3 Month 30
|
101.6 Units per milliliter (U/mL)
Interval 77.6 to 133.1
|
24.9 Units per milliliter (U/mL)
Interval 19.0 to 32.6
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST4 Day 1
|
20.8 Units per milliliter (U/mL)
Interval 19.2 to 22.4
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST4 Day 29
|
21.2 Units per milliliter (U/mL)
Interval 19.5 to 23.1
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST4 Day 57
|
22.2 Units per milliliter (U/mL)
Interval 19.6 to 25.1
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST4 Day 85
|
108.9 Units per milliliter (U/mL)
Interval 75.9 to 156.3
|
100.7 Units per milliliter (U/mL)
Interval 65.1 to 155.6
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST4 Day 180
|
30.1 Units per milliliter (U/mL)
Interval 24.7 to 36.6
|
28.4 Units per milliliter (U/mL)
Interval 21.2 to 38.2
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST4 Day 208
|
376.6 Units per milliliter (U/mL)
Interval 261.1 to 543.3
|
455.3 Units per milliliter (U/mL)
Interval 268.2 to 773.1
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST4 Day 545
|
28.8 Units per milliliter (U/mL)
Interval 23.8 to 34.8
|
31.3 Units per milliliter (U/mL)
Interval 22.5 to 43.7
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST4 Month 19
|
1661.1 Units per milliliter (U/mL)
Interval 1156.4 to 2386.0
|
26.5 Units per milliliter (U/mL)
Interval 19.9 to 35.4
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST4 Month 24
|
200.7 Units per milliliter (U/mL)
Interval 150.9 to 266.8
|
24.6 Units per milliliter (U/mL)
Interval 18.9 to 32.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST4 Month 30
|
72.3 Units per milliliter (U/mL)
Interval 52.2 to 100.1
|
22.1 Units per milliliter (U/mL)
Interval 17.9 to 27.3
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST5 Day 1
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST5 Day 29
|
22.1 Units per milliliter (U/mL)
Interval 19.5 to 25.0
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST5 Day 85
|
100.9 Units per milliliter (U/mL)
Interval 70.6 to 144.1
|
127.4 Units per milliliter (U/mL)
Interval 85.5 to 189.8
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST5 Day 180
|
26.5 Units per milliliter (U/mL)
Interval 22.3 to 31.6
|
32.3 Units per milliliter (U/mL)
Interval 23.4 to 44.7
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST5 Day 208
|
370.6 Units per milliliter (U/mL)
Interval 257.3 to 533.8
|
528.4 Units per milliliter (U/mL)
Interval 330.8 to 844.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST5 Day 365
|
43.9 Units per milliliter (U/mL)
Interval 32.5 to 59.3
|
59.4 Units per milliliter (U/mL)
Interval 35.9 to 98.4
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST5 Day 545
|
25.0 Units per milliliter (U/mL)
Interval 21.1 to 29.7
|
31.1 Units per milliliter (U/mL)
Interval 22.0 to 44.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST5 Month 19
|
1507.9 Units per milliliter (U/mL)
Interval 1066.0 to 2133.0
|
25.5 Units per milliliter (U/mL)
Interval 19.2 to 33.8
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST5 Month 24
|
170.2 Units per milliliter (U/mL)
Interval 127.2 to 227.7
|
23.7 Units per milliliter (U/mL)
Interval 18.5 to 30.3
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST5 Month 30
|
74.0 Units per milliliter (U/mL)
Interval 54.9 to 99.7
|
23.6 Units per milliliter (U/mL)
Interval 18.6 to 29.9
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST6 Day 1
|
20.9 Units per milliliter (U/mL)
Interval 19.2 to 22.7
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST6 Day 29
|
22.0 Units per milliliter (U/mL)
Interval 19.6 to 24.7
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST6 Day 57
|
24.8 Units per milliliter (U/mL)
Interval 20.7 to 29.9
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST6 Day 85
|
82.0 Units per milliliter (U/mL)
Interval 57.3 to 117.3
|
116.5 Units per milliliter (U/mL)
Interval 74.3 to 182.5
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST6 Day 180
|
29.2 Units per milliliter (U/mL)
Interval 23.8 to 35.7
|
36.4 Units per milliliter (U/mL)
Interval 25.4 to 52.2
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST6 Day 208
|
351.9 Units per milliliter (U/mL)
Interval 246.7 to 502.0
|
509.0 Units per milliliter (U/mL)
Interval 308.6 to 839.4
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST6 Day 365
|
46.8 Units per milliliter (U/mL)
Interval 33.7 to 65.0
|
67.3 Units per milliliter (U/mL)
Interval 41.6 to 108.7
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST6 Day 545
|
26.3 Units per milliliter (U/mL)
Interval 21.6 to 32.0
|
29.1 Units per milliliter (U/mL)
Interval 21.0 to 40.4
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST6 Month 19
|
1406.8 Units per milliliter (U/mL)
Interval 996.2 to 1986.7
|
28.7 Units per milliliter (U/mL)
Interval 21.1 to 39.2
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST6 Month 24
|
181.5 Units per milliliter (U/mL)
Interval 138.9 to 237.1
|
25.8 Units per milliliter (U/mL)
Interval 19.9 to 33.5
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6): Booster Per-protocol (PP) Population
ST6 Month 30
|
76.0 Units per milliliter (U/mL)
Interval 55.7 to 103.8
|
23.8 Units per milliliter (U/mL)
Interval 18.4 to 30.6
|
—
|
SECONDARY outcome
Timeframe: Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30Population: Booster PP population, excluded those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity) and who were enrolled into the booster phase despite exclusion from the PP population of main study phase. Here, "Number Analyzed" signifies participants evaluable for this outcome measure at specified time points.
SCR for each OspA serotype specific IgG ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12), 545 (Month 18), Month 19, Month 24, and Month 30. Seroconversion for ELISA was defined as 1) for participants that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive at a certain time point or 2) for participants that are seropositive at Visit 1 (baseline): greater than or equal to (\>=) 4-fold rise in IgG antibody titer from Visit 1. SCR was reported as percentage of participants. Percentages are based on the number of participants with non-missing observations. The outcome measure was planned to be analyzed for Booster PP population from Day 29 to Day 545 of main study phase and from day of vaccination in Month 18 up to Month 30 of booster phase.
Outcome measures
| Measure |
VLA15 With Alum Lower Dose
n=37 Participants
Main Study Phase: VLA15 with Alum lower dose - Booster Phase: arm discontinued VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
VLA15 With Alum Higher Dose
n=18 Participants
Main Study Phase: VLA15 with Alum higher dose - Booster Phase: VLA15 higher dose or placebo VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
Placebo
Main Study Phase: placebo - Booster Phase: arm discontinued Placebo: PBS (Phosphate Buffered Saline).
|
|---|---|---|---|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST2 Day 57
|
8.1 Percentage of Participants
Interval 2.8 to 21.3
|
0.0 Percentage of Participants
Interval 0.0 to 17.6
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST2 Day 85
|
97.3 Percentage of Participants
Interval 86.2 to 99.5
|
88.2 Percentage of Participants
Interval 65.7 to 96.7
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST2 Day 180
|
48.6 Percentage of Participants
Interval 33.4 to 64.1
|
33.3 Percentage of Participants
Interval 16.3 to 56.3
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST2 Day 208
|
97.1 Percentage of Participants
Interval 85.5 to 99.5
|
100 Percentage of Participants
Interval 81.6 to 100.0
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST2 Day 365
|
75.7 Percentage of Participants
Interval 59.9 to 86.6
|
70.6 Percentage of Participants
Interval 46.9 to 86.7
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST2 Day 545
|
35.1 Percentage of Participants
Interval 21.8 to 51.2
|
44.4 Percentage of Participants
Interval 24.6 to 66.3
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST2 Month 19
|
100 Percentage of Participants
Interval 90.6 to 100.0
|
50.0 Percentage of Participants
Interval 29.0 to 71.0
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST2 Month 24
|
100 Percentage of Participants
Interval 90.6 to 100.0
|
23.5 Percentage of Participants
Interval 9.6 to 47.3
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST2 Month 30
|
73.0 Percentage of Participants
Interval 57.0 to 84.6
|
5.9 Percentage of Participants
Interval 1.0 to 27.0
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST3 Day 29
|
0.0 Percentage of Participants
Interval 0.0 to 9.4
|
0.0 Percentage of Participants
Interval 0.0 to 17.6
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST3 Day 57
|
2.7 Percentage of Participants
Interval 0.5 to 13.8
|
0.0 Percentage of Participants
Interval 0.0 to 17.6
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST3 Day 85
|
89.2 Percentage of Participants
Interval 75.3 to 95.7
|
100 Percentage of Participants
Interval 81.6 to 100.0
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST3 Day 180
|
59.5 Percentage of Participants
Interval 43.5 to 73.7
|
50.0 Percentage of Participants
Interval 29.0 to 71.0
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST3 Day 208
|
97.1 Percentage of Participants
Interval 85.5 to 99.5
|
100 Percentage of Participants
Interval 81.6 to 100.0
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST3 Day 365
|
73.0 Percentage of Participants
Interval 57.0 to 84.6
|
70.6 Percentage of Participants
Interval 46.9 to 86.7
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST3 Day 545
|
32.4 Percentage of Participants
Interval 19.6 to 48.5
|
44.4 Percentage of Participants
Interval 24.6 to 66.3
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST3 Month 19
|
100 Percentage of Participants
Interval 90.6 to 100.0
|
44.4 Percentage of Participants
Interval 24.6 to 66.3
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST3 Month 24
|
100 Percentage of Participants
Interval 90.6 to 100.0
|
29.4 Percentage of Participants
Interval 13.3 to 53.1
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST3 Month 30
|
89.2 Percentage of Participants
Interval 75.3 to 95.7
|
17.6 Percentage of Participants
Interval 6.2 to 41.0
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST4 Day 29
|
2.7 Percentage of Participants
Interval 0.5 to 13.8
|
0.0 Percentage of Participants
Interval 0.0 to 17.6
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST4 Day 57
|
5.4 Percentage of Participants
Interval 1.5 to 17.7
|
0.0 Percentage of Participants
Interval 0.0 to 17.6
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST4 Day 85
|
81.1 Percentage of Participants
Interval 65.8 to 90.5
|
88.2 Percentage of Participants
Interval 65.7 to 96.7
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST4 Day 180
|
32.4 Percentage of Participants
Interval 19.6 to 48.5
|
27.8 Percentage of Participants
Interval 12.5 to 50.9
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST4 Day 208
|
97.1 Percentage of Participants
Interval 85.5 to 99.5
|
100 Percentage of Participants
Interval 81.6 to 100.0
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST4 Day 365
|
56.8 Percentage of Participants
Interval 40.9 to 71.3
|
52.9 Percentage of Participants
Interval 31.0 to 73.8
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST4 Day 545
|
29.7 Percentage of Participants
Interval 17.5 to 45.8
|
38.9 Percentage of Participants
Interval 20.3 to 61.4
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST4 Month 19
|
100 Percentage of Participants
Interval 90.6 to 100.0
|
22.2 Percentage of Participants
Interval 9.0 to 45.2
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST4 Month 24
|
100 Percentage of Participants
Interval 90.6 to 100.0
|
17.6 Percentage of Participants
Interval 6.2 to 41.0
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST4 Month 30
|
73.0 Percentage of Participants
Interval 57.0 to 84.6
|
5.9 Percentage of Participants
Interval 1.0 to 27.0
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST5 Day 29
|
8.1 Percentage of Participants
Interval 2.8 to 21.3
|
0.0 Percentage of Participants
Interval 0.0 to 17.6
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST5 Day 57
|
10.8 Percentage of Participants
Interval 4.3 to 24.7
|
0.0 Percentage of Participants
Interval 0.0 to 17.6
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST5 Day 85
|
78.4 Percentage of Participants
Interval 62.8 to 88.6
|
94.1 Percentage of Participants
Interval 73.0 to 99.0
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST5 Day 180
|
24.3 Percentage of Participants
Interval 13.4 to 40.1
|
38.9 Percentage of Participants
Interval 20.3 to 61.4
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST5 Day 208
|
97.1 Percentage of Participants
Interval 85.5 to 99.5
|
100 Percentage of Participants
Interval 81.6 to 100.0
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST5 Day 365
|
48.6 Percentage of Participants
Interval 33.4 to 64.1
|
70.6 Percentage of Participants
Interval 46.9 to 86.7
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST5 Day 545
|
18.9 Percentage of Participants
Interval 9.5 to 34.2
|
33.3 Percentage of Participants
Interval 16.3 to 56.3
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST5 Month 19
|
100 Percentage of Participants
Interval 90.6 to 100.0
|
16.7 Percentage of Participants
Interval 5.8 to 39.2
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST5 Month 24
|
97.3 Percentage of Participants
Interval 86.2 to 99.5
|
11.8 Percentage of Participants
Interval 3.3 to 34.3
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST5 Month 30
|
81.1 Percentage of Participants
Interval 65.8 to 90.5
|
11.8 Percentage of Participants
Interval 3.3 to 34.3
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST6 Day 29
|
5.4 Percentage of Participants
Interval 1.5 to 17.7
|
0.0 Percentage of Participants
Interval 0.0 to 17.6
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST6 Day 57
|
13.5 Percentage of Participants
Interval 5.9 to 28.0
|
0.0 Percentage of Participants
Interval 0.0 to 17.6
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST6 Day 85
|
70.3 Percentage of Participants
Interval 54.2 to 82.5
|
88.2 Percentage of Participants
Interval 65.7 to 96.7
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST6 Day 180
|
27.0 Percentage of Participants
Interval 15.4 to 43.0
|
44.4 Percentage of Participants
Interval 24.6 to 66.3
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST6 Day 208
|
97.1 Percentage of Participants
Interval 85.5 to 99.5
|
100 Percentage of Participants
Interval 81.6 to 100.0
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST6 Day 365
|
45.9 Percentage of Participants
Interval 31.0 to 61.6
|
76.5 Percentage of Participants
Interval 52.7 to 90.4
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST6 Day 545
|
16.2 Percentage of Participants
Interval 7.7 to 31.1
|
27.8 Percentage of Participants
Interval 12.5 to 50.9
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST6 Month 19
|
100 Percentage of Participants
Interval 90.6 to 100.0
|
27.8 Percentage of Participants
Interval 12.5 to 50.9
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST6 Month 24
|
97.3 Percentage of Participants
Interval 86.2 to 99.5
|
23.5 Percentage of Participants
Interval 9.6 to 47.3
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST6 Month 30
|
73.0 Percentage of Participants
Interval 57.0 to 84.6
|
11.8 Percentage of Participants
Interval 3.3 to 34.3
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST1 Month 30
|
56.8 Percentage of Participants
Interval 40.9 to 71.3
|
5.9 Percentage of Participants
Interval 1.0 to 27.0
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST1 Day 29
|
2.7 Percentage of Participants
Interval 0.5 to 13.8
|
0.0 Percentage of Participants
Interval 0.0 to 17.6
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST1 Day 57
|
8.1 Percentage of Participants
Interval 2.8 to 21.3
|
0.0 Percentage of Participants
Interval 0.0 to 17.6
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST1 Day 85
|
64.9 Percentage of Participants
Interval 48.8 to 78.2
|
70.6 Percentage of Participants
Interval 46.9 to 86.7
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST1 Day 180
|
29.7 Percentage of Participants
Interval 17.5 to 45.8
|
16.7 Percentage of Participants
Interval 5.8 to 39.2
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST1 Day 208
|
97.1 Percentage of Participants
Interval 85.5 to 99.5
|
100 Percentage of Participants
Interval 81.6 to 100.0
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST1 Day 365
|
43.2 Percentage of Participants
Interval 28.7 to 59.1
|
29.4 Percentage of Participants
Interval 13.3 to 53.1
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST1 Day 545
|
16.2 Percentage of Participants
Interval 7.7 to 31.1
|
11.1 Percentage of Participants
Interval 3.1 to 32.8
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST1 Month 19
|
100 Percentage of Participants
Interval 90.6 to 100.0
|
11.1 Percentage of Participants
Interval 3.1 to 32.8
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST1 Month 24
|
89.2 Percentage of Participants
Interval 75.3 to 95.7
|
5.9 Percentage of Participants
Interval 1.0 to 27.0
|
—
|
|
SCRs for Each OspA Serotype Specific IgG (ST1 to ST6): Booster PP Population
ST2 Day 29
|
10.8 Percentage of Participants
Interval 4.3 to 24.7
|
0.0 Percentage of Participants
Interval 0.0 to 17.6
|
—
|
SECONDARY outcome
Timeframe: Day 1 (baseline from where comparison was done), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30Population: Booster PP population, excluded those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity) and who were enrolled into the booster phase despite exclusion from the PP population of main study phase. Here, "Number Analyzed" signifies participants evaluable for this outcome measure at specified time points.
GMFR as compared to baseline for IgG against each Osp serotype ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12), 545 (Month 18), Month 19, Month 24 and Month 30 were reported in this outcome measure. The outcome measure was planned to be analyzed for Booster PP population from Day 1 to Day 545 of main study phase and from day of vaccination in Month 18 up to Month 30 of booster phase.
Outcome measures
| Measure |
VLA15 With Alum Lower Dose
n=37 Participants
Main Study Phase: VLA15 with Alum lower dose - Booster Phase: arm discontinued VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
VLA15 With Alum Higher Dose
n=18 Participants
Main Study Phase: VLA15 with Alum higher dose - Booster Phase: VLA15 higher dose or placebo VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
Placebo
Main Study Phase: placebo - Booster Phase: arm discontinued Placebo: PBS (Phosphate Buffered Saline).
|
|---|---|---|---|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST6 Day 57
|
1.2 Fold Rise
Interval 1.0 to 1.4
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST6 Day 85
|
3.9 Fold Rise
Interval 2.8 to 5.6
|
5.8 Fold Rise
Interval 3.7 to 9.1
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST6 Day 180
|
1.4 Fold Rise
Interval 1.2 to 1.7
|
1.8 Fold Rise
Interval 1.3 to 2.6
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST6 Day 208
|
16.8 Fold Rise
Interval 11.8 to 24.0
|
25.4 Fold Rise
Interval 15.4 to 42.0
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST6 Day 365
|
2.2 Fold Rise
Interval 1.6 to 3.1
|
3.4 Fold Rise
Interval 2.1 to 5.4
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST1 Day 29
|
1.0 Fold Rise
Interval 1.0 to 1.1
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST1 Day 57
|
1.1 Fold Rise
Interval 1.0 to 1.3
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST1 Day 85
|
3.9 Fold Rise
Interval 2.6 to 5.7
|
3.4 Fold Rise
Interval 2.1 to 5.5
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST1 Day 180
|
1.3 Fold Rise
Interval 1.2 to 1.6
|
1.2 Fold Rise
Interval 1.0 to 1.5
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST1 Day 208
|
14.2 Fold Rise
Interval 9.7 to 21.0
|
17.5 Fold Rise
Interval 9.2 to 33.1
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST1 Day 365
|
1.9 Fold Rise
Interval 1.5 to 2.6
|
1.9 Fold Rise
Interval 1.0 to 3.3
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST1 Day 545
|
1.2 Fold Rise
Interval 1.0 to 1.4
|
1.2 Fold Rise
Interval 0.9 to 1.6
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST1 Month 19
|
62.4 Fold Rise
Interval 42.6 to 91.4
|
1.2 Fold Rise
Interval 0.9 to 1.5
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST1 Month 24
|
6.7 Fold Rise
Interval 4.7 to 9.6
|
1.1 Fold Rise
Interval 0.9 to 1.4
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST1 Month 30
|
2.6 Fold Rise
Interval 1.9 to 3.7
|
1.1 Fold Rise
Interval 0.9 to 1.4
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST2 Day 29
|
1.2 Fold Rise
Interval 1.0 to 1.4
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST2 Day 57
|
1.2 Fold Rise
Interval 1.0 to 1.4
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST2 Day 85
|
11.0 Fold Rise
Interval 7.8 to 15.4
|
9.4 Fold Rise
Interval 5.5 to 16.1
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST2 Day 180
|
2.1 Fold Rise
Interval 1.6 to 2.7
|
1.7 Fold Rise
Interval 1.1 to 2.4
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST2 Day 208
|
30.3 Fold Rise
Interval 21.0 to 43.9
|
34.7 Fold Rise
Interval 21.4 to 56.4
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST2 Day 365
|
3.8 Fold Rise
Interval 2.7 to 5.3
|
3.8 Fold Rise
Interval 2.2 to 6.5
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST2 Day 545
|
1.6 Fold Rise
Interval 1.3 to 2.0
|
1.8 Fold Rise
Interval 1.3 to 2.6
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST2 Month 19
|
109.7 Fold Rise
Interval 78.3 to 153.7
|
1.8 Fold Rise
Interval 1.3 to 2.6
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST2 Month 24
|
12.9 Fold Rise
Interval 9.9 to 16.9
|
1.3 Fold Rise
Interval 1.0 to 1.7
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST2 Month 30
|
4.5 Fold Rise
Interval 3.2 to 6.3
|
1.1 Fold Rise
Interval 0.9 to 1.3
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST3 Day 29
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST3 Day 57
|
1.1 Fold Rise
Interval 0.9 to 1.3
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST3 Day 85
|
11.8 Fold Rise
Interval 7.8 to 17.7
|
11.9 Fold Rise
Interval 7.6 to 18.5
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST3 Day 180
|
2.4 Fold Rise
Interval 1.8 to 3.1
|
2.2 Fold Rise
Interval 1.4 to 3.4
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST3 Day 208
|
31.6 Fold Rise
Interval 21.6 to 46.3
|
33.3 Fold Rise
Interval 19.7 to 56.4
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST3 Day 365
|
3.9 Fold Rise
Interval 2.9 to 5.4
|
4.1 Fold Rise
Interval 2.2 to 7.5
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST3 Day 545
|
1.6 Fold Rise
Interval 1.2 to 1.9
|
2.0 Fold Rise
Interval 1.3 to 3.0
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST3 Month 19
|
95.8 Fold Rise
Interval 66.0 to 139.0
|
1.8 Fold Rise
Interval 1.2 to 2.6
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST3 Month 24
|
13.3 Fold Rise
Interval 10.1 to 17.4
|
1.5 Fold Rise
Interval 1.0 to 2.0
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST3 Month 30
|
5.1 Fold Rise
Interval 3.9 to 6.7
|
1.2 Fold Rise
Interval 0.9 to 1.6
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST4 Day 29
|
1.0 Fold Rise
Interval 1.0 to 1.1
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST4 Day 57
|
1.1 Fold Rise
Interval 1.0 to 1.2
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST4 Day 85
|
5.2 Fold Rise
Interval 3.7 to 7.4
|
5.0 Fold Rise
Interval 3.3 to 7.8
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST4 Day 180
|
1.4 Fold Rise
Interval 1.2 to 1.7
|
1.4 Fold Rise
Interval 1.1 to 1.9
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST4 Day 208
|
18.1 Fold Rise
Interval 12.6 to 25.9
|
22.8 Fold Rise
Interval 13.4 to 38.7
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST6 Day 29
|
1.1 Fold Rise
Interval 1.0 to 1.1
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST4 Day 365
|
2.3 Fold Rise
Interval 1.7 to 3.0
|
2.3 Fold Rise
Interval 1.3 to 4.0
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST4 Day 545
|
1.4 Fold Rise
Interval 1.2 to 1.6
|
1.6 Fold Rise
Interval 1.1 to 2.2
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST4 Month 19
|
79.9 Fold Rise
Interval 56.5 to 113.1
|
1.3 Fold Rise
Interval 1.0 to 1.8
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST4 Month 24
|
9.7 Fold Rise
Interval 7.3 to 12.8
|
1.2 Fold Rise
Interval 0.9 to 1.6
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST4 Month 30
|
3.5 Fold Rise
Interval 2.5 to 4.8
|
1.1 Fold Rise
Interval 0.9 to 1.4
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST5 Day 29
|
1.1 Fold Rise
Interval 1.0 to 1.2
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST5 Day 57
|
1.2 Fold Rise
Interval 1.0 to 1.4
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST5 Day 85
|
5.0 Fold Rise
Interval 3.5 to 7.2
|
6.4 Fold Rise
Interval 4.3 to 9.5
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST5 Day 180
|
1.3 Fold Rise
Interval 1.1 to 1.6
|
1.6 Fold Rise
Interval 1.2 to 2.2
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST5 Day 208
|
18.5 Fold Rise
Interval 12.9 to 26.7
|
26.4 Fold Rise
Interval 16.5 to 42.2
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST5 Day 365
|
2.2 Fold Rise
Interval 1.6 to 3.0
|
3.0 Fold Rise
Interval 1.8 to 4.9
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST5 Day 545
|
1.3 Fold Rise
Interval 1.1 to 1.5
|
1.6 Fold Rise
Interval 1.1 to 2.2
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST5 Month 19
|
75.4 Fold Rise
Interval 53.3 to 106.7
|
1.3 Fold Rise
Interval 1.0 to 1.7
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST5 Month 24
|
8.5 Fold Rise
Interval 6.4 to 11.4
|
1.2 Fold Rise
Interval 0.9 to 1.5
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST5 Month 30
|
3.7 Fold Rise
Interval 2.7 to 5.0
|
1.2 Fold Rise
Interval 0.9 to 1.5
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST6 Day 545
|
1.3 Fold Rise
Interval 1.1 to 1.5
|
1.5 Fold Rise
Interval 1.1 to 2.0
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST6 Month 19
|
67.5 Fold Rise
Interval 48.4 to 94.0
|
1.4 Fold Rise
Interval 1.1 to 2.0
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST6 Month 24
|
8.7 Fold Rise
Interval 6.7 to 11.4
|
1.3 Fold Rise
Interval 1.0 to 1.7
|
—
|
|
GMFR as Compared to Baseline for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST6 Month 30
|
3.6 Fold Rise
Interval 2.7 to 4.9
|
1.2 Fold Rise
Interval 0.9 to 1.5
|
—
|
SECONDARY outcome
Timeframe: Day 208 (from where comparison was done), Month 19, Month 24 and Month 30Population: Booster PP population, excluded those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity) and who were enrolled into the booster phase despite exclusion from the PP population of main study phase. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for this outcome measure at specified time points.
GMFR as compared to Day 208 for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Month 19, Month 24 and Month 30. The outcome measure was planned to be analyzed for Booster PP population from Day 208 of main study phase and from day of vaccination in Month 18 up to Month 30 of booster phase.
Outcome measures
| Measure |
VLA15 With Alum Lower Dose
n=35 Participants
Main Study Phase: VLA15 with Alum lower dose - Booster Phase: arm discontinued VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
VLA15 With Alum Higher Dose
n=17 Participants
Main Study Phase: VLA15 with Alum higher dose - Booster Phase: VLA15 higher dose or placebo VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
Placebo
Main Study Phase: placebo - Booster Phase: arm discontinued Placebo: PBS (Phosphate Buffered Saline).
|
|---|---|---|---|
|
GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST1 Month 19
|
4.2 Fold Rise
Interval 3.4 to 5.2
|
0.1 Fold Rise
Interval 0.0 to 0.1
|
—
|
|
GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST1 Month 24
|
0.5 Fold Rise
Interval 0.4 to 0.6
|
0.1 Fold Rise
Interval 0.0 to 0.1
|
—
|
|
GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST1 Month 30
|
0.2 Fold Rise
Interval 0.1 to 0.2
|
0.1 Fold Rise
Interval 0.0 to 0.1
|
—
|
|
GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST2 Month 19
|
3.5 Fold Rise
Interval 2.9 to 4.3
|
0.1 Fold Rise
Interval 0.0 to 0.1
|
—
|
|
GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST2 Month 24
|
0.4 Fold Rise
Interval 0.3 to 0.5
|
0.0 Fold Rise
Interval 0.0 to 0.1
|
—
|
|
GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST2 Month 30
|
0.1 Fold Rise
Interval 0.1 to 0.2
|
0.0 Fold Rise
Interval 0.0 to 0.0
|
—
|
|
GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST3 Month 19
|
2.9 Fold Rise
Interval 2.3 to 3.5
|
0.1 Fold Rise
Interval 0.0 to 0.1
|
—
|
|
GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST3 Month 24
|
0.4 Fold Rise
Interval 0.3 to 0.5
|
0.0 Fold Rise
Interval 0.0 to 0.1
|
—
|
|
GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST3 Month 30
|
0.2 Fold Rise
Interval 0.1 to 0.2
|
0.0 Fold Rise
Interval 0.0 to 0.1
|
—
|
|
GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST4 Month 19
|
4.2 Fold Rise
Interval 3.5 to 5.1
|
0.1 Fold Rise
Interval 0.0 to 0.1
|
—
|
|
GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST4 Month 24
|
0.5 Fold Rise
Interval 0.4 to 0.7
|
0.1 Fold Rise
Interval 0.0 to 0.1
|
—
|
|
GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST4 Month 30
|
0.2 Fold Rise
Interval 0.1 to 0.3
|
0.0 Fold Rise
Interval 0.0 to 0.1
|
—
|
|
GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST5 Month 19
|
4.0 Fold Rise
Interval 3.3 to 4.8
|
0.0 Fold Rise
Interval 0.0 to 0.1
|
—
|
|
GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST5 Month 24
|
0.5 Fold Rise
Interval 0.4 to 0.6
|
0.0 Fold Rise
Interval 0.0 to 0.1
|
—
|
|
GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST5 Month 30
|
0.2 Fold Rise
Interval 0.1 to 0.3
|
0.0 Fold Rise
Interval 0.0 to 0.1
|
—
|
|
GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST6 Month 19
|
3.9 Fold Rise
Interval 3.2 to 4.7
|
0.1 Fold Rise
Interval 0.0 to 0.1
|
—
|
|
GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST6 Month 24
|
0.5 Fold Rise
Interval 0.4 to 0.7
|
0.1 Fold Rise
Interval 0.0 to 0.1
|
—
|
|
GMFR as Compared to Day 208 for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST6 Month 30
|
0.2 Fold Rise
Interval 0.2 to 0.3
|
0.0 Fold Rise
Interval 0.0 to 0.1
|
—
|
SECONDARY outcome
Timeframe: Month 18 (from where comparison was done), Month 19, Month 24 and Month 30Population: Booster PP population, excluded those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity) and who were enrolled into the booster phase despite exclusion from the PP population of main study phase. Here, "Number Analyzed" signifies participants evaluable for this outcome measure at specified time points.
GMFR as compared to Month 18 (pre-booster) for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Month 19, Month 24 and Month 30. The outcome measure was planned to be analyzed for Booster PP population.
Outcome measures
| Measure |
VLA15 With Alum Lower Dose
n=37 Participants
Main Study Phase: VLA15 with Alum lower dose - Booster Phase: arm discontinued VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
VLA15 With Alum Higher Dose
n=18 Participants
Main Study Phase: VLA15 with Alum higher dose - Booster Phase: VLA15 higher dose or placebo VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
Placebo
Main Study Phase: placebo - Booster Phase: arm discontinued Placebo: PBS (Phosphate Buffered Saline).
|
|---|---|---|---|
|
GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST1 Month 19
|
51.3 Fold Rise
Interval 37.1 to 71.0
|
1.0 Fold Rise
Interval 1.0 to 1.0
|
—
|
|
GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST1 Month 24
|
5.5 Fold Rise
Interval 4.2 to 7.3
|
0.9 Fold Rise
Interval 0.8 to 1.0
|
—
|
|
GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST1 Month 30
|
2.2 Fold Rise
Interval 1.7 to 2.8
|
0.9 Fold Rise
Interval 0.8 to 1.0
|
—
|
|
GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST2 Month 19
|
69.1 Fold Rise
Interval 54.2 to 88.0
|
1.0 Fold Rise
Interval 0.9 to 1.2
|
—
|
|
GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST2 Month 24
|
8.1 Fold Rise
Interval 6.8 to 9.8
|
0.8 Fold Rise
Interval 0.6 to 0.9
|
—
|
|
GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST2 Month 30
|
2.8 Fold Rise
Interval 2.2 to 3.6
|
0.6 Fold Rise
Interval 0.5 to 0.9
|
—
|
|
GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST3 Month 19
|
61.7 Fold Rise
Interval 46.2 to 82.5
|
0.9 Fold Rise
Interval 0.8 to 1.0
|
—
|
|
GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST3 Month 24
|
8.6 Fold Rise
Interval 7.0 to 10.4
|
0.8 Fold Rise
Interval 0.6 to 1.0
|
—
|
|
GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST3 Month 30
|
3.3 Fold Rise
Interval 2.6 to 4.0
|
0.7 Fold Rise
Interval 0.5 to 0.9
|
—
|
|
GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST4 Month 19
|
57.7 Fold Rise
Interval 42.4 to 78.6
|
0.8 Fold Rise
Interval 0.7 to 1.0
|
—
|
|
GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST4 Month 24
|
7.0 Fold Rise
Interval 5.6 to 8.7
|
0.8 Fold Rise
Interval 0.7 to 1.0
|
—
|
|
GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST4 Month 30
|
2.5 Fold Rise
Interval 2.0 to 3.2
|
0.7 Fold Rise
Interval 0.6 to 0.9
|
—
|
|
GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST5 Month 19
|
60.2 Fold Rise
Interval 45.1 to 80.4
|
0.8 Fold Rise
Interval 0.7 to 1.0
|
—
|
|
GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST5 Month 24
|
6.8 Fold Rise
Interval 5.4 to 8.6
|
0.8 Fold Rise
Interval 0.7 to 1.0
|
—
|
|
GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST5 Month 30
|
3.0 Fold Rise
Interval 2.3 to 3.8
|
0.8 Fold Rise
Interval 0.7 to 1.0
|
—
|
|
GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST6 Month 19
|
53.5 Fold Rise
Interval 39.2 to 73.2
|
1.0 Fold Rise
Interval 0.8 to 1.2
|
—
|
|
GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST6 Month 24
|
6.9 Fold Rise
Interval 5.4 to 8.9
|
0.9 Fold Rise
Interval 0.9 to 1.0
|
—
|
|
GMFR as Compared to Month 18 (Pre-booster) for IgG Against Each OspA Serotype (ST1 to ST6): Booster PP Population
ST6 Month 30
|
2.9 Fold Rise
Interval 2.2 to 3.8
|
0.9 Fold Rise
Interval 0.7 to 1.0
|
—
|
SECONDARY outcome
Timeframe: At Day 1 (Month 0), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30Population: Booster PP population, excluded those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity) and who were enrolled into the booster phase despite exclusion from the PP population of main study phase. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for this outcome measure at specified time points.
GMTs for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 1 (Month 0), 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12), 545 (Month 18), Month 19, Month 24 and Month 30 stratified by age group: 18 - 49 years. The outcome measure was planned to be analyzed for Booster PP population from Day 1 to Day 545 of main study phase and from day of vaccination in Month 18 up to Month 30 of booster phase.
Outcome measures
| Measure |
VLA15 With Alum Lower Dose
n=22 Participants
Main Study Phase: VLA15 with Alum lower dose - Booster Phase: arm discontinued VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
VLA15 With Alum Higher Dose
n=13 Participants
Main Study Phase: VLA15 with Alum higher dose - Booster Phase: VLA15 higher dose or placebo VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
Placebo
Main Study Phase: placebo - Booster Phase: arm discontinued Placebo: PBS (Phosphate Buffered Saline).
|
|---|---|---|---|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST5 Day 57
|
23.6 Units per milliliter (U/mL)
Interval 18.1 to 30.6
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST5 Day 29
|
21.0 Units per milliliter (U/mL)
Interval 19.0 to 23.1
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST1 Day 29
|
21.6 Units per milliliter (U/mL)
Interval 19.3 to 24.1
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST1 Day 57
|
22.5 Units per milliliter (U/mL)
Interval 19.7 to 25.8
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST1 Day 85
|
103.1 Units per milliliter (U/mL)
Interval 60.3 to 176.4
|
62.8 Units per milliliter (U/mL)
Interval 33.6 to 117.4
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST1 Day 180
|
29.2 Units per milliliter (U/mL)
Interval 23.0 to 37.0
|
21.9 Units per milliliter (U/mL)
Interval 18.0 to 26.7
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST1 Day 208
|
335.9 Units per milliliter (U/mL)
Interval 199.7 to 565.0
|
335.3 Units per milliliter (U/mL)
Interval 189.4 to 593.7
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST1 Day 365
|
39.3 Units per milliliter (U/mL)
Interval 27.5 to 56.4
|
34.8 Units per milliliter (U/mL)
Interval 20.6 to 58.7
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST1 Day 545
|
24.6 Units per milliliter (U/mL)
Interval 20.0 to 30.2
|
21.4 Units per milliliter (U/mL)
Interval 18.4 to 24.9
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST1 Month 19
|
1551.7 Units per milliliter (U/mL)
Interval 943.9 to 2550.8
|
21.4 Units per milliliter (U/mL)
Interval 18.5 to 24.8
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST1 Month 24
|
142.1 Units per milliliter (U/mL)
Interval 90.9 to 222.1
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST1 Month 30
|
56.4 Units per milliliter (U/mL)
Interval 37.6 to 84.8
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST2 Day 1
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST2 Day 29
|
24.7 Units per milliliter (U/mL)
Interval 19.3 to 31.7
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST2 Day 57
|
25.7 Units per milliliter (U/mL)
Interval 18.9 to 35.0
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST2 Day 85
|
252.1 Units per milliliter (U/mL)
Interval 160.9 to 395.1
|
213.1 Units per milliliter (U/mL)
Interval 110.0 to 412.8
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST2 Day 180
|
43.0 Units per milliliter (U/mL)
Interval 29.5 to 62.6
|
36.4 Units per milliliter (U/mL)
Interval 22.4 to 59.3
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST2 Day 208
|
608.9 Units per milliliter (U/mL)
Interval 428.2 to 866.0
|
761.7 Units per milliliter (U/mL)
Interval 531.8 to 1091.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST2 Day 365
|
65.0 Units per milliliter (U/mL)
Interval 44.5 to 94.8
|
88.8 Units per milliliter (U/mL)
Interval 53.3 to 148.1
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST2 Day 545
|
28.9 Units per milliliter (U/mL)
Interval 22.6 to 37.0
|
38.3 Units per milliliter (U/mL)
Interval 26.0 to 56.5
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST2 Month 19
|
2199.0 Units per milliliter (U/mL)
Interval 1423.5 to 3396.9
|
40.2 Units per milliliter (U/mL)
Interval 28.0 to 57.7
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST2 Month 24
|
230.4 Units per milliliter (U/mL)
Interval 166.9 to 317.9
|
25.1 Units per milliliter (U/mL)
Interval 19.3 to 32.7
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST2 Month 30
|
72.8 Units per milliliter (U/mL)
Interval 45.9 to 115.3
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST3 Day 1
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST3 Day 29
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST3 Day 57
|
23.1 Units per milliliter (U/mL)
Interval 17.1 to 31.1
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST3 Day 85
|
280.1 Units per milliliter (U/mL)
Interval 162.1 to 483.9
|
266.8 Units per milliliter (U/mL)
Interval 154.9 to 459.4
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST3 Day 180
|
52.8 Units per milliliter (U/mL)
Interval 37.8 to 73.9
|
45.9 Units per milliliter (U/mL)
Interval 26.6 to 79.4
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST3 Day 208
|
710.0 Units per milliliter (U/mL)
Interval 476.3 to 1058.3
|
696.6 Units per milliliter (U/mL)
Interval 449.8 to 1078.7
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST3 Day 365
|
78.1 Units per milliliter (U/mL)
Interval 53.2 to 114.6
|
91.0 Units per milliliter (U/mL)
Interval 50.6 to 163.7
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST3 Day 545
|
30.4 Units per milliliter (U/mL)
Interval 22.7 to 40.7
|
41.5 Units per milliliter (U/mL)
Interval 27.0 to 63.7
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST3 Month 19
|
1997.3 Units per milliliter (U/mL)
Interval 1280.0 to 3116.6
|
37.5 Units per milliliter (U/mL)
Interval 25.6 to 55.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST3 Month 24
|
246.0 Units per milliliter (U/mL)
Interval 174.9 to 346.2
|
28.3 Units per milliliter (U/mL)
Interval 20.3 to 39.5
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST3 Month 30
|
96.3 Units per milliliter (U/mL)
Interval 68.9 to 134.8
|
23.3 Units per milliliter (U/mL)
Interval 18.5 to 29.2
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST4 Day 1
|
21.3 Units per milliliter (U/mL)
Interval 18.7 to 24.4
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST4 Day 29
|
22.0 Units per milliliter (U/mL)
Interval 19.1 to 25.5
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST4 Day 57
|
23.8 Units per milliliter (U/mL)
Interval 19.3 to 29.4
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST4 Day 85
|
134.8 Units per milliliter (U/mL)
Interval 82.5 to 220.4
|
105.4 Units per milliliter (U/mL)
Interval 61.4 to 180.8
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST4 Day 180
|
31.1 Units per milliliter (U/mL)
Interval 23.5 to 41.1
|
29.5 Units per milliliter (U/mL)
Interval 20.3 to 43.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST4 Day 208
|
432.0 Units per milliliter (U/mL)
Interval 288.2 to 647.4
|
458.6 Units per milliliter (U/mL)
Interval 306.9 to 685.3
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST4 Day 365
|
45.8 Units per milliliter (U/mL)
Interval 31.9 to 65.8
|
47.3 Units per milliliter (U/mL)
Interval 29.9 to 74.9
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST4 Day 545
|
29.3 Units per milliliter (U/mL)
Interval 22.8 to 37.5
|
28.6 Units per milliliter (U/mL)
Interval 21.4 to 38.2
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST4 Month 19
|
1817.7 Units per milliliter (U/mL)
Interval 1179.3 to 2801.5
|
25.4 Units per milliliter (U/mL)
Interval 19.3 to 33.4
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST4 Month 24
|
191.7 Units per milliliter (U/mL)
Interval 138.8 to 264.8
|
22.8 Units per milliliter (U/mL)
Interval 18.7 to 27.8
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST4 Month 30
|
66.8 Units per milliliter (U/mL)
Interval 44.8 to 99.5
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST5 Day 1
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST5 Day 85
|
120.6 Units per milliliter (U/mL)
Interval 74.6 to 195.0
|
122.6 Units per milliliter (U/mL)
Interval 70.7 to 212.7
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST5 Day 180
|
27.4 Units per milliliter (U/mL)
Interval 21.5 to 34.9
|
31.9 Units per milliliter (U/mL)
Interval 21.4 to 47.4
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST5 Day 208
|
380.7 Units per milliliter (U/mL)
Interval 238.8 to 607.1
|
506.8 Units per milliliter (U/mL)
Interval 323.4 to 794.1
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST5 Day 365
|
42.5 Units per milliliter (U/mL)
Interval 29.7 to 60.9
|
55.0 Units per milliliter (U/mL)
Interval 32.7 to 92.6
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST5 Day 545
|
25.1 Units per milliliter (U/mL)
Interval 20.5 to 30.7
|
31.6 Units per milliliter (U/mL)
Interval 21.5 to 46.5
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST5 Month 19
|
1600.5 Units per milliliter (U/mL)
Interval 1002.8 to 2554.6
|
24.4 Units per milliliter (U/mL)
Interval 18.1 to 32.8
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST6 Month 19
|
1449.3 Units per milliliter (U/mL)
Interval 878.4 to 2391.3
|
28.7 Units per milliliter (U/mL)
Interval 20.3 to 40.6
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST5 Month 24
|
160.2 Units per milliliter (U/mL)
Interval 109.5 to 234.3
|
22.2 Units per milliliter (U/mL)
Interval 17.6 to 27.9
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST5 Month 30
|
78.1 Units per milliliter (U/mL)
Interval 57.1 to 106.7
|
22.3 Units per milliliter (U/mL)
Interval 17.6 to 28.1
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST6 Day 1
|
21.5 Units per milliliter (U/mL)
Interval 18.5 to 24.8
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST6 Day 29
|
22.7 Units per milliliter (U/mL)
Interval 18.9 to 27.3
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST6 Day 57
|
27.3 Units per milliliter (U/mL)
Interval 20.4 to 36.5
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST6 Day 85
|
90.2 Units per milliliter (U/mL)
Interval 53.9 to 151.0
|
121.4 Units per milliliter (U/mL)
Interval 72.1 to 204.5
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST6 Day 180
|
28.5 Units per milliliter (U/mL)
Interval 21.7 to 37.5
|
34.4 Units per milliliter (U/mL)
Interval 21.8 to 54.1
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST6 Day 208
|
346.1 Units per milliliter (U/mL)
Interval 217.3 to 551.1
|
502.5 Units per milliliter (U/mL)
Interval 314.1 to 803.8
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST6 Day 365
|
42.8 Units per milliliter (U/mL)
Interval 28.7 to 63.8
|
63.1 Units per milliliter (U/mL)
Interval 38.1 to 104.4
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST6 Day 545
|
25.4 Units per milliliter (U/mL)
Interval 20.0 to 32.4
|
28.7 Units per milliliter (U/mL)
Interval 20.3 to 40.6
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST6 Month 24
|
163.8 Units per milliliter (U/mL)
Interval 115.0 to 233.2
|
25.1 Units per milliliter (U/mL)
Interval 19.1 to 32.8
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST6 Month 30
|
69.6 Units per milliliter (U/mL)
Interval 48.1 to 100.7
|
22.1 Units per milliliter (U/mL)
Interval 17.7 to 27.7
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST1 Day 1
|
20.8 Units per milliliter (U/mL)
Interval 19.2 to 22.5
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
SECONDARY outcome
Timeframe: At Day 1 (Month 0), Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30Population: Booster PP population, excluded those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity) and who were enrolled into the booster phase despite exclusion from the PP population of main study phase. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for this outcome measure at specified time points.
GMTs for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 1 (Month 0), 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12), 545 (Month 18), Month 19, Month 24 and Month 30 stratified by age group: 50 - 65 years. The outcome measure was planned to be analyzed for Booster PP population from Day 1 to Day 545 of main study phase and from day of vaccination in Month 18 up to Month 30 of booster phase.
Outcome measures
| Measure |
VLA15 With Alum Lower Dose
n=15 Participants
Main Study Phase: VLA15 with Alum lower dose - Booster Phase: arm discontinued VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
VLA15 With Alum Higher Dose
n=5 Participants
Main Study Phase: VLA15 with Alum higher dose - Booster Phase: VLA15 higher dose or placebo VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
Placebo
Main Study Phase: placebo - Booster Phase: arm discontinued Placebo: PBS (Phosphate Buffered Saline).
|
|---|---|---|---|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST6 Month 30
|
86.5 Units per milliliter (U/mL)
Interval 47.6 to 157.4
|
28.1 Units per milliliter (U/mL)
Interval 10.9 to 72.5
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST1 Day 1
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST1 Day 29
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST1 Day 57
|
22.8 Units per milliliter (U/mL)
Interval 17.2 to 30.3
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST1 Day 85
|
53.3 Units per milliliter (U/mL)
Interval 29.6 to 95.9
|
78.8 Units per milliliter (U/mL)
Interval 24.0 to 259.4
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST1 Day 180
|
25.4 Units per milliliter (U/mL)
Interval 20.2 to 31.9
|
31.6 Units per milliliter (U/mL)
Interval 14.3 to 69.6
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST1 Day 208
|
236.6 Units per milliliter (U/mL)
Interval 124.2 to 450.7
|
386.0 Units per milliliter (U/mL)
Interval 32.8 to 4546.3
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST1 Day 365
|
40.2 Units per milliliter (U/mL)
Interval 24.4 to 66.0
|
44.1 Units per milliliter (U/mL)
Interval 4.9 to 396.6
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST1 Day 545
|
25.3 Units per milliliter (U/mL)
Interval 19.0 to 33.8
|
32.3 Units per milliliter (U/mL)
Interval 8.5 to 122.8
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST1 Month 19
|
959.7 Units per milliliter (U/mL)
Interval 482.2 to 1910.2
|
30.7 Units per milliliter (U/mL)
Interval 9.4 to 100.7
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST1 Month 24
|
130.8 Units per milliliter (U/mL)
Interval 66.8 to 256.0
|
28.8 Units per milliliter (U/mL)
Interval 10.5 to 79.3
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST1 Month 30
|
50.8 Units per milliliter (U/mL)
Interval 26.7 to 96.6
|
28.2 Units per milliliter (U/mL)
Interval 10.8 to 73.5
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST2 Day 1
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST2 Day 29
|
21.4 Units per milliliter (U/mL)
Interval 18.5 to 24.9
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST2 Day 57
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST2 Day 85
|
178.8 Units per milliliter (U/mL)
Interval 102.1 to 313.1
|
137.8 Units per milliliter (U/mL)
Interval 33.9 to 559.6
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST2 Day 180
|
38.3 Units per milliliter (U/mL)
Interval 24.2 to 60.5
|
26.8 Units per milliliter (U/mL)
Interval 11.9 to 60.2
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST2 Day 208
|
602.4 Units per milliliter (U/mL)
Interval 260.7 to 1391.7
|
557.0 Units per milliliter (U/mL)
Interval 75.6 to 4104.2
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST2 Day 365
|
96.1 Units per milliliter (U/mL)
Interval 51.6 to 179.2
|
51.1 Units per milliliter (U/mL)
Interval 7.6 to 344.7
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST2 Day 545
|
36.5 Units per milliliter (U/mL)
Interval 22.5 to 59.2
|
30.4 Units per milliliter (U/mL)
Interval 9.5 to 96.6
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST2 Month 19
|
2187.9 Units per milliliter (U/mL)
Interval 1198.0 to 3995.8
|
29.3 Units per milliliter (U/mL)
Interval 10.2 to 84.1
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST2 Month 24
|
306.4 Units per milliliter (U/mL)
Interval 184.2 to 509.5
|
28.4 Units per milliliter (U/mL)
Interval 10.7 to 75.4
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST2 Month 30
|
121.2 Units per milliliter (U/mL)
Interval 70.6 to 207.9
|
27.3 Units per milliliter (U/mL)
Interval 11.5 to 64.9
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST3 Day 1
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST3 Day 29
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST3 Day 57
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST3 Day 85
|
181.8 Units per milliliter (U/mL)
Interval 92.4 to 357.8
|
179.8 Units per milliliter (U/mL)
Interval 57.8 to 559.6
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST3 Day 180
|
40.8 Units per milliliter (U/mL)
Interval 26.0 to 64.1
|
39.0 Units per milliliter (U/mL)
Interval 11.4 to 133.7
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST3 Day 208
|
530.4 Units per milliliter (U/mL)
Interval 234.5 to 1199.8
|
599.0 Units per milliliter (U/mL)
Interval 73.4 to 4891.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST3 Day 365
|
79.7 Units per milliliter (U/mL)
Interval 43.1 to 147.3
|
61.6 Units per milliliter (U/mL)
Interval 6.7 to 566.4
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST3 Day 545
|
32.1 Units per milliliter (U/mL)
Interval 21.6 to 47.6
|
34.9 Units per milliliter (U/mL)
Interval 7.4 to 163.5
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST3 Month 19
|
1803.1 Units per milliliter (U/mL)
Interval 878.3 to 3701.5
|
31.8 Units per milliliter (U/mL)
Interval 8.8 to 115.6
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST3 Month 24
|
297.8 Units per milliliter (U/mL)
Interval 183.0 to 484.6
|
30.9 Units per milliliter (U/mL)
Interval 9.3 to 102.9
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST3 Month 30
|
109.9 Units per milliliter (U/mL)
Interval 66.6 to 181.3
|
29.2 Units per milliliter (U/mL)
Interval 10.2 to 83.7
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST4 Day 1
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST4 Day 29
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST4 Day 57
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST4 Day 85
|
79.7 Units per milliliter (U/mL)
Interval 45.8 to 138.7
|
90.2 Units per milliliter (U/mL)
Interval 28.5 to 285.4
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST4 Day 180
|
28.6 Units per milliliter (U/mL)
Interval 21.4 to 38.4
|
25.8 Units per milliliter (U/mL)
Interval 12.8 to 52.1
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST4 Day 208
|
306.6 Units per milliliter (U/mL)
Interval 144.9 to 648.8
|
447.5 Units per milliliter (U/mL)
Interval 49.6 to 4039.3
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST4 Day 365
|
50.0 Units per milliliter (U/mL)
Interval 30.2 to 82.7
|
44.5 Units per milliliter (U/mL)
Interval 4.8 to 411.4
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST4 Day 545
|
28.1 Units per milliliter (U/mL)
Interval 20.1 to 39.2
|
39.7 Units per milliliter (U/mL)
Interval 10.8 to 146.7
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST4 Month 19
|
1455.5 Units per milliliter (U/mL)
Interval 726.5 to 2916.0
|
29.8 Units per milliliter (U/mL)
Interval 9.9 to 89.8
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST4 Month 24
|
214.6 Units per milliliter (U/mL)
Interval 121.0 to 380.7
|
29.3 Units per milliliter (U/mL)
Interval 10.2 to 84.1
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST4 Month 30
|
81.2 Units per milliliter (U/mL)
Interval 44.1 to 149.3
|
28.1 Units per milliliter (U/mL)
Interval 10.9 to 72.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST5 Day 1
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST5 Day 29
|
23.8 Units per milliliter (U/mL)
Interval 17.9 to 31.8
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST5 Day 57
|
22.8 Units per milliliter (U/mL)
Interval 18.7 to 27.8
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST5 Day 85
|
77.7 Units per milliliter (U/mL)
Interval 44.0 to 137.0
|
139.8 Units per milliliter (U/mL)
Interval 69.1 to 282.8
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST5 Day 180
|
25.4 Units per milliliter (U/mL)
Interval 19.2 to 33.6
|
33.5 Units per milliliter (U/mL)
Interval 13.8 to 81.4
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST5 Day 208
|
356.0 Units per milliliter (U/mL)
Interval 182.9 to 693.0
|
584.1 Units per milliliter (U/mL)
Interval 104.2 to 3275.4
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST5 Day 365
|
45.9 Units per milliliter (U/mL)
Interval 25.7 to 82.1
|
71.6 Units per milliliter (U/mL)
Interval 12.7 to 403.9
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST5 Day 545
|
24.9 Units per milliliter (U/mL)
Interval 17.8 to 34.9
|
30.0 Units per milliliter (U/mL)
Interval 9.8 to 92.1
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST5 Month 19
|
1381.6 Units per milliliter (U/mL)
Interval 772.7 to 2470.1
|
28.5 Units per milliliter (U/mL)
Interval 10.7 to 75.9
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST5 Month 24
|
186.0 Units per milliliter (U/mL)
Interval 111.8 to 309.2
|
27.6 Units per milliliter (U/mL)
Interval 11.3 to 67.4
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST5 Month 30
|
68.3 Units per milliliter (U/mL)
Interval 36.3 to 128.6
|
27.0 Units per milliliter (U/mL)
Interval 11.7 to 62.3
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST6 Day 1
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST6 Day 29
|
21.1 Units per milliliter (U/mL)
Interval 18.8 to 23.6
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST6 Day 57
|
21.7 Units per milliliter (U/mL)
Interval 18.3 to 25.7
|
20.0 Units per milliliter (U/mL)
Interval 20.0 to 20.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST6 Day 85
|
71.4 Units per milliliter (U/mL)
Interval 42.1 to 120.9
|
105.4 Units per milliliter (U/mL)
Interval 27.3 to 407.4
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST6 Day 180
|
30.1 Units per milliliter (U/mL)
Interval 21.4 to 42.4
|
42.2 Units per milliliter (U/mL)
Interval 17.5 to 102.0
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST6 Day 208
|
360.9 Units per milliliter (U/mL)
Interval 192.4 to 676.9
|
525.1 Units per milliliter (U/mL)
Interval 80.5 to 3426.2
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST6 Day 365
|
53.4 Units per milliliter (U/mL)
Interval 28.8 to 98.9
|
78.6 Units per milliliter (U/mL)
Interval 15.5 to 398.1
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST6 Day 545
|
27.6 Units per milliliter (U/mL)
Interval 19.0 to 40.0
|
30.2 Units per milliliter (U/mL)
Interval 9.6 to 95.3
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST6 Month 19
|
1346.7 Units per milliliter (U/mL)
Interval 811.0 to 2236.3
|
28.8 Units per milliliter (U/mL)
Interval 10.5 to 79.3
|
—
|
|
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST6 Month 24
|
210.9 Units per milliliter (U/mL)
Interval 134.5 to 330.8
|
27.7 Units per milliliter (U/mL)
Interval 11.2 to 68.5
|
—
|
SECONDARY outcome
Timeframe: Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30Population: Booster PP population, excluded those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity) and who were enrolled into the booster phase despite exclusion from the PP population of main study phase. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for this outcome measure at specified time points.
SCR for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12), 545 (Month 18), Month 19, Month 24 and Month 30 stratified by age group: 18 - 49 years was presented in this outcome measure. Seroconversion for ELISA was defined as 1) for participants that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive at a certain time point or 2) for participants that are seropositive at Visit 1 (baseline): \>=4-fold rise in IgG antibody titer from Visit 1. SCR was reported as percentage of participants. The outcome measure was planned to be analyzed for Booster PP population from Day 29 to Day 545 of main study phase and from day of vaccination in Month 18 up to Month 30 of booster phase.
Outcome measures
| Measure |
VLA15 With Alum Lower Dose
n=22 Participants
Main Study Phase: VLA15 with Alum lower dose - Booster Phase: arm discontinued VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
VLA15 With Alum Higher Dose
n=13 Participants
Main Study Phase: VLA15 with Alum higher dose - Booster Phase: VLA15 higher dose or placebo VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
Placebo
Main Study Phase: placebo - Booster Phase: arm discontinued Placebo: PBS (Phosphate Buffered Saline).
|
|---|---|---|---|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST2 Day 365
|
72.7 Percentage of Participants
Interval 51.8 to 86.8
|
83.3 Percentage of Participants
Interval 55.2 to 95.3
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST1 Day 29
|
4.5 Percentage of Participants
Interval 0.8 to 21.8
|
0.0 Percentage of Participants
Interval 0.0 to 22.8
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST1 Day 57
|
9.1 Percentage of Participants
Interval 2.5 to 27.8
|
0.0 Percentage of Participants
Interval 0.0 to 22.8
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST1 Day 85
|
72.7 Percentage of Participants
Interval 51.8 to 86.8
|
66.7 Percentage of Participants
Interval 39.1 to 86.2
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST1 Day 180
|
31.8 Percentage of Participants
Interval 16.4 to 52.7
|
7.7 Percentage of Participants
Interval 1.4 to 33.3
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST1 Day 208
|
95.2 Percentage of Participants
Interval 77.3 to 99.2
|
100 Percentage of Participants
Interval 75.8 to 100.0
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST1 Day 365
|
40.9 Percentage of Participants
Interval 23.3 to 61.3
|
33.3 Percentage of Participants
Interval 13.8 to 60.9
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST1 Day 545
|
13.6 Percentage of Participants
Interval 4.7 to 33.3
|
7.7 Percentage of Participants
Interval 1.4 to 33.3
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST1 Month 19
|
100 Percentage of Participants
Interval 85.1 to 100.0
|
7.7 Percentage of Participants
Interval 1.4 to 33.3
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST1 Month 24
|
90.9 Percentage of Participants
Interval 72.2 to 97.5
|
0.0 Percentage of Participants
Interval 0.0 to 24.2
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST1 Month 30
|
63.6 Percentage of Participants
Interval 43.0 to 80.3
|
0.0 Percentage of Participants
Interval 0.0 to 24.2
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST2 Day 29
|
13.6 Percentage of Participants
Interval 4.7 to 33.3
|
0.0 Percentage of Participants
Interval 0.0 to 22.8
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST2 Day 57
|
13.6 Percentage of Participants
Interval 4.7 to 33.3
|
0.0 Percentage of Participants
Interval 0.0 to 22.8
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST2 Day 85
|
100 Percentage of Participants
Interval 85.1 to 100.0
|
91.7 Percentage of Participants
Interval 64.6 to 98.5
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST2 Day 180
|
50.0 Percentage of Participants
Interval 30.7 to 69.3
|
38.5 Percentage of Participants
Interval 17.7 to 64.5
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST2 Day 208
|
100 Percentage of Participants
Interval 84.5 to 100.0
|
100 Percentage of Participants
Interval 75.8 to 100.0
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST2 Day 545
|
31.8 Percentage of Participants
Interval 16.4 to 52.7
|
53.8 Percentage of Participants
Interval 29.1 to 76.8
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST2 Month 19
|
100 Percentage of Participants
Interval 85.1 to 100.0
|
61.5 Percentage of Participants
Interval 35.5 to 82.3
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST2 Month 24
|
100 Percentage of Participants
Interval 85.1 to 100.0
|
25.0 Percentage of Participants
Interval 8.9 to 53.2
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST2 Month 30
|
63.6 Percentage of Participants
Interval 43.0 to 80.3
|
0.0 Percentage of Participants
Interval 0.0 to 24.2
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST3 Day 29
|
0.0 Percentage of Participants
Interval 0.0 to 14.9
|
0.0 Percentage of Participants
Interval 0.0 to 22.8
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST3 Day 57
|
4.5 Percentage of Participants
Interval 0.8 to 21.8
|
0.0 Percentage of Participants
Interval 0.0 to 22.8
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST3 Day 85
|
90.9 Percentage of Participants
Interval 72.2 to 97.5
|
100 Percentage of Participants
Interval 75.8 to 100.0
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST3 Day 180
|
68.2 Percentage of Participants
Interval 47.3 to 83.6
|
53.8 Percentage of Participants
Interval 29.1 to 76.8
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST3 Day 208
|
100 Percentage of Participants
Interval 84.5 to 100.0
|
100 Percentage of Participants
Interval 75.8 to 100.0
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST3 Day 365
|
77.3 Percentage of Participants
Interval 56.6 to 89.9
|
83.3 Percentage of Participants
Interval 55.2 to 95.3
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST3 Day 545
|
31.8 Percentage of Participants
Interval 16.4 to 52.7
|
53.8 Percentage of Participants
Interval 29.1 to 76.8
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST3 Month 19
|
100 Percentage of Participants
Interval 85.1 to 100.0
|
53.8 Percentage of Participants
Interval 29.1 to 76.8
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST3 Month 24
|
100 Percentage of Participants
Interval 85.1 to 100.0
|
33.3 Percentage of Participants
Interval 13.8 to 60.9
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST3 Month 30
|
90.9 Percentage of Participants
Interval 72.2 to 97.5
|
16.7 Percentage of Participants
Interval 4.7 to 44.8
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST4 Day 29
|
4.5 Percentage of Participants
Interval 0.8 to 21.8
|
0.0 Percentage of Participants
Interval 0.0 to 22.8
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST4 Day 57
|
9.1 Percentage of Participants
Interval 2.5 to 27.8
|
0.0 Percentage of Participants
Interval 0.0 to 22.8
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST4 Day 85
|
86.4 Percentage of Participants
Interval 66.7 to 95.3
|
91.7 Percentage of Participants
Interval 64.6 to 98.5
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST4 Day 180
|
31.8 Percentage of Participants
Interval 16.4 to 52.7
|
30.8 Percentage of Participants
Interval 12.7 to 57.6
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST4 Day 208
|
100 Percentage of Participants
Interval 84.5 to 100.0
|
100 Percentage of Participants
Interval 75.8 to 100.0
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST4 Day 365
|
54.5 Percentage of Participants
Interval 34.7 to 73.1
|
66.7 Percentage of Participants
Interval 39.1 to 86.2
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST4 Day 545
|
31.8 Percentage of Participants
Interval 16.4 to 52.7
|
38.5 Percentage of Participants
Interval 17.7 to 64.5
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST4 Month 19
|
100 Percentage of Participants
Interval 85.1 to 100.0
|
23.1 Percentage of Participants
Interval 8.2 to 50.3
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST4 Month 24
|
100 Percentage of Participants
Interval 85.1 to 100.0
|
16.7 Percentage of Participants
Interval 4.7 to 44.8
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST4 Month 30
|
68.2 Percentage of Participants
Interval 47.3 to 83.6
|
0.0 Percentage of Participants
Interval 0.0 to 24.2
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST5 Day 29
|
4.5 Percentage of Participants
Interval 0.8 to 21.8
|
0.0 Percentage of Participants
Interval 0.0 to 22.8
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST5 Day 57
|
9.1 Percentage of Participants
Interval 2.5 to 27.8
|
0.0 Percentage of Participants
Interval 0.0 to 22.8
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST5 Day 85
|
81.8 Percentage of Participants
Interval 61.5 to 92.7
|
91.7 Percentage of Participants
Interval 64.6 to 98.5
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST5 Day 180
|
27.3 Percentage of Participants
Interval 13.2 to 48.2
|
38.5 Percentage of Participants
Interval 17.7 to 64.5
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST5 Day 208
|
95.2 Percentage of Participants
Interval 77.3 to 99.2
|
100 Percentage of Participants
Interval 75.8 to 100.0
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST5 Day 365
|
50.0 Percentage of Participants
Interval 30.7 to 69.3
|
66.7 Percentage of Participants
Interval 39.1 to 86.2
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST5 Day 545
|
22.7 Percentage of Participants
Interval 10.1 to 43.4
|
38.5 Percentage of Participants
Interval 17.7 to 64.5
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST5 Month 19
|
100 Percentage of Participants
Interval 85.1 to 100.0
|
15.4 Percentage of Participants
Interval 4.3 to 42.2
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST5 Month 24
|
95.5 Percentage of Participants
Interval 78.2 to 99.2
|
8.3 Percentage of Participants
Interval 1.5 to 35.4
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST5 Month 30
|
90.9 Percentage of Participants
Interval 72.2 to 97.5
|
8.3 Percentage of Participants
Interval 1.5 to 35.4
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST6 Day 29
|
4.5 Percentage of Participants
Interval 0.8 to 21.8
|
0.0 Percentage of Participants
Interval 0.0 to 22.8
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST6 Day 57
|
18.2 Percentage of Participants
Interval 7.3 to 38.5
|
0.0 Percentage of Participants
Interval 0.0 to 22.8
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST6 Day 85
|
68.2 Percentage of Participants
Interval 47.3 to 83.6
|
91.7 Percentage of Participants
Interval 64.6 to 98.5
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST6 Day 180
|
22.7 Percentage of Participants
Interval 10.1 to 43.4
|
38.5 Percentage of Participants
Interval 17.7 to 64.5
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST6 Day 208
|
95.2 Percentage of Participants
Interval 77.3 to 99.2
|
100 Percentage of Participants
Interval 75.8 to 100.0
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST6 Day 365
|
40.9 Percentage of Participants
Interval 23.3 to 61.3
|
75.0 Percentage of Participants
Interval 46.8 to 91.1
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST6 Day 545
|
13.6 Percentage of Participants
Interval 4.7 to 33.3
|
30.8 Percentage of Participants
Interval 12.7 to 57.6
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST6 Month 19
|
100 Percentage of Participants
Interval 85.1 to 100.0
|
30.8 Percentage of Participants
Interval 12.7 to 57.6
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST6 Month 24
|
95.5 Percentage of Participants
Interval 78.2 to 99.2
|
25.0 Percentage of Participants
Interval 8.9 to 53.2
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 18 - 49 Years
ST6 Month 30
|
72.7 Percentage of Participants
Interval 51.8 to 86.8
|
8.3 Percentage of Participants
Interval 1.5 to 35.4
|
—
|
SECONDARY outcome
Timeframe: Day 29 (Month 1), Day 57 (Month 2), Day 85 (Month 3), Day 180 (Month 6), Day 208 (Month 7), Day 365 (Month 12), Day 545 (Month 18), Month 19, Month 24, and Month 30Population: Booster PP population, excluded those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity) and who were enrolled into the booster phase despite exclusion from the PP population of main study phase. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for this outcome measure at specified time points.
SCR for IgG against each OspA serotype ST1 to ST6, determined by ELISA, at Day 29 (Month 1), 57 (Month 2), 85 (Month 3), 180 (Month 6), 208 (Month 7), 365 (Month 12), 545 (Month 18), Month 19, Month 24, and Month 30 stratified by age group: 50 - 65 years. Seroconversion for ELISA was defined as 1) for participants that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive at a certain time point or 2) for participants that are seropositive at Visit 1 (baseline): \>=4-fold rise in IgG antibody titer from Visit 1. SCR was reported as percentage of participants. The outcome measure was planned to be analyzed for Booster PP population from Day 29 to Day 545 of main study phase and from day of vaccination in Month 18 up to Month 30 of booster phase.
Outcome measures
| Measure |
VLA15 With Alum Lower Dose
n=15 Participants
Main Study Phase: VLA15 with Alum lower dose - Booster Phase: arm discontinued VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
VLA15 With Alum Higher Dose
n=5 Participants
Main Study Phase: VLA15 with Alum higher dose - Booster Phase: VLA15 higher dose or placebo VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
Placebo
Main Study Phase: placebo - Booster Phase: arm discontinued Placebo: PBS (Phosphate Buffered Saline).
|
|---|---|---|---|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST3 Day 57
|
0.0 Percentage of Participants
Interval 0.0 to 20.4
|
0.0 Percentage of Participants
Interval 0.0 to 43.4
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST3 Day 85
|
86.7 Percentage of Participants
Interval 62.1 to 96.3
|
100 Percentage of Participants
Interval 56.6 to 100.0
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST3 Day 180
|
46.7 Percentage of Participants
Interval 24.8 to 69.9
|
40.0 Percentage of Participants
Interval 11.8 to 76.9
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST1 Day 29
|
0.0 Percentage of Participants
Interval 0.0 to 20.4
|
0.0 Percentage of Participants
Interval 0.0 to 43.4
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST1 Day 57
|
6.7 Percentage of Participants
Interval 1.2 to 29.8
|
0.0 Percentage of Participants
Interval 0.0 to 43.4
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST1 Day 85
|
53.3 Percentage of Participants
Interval 30.1 to 75.2
|
80.0 Percentage of Participants
Interval 37.6 to 96.4
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST1 Day 180
|
26.7 Percentage of Participants
Interval 10.9 to 52.0
|
40.0 Percentage of Participants
Interval 11.8 to 76.9
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST1 Day 208
|
100 Percentage of Participants
Interval 78.5 to 100.0
|
100 Percentage of Participants
Interval 56.6 to 100.0
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST1 Day 365
|
46.7 Percentage of Participants
Interval 24.8 to 69.9
|
20.0 Percentage of Participants
Interval 3.6 to 62.4
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST1 Day 545
|
20.0 Percentage of Participants
Interval 7.0 to 45.2
|
20.0 Percentage of Participants
Interval 3.6 to 62.4
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST1 Month 19
|
100 Percentage of Participants
Interval 79.6 to 100.0
|
20.0 Percentage of Participants
Interval 3.6 to 62.4
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST1 Month 24
|
86.7 Percentage of Participants
Interval 62.1 to 96.3
|
20.0 Percentage of Participants
Interval 3.6 to 62.4
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST1 Month 30
|
46.7 Percentage of Participants
Interval 24.8 to 69.9
|
20.0 Percentage of Participants
Interval 3.6 to 62.4
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST2 Day 29
|
6.7 Percentage of Participants
Interval 1.2 to 29.8
|
0.0 Percentage of Participants
Interval 0.0 to 43.4
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST2 Day 57
|
0.0 Percentage of Participants
Interval 0.0 to 20.4
|
0.0 Percentage of Participants
Interval 0.0 to 43.4
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST2 Day 85
|
93.3 Percentage of Participants
Interval 70.2 to 98.8
|
80.0 Percentage of Participants
Interval 37.6 to 96.4
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST2 Day 180
|
46.7 Percentage of Participants
Interval 24.8 to 69.9
|
20.0 Percentage of Participants
Interval 3.6 to 62.4
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST2 Day 208
|
92.9 Percentage of Participants
Interval 68.5 to 98.7
|
100 Percentage of Participants
Interval 56.6 to 100.0
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST2 Day 365
|
80.0 Percentage of Participants
Interval 54.8 to 93.0
|
40.0 Percentage of Participants
Interval 11.8 to 76.9
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST2 Day 545
|
40.0 Percentage of Participants
Interval 19.8 to 64.3
|
20.0 Percentage of Participants
Interval 3.6 to 62.4
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST2 Month 19
|
100 Percentage of Participants
Interval 79.6 to 100.0
|
20.0 Percentage of Participants
Interval 3.6 to 62.4
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST2 Month 24
|
100 Percentage of Participants
Interval 79.6 to 100.0
|
20.0 Percentage of Participants
Interval 3.6 to 62.4
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST2 Month 30
|
86.7 Percentage of Participants
Interval 62.1 to 96.3
|
20.0 Percentage of Participants
Interval 3.6 to 62.4
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST3 Day 29
|
0.0 Percentage of Participants
Interval 0.0 to 20.4
|
0.0 Percentage of Participants
Interval 0.0 to 43.4
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST3 Day 208
|
92.9 Percentage of Participants
Interval 68.5 to 98.7
|
100 Percentage of Participants
Interval 56.6 to 100.0
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST3 Day 365
|
66.7 Percentage of Participants
Interval 41.7 to 84.8
|
40.0 Percentage of Participants
Interval 11.8 to 76.9
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST3 Day 545
|
33.3 Percentage of Participants
Interval 15.2 to 58.3
|
20.0 Percentage of Participants
Interval 3.6 to 62.4
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST3 Month 19
|
100 Percentage of Participants
Interval 79.6 to 100.0
|
20.0 Percentage of Participants
Interval 3.6 to 62.4
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST3 Month 24
|
100 Percentage of Participants
Interval 79.6 to 100.0
|
20.0 Percentage of Participants
Interval 3.6 to 62.4
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST3 Month 30
|
86.7 Percentage of Participants
Interval 62.1 to 96.3
|
20.0 Percentage of Participants
Interval 3.6 to 62.4
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST4 Day 29
|
0.0 Percentage of Participants
Interval 0.0 to 20.4
|
0.0 Percentage of Participants
Interval 0.0 to 43.4
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST4 Day 57
|
0.0 Percentage of Participants
Interval 0.0 to 20.4
|
0.0 Percentage of Participants
Interval 0.0 to 43.4
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST4 Day 85
|
73.3 Percentage of Participants
Interval 48.0 to 89.1
|
80.0 Percentage of Participants
Interval 37.6 to 96.4
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST4 Day 180
|
33.3 Percentage of Participants
Interval 15.2 to 58.3
|
20.0 Percentage of Participants
Interval 3.6 to 62.4
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST4 Day 208
|
92.9 Percentage of Participants
Interval 68.5 to 98.7
|
100 Percentage of Participants
Interval 56.6 to 100.0
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST4 Day 365
|
60.0 Percentage of Participants
Interval 35.7 to 80.2
|
20.0 Percentage of Participants
Interval 3.6 to 62.4
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST4 Day 545
|
26.7 Percentage of Participants
Interval 10.9 to 52.0
|
40.0 Percentage of Participants
Interval 11.8 to 76.9
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST4 Month 19
|
100 Percentage of Participants
Interval 79.6 to 100.0
|
20.0 Percentage of Participants
Interval 3.6 to 62.4
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST4 Month 24
|
100 Percentage of Participants
Interval 79.6 to 100.0
|
20.0 Percentage of Participants
Interval 3.6 to 62.4
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST4 Month 30
|
80.0 Percentage of Participants
Interval 54.8 to 93.0
|
20.0 Percentage of Participants
Interval 3.6 to 62.4
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST5 Day 29
|
13.3 Percentage of Participants
Interval 3.7 to 37.9
|
0.0 Percentage of Participants
Interval 0.0 to 43.4
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST5 Day 57
|
13.3 Percentage of Participants
Interval 3.7 to 37.9
|
0.0 Percentage of Participants
Interval 0.0 to 43.4
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST5 Day 85
|
73.3 Percentage of Participants
Interval 48.0 to 89.1
|
100 Percentage of Participants
Interval 56.6 to 100.0
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST5 Day 180
|
20.0 Percentage of Participants
Interval 7.0 to 45.2
|
40.0 Percentage of Participants
Interval 11.8 to 76.9
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST5 Day 208
|
100 Percentage of Participants
Interval 78.5 to 100.0
|
100 Percentage of Participants
Interval 56.6 to 100.0
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST5 Day 365
|
46.7 Percentage of Participants
Interval 24.8 to 69.9
|
80.0 Percentage of Participants
Interval 37.6 to 96.4
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST5 Day 545
|
13.3 Percentage of Participants
Interval 3.7 to 37.9
|
20.0 Percentage of Participants
Interval 3.6 to 62.4
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST5 Month 19
|
100 Percentage of Participants
Interval 79.6 to 100.0
|
20.0 Percentage of Participants
Interval 3.6 to 62.4
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST5 Month 24
|
100 Percentage of Participants
Interval 79.6 to 100.0
|
20.0 Percentage of Participants
Interval 3.6 to 62.4
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST5 Month 30
|
66.7 Percentage of Participants
Interval 41.7 to 84.8
|
20.0 Percentage of Participants
Interval 3.6 to 62.4
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST6 Day 29
|
6.7 Percentage of Participants
Interval 1.2 to 29.8
|
0.0 Percentage of Participants
Interval 0.0 to 43.4
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST6 Day 57
|
6.7 Percentage of Participants
Interval 1.2 to 29.8
|
0.0 Percentage of Participants
Interval 0.0 to 43.4
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST6 Day 85
|
73.3 Percentage of Participants
Interval 48.0 to 89.1
|
80.0 Percentage of Participants
Interval 37.6 to 96.4
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST6 Day 180
|
33.3 Percentage of Participants
Interval 15.2 to 58.3
|
60.0 Percentage of Participants
Interval 23.1 to 88.2
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST6 Day 208
|
100 Percentage of Participants
Interval 78.5 to 100.0
|
100 Percentage of Participants
Interval 56.6 to 100.0
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST6 Day 365
|
53.3 Percentage of Participants
Interval 30.1 to 75.2
|
80.0 Percentage of Participants
Interval 37.6 to 96.4
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST6 Day 545
|
20.0 Percentage of Participants
Interval 7.0 to 45.2
|
20.0 Percentage of Participants
Interval 3.6 to 62.4
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST6 Month 19
|
100 Percentage of Participants
Interval 79.6 to 100.0
|
20.0 Percentage of Participants
Interval 3.6 to 62.4
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST6 Month 24
|
100 Percentage of Participants
Interval 79.6 to 100.0
|
20.0 Percentage of Participants
Interval 3.6 to 62.4
|
—
|
|
SCR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group in Booster PP Population: Group 50 - 65 Years
ST6 Month 30
|
73.3 Percentage of Participants
Interval 48.0 to 89.1
|
20.0 Percentage of Participants
Interval 3.6 to 62.4
|
—
|
SECONDARY outcome
Timeframe: From Day of vaccination in booster phase (Month 18) up to Month 30 (Approximately maximum up to 12 Months)Population: Booster safety population included all participants who received the booster vaccination.
SAE was any untoward medical occurrence that at any dose resulted in any of the following outcomes or deemed significant for any other reason: death; required inpatient prolonged existing hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly/birth defect. Two-sided 95% confidence intervals were calculated according to Altman method.
Outcome measures
| Measure |
VLA15 With Alum Lower Dose
n=39 Participants
Main Study Phase: VLA15 with Alum lower dose - Booster Phase: arm discontinued VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
VLA15 With Alum Higher Dose
n=19 Participants
Main Study Phase: VLA15 with Alum higher dose - Booster Phase: VLA15 higher dose or placebo VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
Placebo
Main Study Phase: placebo - Booster Phase: arm discontinued Placebo: PBS (Phosphate Buffered Saline).
|
|---|---|---|---|
|
Percentage of Participants With SAEs During the Entire Booster Phase
|
7.7 Percentage of Participants
Interval 2.7 to 20.3
|
0.0 Percentage of Participants
Interval 0.0 to 16.8
|
—
|
SECONDARY outcome
Timeframe: From Day of vaccination in booster phase (Month 18) up to Month 30 (Approximately maximum up to 12 Months)Population: Booster safety population included all participants who received the booster vaccination.
SAE was any untoward medical occurrence that at any dose resulted in any of the following outcomes or deemed significant for any other reason: death; required inpatient prolonged existing hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly/birth defect. Relatedness to study vaccine was assessed by the investigator. Two-sided 95% confidence intervals were calculated according to Altman method.
Outcome measures
| Measure |
VLA15 With Alum Lower Dose
n=39 Participants
Main Study Phase: VLA15 with Alum lower dose - Booster Phase: arm discontinued VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
VLA15 With Alum Higher Dose
n=19 Participants
Main Study Phase: VLA15 with Alum higher dose - Booster Phase: VLA15 higher dose or placebo VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
Placebo
Main Study Phase: placebo - Booster Phase: arm discontinued Placebo: PBS (Phosphate Buffered Saline).
|
|---|---|---|---|
|
Percentage of Participants With Related SAEs During the Entire Booster Phase
|
0.0 Percentage of Participants
Interval 0.0 to 9.0
|
0.0 Percentage of Participants
Interval 0.0 to 16.8
|
—
|
SECONDARY outcome
Timeframe: From Day of vaccination in booster phase (Month 18) up to Month 30 (Approximately maximum up to 12 Months)Population: Booster safety population included all participants who received the booster vaccination.
AESIs were defined as serious or non-serious AEs which were of scientific and medical concern specific to the investigational product. Two-sided 95% confidence intervals were calculated according to Altman method.
Outcome measures
| Measure |
VLA15 With Alum Lower Dose
n=39 Participants
Main Study Phase: VLA15 with Alum lower dose - Booster Phase: arm discontinued VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
VLA15 With Alum Higher Dose
n=19 Participants
Main Study Phase: VLA15 with Alum higher dose - Booster Phase: VLA15 higher dose or placebo VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
Placebo
Main Study Phase: placebo - Booster Phase: arm discontinued Placebo: PBS (Phosphate Buffered Saline).
|
|---|---|---|---|
|
Percentage of Participants With Adverse Event of Special Interest (AESIs) During the Entire Booster Phase
|
2.6 Percentage of Participants
Interval 0.5 to 13.2
|
0.0 Percentage of Participants
Interval 0.0 to 16.8
|
—
|
SECONDARY outcome
Timeframe: From Day of vaccination in booster phase (Month 18) up to Month 30 (Approximately maximum up to 12 Months)Population: Booster safety population included all participants who received the booster vaccination.
AESIs were defined as serious or non-serious AEs which were of scientific and medical concern specific to the investigational product. Relatedness to study vaccine was assessed by the investigator. Two-sided 95% confidence intervals were calculated according to Altman method.
Outcome measures
| Measure |
VLA15 With Alum Lower Dose
n=39 Participants
Main Study Phase: VLA15 with Alum lower dose - Booster Phase: arm discontinued VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
VLA15 With Alum Higher Dose
n=19 Participants
Main Study Phase: VLA15 with Alum higher dose - Booster Phase: VLA15 higher dose or placebo VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
Placebo
Main Study Phase: placebo - Booster Phase: arm discontinued Placebo: PBS (Phosphate Buffered Saline).
|
|---|---|---|---|
|
Percentage of Participants With Related AESIs During the Entire Booster Phase
|
0.0 Percentage of Participants
Interval 0.0 to 9.0
|
0.0 Percentage of Participants
Interval 0.0 to 16.8
|
—
|
SECONDARY outcome
Timeframe: From Day of vaccination in booster phase (Month 18) up to Month 19 (Approximately for 1 Month)Population: Booster safety population included all participants who received the booster vaccination.
An unsolicited AE includes any untoward medical occurrence in a clinical investigation participant temporally associated with the use of investigational product, whether or not related to investigational product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up (more than 6 days after vaccination) for solicited symptoms. Two-sided 95% confidence intervals were calculated according to Altman method.
Outcome measures
| Measure |
VLA15 With Alum Lower Dose
n=39 Participants
Main Study Phase: VLA15 with Alum lower dose - Booster Phase: arm discontinued VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
VLA15 With Alum Higher Dose
n=19 Participants
Main Study Phase: VLA15 with Alum higher dose - Booster Phase: VLA15 higher dose or placebo VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
Placebo
Main Study Phase: placebo - Booster Phase: arm discontinued Placebo: PBS (Phosphate Buffered Saline).
|
|---|---|---|---|
|
Percentage of Participants With Unsolicited AEs During the Booster Phase up to Month 19
|
15.4 Percentage of Participants
Interval 7.2 to 29.7
|
5.3 Percentage of Participants
Interval 0.9 to 24.6
|
—
|
SECONDARY outcome
Timeframe: From Day of vaccination in booster phase (Month 18) up to Month 19 (Approximately for 1 Month)Population: Booster safety population included all participants who received the booster vaccination.
An unsolicited AE included any untoward medical occurrence in a clinical investigation participant temporally associated with the use of investigational product, whether or not related to investigational product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up (more than 6 days after vaccination) for solicited symptoms. Relatedness to study vaccine was assessed by the investigator. Two-sided 95% confidence intervals were calculated according to Altman method.
Outcome measures
| Measure |
VLA15 With Alum Lower Dose
n=39 Participants
Main Study Phase: VLA15 with Alum lower dose - Booster Phase: arm discontinued VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
VLA15 With Alum Higher Dose
n=19 Participants
Main Study Phase: VLA15 with Alum higher dose - Booster Phase: VLA15 higher dose or placebo VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
Placebo
Main Study Phase: placebo - Booster Phase: arm discontinued Placebo: PBS (Phosphate Buffered Saline).
|
|---|---|---|---|
|
Percentage of Participants With Related Unsolicited AEs During the Booster Phase up to Month 19
|
5.1 Percentage of Participants
Interval 1.4 to 16.9
|
0.0 Percentage of Participants
Interval 0.0 to 16.8
|
—
|
SECONDARY outcome
Timeframe: Within 7 days after booster vaccinationPopulation: Booster safety population included all participants who received the booster vaccination.
Solicited local AEs included pain, tenderness, induration (hardening), swelling and erythema (redness). Solicited systemic AEs included headache, myalgia (muscle pain), arthralgia (joint pain), fever (oral body temperature), flu-like symptoms, nausea, vomiting and fatigue. Two-sided 95% confidence intervals were calculated according to Altman method.
Outcome measures
| Measure |
VLA15 With Alum Lower Dose
n=39 Participants
Main Study Phase: VLA15 with Alum lower dose - Booster Phase: arm discontinued VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
VLA15 With Alum Higher Dose
n=19 Participants
Main Study Phase: VLA15 with Alum higher dose - Booster Phase: VLA15 higher dose or placebo VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
Placebo
Main Study Phase: placebo - Booster Phase: arm discontinued Placebo: PBS (Phosphate Buffered Saline).
|
|---|---|---|---|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Booster Vaccination
Solicited local AEs
|
89.7 Percentage of Participants
Interval 76.4 to 95.9
|
42.1 Percentage of Participants
Interval 23.1 to 63.7
|
—
|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Booster Vaccination
Solicited systemic AEs
|
51.3 Percentage of Participants
Interval 36.2 to 66.1
|
31.6 Percentage of Participants
Interval 15.4 to 54.0
|
—
|
SECONDARY outcome
Timeframe: SAEs and AESIs: From Day of vaccination in booster phase (Month 18) up to Month 30 (Approximately maximum up to 12 Months); AEs: From Day of vaccination in booster phase (Month 18) up to Month 19 (Approximately for 1 Month)Population: Booster safety population included all participants who received the booster vaccination. Here "Number Analyzed" signifies participants evaluable for this outcome measure at specified rows.
Percentage of participants with SAEs, AESIs, solicited and unsolicited AEs during booster phase stratified by age group 18-49 years and 50-65 years were reported. SAE: any untoward medical occurrence that at any dose resulted in any of the following outcomes or deemed significant for any other reason: death; required inpatient prolonged existing hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly/birth defect. AESI: any AEs of scientific/medical concern specific to study vaccine; Solicited AE: predefined reactions at injection site or systemic reactions after each vaccination. Unsolicited AE: any untoward medical occurrence in participant associated with use of study vaccine, whether or not related to study vaccine, reported in addition to solicited and any solicited symptom with onset outside specified period of follow-up.
Outcome measures
| Measure |
VLA15 With Alum Lower Dose
n=39 Participants
Main Study Phase: VLA15 with Alum lower dose - Booster Phase: arm discontinued VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
VLA15 With Alum Higher Dose
n=19 Participants
Main Study Phase: VLA15 with Alum higher dose - Booster Phase: VLA15 higher dose or placebo VLA15: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
Placebo
Main Study Phase: placebo - Booster Phase: arm discontinued Placebo: PBS (Phosphate Buffered Saline).
|
|---|---|---|---|
|
Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Booster Phase
SAE: 18-49 Years
|
4.5 Percentage of Participants
Interval 0.8 to 21.8
|
0.0 Percentage of Participants
Interval 0.0 to 21.5
|
—
|
|
Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Booster Phase
SAE: 50-65 Years
|
11.8 Percentage of Participants
Interval 3.3 to 34.3
|
0.0 Percentage of Participants
Interval 0.0 to 43.4
|
—
|
|
Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Booster Phase
AESI: 18-49 Years
|
0.0 Percentage of Participants
Interval 0.0 to 14.9
|
0.0 Percentage of Participants
Interval 0.0 to 21.5
|
—
|
|
Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Booster Phase
AESI: 50-65 Years
|
5.9 Percentage of Participants
Interval 1.0 to 27.0
|
0.0 Percentage of Participants
Interval 0.0 to 43.4
|
—
|
|
Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Booster Phase
Solicited AE: 18-49 Years
|
86.4 Percentage of Participants
Interval 66.7 to 95.3
|
42.9 Percentage of Participants
Interval 21.4 to 67.4
|
—
|
|
Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Booster Phase
Solicited AE: 50-65 Years
|
94.1 Percentage of Participants
Interval 73.0 to 99.0
|
80.0 Percentage of Participants
Interval 37.6 to 96.4
|
—
|
|
Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Booster Phase
Unsolicited AE: 18-49 Years
|
9.1 Percentage of Participants
Interval 2.5 to 27.8
|
0.0 Percentage of Participants
Interval 0.0 to 21.5
|
—
|
|
Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group During the Booster Phase
Unsolicited AE: 50-65 Years
|
23.5 Percentage of Participants
Interval 9.6 to 47.3
|
20.0 Percentage of Participants
Interval 3.6 to 62.4
|
—
|
Adverse Events
Main Study Phase: VLA15 With Alum Lower Dose
Serious events: 4 serious events
Other events: 94 other events
Deaths: 0 deaths
Main Study Phase: VLA15 With Alum Higher Dose
Serious events: 4 serious events
Other events: 97 other events
Deaths: 0 deaths
Main Study Phase: Placebo
Serious events: 2 serious events
Other events: 40 other events
Deaths: 0 deaths
Booster Phase: VLA15 With Alum Higher Dose
Serious events: 3 serious events
Other events: 35 other events
Deaths: 0 deaths
Booster Phase: Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Main Study Phase: VLA15 With Alum Lower Dose
n=97 participants at risk
0.75 ml injection of VLA15 w/ alum applied at Days 1, 57, and 180. VLA15 is a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
Main Study Phase: VLA15 With Alum Higher Dose
n=98 participants at risk
1 ml injection of VLA15 w/ alum applied at Days 1, 57, and 180. VLA15 is a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
Main Study Phase: Placebo
n=51 participants at risk
1 ml injection of placebo applied at Days 1, 57, and 180. Placebo: phosphate buffered saline (PBS) solution.
|
Booster Phase: VLA15 With Alum Higher Dose
n=39 participants at risk
Participants who received higher dose of VLA15 with alum in main study phase were randomized to receive a single booster dose of VLA15 with alum higher dose vaccine at Month 18 in booster phase.
|
Booster Phase: Placebo
n=19 participants at risk
Participants who received higher dose of VLA15 with alum in main study phase were randomized to receive a single dose of placebo at Month 18 in booster phase.
|
|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/97 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/98 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
2.0%
1/51 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/39 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/19 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
1.0%
1/97 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/98 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/51 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/39 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/19 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.0%
1/97 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/98 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/51 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/39 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/19 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/97 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
1.0%
1/98 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/51 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/39 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/19 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/97 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
1.0%
1/98 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/51 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
2.6%
1/39 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/19 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
|
Ear and labyrinth disorders
Vertigo
|
1.0%
1/97 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/98 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/51 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/39 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/19 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/97 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
1.0%
1/98 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/51 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/39 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/19 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.00%
0/97 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/98 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
2.0%
1/51 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/39 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/19 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/97 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
1.0%
1/98 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/51 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/39 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/19 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
1.0%
1/97 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/98 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/51 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/39 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/19 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/97 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
1.0%
1/98 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/51 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/39 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/19 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/97 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/98 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/51 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
2.6%
1/39 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/19 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/97 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/98 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/51 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
2.6%
1/39 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/19 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
Other adverse events
| Measure |
Main Study Phase: VLA15 With Alum Lower Dose
n=97 participants at risk
0.75 ml injection of VLA15 w/ alum applied at Days 1, 57, and 180. VLA15 is a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
Main Study Phase: VLA15 With Alum Higher Dose
n=98 participants at risk
1 ml injection of VLA15 w/ alum applied at Days 1, 57, and 180. VLA15 is a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate.
|
Main Study Phase: Placebo
n=51 participants at risk
1 ml injection of placebo applied at Days 1, 57, and 180. Placebo: phosphate buffered saline (PBS) solution.
|
Booster Phase: VLA15 With Alum Higher Dose
n=39 participants at risk
Participants who received higher dose of VLA15 with alum in main study phase were randomized to receive a single booster dose of VLA15 with alum higher dose vaccine at Month 18 in booster phase.
|
Booster Phase: Placebo
n=19 participants at risk
Participants who received higher dose of VLA15 with alum in main study phase were randomized to receive a single dose of placebo at Month 18 in booster phase.
|
|---|---|---|---|---|---|
|
General disorders
Injection site pain
|
95.9%
93/97 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
96.9%
95/98 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
31.4%
16/51 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
89.7%
35/39 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
26.3%
5/19 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
|
General disorders
Injection site erythema
|
28.9%
28/97 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
41.8%
41/98 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
15.7%
8/51 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
17.9%
7/39 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
15.8%
3/19 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
|
General disorders
Fatigue
|
32.0%
31/97 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
33.7%
33/98 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
25.5%
13/51 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
20.5%
8/39 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
10.5%
2/19 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
|
General disorders
Injection site induration
|
27.8%
27/97 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
29.6%
29/98 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
2.0%
1/51 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
5.1%
2/39 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/19 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
|
General disorders
Injection site swelling
|
24.7%
24/97 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
32.7%
32/98 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
2.0%
1/51 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
7.7%
3/39 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
5.3%
1/19 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
|
General disorders
Influenza like illness
|
18.6%
18/97 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
9.2%
9/98 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
19.6%
10/51 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
2.6%
1/39 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/19 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
|
General disorders
Pyrexia
|
8.2%
8/97 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
6.1%
6/98 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
2.0%
1/51 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/39 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/19 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
|
General disorders
Injection site pruritus
|
0.00%
0/97 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
5.1%
5/98 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/51 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/39 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/19 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
55.7%
54/97 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
56.1%
55/98 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
21.6%
11/51 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
28.2%
11/39 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
5.3%
1/19 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
24.7%
24/97 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
23.5%
23/98 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
15.7%
8/51 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
10.3%
4/39 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
5.3%
1/19 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
|
Nervous system disorders
Headache
|
46.4%
45/97 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
45.9%
45/98 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
35.3%
18/51 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
20.5%
8/39 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
21.1%
4/19 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
|
Gastrointestinal disorders
Nausea
|
18.6%
18/97 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
17.3%
17/98 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
11.8%
6/51 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
7.7%
3/39 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/19 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
2/97 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
5.1%
5/98 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/51 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
2.6%
1/39 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/19 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.3%
10/97 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
7.1%
7/98 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
7.8%
4/51 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/39 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/19 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
|
Infections and infestations
Nasopharyngitis
|
7.2%
7/97 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
6.1%
6/98 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
7.8%
4/51 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/39 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/19 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
|
Infections and infestations
Sinusitis
|
3.1%
3/97 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/98 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
9.8%
5/51 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/39 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/19 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
|
Infections and infestations
Influenza
|
2.1%
2/97 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
1.0%
1/98 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
5.9%
3/51 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/39 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/19 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.1%
4/97 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
5.1%
5/98 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
5.9%
3/51 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/39 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/19 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
|
Investigations
Red blood cells urine positive
|
2.1%
2/97 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
2.0%
2/98 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
5.9%
3/51 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/39 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/19 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
|
Infections and infestations
COVID-19
|
4.1%
4/97 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
5.1%
5/98 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
2.0%
1/51 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/39 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/19 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
4.1%
4/97 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
5.1%
5/98 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
3.9%
2/51 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/39 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/19 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/97 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
1.0%
1/98 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
5.9%
3/51 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/39 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/19 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/97 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/98 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/51 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
0.00%
0/39 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
5.3%
1/19 • Solicited AEs (systematic assessment [SA]): up to 7 days after each vaccination; Main study phase: unsolicited AEs (non-SA) including SAEs: up to Day 545; Booster phase: unsolicited AEs (non-SA): From day of vaccination in booster phase (Month 18) up to Month 19 (1 month), SAEs: From day of vaccination in booster phase (Month 18) up to Month 30 (12 months)
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 were collected by systematic assessment through participant diaries. Safety population: participants who entered into study and received at least 1 dose of vaccination. For Booster phase, Safety booster population was used.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place