Trial Outcomes & Findings for Dose-Confirmation, Immunogenicity and Safety Study of the Clostridium Difficile Vaccine Candidate VLA84 in Healthy Adults Aged 50 Years and Older. Phase II Study (NCT NCT02316470)
NCT ID: NCT02316470
Last Updated: 2017-06-08
Results Overview
Seroconversion Rate (SCR), defined as percentage of subjects achieving a ≥4-fold increase in antibody titer from Day 0, for IgG against both Toxin A and Toxin B on Day 56;
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
500 participants
Primary outcome timeframe
Day 56
Results posted on
2017-06-08
Participant Flow
Participant milestones
| Measure |
VLA84 75 mcg (Microgram) w/o Alum
VLA84 75 mcg w/o Alum consists of 1 injection of 0.75 mL (milliliters) VLA84 w/o Alum and 1 injection of 0.75 mL Placebo Vaccination Days: 0, 7 and 28
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution
|
VLA84 200 mcg w/o Alum
VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
VLA84 200 mcg w/ Alum
VLA84 200 mcg w/ (with) Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
Placebo
Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28
Placebo: phosphate buffered saline (PBS) solution
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
148
|
152
|
152
|
48
|
|
Overall Study
COMPLETED
|
143
|
146
|
147
|
46
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
5
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dose-Confirmation, Immunogenicity and Safety Study of the Clostridium Difficile Vaccine Candidate VLA84 in Healthy Adults Aged 50 Years and Older. Phase II Study
Baseline characteristics by cohort
| Measure |
VLA84 75 mcg (Microgram) w/o Alum
n=148 Participants
VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution
|
VLA84 200 mcg w/o Alum
n=152 Participants
VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
VLA84 200 mcg With Alum
n=152 Participants
VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
Placebo
n=48 Participants
Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution
|
Total
n=500 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
72 Participants
n=39 Participants
|
77 Participants
n=41 Participants
|
77 Participants
n=35 Participants
|
24 Participants
n=31 Participants
|
250 Participants
n=146 Participants
|
|
Age, Categorical
>=65 years
|
76 Participants
n=39 Participants
|
75 Participants
n=41 Participants
|
75 Participants
n=35 Participants
|
24 Participants
n=31 Participants
|
250 Participants
n=146 Participants
|
|
Age, Continuous
|
64.3 years
STANDARD_DEVIATION 8.86 • n=39 Participants
|
64.1 years
STANDARD_DEVIATION 9.34 • n=41 Participants
|
63.9 years
STANDARD_DEVIATION 9.15 • n=35 Participants
|
63.7 years
STANDARD_DEVIATION 9.49 • n=31 Participants
|
64.0 years
STANDARD_DEVIATION 9.13 • n=146 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=39 Participants
|
82 Participants
n=41 Participants
|
87 Participants
n=35 Participants
|
24 Participants
n=31 Participants
|
268 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=39 Participants
|
70 Participants
n=41 Participants
|
65 Participants
n=35 Participants
|
24 Participants
n=31 Participants
|
232 Participants
n=146 Participants
|
|
Region of Enrollment
United States
|
118 Participants
n=39 Participants
|
119 Participants
n=41 Participants
|
118 Participants
n=35 Participants
|
39 Participants
n=31 Participants
|
394 Participants
n=146 Participants
|
|
Region of Enrollment
Germany
|
30 Participants
n=39 Participants
|
33 Participants
n=41 Participants
|
34 Participants
n=35 Participants
|
9 Participants
n=31 Participants
|
106 Participants
n=146 Participants
|
PRIMARY outcome
Timeframe: Day 56Population: per-protocol population,i.e., subjects who received at least one study vaccination without any major protocol deviation up to Day 210
Seroconversion Rate (SCR), defined as percentage of subjects achieving a ≥4-fold increase in antibody titer from Day 0, for IgG against both Toxin A and Toxin B on Day 56;
Outcome measures
| Measure |
VLA84 75 mcg (Microgram) w/o Alum
n=137 Participants
VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution
|
VLA84 200 mcg w/o Alum
n=135 Participants
VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
VLA84 200 mcg With Alum
n=141 Participants
VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
Placebo
n=46 Participants
Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution
|
|---|---|---|---|---|
|
Seroconversion Rate (SCR) on Day 56
|
71.5 percentage of study participants
Interval 63.5 to 78.4
|
83.0 percentage of study participants
Interval 75.7 to 88.4
|
59.6 percentage of study participants
Interval 51.3 to 67.3
|
0.0 percentage of study participants
Interval 0.0 to 7.7
|
SECONDARY outcome
Timeframe: Days 14, 28, 35, 120 and 210Population: per-protocol population,i.e., subjects who received at least one study vaccination without any major protocol deviation up to Day 210
Seroconversion Rate (SCR), defined as percentage of subjects achieving a ≥4-fold increase in antibody titer from Day 0, for IgG against both Toxin A and Toxin B on Day 14, 28, 35, 120 and 210;
Outcome measures
| Measure |
VLA84 75 mcg (Microgram) w/o Alum
n=137 Participants
VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution
|
VLA84 200 mcg w/o Alum
n=135 Participants
VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
VLA84 200 mcg With Alum
n=141 Participants
VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
Placebo
n=46 Participants
Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution
|
|---|---|---|---|---|
|
SCR for IgG (Immunoglobulin G) Against Both Toxin A and Toxin B
SCR at Day 14
|
31.4 percentage of participants
Interval 24.2 to 39.6
|
38.8 percentage of participants
Interval 31.0 to 47.3
|
27.7 percentage of participants
Interval 20.9 to 35.6
|
2.2 percentage of participants
Interval 0.4 to 11.3
|
|
SCR for IgG (Immunoglobulin G) Against Both Toxin A and Toxin B
SCR at Day 28
|
38.0 percentage of participants
Interval 30.3 to 46.3
|
49.6 percentage of participants
Interval 41.3 to 58.0
|
37.6 percentage of participants
Interval 30.0 to 45.8
|
2.2 percentage of participants
Interval 0.4 to 11.3
|
|
SCR for IgG (Immunoglobulin G) Against Both Toxin A and Toxin B
SCR at Day 210
|
54.5 percentage of participants
Interval 46.0 to 62.7
|
68.9 percentage of participants
Interval 60.6 to 76.2
|
44.5 percentage of participants
Interval 36.5 to 52.9
|
0.0 percentage of participants
Interval 0.0 to 7.9
|
|
SCR for IgG (Immunoglobulin G) Against Both Toxin A and Toxin B
SCR at Day 35
|
56.9 percentage of participants
Interval 48.6 to 64.9
|
68.9 percentage of participants
Interval 60.6 to 76.1
|
50.4 percentage of participants
Interval 42.2 to 58.5
|
2.2 percentage of participants
Interval 0.4 to 11.3
|
|
SCR for IgG (Immunoglobulin G) Against Both Toxin A and Toxin B
SCR at Day 120
|
64.2 percentage of participants
Interval 55.9 to 71.8
|
77.4 percentage of participants
Interval 69.6 to 83.7
|
53.6 percentage of participants
Interval 45.3 to 61.1
|
0.0 percentage of participants
Interval 0.0 to 7.9
|
SECONDARY outcome
Timeframe: 14, 28, 35, 56, 120 and 210Population: per-protocol population,i.e., subjects who received at least one study vaccination without any major protocol deviation up to Day 210
Seroconversion Rate (SCR), defined as percentage of subjects achieving a ≥4-fold increase in antibody titer from Day 0, for IgG against Toxin A;
Outcome measures
| Measure |
VLA84 75 mcg (Microgram) w/o Alum
n=137 Participants
VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution
|
VLA84 200 mcg w/o Alum
n=135 Participants
VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
VLA84 200 mcg With Alum
n=141 Participants
VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
Placebo
n=46 Participants
Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution
|
|---|---|---|---|---|
|
Seroconversion Rate (SCR) for IgG Against Toxin A
SCR at Day 14
|
36.5 percentage of participants
Interval 28.9 to 44.8
|
46.3 percentage of participants
Interval 38.0 to 54.7
|
36.2 percentage of participants
Interval 28.7 to 44.4
|
4.3 percentage of participants
Interval 1.2 to 14.5
|
|
Seroconversion Rate (SCR) for IgG Against Toxin A
SCR at Day 28
|
51.8 percentage of participants
Interval 43.5 to 60.0
|
63.0 percentage of participants
Interval 54.6 to 70.6
|
69.5 percentage of participants
Interval 61.5 to 76.5
|
4.3 percentage of participants
Interval 1.2 to 14.5
|
|
Seroconversion Rate (SCR) for IgG Against Toxin A
SCR at Day 35
|
70.1 percentage of participants
Interval 61.9 to 77.1
|
80.0 percentage of participants
Interval 72.5 to 85.9
|
90.8 percentage of participants
Interval 84.9 to 94.5
|
4.3 percentage of participants
Interval 1.2 to 14.5
|
|
Seroconversion Rate (SCR) for IgG Against Toxin A
SCR at Day 56
|
92.0 percentage of participants
Interval 86.2 to 95.5
|
94.1 percentage of participants
Interval 88.7 to 97.0
|
96.5 percentage of participants
Interval 92.0 to 98.5
|
0.0 percentage of participants
Interval 0.0 to 7.7
|
|
Seroconversion Rate (SCR) for IgG Against Toxin A
SCR at Day 120
|
88.3 percentage of participants
Interval 81.9 to 92.7
|
91.7 percentage of participants
Interval 85.8 to 95.3
|
95.7 percentage of participants
Interval 91.0 to 98.0
|
0.0 percentage of participants
Interval 0.0 to 7.9
|
|
Seroconversion Rate (SCR) for IgG Against Toxin A
SCR at Day 210
|
85.1 percentage of participants
Interval 78.1 to 90.1
|
87.1 percentage of participants
Interval 80.3 to 91.8
|
93.4 percentage of participants
Interval 88.0 to 96.5
|
2.2 percentage of participants
Interval 0.4 to 11.6
|
SECONDARY outcome
Timeframe: Days 14, 28, 35, 56, 120 and 210Population: per-protocol population,i.e., subjects who received at least one study vaccination without any major protocol deviation up to Day 210
Seroconversion Rate (SCR), defined as percentage of subjects achieving a ≥4-fold increase in antibody titer from Day 0, for IgG against Toxin B;
Outcome measures
| Measure |
VLA84 75 mcg (Microgram) w/o Alum
n=137 Participants
VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution
|
VLA84 200 mcg w/o Alum
n=135 Participants
VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
VLA84 200 mcg With Alum
n=141 Participants
VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
Placebo
n=46 Participants
Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution
|
|---|---|---|---|---|
|
Seroconversion Rate (SCR) for IgG Against Toxin B
SCR at Day 35
|
56.9 percentage of participants
Interval 48.6 to 64.9
|
70.4 percentage of participants
Interval 62.2 to 77.4
|
50.4 percentage of participants
Interval 42.2 to 58.5
|
4.3 percentage of participants
Interval 1.2 to 14.5
|
|
Seroconversion Rate (SCR) for IgG Against Toxin B
SCR at Day 56
|
71.5 percentage of participants
Interval 63.5 to 78.4
|
83.7 percentage of participants
Interval 76.6 to 89.0
|
59.6 percentage of participants
Interval 51.3 to 67.3
|
2.2 percentage of participants
Interval 0.4 to 11.3
|
|
Seroconversion Rate (SCR) for IgG Against Toxin B
SCR at Day 120
|
64.2 percentage of participants
Interval 55.9 to 71.8
|
78.2 percentage of participants
Interval 70.4 to 84.4
|
54.3 percentage of participants
Interval 46.0 to 62.3
|
0.0 percentage of participants
Interval 0.0 to 7.9
|
|
Seroconversion Rate (SCR) for IgG Against Toxin B
SCR at Day 210
|
55.2 percentage of participants
Interval 46.8 to 63.4
|
70.5 percentage of participants
Interval 62.2 to 77.6
|
45.3 percentage of participants
Interval 37.2 to 53.6
|
0.0 percentage of participants
Interval 0.0 to 7.9
|
|
Seroconversion Rate (SCR) for IgG Against Toxin B
SCR at Day 14
|
35.0 percentage of participants
Interval 27.6 to 43.3
|
44.0 percentage of participants
Interval 35.9 to 52.5
|
35.5 percentage of participants
Interval 28.0 to 43.6
|
2.2 percentage of participants
Interval 0.4 to 11.3
|
|
Seroconversion Rate (SCR) for IgG Against Toxin B
SCR at Day 28
|
41.6 percentage of participants
Interval 33.7 to 50.5
|
53.3 percentage of participants
Interval 44.9 to 61.5
|
41.1 percentage of participants
Interval 33.4 to 49.4
|
2.2 percentage of participants
Interval 0.4 to 11.3
|
SECONDARY outcome
Timeframe: Days 0, 14, 28, 35, 56, 120 and 210Population: PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210
Geometric Mean Titer (GMT) for IgG against Toxin A as determined by ELISA on Days 0, 14, 28, 35, 56 (primary endpoint time point), 120 and 210;
Outcome measures
| Measure |
VLA84 75 mcg (Microgram) w/o Alum
n=137 Participants
VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution
|
VLA84 200 mcg w/o Alum
n=135 Participants
VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
VLA84 200 mcg With Alum
n=141 Participants
VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
Placebo
n=46 Participants
Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution
|
|---|---|---|---|---|
|
Geometric Mean Titer (GMT) for IgG Against Toxin A
GMT at Day 0
|
40.5 EU/ml
Interval 35.7 to 45.9
|
37.4 EU/ml
Interval 33.4 to 41.8
|
44.9 EU/ml
Interval 39.2 to 51.4
|
37.6 EU/ml
Interval 30.0 to 47.2
|
|
Geometric Mean Titer (GMT) for IgG Against Toxin A
GMT at Day 14
|
227.2 EU/ml
Interval 144.4 to 357.6
|
350.9 EU/ml
Interval 216.6 to 568.4
|
226.1 EU/ml
Interval 144.9 to 352.6
|
38.1 EU/ml
Interval 29.4 to 49.3
|
|
Geometric Mean Titer (GMT) for IgG Against Toxin A
GMT at Day 28
|
412.3 EU/ml
Interval 266.4 to 638.1
|
623.2 EU/ml
Interval 398.2 to 975.3
|
717.7 EU/ml
Interval 495.7 to 1039.1
|
36.3 EU/ml
Interval 28.4 to 46.6
|
|
Geometric Mean Titer (GMT) for IgG Against Toxin A
GMT at Day 35
|
1056.6 EU/ml
Interval 680.4 to 1640.9
|
2083.7 EU/ml
Interval 1370.8 to 3167.3
|
3545.6 EU/ml
Interval 2577.4 to 4877.6
|
34.9 EU/ml
Interval 28.1 to 43.3
|
|
Geometric Mean Titer (GMT) for IgG Against Toxin A
GMT at Day 56
|
2868.9 EU/ml
Interval 2068.9 to 3978.1
|
4328.5 EU/ml
Interval 3160.5 to 5928.3
|
4687.6 EU/ml
Interval 3650.6 to 6019.3
|
33.9 EU/ml
Interval 28.4 to 40.3
|
|
Geometric Mean Titer (GMT) for IgG Against Toxin A
GMT at Day 120
|
1563.5 EU/ml
Interval 1157.2 to 2112.6
|
2533.8 EU/ml
Interval 1867.4 to 3438.0
|
2416.7 EU/ml
Interval 1926.7 to 3031.3
|
31.4 EU/ml
Interval 27.1 to 36.4
|
|
Geometric Mean Titer (GMT) for IgG Against Toxin A
GMT at Day 210
|
866.0 EU/ml
Interval 650.1 to 1153.6
|
1395.3 EU/ml
Interval 1044.1 to 1864.7
|
1288.8 EU/ml
Interval 1037.9 to 1600.5
|
34.3 EU/ml
Interval 27.7 to 42.5
|
SECONDARY outcome
Timeframe: Days 0, 14, 28, 35, 56, 120 and 210Population: PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210
Geometric Mean Titer (GMT) for IgG against Toxin B as determined by ELISA on Days 0, 14, 28, 35, 56 (primary endpoint time point), 120 and 210;
Outcome measures
| Measure |
VLA84 75 mcg (Microgram) w/o Alum
n=137 Participants
VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution
|
VLA84 200 mcg w/o Alum
n=135 Participants
VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
VLA84 200 mcg With Alum
n=141 Participants
VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
Placebo
n=46 Participants
Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution
|
|---|---|---|---|---|
|
Geometric Mean Titer (GMT) for IgG Against Toxin B
GMT at Day 0
|
150.1 EU/ml
Interval 126.2 to 178.5
|
107.4 EU/ml
Interval 90.3 to 127.8
|
131.9 EU/ml
Interval 109.0 to 159.6
|
104.3 EU/ml
Interval 73.6 to 147.7
|
|
Geometric Mean Titer (GMT) for IgG Against Toxin B
GMT at Day 28
|
949.2 EU/ml
Interval 602.3 to 1495.9
|
1026.5 EU/ml
Interval 636.2 to 1656.2
|
754.5 EU/ml
Interval 476.3 to 1195.2
|
107.6 EU/ml
Interval 76.8 to 150.7
|
|
Geometric Mean Titer (GMT) for IgG Against Toxin B
GMT at Day 35
|
1651.4 EU/ml
Interval 1070.3 to 2547.9
|
2377.1 EU/ml
Interval 1558.6 to 3625.4
|
1165.9 EU/ml
Interval 763.4 to 1780.9
|
107.0 EU/ml
Interval 75.3 to 151.9
|
|
Geometric Mean Titer (GMT) for IgG Against Toxin B
GMT at Day 56
|
2370.5 EU/ml
Interval 1641.2 to 3423.8
|
3336.5 EU/ml
Interval 2398.9 to 4640.7
|
1449.4 EU/ml
Interval 1001.8 to 2097.2
|
107.8 EU/ml
Interval 77.0 to 151.0
|
|
Geometric Mean Titer (GMT) for IgG Against Toxin B
GMT at Day 120
|
1304.5 EU/ml
Interval 942.0 to 1806.5
|
1699.9 EU/ml
Interval 1250.0 to 2311.6
|
881.3 EU/ml
Interval 632.1 to 1228.8
|
92.1 EU/ml
Interval 66.1 to 128.2
|
|
Geometric Mean Titer (GMT) for IgG Against Toxin B
GMT at Day 210
|
863.3 EU/ml
Interval 639.8 to 1165.0
|
1023.0 EU/ml
Interval 770.8 to 1357.7
|
595.4 EU/ml
Interval 431.7 to 821.1
|
96.1 EU/ml
Interval 69.1 to 133.5
|
|
Geometric Mean Titer (GMT) for IgG Against Toxin B
GMT at Day 14
|
778.4 EU/ml
Interval 478.7 to 1265.8
|
951.8 EU/ml
Interval 561.1 to 1614.6
|
585.0 EU/ml
Interval 359.7 to 951.6
|
98.8 EU/ml
Interval 69.4 to 140.7
|
SECONDARY outcome
Timeframe: Days 0, 35, 56, 120 and 210Population: PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210
GMT for Toxin A neutralizing antibodies (TNA) as determined by Toxin Neutralization Assay on Days 0, 35, 56, 120\* and 210 \* TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured.
Outcome measures
| Measure |
VLA84 75 mcg (Microgram) w/o Alum
n=137 Participants
VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution
|
VLA84 200 mcg w/o Alum
n=135 Participants
VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
VLA84 200 mcg With Alum
n=141 Participants
VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
Placebo
n=46 Participants
Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution
|
|---|---|---|---|---|
|
GMT for Toxin A Neutralizing Antibodies
GMT at Day 0
|
11.0 Titer
Interval 10.2 to 11.8
|
10.3 Titer
Interval 9.9 to 10.8
|
10.8 Titer
Interval 10.1 to 11.5
|
10.0 Titer
Interval 10.0 to 10.0
|
|
GMT for Toxin A Neutralizing Antibodies
GMT at Day 35
|
93.5 Titer
Interval 63.3 to 138.1
|
155.2 Titer
Interval 104.9 to 229.7
|
148.7 Titer
Interval 104.3 to 211.9
|
10.3 Titer
Interval 9.7 to 10.9
|
|
GMT for Toxin A Neutralizing Antibodies
GMT at Day 56
|
143.1 Titer
Interval 102.4 to 200.0
|
200.9 Titer
Interval 144.1 to 280.0
|
153.3 Titer
Interval 112.5 to 209.0
|
10.3 Titer
Interval 9.9 to 10.9
|
|
GMT for Toxin A Neutralizing Antibodies
GMT at Day 210
|
95.1 Titer
Interval 69.2 to 130.7
|
168.7 Titer
Interval 122.6 to 232.3
|
189.4 Titer
Interval 148.1 to 242.3
|
10.2 Titer
Interval 9.8 to 10.6
|
SECONDARY outcome
Timeframe: Days 0, 35, 56, 120 and 210Population: PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210
GMT for Toxin B neutralizing antibodies (TNA) as determined by Toxin Neutralization Assay on Days 0, 35, 56, 120\* and 210 \* TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured.
Outcome measures
| Measure |
VLA84 75 mcg (Microgram) w/o Alum
n=137 Participants
VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution
|
VLA84 200 mcg w/o Alum
n=135 Participants
VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
VLA84 200 mcg With Alum
n=141 Participants
VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
Placebo
n=46 Participants
Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution
|
|---|---|---|---|---|
|
GMT for Toxin B Neutralizing Antibodies
GMT at Day 210
|
51.0 Titer
Interval 37.9 to 68.8
|
61.0 Titer
Interval 46.3 to 80.4
|
43.0 Titer
Interval 31.7 to 58.3
|
17.2 Titer
Interval 12.5 to 23.7
|
|
GMT for Toxin B Neutralizing Antibodies
GMT at Day 0
|
17.4 Titer
Interval 14.4 to 20.9
|
15.9 Titer
Interval 13.5 to 18.8
|
19.1 Titer
Interval 15.5 to 23.6
|
18.3 Titer
Interval 13.0 to 25.7
|
|
GMT for Toxin B Neutralizing Antibodies
GMT at Day 35
|
72.9 Titer
Interval 51.0 to 104.3
|
99.6 Titer
Interval 71.0 to 139.9
|
61.6 Titer
Interval 44.0 to 86.4
|
18.6 Titer
Interval 13.3 to 26.1
|
|
GMT for Toxin B Neutralizing Antibodies
GMT at Day 56
|
69.8 Titer
Interval 50.8 to 95.9
|
74.3 Titer
Interval 55.4 to 99.6
|
52.3 Titer
Interval 38.4 to 71.1
|
19.1 Titer
Interval 13.9 to 26.2
|
SECONDARY outcome
Timeframe: Days 14, 28, 35, 56, 120 and 210Population: PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210
Seroconversion Rate (SCR) for IgG against Toxin A, against Toxin B and against both Toxin A and Toxin B on Days 14, 28, 35, 56, 120 and 210, stratified by age group (subjects 50 - \< 65 years and 65 years and older)
Outcome measures
| Measure |
VLA84 75 mcg (Microgram) w/o Alum
n=137 Participants
VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution
|
VLA84 200 mcg w/o Alum
n=135 Participants
VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
VLA84 200 mcg With Alum
n=141 Participants
VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
Placebo
n=46 Participants
Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution
|
|---|---|---|---|---|
|
SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
SCR against Toxin B at Day 120; 50 to < 65
|
58.2 percentage of participants
Interval 46.3 to 69.3
|
80.6 percentage of participants
Interval 69.6 to 88.3
|
50.0 percentage of participants
Interval 38.6 to 61.4
|
0.0 percentage of participants
Interval 0.0 to 14.9
|
|
SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
SCR against Toxin A and B at Day 14; 50 to < 65
|
31.3 percentage of participants
Interval 21.5 to 43.2
|
42.6 percentage of participants
Interval 31.6 to 54.5
|
27.1 percentage of participants
Interval 18.1 to 38.5
|
4.5 percentage of participants
Interval 0.8 to 21.8
|
|
SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
SCR against Toxin A and B at Day 28; 50 to < 65
|
32.8 percentage of participants
Interval 22.8 to 44.7
|
54.4 percentage of participants
Interval 42.7 to 65.7
|
34.3 percentage of participants
Interval 24.2 to 46.0
|
4.5 percentage of participants
Interval 0.8 to 21.8
|
|
SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
SCR against Toxin A and B at Day 35; 50 to < 65
|
55.2 percentage of participants
Interval 43.4 to 66.5
|
72.1 percentage of participants
Interval 60.4 to 81.3
|
50.0 percentage of participants
Interval 38.6 to 61.4
|
4.5 percentage of participants
Interval 0.8 to 21.8
|
|
SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
SCR against Toxin A and B at Day 56; 50 to < 65
|
70.1 percentage of participants
Interval 58.3 to 79.8
|
86.8 percentage of participants
Interval 76.7 to 92.9
|
60.0 percentage of participants
Interval 48.3 to 70.7
|
0.0 percentage of participants
Interval 0.0 to 14.9
|
|
SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
SCR against Toxin A and B at Day 120; 50 to < 65
|
58.2 percentage of participants
Interval 46.3 to 69.3
|
80.6 percentage of participants
Interval 69.6 to 88.3
|
50.0 percentage of participants
Interval 38.6 to 61.4
|
0.0 percentage of participants
Interval 0.0 to 14.9
|
|
SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
SCR against Toxin A and B at Day 210; 50 to < 65
|
47.7 percentage of participants
Interval 36.0 to 59.6
|
72.7 percentage of participants
Interval 61.0 to 82.0
|
41.2 percentage of participants
Interval 30.3 to 53.0
|
0.0 percentage of participants
Interval 0.0 to 14.9
|
|
SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
SCR against Toxin A and B at Day 14; 65 and older
|
31.4 percentage of participants
Interval 21.8 to 43.0
|
34.8 percentage of participants
Interval 24.5 to 46.9
|
28.2 percentage of participants
Interval 19.0 to 39.5
|
0.0 percentage of participants
Interval 0.0 to 13.8
|
|
SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
SCR against Toxin A and B at Day 28; 65 and older
|
42.9 percentage of participants
Interval 31.9 to 54.5
|
44.8 percentage of participants
Interval 33.5 to 56.6
|
40.8 percentage of participants
Interval 30.2 to 52.5
|
0.0 percentage of participants
Interval 0.0 to 13.8
|
|
SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
SCR against Toxin A and B at Day 35; 65 and older
|
58.6 percentage of participants
Interval 46.9 to 69.4
|
65.7 percentage of participants
Interval 53.7 to 75.9
|
50.7 percentage of participants
Interval 39.3 to 62.0
|
0.0 percentage of participants
Interval 0.0 to 13.8
|
|
SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
SCR against Toxin A and B at Day 56; 65 and older
|
72.9 percentage of participants
Interval 61.5 to 81.9
|
79.1 percentage of participants
Interval 67.9 to 87.1
|
59.2 percentage of participants
Interval 47.5 to 69.8
|
0.0 percentage of participants
Interval 0.0 to 13.8
|
|
SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
SCR against Toxin A at Day 14; 50 to < 65
|
34.3 percentage of participants
Interval 24.1 to 46.3
|
52.9 percentage of participants
Interval 41.2 to 64.3
|
38.6 percentage of participants
Interval 28.0 to 50.3
|
9.1 percentage of participants
Interval 2.5 to 27.8
|
|
SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
SCR against Toxin A at Day 28; 50 to < 65
|
49.3 percentage of participants
Interval 37.7 to 60.9
|
67.6 percentage of participants
Interval 55.8 to 77.6
|
74.3 percentage of participants
Interval 63.0 to 83.1
|
9.1 percentage of participants
Interval 2.5 to 27.8
|
|
SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
SCR against Toxin A at Day 35; 50 to < 65
|
74.6 percentage of participants
Interval 63.1 to 83.5
|
85.3 percentage of participants
Interval 75.0 to 91.8
|
94.3 percentage of participants
Interval 86.2 to 97.8
|
9.1 percentage of participants
Interval 2.5 to 27.8
|
|
SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
SCR against Toxin A at Day 56; 50 to < 65
|
89.6 percentage of participants
Interval 80.0 to 94.8
|
97.1 percentage of participants
Interval 89.9 to 99.2
|
95.7 percentage of participants
Interval 88.1 to 98.5
|
0.0 percentage of participants
Interval 0.0 to 14.9
|
|
SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
SCR against Toxin A at Day 120; 50 to < 65
|
86.6 percentage of participants
Interval 76.4 to 92.8
|
94.0 percentage of participants
Interval 85.6 to 97.7
|
95.7 percentage of participants
Interval 88.1 to 98.5
|
0.0 percentage of participants
Interval 0.0 to 14.9
|
|
SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
SCR against Toxin A at Day 210; 50 to < 65
|
81.5 percentage of participants
Interval 70.4 to 89.1
|
92.4 percentage of participants
Interval 83.5 to 96.7
|
95.6 percentage of participants
Interval 87.8 to 98.5
|
4.5 percentage of participants
Interval 0.8 to 21.8
|
|
SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
SCR against Toxin A at Day 14; 65 and older
|
38.6 percentage of participants
Interval 28.0 to 50.3
|
39.4 percentage of participants
Interval 28.5 to 51.5
|
33.8 percentage of participants
Interval 23.9 to 45.4
|
0.0 percentage of participants
Interval 0.0 to 13.8
|
|
SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
SCR against Toxin A at Day 28; 65 and older
|
54.3 percentage of participants
Interval 42.7 to 65.4
|
58.2 percentage of participants
Interval 46.3 to 69.3
|
64.8 percentage of participants
Interval 53.2 to 74.9
|
0.0 percentage of participants
Interval 0.0 to 13.8
|
|
SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
SCR against Toxin A at Day 35; 65 and older
|
65.7 percentage of participants
Interval 54.0 to 75.8
|
74.6 percentage of participants
Interval 63.1 to 83.5
|
87.3 percentage of participants
Interval 77.6 to 93.2
|
0.0 percentage of participants
Interval 0.0 to 13.8
|
|
SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
SCR against Toxin A at Day 56; 65 and older
|
94.3 percentage of participants
Interval 86.2 to 97.8
|
91.0 percentage of participants
Interval 81.8 to 95.8
|
97.2 percentage of participants
Interval 90.3 to 99.2
|
0.0 percentage of participants
Interval 0.0 to 13.8
|
|
SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
SCR against Toxin A at Day 120; 65 and older
|
90.0 percentage of participants
Interval 80.8 to 95.1
|
89.4 percentage of participants
Interval 79.7 to 94.8
|
95.7 percentage of participants
Interval 88.1 to 98.5
|
0.0 percentage of participants
Interval 0.0 to 14.3
|
|
SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
SCR against Toxin A at Day 210; 65 and older
|
88.4 percentage of participants
Interval 78.8 to 94.0
|
81.8 percentage of participants
Interval 70.9 to 89.3
|
91.3 percentage of participants
Interval 82.3 to 96.0
|
0.0 percentage of participants
Interval 0.0 to 14.3
|
|
SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
SCR against Toxin B at Day 14; 50 to < 65
|
32.8 percentage of participants
Interval 22.8 to 44.7
|
45.6 percentage of participants
Interval 34.3 to 57.3
|
30.0 percentage of participants
Interval 20.5 to 41.5
|
4.5 percentage of participants
Interval 0.8 to 21.8
|
|
SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
SCR against Toxin B at Day 28; 50 to < 65
|
37.3 percentage of participants
Interval 26.7 to 49.3
|
55.9 percentage of participants
Interval 44.1 to 67.1
|
35.7 percentage of participants
Interval 25.5 to 47.4
|
4.5 percentage of participants
Interval 0.8 to 21.8
|
|
SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
SCR against Toxin B at Day 35; 50 to < 65
|
55.2 percentage of participants
Interval 43.4 to 66.5
|
72.1 percentage of participants
Interval 60.4 to 81.3
|
50.0 percentage of participants
Interval 38.6 to 61.4
|
9.1 percentage of participants
Interval 2.5 to 27.8
|
|
SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
SCR against Toxin B at Day 56; 50 to < 65
|
70.1 percentage of participants
Interval 58.3 to 79.8
|
86.8 percentage of participants
Interval 76.7 to 92.9
|
60.0 percentage of participants
Interval 48.3 to 70.7
|
0.0 percentage of participants
Interval 0.0 to 14.9
|
|
SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
SCR against Toxin B at Day 210; 50 to < 65
|
49.2 percentage of participants
Interval 37.5 to 61.1
|
74.2 percentage of participants
Interval 62.6 to 83.3
|
41.2 percentage of participants
Interval 30.3 to 53.0
|
0.0 percentage of participants
Interval 0.0 to 14.9
|
|
SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
SCR against Toxin B at Day 14; 65 and older
|
37.1 percentage of participants
Interval 26.8 to 48.9
|
42.4 percentage of participants
Interval 31.2 to 54.4
|
40.8 percentage of participants
Interval 30.2 to 52.5
|
0.0 percentage of participants
Interval 0.0 to 13.8
|
|
SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
SCR against Toxin B at Day 28; 65 and older
|
45.7 percentage of participants
Interval 34.6 to 57.3
|
50.7 percentage of participants
Interval 39.1 to 62.3
|
46.5 percentage of participants
Interval 35.4 to 58.0
|
0.0 percentage of participants
Interval 0.0 to 13.8
|
|
SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
SCR against Toxin B at Day 35; 65 and older
|
58.6 percentage of participants
Interval 46.9 to 69.4
|
68.7 percentage of participants
Interval 56.8 to 78.5
|
50.7 percentage of participants
Interval 39.3 to 62.0
|
0.0 percentage of participants
Interval 0.0 to 13.8
|
|
SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
SCR against Toxin B at Day 56; 65 and older
|
72.9 percentage of participants
Interval 61.5 to 81.9
|
80.6 percentage of participants
Interval 69.6 to 88.3
|
59.2 percentage of participants
Interval 47.5 to 69.8
|
4.2 percentage of participants
Interval 0.7 to 20.2
|
|
SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
SCR against Toxin B at Day 120; 65 and older
|
70.0 percentage of participants
Interval 58.5 to 79.5
|
75.8 percentage of participants
Interval 64.2 to 84.5
|
58.6 percentage of participants
Interval 46.9 to 69.4
|
0.0 percentage of participants
Interval 0.0 to 14.3
|
|
SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
SCR against Toxin B at Day 210; 65 and older
|
60.9 percentage of participants
Interval 49.1 to 71.5
|
66.7 percentage of participants
Interval 54.7 to 76.8
|
49.3 percentage of participants
Interval 37.8 to 60.8
|
0.0 percentage of participants
Interval 0.0 to 14.3
|
|
SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
SCR against Toxin A and B at Day 120; 65 and older
|
70.0 percentage of participants
Interval 58.5 to 79.5
|
74.2 percentage of participants
Interval 62.6 to 83.3
|
57.1 percentage of participants
Interval 45.5 to 68.1
|
0.0 percentage of participants
Interval 0.0 to 14.3
|
|
SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
SCR against Toxin A and B at Day 210; 65 and older
|
60.9 percentage of participants
Interval 49.1 to 71.5
|
65.2 percentage of participants
Interval 53.1 to 75.5
|
47.8 percentage of participants
Interval 36.5 to 59.4
|
0.0 percentage of participants
Interval 0.0 to 14.3
|
SECONDARY outcome
Timeframe: Days 0, 14, 28, 35, 56, 120, 210Population: PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210
GMT for IgG against Toxin A and against Toxin B on Days 0, 14, 28, 35, 56, 120 and 210, stratified by age group (subjects 50 - \< 65 years and 65 years and older)
Outcome measures
| Measure |
VLA84 75 mcg (Microgram) w/o Alum
n=137 Participants
VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution
|
VLA84 200 mcg w/o Alum
n=135 Participants
VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
VLA84 200 mcg With Alum
n=141 Participants
VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
Placebo
n=46 Participants
Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution
|
|---|---|---|---|---|
|
GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group
Toxin A: GMT at Day 0, 50 - < 65
|
42.6 EU/ml
Interval 35.6 to 51.0
|
37.7 EU/ml
Interval 32.4 to 43.9
|
41.2 EU/ml
Interval 34.5 to 49.3
|
31.4 EU/ml
Interval 2.45 to 40.3
|
|
GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group
Toxin A: GMT at Day 14, 50 - < 65
|
248.0 EU/ml
Interval 126.1 to 487.7
|
531.3 EU/ml
Interval 252.6 to 1117.5
|
216.4 EU/ml
Interval 117.8 to 397.6
|
37.7 EU/ml
Interval 25.6 to 55.7
|
|
GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group
Toxin A: GMT at Day 28, 50 - < 65
|
400.1 EU/ml
Interval 213.3 to 750.3
|
851.8 EU/ml
Interval 436.4 to 1662.5
|
704.2 EU/ml
Interval 429.0 to 1155.7
|
37.1 EU/ml
Interval 25.6 to 53.7
|
|
GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group
Toxin A: GMT at Day 35, 50 - < 65
|
1053.1 EU/ml
Interval 562.9 to 1970.1
|
2579.7 EU/ml
Interval 1444.9 to 4605.9
|
3502.1 EU/ml
Interval 2274.0 to 5393.3
|
38.1 EU/ml
Interval 25.4 to 57.1
|
|
GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group
Toxin A: GMT at Day 56, 50 - < 65
|
2581.7 EU/ml
Interval 1642.1 to 4058.7
|
4566.4 EU/ml
Interval 3027.4 to 6887.7
|
4344.8 EU/ml
Interval 3077.1 to 6134.8
|
30.5 EU/ml
Interval 23.6 to 39.5
|
|
GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group
Toxin A: GMT at Day 0, 65 and older
|
38.5 EU/ml
Interval 32.3 to 46.0
|
37.0 EU/ml
Interval 31.3 to 43.8
|
48.8 EU/ml
Interval 39.7 to 59.9
|
44.3 EU/ml
Interval 30.4 to 64.6
|
|
GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group
Toxin A: GMT at Day 14, 65 and older
|
209.0 EU/ml
Interval 112.1 to 389.7
|
228.8 EU/ml
Interval 124.0 to 422.3
|
236.0 EU/ml
Interval 121.7 to 457.9
|
38.5 EU/ml
Interval 26.5 to 55.8
|
|
GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group
Toxin A: GMT at Day 28, 65 and older
|
424.4 EU/ml
Interval 227.8 to 790.7
|
453.8 EU/ml
Interval 248.4 to 829.1
|
731.4 EU/ml
Interval 417.2 to 1282.0
|
35.6 EU/ml
Interval 24.8 to 51.1
|
|
GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group
Toxin A: GMT at Day 35, 65 and older
|
1060.0 EU/ml
Interval 562.3 to 1998.3
|
1677.7 EU/ml
Interval 906.5 to 3104.9
|
3589.1 EU/ml
Interval 2221.7 to 5798.0
|
32.1 EU/ml
Interval 25.8 to 40.1
|
|
GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group
Toxin A: GMT at Day 56, 65 and older
|
3173.6 EU/ml
Interval 1962.2 to 5133.0
|
4099.8 EU/ml
Interval 2517.4 to 6676.7
|
5052.1 EU/ml
Interval 3491.8 to 7309.7
|
37.3 EU/ml
Interval 29.0 to 47.9
|
|
GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group
Toxin A: GMT at Day 120, 65 and older
|
1747.7 EU/ml
Interval 1130.8 to 2701.3
|
2478.7 EU/ml
Interval 1556.9 to 3946.1
|
2629.1 EU/ml
Interval 1886.1 to 3664.9
|
32.9 EU/ml
Interval 26.6 to 40.7
|
|
GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group
Toxin A: GMT at Day 210, 65 and older
|
941.1 EU/ml
Interval 624.4 to 1418.4
|
1288.6 EU/ml
Interval 817.9 to 2030.1
|
1307.8 EU/ml
Interval 969.1 to 1765.0
|
35.6 EU/ml
Interval 25.5 to 49.8
|
|
GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group
Toxin B: GMT at Day 0, 50 - < 65
|
142.6 EU/ml
Interval 113.2 to 179.7
|
114.6 EU/ml
Interval 91.8 to 142.9
|
131.7 EU/ml
Interval 100.5 to 172.7
|
87.8 EU/ml
Interval 57.4 to 134.4
|
|
GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group
Toxin B: GMT at Day 14, 50 - < 65
|
630.3 EU/ml
Interval 323.6 to 1227.8
|
1101.1 EU/ml
Interval 523.3 to 2316.7
|
476.7 EU/ml
Interval 233.6 to 973.0
|
83.9 EU/ml
Interval 54.6 to 128.7
|
|
GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group
Toxin B: GMT at Day 28, 50 - < 65
|
729.3 EU/ml
Interval 391.8 to 1357.8
|
1292.3 EU/ml
Interval 672.1 to 2484.8
|
569.8 EU/ml
Interval 299.4 to 1084.6
|
94.8 EU/ml
Interval 62.0 to 145.2
|
|
GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group
Toxin B: GMT at Day 35, 50 - < 65
|
1392.2 EU/ml
Interval 759.2 to 2553.0
|
2962.2 EU/ml
Interval 1677.0 to 5232.3
|
1039.7 EU/ml
Interval 578.9 to 1867.3
|
103.3 EU/ml
Interval 65.4 to 163.1
|
|
GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group
Toxin B: GMT at Day 56, 50 - < 65
|
1832.7 EU/ml
Interval 1111.0 to 3023.2
|
3960.3 EU/ml
Interval 2546.8 to 6158.5
|
1316.9 EU/ml
Interval 777.9 to 2229.3
|
83.7 EU/ml
Interval 53.9 to 130.1
|
|
GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group
Toxin B: GMT at Day 120, 50 - < 65
|
1034.5 EU/ml
Interval 659.6 to 1622.4
|
2135.4 EU/ml
Interval 1408.7 to 3237.0
|
745.6 EU/ml
Interval 465.6 to 1193.8
|
79.7 EU/ml
Interval 53.0 to 119.9
|
|
GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group
Toxin B: GMT at Day 210, 50 - < 65
|
714.1 EU/ml
Interval 467.8 to 1090.1
|
1317.8 EU/ml
Interval 894.2 to 1942.2
|
501.1 EU/ml
Interval 314.3 to 799.0
|
79.2 EU/ml
Interval 52.6 to 119.3
|
|
GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group
Toxin B: GMT at Day 0, 65 and older
|
157.6 EU/ml
Interval 121.3 to 204.8
|
100.6 EU/ml
Interval 76.6 to 132.2
|
132.1 EU/ml
Interval 100.3 to 174.0
|
122.1 EU/ml
Interval 69.3 to 215.0
|
|
GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group
Toxin B: GMT at Day 14, 65 and older
|
952.7 EU/ml
Interval 464.3 to 1955.0
|
819.1 EU/ml
Interval 379.5 to 1768.1
|
715.9 EU/ml
Interval 364.0 to 1408.0
|
114.8 EU/ml
Interval 64.5 to 204.5
|
|
GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group
Toxin B: GMT at Day 28, 65 and older
|
1221.5 EU/ml
Interval 623.7 to 2392.2
|
812.5 EU/ml
Interval 398.7 to 1656.0
|
995.1 EU/ml
Interval 511.1 to 1937.6
|
120.7 EU/ml
Interval 70.2 to 207.6
|
|
GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group
Toxin B: GMT at Day 35, 65 and older
|
1944.5 EU/ml
Interval 1033.9 to 3657.3
|
1901.3 EU/ml
Interval 1007.7 to 3587.3
|
1305.4 EU/ml
Interval 698.7 to 2439.0
|
110.4 EU/ml
Interval 63.1 to 193.1
|
|
GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group
Toxin B: GMT at Day 56, 65 and older
|
3032.4 EU/ml
Interval 1762.3 to 5217.7
|
2803.8 EU/ml
Interval 1701.9 to 4619.1
|
1593.2 EU/ml
Interval 937.3 to 2707.9
|
136.0 EU/ml
Interval 81.1 to 227.9
|
|
GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group
Toxin B: GMT at Day 120, 65 and older
|
1628.7 EU/ml
Interval 1013.3 to 2617.7
|
1348.5 EU/ml
Interval 853.6 to 2130.3
|
1041.9 EU/ml
Interval 646.2 to 1679.8
|
105.7 EU/ml
Interval 61.4 to 181.9
|
|
GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group
Toxin B: GMT at Day 210, 65 and older
|
1032.3 EU/ml
Interval 671.4 to 1587.3
|
794.1 EU/ml
Interval 525.2 to 1200.7
|
705.6 EU/ml
Interval 449.6 to 1107.4
|
115.5 EU/ml
Interval 67.9 to 196.6
|
|
GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group
Toxin A: GMT at Day 120, 50 - < 65
|
1391.8 EU/ml
Interval 910.6 to 2127.3
|
2589.3 EU/ml
Interval 1720.9 to 3896.0
|
2221.4 EU/ml
Interval 1620.5 to 3045.0
|
29.9 EU/ml
Interval 24.0 to 37.3
|
|
GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group
Toxin A: GMT at Day 210, 50 - < 65
|
792.9 EU/ml
Interval 526.2 to 1194.8
|
1510.9 EU/ml
Interval 1042.1 to 2190.7
|
1269.8 EU/ml
Interval 921.6 to 1749.7
|
33.0 EU/ml
Interval 24.7 to 44.2
|
SECONDARY outcome
Timeframe: Days 0, 35, 56, 120 and 210Population: PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210
GMTs for Toxin A neutralizing antibodies and for Toxin B neutralizing antibodies as determined by Toxin Neutralization Assay on Days 0, 35, 56, 120\* and 210, stratified by age group (subjects 50 - \< 65 years and 65 years and older) \* TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured.
Outcome measures
| Measure |
VLA84 75 mcg (Microgram) w/o Alum
n=137 Participants
VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution
|
VLA84 200 mcg w/o Alum
n=135 Participants
VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
VLA84 200 mcg With Alum
n=141 Participants
VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
Placebo
n=46 Participants
Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution
|
|---|---|---|---|---|
|
GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group
Toxin A: GMT at Day 0, 50 - < 65
|
10.8 Titer
Interval 10.0 to 11.6
|
10.6 Titer
Interval 9.7 to 11.6
|
10.9 Titer
Interval 10.0 to 12.0
|
10.0 Titer
Interval 10.0 to 10.0
|
|
GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group
Toxin A: GMT at Day 35, 50 - < 65
|
101.7 Titer
Interval 56.0 to 184.5
|
199.4 Titer
Interval 112.5 to 353.4
|
130.3 Titer
Interval 82.4 to 206.1
|
10.6 Titer
Interval 9.4 to 12.0
|
|
GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group
Toxin A: GMT at Day 56, 50 - < 65
|
138.2 Titer
Interval 82.9 to 230.4
|
215.3 Titer
Interval 130.5 to 355.1
|
124.3 Titer
Interval 81.6 to 189.3
|
10.0 Titer
Interval 10.0 to 10.0
|
|
GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group
Toxin A: GMT at Day 210, 50 - < 65
|
81.3 Titer
Interval 49.9 to 132.4
|
187.5 Titer
Interval 118.1 to 297.7
|
188.4 Titer
Interval 135.1 to 262.6
|
10.0 Titer
Interval 10.0 to 10.0
|
|
GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group
Toxin A: GMT at Day 0, 65 and older
|
11.2 Titer
Interval 9.8 to 12.7
|
10.0 Titer
Interval 10.0 to 10.0
|
10.6 Titer
Interval 9.6 to 11.6
|
10.0 Titer
Interval 10.0 to 10.0
|
|
GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group
Toxin A: GMT at Day 35, 65 and older
|
86.2 Titer
Interval 51.2 to 145.3
|
120.4 Titer
Interval 70.0 to 207.1
|
169.3 Titer
Interval 97.8 to 293.1
|
10.0 Titer
Interval 10.0 to 10.0
|
|
GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group
Toxin A: GMT at Day 56, 65 and older
|
148.0 Titer
Interval 94.5 to 231.6
|
187.3 Titer
Interval 119.6 to 293.2
|
188.5 Titer
Interval 119.0 to 298.6
|
10.7 Titer
Interval 9.7 to 11.7
|
|
GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group
Toxin A: GMT at Day 210, 65 and older
|
110.3 Titer
Interval 72.4 to 168.1
|
151.9 Titer
Interval 96.7 to 238.6
|
190.5 Titer
Interval 131.4 to 276.1
|
10.4 Titer
Interval 9.6 to 11.2
|
|
GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group
Toxin B: GMT at Day 0, 50 - < 65
|
15.4 Titer
Interval 12.3 to 19.4
|
16.7 Titer
Interval 13.1 to 21.3
|
19.3 Titer
Interval 14.3 to 26.2
|
13.6 Titer
Interval 9.3 to 19.8
|
|
GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group
Toxin B: GMT at Day 56, 50 - < 65
|
56.9 Titer
Interval 36.5 to 88.7
|
95.0 Titer
Interval 62.5 to 144.3
|
53.9 Titer
Interval 34.3 to 84.6
|
14.9 Titer
Interval 10.4 to 21.4
|
|
GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group
Toxin B: GMT at Day 210, 50 - < 65
|
44.1 Titer
Interval 29.0 to 67.0
|
69.9 Titer
Interval 47.4 to 102.9
|
40.3 Titer
Interval 25.6 to 63.3
|
14.1 Titer
Interval 9.7 to 20.3
|
|
GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group
Toxin B: GMT at Day 0, 65 and older
|
19.5 Titer
Interval 14.6 to 26.0
|
15.2 Titer
Interval 12.0 to 19.2
|
18.9 Titer
Interval 14.1 to 25.5
|
24.1 Titer
Interval 13.9 to 42.0
|
|
GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group
Toxin B: GMT at Day 35, 65 and older
|
88.7 Titer
Interval 52.0 to 151.4
|
86.7 Titer
Interval 52.6 to 142.9
|
61.6 Titer
Interval 38.9 to 97.6
|
23.8 Titer
Interval 13.7 to 41.3
|
|
GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group
Toxin B: GMT at Day 56, 65 and older
|
84.8 Titer
Interval 53.5 to 134.5
|
57.9 Titer
Interval 38.3 to 87.5
|
50.7 Titer
Interval 32.9 to 78.2
|
23.8 Titer
Interval 14.2 to 40.1
|
|
GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group
Toxin B: GMT at Day 210, 65 and older
|
58.6 Titer
Interval 38.0 to 90.3
|
53.3 Titer
Interval 35.8 to 79.5
|
45.9 Titer
Interval 30.2 to 69.7
|
20.9 Titer
Interval 12.3 to 35.7
|
|
GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group
Toxin B: GMT at Day 35, 50 - < 65
|
59.4 Titer
Interval 36.6 to 96.2
|
114.2 Titer
Interval 71.4 to 182.9
|
61.7 Titer
Interval 37.2 to 102.4
|
14.2 Titer
Interval 9.7 to 20.9
|
SECONDARY outcome
Timeframe: Days 35, 56, 120, 210Population: PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210
Responder Rate (RR) (defined as percentage of subjects achieving a ≥4-fold increase in neutralizing antibody titer from Day 0) for neutralizing antibodies against both Toxin A and Toxin B on Days 35, 56, 120\* and 210 \* TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured.
Outcome measures
| Measure |
VLA84 75 mcg (Microgram) w/o Alum
n=137 Participants
VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution
|
VLA84 200 mcg w/o Alum
n=135 Participants
VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
VLA84 200 mcg With Alum
n=141 Participants
VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
Placebo
n=46 Participants
Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution
|
|---|---|---|---|---|
|
Responder Rate (RR) for Neutralizing Antibodies Against Both Toxin A and Toxin B
RR Day 35
|
42.3 percentage of participants
Interval 34.4 to 50.7
|
54.1 percentage of participants
Interval 45.7 to 62.3
|
40.4 percentage of participants
Interval 32.7 to 48.7
|
0.0 percentage of participants
Interval 0.0 to 7.7
|
|
Responder Rate (RR) for Neutralizing Antibodies Against Both Toxin A and Toxin B
RR Day 56
|
46.0 percentage of participants
Interval 37.9 to 54.3
|
51.9 percentage of participants
Interval 43.5 to 60.1
|
36.9 percentage of participants
Interval 29.4 to 45.1
|
0.0 percentage of participants
Interval 0.0 to 7.7
|
|
Responder Rate (RR) for Neutralizing Antibodies Against Both Toxin A and Toxin B
RR Day 210
|
38.1 percentage of participants
Interval 30.3 to 46.5
|
46.2 percentage of participants
Interval 37.9 to 54.7
|
27.7 percentage of participants
Interval 20.9 to 35.8
|
0.0 percentage of participants
Interval 0.0 to 7.9
|
SECONDARY outcome
Timeframe: Days 35, 56, 120 and 210Population: PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210
Responder Rate (RR) (defined as percentage of subjects achieving a ≥4-fold increase in neutralizing antibody titer from Day 0) for neutralizing antibodies against Toxin A on Days 35, 56, 120\* and 210 \* TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured.
Outcome measures
| Measure |
VLA84 75 mcg (Microgram) w/o Alum
n=137 Participants
VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution
|
VLA84 200 mcg w/o Alum
n=135 Participants
VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
VLA84 200 mcg With Alum
n=141 Participants
VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
Placebo
n=46 Participants
Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution
|
|---|---|---|---|---|
|
Responder Rate (RR) for Toxin A Neutralizing Antibodies
RR Day 210
|
62.7 percentage of participants
Interval 54.3 to 70.4
|
75.0 percentage of participants
Interval 67.0 to 81.6
|
84.7 percentage of participants
Interval 77.7 to 89.8
|
0.0 percentage of participants
Interval 0.0 to 7.9
|
|
Responder Rate (RR) for Toxin A Neutralizing Antibodies
RR Day 35
|
55.5 percentage of participants
Interval 47.1 to 63.5
|
68.1 percentage of participants
Interval 59.9 to 75.4
|
67.4 percentage of participants
Interval 59.3 to 74.6
|
0.0 percentage of participants
Interval 0.0 to 7.7
|
|
Responder Rate (RR) for Toxin A Neutralizing Antibodies
RR Day 56
|
68.6 percentage of participants
Interval 60.4 to 75.8
|
78.5 percentage of participants
Interval 70.9 to 84.6
|
76.6 percentage of participants
Interval 69.0 to 82.8
|
0.0 percentage of participants
Interval 0.0 to 7.7
|
SECONDARY outcome
Timeframe: Days 35, 56, 120 and 210Population: PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210
Responder Rate (RR) (defined as percentage of subjects achieving a ≥4-fold increase in neutralizing antibody titer from Day 0) for neutralizing antibodies against Toxin B on Days 35, 56, 120\* and 210 \* TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured.
Outcome measures
| Measure |
VLA84 75 mcg (Microgram) w/o Alum
n=137 Participants
VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution
|
VLA84 200 mcg w/o Alum
n=135 Participants
VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
VLA84 200 mcg With Alum
n=141 Participants
VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
Placebo
n=46 Participants
Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution
|
|---|---|---|---|---|
|
Responder Rate (RR) for Toxin B Neutralizing Antibodies
RR Day 56
|
52.6 percentage of participants
Interval 44.2 to 60.7
|
56.3 percentage of participants
Interval 47.9 to 64.4
|
38.3 percentage of participants
Interval 30.7 to 46.5
|
0.0 percentage of participants
Interval 0.0 to 7.7
|
|
Responder Rate (RR) for Toxin B Neutralizing Antibodies
RR Day 210
|
39.6 percentage of participants
Interval 31.7 to 48.0
|
47.0 percentage of participants
Interval 38.7 to 55.4
|
27.7 percentage of participants
Interval 20.9 to 35.8
|
2.2 percentage of participants
Interval 0.4 to 11.6
|
|
Responder Rate (RR) for Toxin B Neutralizing Antibodies
RR Day 35
|
48.2 percentage of participants
Interval 40.0 to 56.5
|
57.8 percentage of participants
Interval 49.3 to 65.8
|
42.6 percentage of participants
Interval 34.7 to 50.8
|
0.0 percentage of participants
Interval 0.0 to 7.7
|
SECONDARY outcome
Timeframe: Days 35, 56, 120 and 210Population: PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210
Responder Rate for neutralizing antibodies against Toxin A (RR Tox A), against Toxin B (RR Tox B) and against both Toxin A and Toxin B (RR Tox A and B) on Days 35, 56, 120\* and 210, stratified by age group (subjects 50 - \< 65 years and 65 years and older) \* TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured.
Outcome measures
| Measure |
VLA84 75 mcg (Microgram) w/o Alum
n=137 Participants
VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution
|
VLA84 200 mcg w/o Alum
n=135 Participants
VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
VLA84 200 mcg With Alum
n=141 Participants
VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
Placebo
n=46 Participants
Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution
|
|---|---|---|---|---|
|
Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
RR Tox A and B Day 35, 50 - < 60
|
38.8 percentage of participants
Interval 28.0 to 50.8
|
55.9 percentage of participants
Interval 44.1 to 67.1
|
42.9 percentage of participants
Interval 31.9 to 54.5
|
0.0 percentage of participants
Interval 0.0 to 14.9
|
|
Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
RR Tox A and B Day 56, 50 - < 60
|
49.3 percentage of participants
Interval 37.7 to 60.9
|
57.4 percentage of participants
Interval 45.5 to 68.4
|
35.7 percentage of participants
Interval 25.5 to 47.4
|
0.0 percentage of participants
Interval 0.0 to 14.9
|
|
Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
RR Tox A and B Day 210, 50 - < 60
|
36.9 percentage of participants
Interval 26.2 to 49.1
|
50.0 percentage of participants
Interval 38.3 to 61.7
|
25.0 percentage of participants
Interval 16.2 to 36.4
|
0.0 percentage of participants
Interval 0.0 to 14.9
|
|
Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
RR Tox A and B Day 35, 60 and older
|
45.7 percentage of participants
Interval 34.6 to 57.3
|
52.2 percentage of participants
Interval 40.5 to 63.7
|
38.0 percentage of participants
Interval 27.6 to 49.7
|
0.0 percentage of participants
Interval 0.0 to 13.8
|
|
Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
RR Tox A and B Day 56, 60 and older
|
42.9 percentage of participants
Interval 31.9 to 54.5
|
46.3 percentage of participants
Interval 34.9 to 58.1
|
38.0 percentage of participants
Interval 27.6 to 49.7
|
0.0 percentage of participants
Interval 0.0 to 13.8
|
|
Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
RR Tox A and B Day 210, 60 and older
|
39.1 percentage of participants
Interval 28.5 to 50.9
|
42.4 percentage of participants
Interval 31.2 to 54.4
|
30.4 percentage of participants
Interval 20.8 to 42.1
|
0.0 percentage of participants
Interval 0.0 to 14.3
|
|
Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
RR Tox A Day 35, 50 - < 60
|
53.7 percentage of participants
Interval 41.9 to 65.1
|
70.6 percentage of participants
Interval 58.9 to 80.1
|
67.1 percentage of participants
Interval 55.5 to 77.0
|
0.0 percentage of participants
Interval 0.0 to 14.9
|
|
Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
RR Tox A Day 56, 60 and older
|
70.0 percentage of participants
Interval 58.5 to 79.5
|
79.1 percentage of participants
Interval 67.9 to 87.1
|
80.3 percentage of participants
Interval 69.6 to 87.9
|
0.0 percentage of participants
Interval 0.0 to 13.9
|
|
Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
RR Tox A Day 210, 60 and older
|
68.1 percentage of participants
Interval 56.4 to 77.9
|
72.7 percentage of participants
Interval 61.0 to 82.0
|
85.5 percentage of participants
Interval 75.3 to 91.9
|
0.0 percentage of participants
Interval 0.0 to 14.3
|
|
Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
RR Tox B Day 35, 50 - < 60
|
43.3 percentage of participants
Interval 32.1 to 55.2
|
61.8 percentage of participants
Interval 49.9 to 72.4
|
42.9 percentage of participants
Interval 31.9 to 54.5
|
0.0 percentage of participants
Interval 0.0 to 14.9
|
|
Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
RR Tox B Day 56, 50 - < 60
|
52.2 percentage of participants
Interval 40.5 to 63.7
|
61.8 percentage of participants
Interval 49.9 to 72.4
|
37.1 percentage of participants
Interval 26.8 to 48.9
|
0.0 percentage of participants
Interval 0.0 to 14.9
|
|
Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
RR Tox B Day 210, 50 - < 60
|
40.0 percentage of participants
Interval 29.0 to 52.1
|
50.0 percentage of participants
Interval 38.3 to 61.7
|
25.0 percentage of participants
Interval 16.2 to 36.4
|
4.5 percentage of participants
Interval 0.8 to 21.8
|
|
Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
RR Tox B Day 35, 60 and older
|
52.9 percentage of participants
Interval 41.3 to 64.1
|
53.7 percentage of participants
Interval 41.9 to 65.1
|
42.3 percentage of participants
Interval 31.5 to 53.8
|
0.0 percentage of participants
Interval 0.0 to 13.8
|
|
Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
RR Tox B Day 56, 60 and older
|
52.9 percentage of participants
Interval 41.3 to 64.1
|
50.7 percentage of participants
Interval 39.1 to 62.3
|
39.4 percentage of participants
Interval 28.9 to 51.1
|
0.0 percentage of participants
Interval 0.0 to 13.8
|
|
Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
RR Tox B Day 210, 60 and older
|
39.1 percentage of participants
Interval 28.5 to 50.9
|
43.9 percentage of participants
Interval 32.6 to 55.9
|
30.4 percentage of participants
Interval 20.8 to 42.1
|
0.0 percentage of participants
Interval 0.0 to 14.3
|
|
Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
RR Tox A Day 56, 50 - < 60
|
67.2 percentage of participants
Interval 55.3 to 77.2
|
77.9 percentage of participants
Interval 66.7 to 86.2
|
72.9 percentage of participants
Interval 61.5 to 81.9
|
0.0 percentage of participants
Interval 0.0 to 14.9
|
|
Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
RR Tox A Day 210, 50 - < 60
|
56.9 percentage of participants
Interval 44.8 to 68.2
|
77.3 percentage of participants
Interval 65.8 to 85.7
|
83.8 percentage of participants
Interval 73.3 to 90.7
|
0.0 percentage of participants
Interval 0.0 to 14.9
|
|
Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group
RR Tox A Day 35, 60 and older
|
57.1 percentage of participants
Interval 45.5 to 68.1
|
65.7 percentage of participants
Interval 53.7 to 75.9
|
67.6 percentage of participants
Interval 56.1 to 77.3
|
0.0 percentage of participants
Interval 0.0 to 13.8
|
SECONDARY outcome
Timeframe: Day 56 and Day 210Population: Safety Population = study participants who received at least one study vaccination
percentage of study participants with at least one SAE starting up to Day 56 and up to Day 210
Outcome measures
| Measure |
VLA84 75 mcg (Microgram) w/o Alum
n=148 Participants
VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution
|
VLA84 200 mcg w/o Alum
n=152 Participants
VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
VLA84 200 mcg With Alum
n=152 Participants
VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
Placebo
n=48 Participants
Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution
|
|---|---|---|---|---|
|
Rate of Study Participants With at Least One SAE (Serious Adverse Event)
up to Day 56
|
0.7 percentage of participants
Interval 0.1 to 3.7
|
0.7 percentage of participants
Interval 0.1 to 3.6
|
0.0 percentage of participants
Interval 0.0 to 2.5
|
4.2 percentage of participants
Interval 1.2 to 14.0
|
|
Rate of Study Participants With at Least One SAE (Serious Adverse Event)
up to Day 210
|
2.7 percentage of participants
Interval 1.1 to 6.7
|
3.3 percentage of participants
Interval 1.4 to 7.5
|
2.0 percentage of participants
Interval 0.7 to 5.6
|
4.2 percentage of participants
Interval 1.2 to 14.0
|
SECONDARY outcome
Timeframe: Day 56 and Day 210Population: Safety Population = study participants with at least one study vaccination
percentage of study participants with at least one related SAE starting up to Day 56 and up to Day 210
Outcome measures
| Measure |
VLA84 75 mcg (Microgram) w/o Alum
n=148 Participants
VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution
|
VLA84 200 mcg w/o Alum
n=152 Participants
VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
VLA84 200 mcg With Alum
n=152 Participants
VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
Placebo
n=48 Participants
Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution
|
|---|---|---|---|---|
|
Rate of Study Participants With at Least One Related SAE
up to Day 56
|
0.0 percentage of participants
Interval 0.0 to 2.5
|
0.0 percentage of participants
Interval 0.0 to 2.5
|
0.0 percentage of participants
Interval 0.0 to 2.5
|
0.0 percentage of participants
Interval 0.0 to 7.4
|
|
Rate of Study Participants With at Least One Related SAE
up to Day 210
|
0.0 percentage of participants
Interval 0.0 to 2.5
|
0.0 percentage of participants
Interval 0.0 to 2.5
|
0.0 percentage of participants
Interval 0.0 to 2.5
|
0.0 percentage of participants
Interval 0.0 to 7.4
|
SECONDARY outcome
Timeframe: Day 56 and Day 210Population: Safety Population = study participants with at least one study vaccination
percentage of study participants with at least one unsolicited AE starting up to Day 56 and Day 210 (incl. clinically significant laboratory parameter changes)
Outcome measures
| Measure |
VLA84 75 mcg (Microgram) w/o Alum
n=148 Participants
VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution
|
VLA84 200 mcg w/o Alum
n=152 Participants
VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
VLA84 200 mcg With Alum
n=152 Participants
VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
Placebo
n=48 Participants
Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution
|
|---|---|---|---|---|
|
Rate of Study Participants With at Least One Unsolicited AEs (Adverse Event)
up to Day 56
|
33.1 percentage of participants
Interval 26.0 to 41.0
|
32.2 percentage of participants
Interval 25.3 to 40.0
|
30.9 percentage of participants
Interval 24.1 to 38.7
|
29.2 percentage of participants
Interval 18.2 to 43.2
|
|
Rate of Study Participants With at Least One Unsolicited AEs (Adverse Event)
up to Day 210
|
43.9 percentage of participants
Interval 36.2 to 52.0
|
39.5 percentage of participants
Interval 32.1 to 47.4
|
40.1 percentage of participants
Interval 32.7 to 48.1
|
37.5 percentage of participants
Interval 25.2 to 51.6
|
SECONDARY outcome
Timeframe: Day 56 and Day 210Population: Safety Population = study participants with at least one study vaccination
percentage of study participants with at least one related unsolicited AE starting up to Day 56 and Day 210 (incl. clinically significant laboratory parameter changes)
Outcome measures
| Measure |
VLA84 75 mcg (Microgram) w/o Alum
n=148 Participants
VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution
|
VLA84 200 mcg w/o Alum
n=152 Participants
VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
VLA84 200 mcg With Alum
n=152 Participants
VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
Placebo
n=48 Participants
Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution
|
|---|---|---|---|---|
|
Rate of Study Participants With at Least One Related Unsolicited AE
up to Day 56
|
11.5 percentage of participants
Interval 7.3 to 17.6
|
12.5 percentage of participants
Interval 8.2 to 18.7
|
7.9 percentage of participants
Interval 4.6 to 13.3
|
4.2 percentage of participants
Interval 1.2 to 14.0
|
|
Rate of Study Participants With at Least One Related Unsolicited AE
up to Day 210
|
11.5 percentage of participants
Interval 7.3 to 17.6
|
13.2 percentage of participants
Interval 8.7 to 19.5
|
7.9 percentage of participants
Interval 4.6 to 13.3
|
4.2 percentage of participants
Interval 1.2 to 14.0
|
SECONDARY outcome
Timeframe: within 7 Days after each vaccinationPopulation: Safety Population = study participants with at least one study vaccination
percentage of study participants with solicited local and systemic AE within 7 days after each and after any vaccination, collected via a subject diary with predefined terms
Outcome measures
| Measure |
VLA84 75 mcg (Microgram) w/o Alum
n=148 Participants
VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution
|
VLA84 200 mcg w/o Alum
n=152 Participants
VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
VLA84 200 mcg With Alum
n=152 Participants
VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
Placebo
n=48 Participants
Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution
|
|---|---|---|---|---|
|
Rates of Study Participants With at Least One Solicited Local and Systemic AE
any local solicited AE, after 1st vaccination
|
17.0 percentage of participants
Interval 11.8 to 23.9
|
19.1 percentage of participants
Interval 13.6 to 26.1
|
19.7 percentage of participants
Interval 14.2 to 26.8
|
14.9 percentage of participants
Interval 7.4 to 27.7
|
|
Rates of Study Participants With at Least One Solicited Local and Systemic AE
any local solicited AE, after 2nd vaccination
|
17.2 percentage of participants
Interval 12.0 to 24.2
|
29.6 percentage of participants
Interval 22.9 to 37.3
|
30.9 percentage of participants
Interval 24.1 to 38.7
|
12.8 percentage of participants
Interval 6.0 to 25.2
|
|
Rates of Study Participants With at Least One Solicited Local and Systemic AE
any local solicited AE, after 3rd vaccination
|
15.3 percentage of participants
Interval 10.3 to 22.0
|
29.3 percentage of participants
Interval 22.5 to 37.1
|
25.0 percentage of participants
Interval 18.7 to 32.5
|
10.6 percentage of participants
Interval 4.6 to 22.6
|
|
Rates of Study Participants With at Least One Solicited Local and Systemic AE
any local solicited AE, overall
|
28.6 percentage of participants
Interval 21.9 to 36.3
|
48.0 percentage of participants
Interval 40.2 to 55.9
|
46.7 percentage of participants
Interval 39.0 to 54.6
|
21.3 percentage of participants
Interval 12.0 to 34.9
|
|
Rates of Study Participants With at Least One Solicited Local and Systemic AE
any systemic solicited AE, after 1st vaccination
|
23.1 percentage of participants
Interval 17.0 to 30.6
|
23.7 percentage of participants
Interval 17.6 to 31.0
|
21.1 percentage of participants
Interval 15.3 to 28.2
|
21.3 percentage of participants
Interval 12.0 to 34.9
|
|
Rates of Study Participants With at Least One Solicited Local and Systemic AE
any systemic solicited AE, after 2nd vaccination
|
17.8 percentage of participants
Interval 12.5 to 24.8
|
27.6 percentage of participants
Interval 21.1 to 35.2
|
17.8 percentage of participants
Interval 12.5 to 24.6
|
14.9 percentage of participants
Interval 7.4 to 27.7
|
|
Rates of Study Participants With at Least One Solicited Local and Systemic AE
any systemic solicited AE, after 3rd vaccination
|
13.2 percentage of participants
Interval 8.6 to 19.7
|
16.3 percentage of participants
Interval 11.2 to 23.1
|
16.9 percentage of participants
Interval 11.7 to 23.7
|
12.8 percentage of participants
Interval 6.0 to 25.2
|
|
Rates of Study Participants With at Least One Solicited Local and Systemic AE
any systemic solicited AE, overall
|
35.4 percentage of participants
Interval 28.1 to 43.4
|
42.1 percentage of participants
Interval 34.5 to 50.1
|
37.5 percentage of participants
Interval 30.2 to 45.4
|
38.3 percentage of participants
Interval 25.8 to 52.6
|
SECONDARY outcome
Timeframe: Day 56 and Day 210Population: Safety Population = study participants with at least one study vaccination
percentage of study participants with at least one SAE, related SAE, unsolicited (unsol.) AE (incl. clinically significant laboratory parameter changes) and related unsolicited AE, starting up to Day 56 and Day 210, stratified by age group (subjects 50 - \< 65 years and 65 years and older (65+))
Outcome measures
| Measure |
VLA84 75 mcg (Microgram) w/o Alum
n=148 Participants
VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution
|
VLA84 200 mcg w/o Alum
n=152 Participants
VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
VLA84 200 mcg With Alum
n=152 Participants
VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
Placebo
n=48 Participants
Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution
|
|---|---|---|---|---|
|
Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group
SAEs up to Day 56, 50 - < 60
|
0.0 percentage of participants
Interval 0.0 to 5.1
|
1.3 percentage of participants
Interval 0.2 to 7.0
|
0.0 percentage of participants
Interval 0.0 to 4.8
|
8.3 percentage of participants
Interval 2.3 to 25.8
|
|
Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group
related SAEs up to Day 210, 50 - < 60
|
0.0 percentage of participants
Interval 0.0 to 5.1
|
0.0 percentage of participants
Interval 0.0 to 4.8
|
0.0 percentage of participants
Interval 0.0 to 4.8
|
0.0 percentage of participants
Interval 0.0 to 13.8
|
|
Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group
any unsolicited AE up to Day 56, 50 - < 60
|
37.5 percentage of participants
Interval 27.2 to 49.0
|
33.8 percentage of participants
Interval 24.2 to 44.9
|
28.6 percentage of participants
Interval 19.7 to 39.5
|
25.0 percentage of participants
Interval 12.0 to 44.9
|
|
Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group
any related unsolicited AE up to Day 56, 50 - < 60
|
12.5 percentage of participants
Interval 6.7 to 22.1
|
11.7 percentage of participants
Interval 6.3 to 20.7
|
9.1 percentage of participants
Interval 4.5 to 17.6
|
8.3 percentage of participants
Interval 2.3 to 25.8
|
|
Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group
any related unsolicited AE up to Day 210, 50 -< 60
|
12.5 percentage of participants
Interval 6.7 to 22.1
|
13.0 percentage of participants
Interval 7.2 to 22.3
|
9.1 percentage of participants
Interval 4.5 to 17.6
|
8.3 percentage of participants
Interval 2.3 to 25.8
|
|
Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group
related SAEs up to Day 56, 65 and older
|
0.0 percentage of participants
Interval 0.0 to 4.8
|
0.0 percentage of participants
Interval 0.0 to 4.9
|
0.0 percentage of participants
Interval 0.0 to 4.9
|
0.0 percentage of participants
Interval 0.0 to 13.8
|
|
Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group
related SAEs up to Day 210, 65 and older
|
0.0 percentage of participants
Interval 0.0 to 4.8
|
0.0 percentage of participants
Interval 0.0 to 4.9
|
0.0 percentage of participants
Interval 0.0 to 4.9
|
0.0 percentage of participants
Interval 0.0 to 13.8
|
|
Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group
any unsolicited AE up to Day 210, 60 and older
|
38.2 percentage of participants
Interval 28.1 to 49.4
|
37.3 percentage of participants
Interval 27.3 to 48.6
|
41.3 percentage of participants
Interval 30.9 to 52.6
|
41.7 percentage of participants
Interval 24.5 to 61.2
|
|
Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group
SAEs up to Day 210, 50 - < 60
|
2.8 percentage of participants
Interval 0.8 to 9.6
|
3.9 percentage of participants
Interval 1.3 to 10.8
|
0.0 percentage of participants
Interval 0.0 to 4.8
|
8.3 percentage of participants
Interval 2.3 to 25.8
|
|
Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group
related SAEs up to Day 56, 50 - < 60
|
0.0 percentage of participants
Interval 0.0 to 5.1
|
0.0 percentage of participants
Interval 0.0 to 4.8
|
0.0 percentage of participants
Interval 0.0 to 4.8
|
0.0 percentage of participants
Interval 0.0 to 13.8
|
|
Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group
any unsolicited AE up to Day 210, 50 - < 60
|
50.0 percentage of participants
Interval 38.7 to 61.3
|
41.6 percentage of participants
Interval 31.2 to 52.7
|
39.0 percentage of participants
Interval 28.8 to 50.1
|
33.3 percentage of participants
Interval 18.0 to 53.3
|
|
Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group
SAEs up to Day 56, 65 and older
|
1.3 percentage of participants
Interval 0.2 to 7.1
|
0.0 percentage of participants
Interval 0.0 to 4.9
|
0.0 percentage of participants
Interval 0.0 to 4.9
|
0.0 percentage of participants
Interval 0.0 to 13.8
|
|
Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group
SAEs up to Day 210, 65 and older
|
2.6 percentage of participants
Interval 0.7 to 9.1
|
2.7 percentage of participants
Interval 0.7 to 9.2
|
4.0 percentage of participants
Interval 1.4 to 11.1
|
0.0 percentage of participants
Interval 0.0 to 13.8
|
|
Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group
any unsolicited AE up to Day 56, 60 and older
|
28.9 percentage of participants
Interval 20.0 to 40.0
|
30.7 percentage of participants
Interval 21.4 to 41.8
|
33.3 percentage of participants
Interval 23.7 to 44.6
|
33.3 percentage of participants
Interval 18.0 to 53.3
|
|
Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group
any related unsol. AE up to Day 56, 60 and older
|
10.5 percentage of participants
Interval 5.4 to 19.4
|
13.3 percentage of participants
Interval 7.4 to 22.8
|
6.7 percentage of participants
Interval 2.9 to 14.7
|
0.0 percentage of participants
Interval 0.0 to 13.8
|
|
Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group
any related unsol. AE up to Day 210, 60 and older
|
10.5 percentage of participants
Interval 5.4 to 19.4
|
13.3 percentage of participants
Interval 7.4 to 22.8
|
6.7 percentage of participants
Interval 2.9 to 14.7
|
0.0 percentage of participants
Interval 0.0 to 13.8
|
SECONDARY outcome
Timeframe: within 7 Days after each vaccinationPopulation: Safety Population = study participants with at least one study vaccination
percentage of participants with solicited (sol.) local and systemic AEs within 7 days after each and after any vaccination (vacc.), collected via a subject diary with predefined terms, stratified by age group (subjects 50 - \< 65 years and 65 years and older)
Outcome measures
| Measure |
VLA84 75 mcg (Microgram) w/o Alum
n=148 Participants
VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution
|
VLA84 200 mcg w/o Alum
n=152 Participants
VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
VLA84 200 mcg With Alum
n=152 Participants
VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
Placebo
n=48 Participants
Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution
|
|---|---|---|---|---|
|
Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group
any systemic sol. AE, after 1st vacc., 50 - < 65
|
29.2 percentage of participants
Interval 19.9 to 40.5
|
26.0 percentage of participants
Interval 17.5 to 36.7
|
24.7 percentage of participants
Interval 16.4 to 35.4
|
21.7 percentage of participants
Interval 9.7 to 41.9
|
|
Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group
any systemic sol. AE, after 2nd vacc., 50 - < 65
|
16.9 percentage of participants
Interval 9.9 to 27.3
|
28.6 percentage of participants
Interval 19.7 to 39.5
|
18.2 percentage of participants
Interval 11.2 to 28.2
|
21.7 percentage of participants
Interval 9.7 to 41.9
|
|
Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group
any systemic sol. AE, after 3rd vacc., 50 - < 65
|
18.8 percentage of participants
Interval 11.4 to 29.6
|
14.9 percentage of participants
Interval 8.5 to 24.7
|
21.6 percentage of participants
Interval 13.8 to 32.3
|
8.7 percentage of participants
Interval 2.4 to 26.8
|
|
Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group
any systemic sol. AE, after 1st vacc.,65 and older
|
17.3 percentage of participants
Interval 10.4 to 27.4
|
21.3 percentage of participants
Interval 13.6 to 31.9
|
17.3 percentage of participants
Interval 10.4 to 27.4
|
20.8 percentage of participants
Interval 9.2 to 40.5
|
|
Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group
any systemic sol. AE, after 2nd vacc.,65 and older
|
18.7 percentage of participants
Interval 11.5 to 28.9
|
26.7 percentage of participants
Interval 18.0 to 37.6
|
17.3 percentage of participants
Interval 10.4 to 27.4
|
8.3 percentage of participants
Interval 2.3 to 25.8
|
|
Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group
any systemic sol. AE, after 3rd vacc.,65 and older
|
8.0 percentage of participants
Interval 3.7 to 16.4
|
17.8 percentage of participants
Interval 10.7 to 28.1
|
12.2 percentage of participants
Interval 6.5 to 21.5
|
16.7 percentage of participants
Interval 6.7 to 35.9
|
|
Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group
any systemic sol. AE, overall ,65 and older
|
30.7 percentage of participants
Interval 21.4 to 41.8
|
37.3 percentage of participants
Interval 27.3 to 48.6
|
30.7 percentage of participants
Interval 21.4 to 41.8
|
37.5 percentage of participants
Interval 21.2 to 57.3
|
|
Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group
any systemic sol. AE, overall, 50 - < 65
|
40.3 percentage of participants
Interval 29.7 to 51.8
|
46.8 percentage of participants
Interval 36.0 to 57.8
|
44.2 percentage of participants
Interval 33.6 to 55.3
|
39.1 percentage of participants
Interval 22.2 to 59.2
|
|
Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group
any local sol. AE, after 1st vacc., 50 -< 65
|
18.1 percentage of participants
Interval 10.9 to 28.5
|
27.3 percentage of participants
Interval 18.6 to 38.1
|
18.2 percentage of participants
Interval 11.2 to 28.2
|
17.4 percentage of participants
Interval 7.0 to 37.1
|
|
Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group
any local sol. AE, after 2nd vacc., 50 -< 65
|
14.3 percentage of participants
Interval 7.9 to 24.3
|
31.2 percentage of participants
Interval 21.9 to 42.2
|
33.8 percentage of participants
Interval 24.2 to 44.9
|
17.4 percentage of participants
Interval 7.0 to 37.1
|
|
Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group
any local sol. AE, after 3rd vacc., 50 -< 65
|
17.4 percentage of participants
Interval 10.2 to 28.0
|
32.4 percentage of participants
Interval 22.9 to 43.7
|
23.0 percentage of participants
Interval 14.9 to 33.7
|
13.0 percentage of participants
Interval 4.5 to 32.1
|
|
Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group
any local sol. AE, overall, 50 -< 65
|
29.2 percentage of participants
Interval 19.9 to 40.5
|
53.2 percentage of participants
Interval 42.2 to 64.0
|
51.9 percentage of participants
Interval 41.0 to 62.7
|
21.7 percentage of participants
Interval 9.7 to 41.9
|
|
Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group
any local sol. AE, after 1st vacc., 65 and older
|
16.0 percentage of participants
Interval 9.4 to 25.9
|
10.7 percentage of participants
Interval 5.5 to 19.7
|
21.3 percentage of participants
Interval 13.6 to 31.9
|
12.5 percentage of participants
Interval 4.3 to 31.0
|
|
Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group
any local sol. AE, after 2nd vacc., 65 and older
|
20.0 percentage of participants
Interval 12.5 to 30.4
|
28.0 percentage of participants
Interval 19.1 to 39.0
|
28.0 percentage of participants
Interval 19.1 to 39.0
|
8.3 percentage of participants
Interval 2.3 to 25.8
|
|
Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group
any local sol. AE, after 3rd vacc., 65 and older
|
13.3 percentage of participants
Interval 7.4 to 22.8
|
26.0 percentage of participants
Interval 17.3 to 37.1
|
27.0 percentage of participants
Interval 18.2 to 38.1
|
8.3 percentage of participants
Interval 2.3 to 25.8
|
|
Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group
any local sol. AE, overall, 65 and older
|
28.0 percentage of participants
Interval 19.1 to 39.0
|
42.7 percentage of participants
Interval 32.1 to 53.9
|
41.3 percentage of participants
Interval 30.9 to 52.6
|
20.8 percentage of participants
Interval 9.2 to 40.5
|
Adverse Events
VLA84 75 mcg (Microgram) w/o Alum
Serious events: 4 serious events
Other events: 75 other events
Deaths: 0 deaths
VLA84 200 mcg w/o Alum
Serious events: 5 serious events
Other events: 94 other events
Deaths: 0 deaths
VLA84 200 mcg With Alum
Serious events: 3 serious events
Other events: 89 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VLA84 75 mcg (Microgram) w/o Alum
n=148 participants at risk
VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution
|
VLA84 200 mcg w/o Alum
n=152 participants at risk
VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
VLA84 200 mcg With Alum
n=152 participants at risk
VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
Placebo
n=48 participants at risk
Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution
|
|---|---|---|---|---|
|
Infections and infestations
Cellulitis
|
0.00%
0/148 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.66%
1/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/48 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
|
Infections and infestations
Gangrene
|
0.00%
0/148 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.66%
1/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/48 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
|
Infections and infestations
Histoplasmosis
|
0.68%
1/148 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/48 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.00%
0/148 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
1.3%
2/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/48 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/148 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.66%
1/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/48 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/148 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.66%
1/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/48 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
|
Cardiac disorders
Cardiac arrest
|
0.68%
1/148 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/48 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/148 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.66%
1/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/48 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.68%
1/148 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/48 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
|
Gastrointestinal disorders
Ileus
|
0.68%
1/148 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/48 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
|
General disorders
Chest pain
|
0.00%
0/148 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.66%
1/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/48 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
|
General disorders
Device dislocation
|
0.68%
1/148 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/48 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
|
Injury, poisoning and procedural complications
Incarcerated incisional hernia
|
0.00%
0/148 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.66%
1/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/48 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.68%
1/148 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/48 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/148 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
2.1%
1/48 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/148 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.66%
1/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/48 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
|
Investigations
International normalised ratio increased
|
0.68%
1/148 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/48 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/148 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.66%
1/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/48 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/148 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.66%
1/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/48 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
|
Psychiatric disorders
Suicidal ideation
|
0.68%
1/148 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/48 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.00%
0/148 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
2.1%
1/48 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
Other adverse events
| Measure |
VLA84 75 mcg (Microgram) w/o Alum
n=148 participants at risk
VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
Placebo: phosphate buffered saline (PBS) solution
|
VLA84 200 mcg w/o Alum
n=152 participants at risk
VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
VLA84 200 mcg With Alum
n=152 participants at risk
VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections
VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
|
Placebo
n=48 participants at risk
Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections
Placebo: phosphate buffered saline (PBS) solution
|
|---|---|---|---|---|
|
General disorders
Injection site pain
|
22.3%
33/148 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
40.8%
62/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
39.5%
60/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
16.7%
8/48 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
|
General disorders
Fatigue
|
16.9%
25/148 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
21.1%
32/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
15.1%
23/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
10.4%
5/48 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
|
General disorders
Influenza like illness
|
11.5%
17/148 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
19.7%
30/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
13.8%
21/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
8.3%
4/48 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
|
General disorders
Injection site erythema
|
8.8%
13/148 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
15.1%
23/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
13.2%
20/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
8.3%
4/48 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
|
General disorders
Injection site pruritus
|
6.1%
9/148 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
11.8%
18/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
9.9%
15/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
2.1%
1/48 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
|
General disorders
Injection site swelling
|
4.7%
7/148 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
9.2%
14/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
11.2%
17/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
4.2%
2/48 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
|
General disorders
Injection site induration
|
4.1%
6/148 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
9.2%
14/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
7.9%
12/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
6.2%
3/48 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
|
General disorders
Pyrexia
|
2.7%
4/148 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
5.9%
9/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
2.0%
3/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/48 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
|
Nervous system disorders
Headache
|
24.3%
36/148 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
20.4%
31/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
23.7%
36/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
27.1%
13/48 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.5%
17/148 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
19.1%
29/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
16.4%
25/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
12.5%
6/48 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
|
Gastrointestinal disorders
Nausea
|
10.8%
16/148 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
7.9%
12/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
9.2%
14/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
12.5%
6/48 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.1%
9/148 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
5.3%
8/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
3.3%
5/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
4.2%
2/48 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
|
Infections and infestations
Sinusitis
|
2.0%
3/148 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.66%
1/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
0.00%
0/152 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
|
6.2%
3/48 • Adverse Events were collected throughout the study, i.e., up to Day 210. Unsolicited local and systemic AEs are defined as follows: any of the solicited local or systemic AEs which has an onset date more than 6 days after vaccination OR any other symptom or untoward medical event. Additionally, subject diaries were dispensed covering the first 7 days after each vaccination (starting on the day of vaccination) to capture predefined AEs typical for vaccinations.
Solicited AEs listed (predefined) in the diaries comprised injection site reactions (pain, itching, tenderness, induration (hardening), swelling, erythema (redness)) or systemic reactions (headache, muscle pain, fever (oral), flu-like symptoms, nausea, vomiting, rash, excessive fatigue). Solicited AEs are per definition regarded as related to IMP.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Not less than 60 days prior to the earlier of Publication or submission for Publication of any Manuscript Sponsor has to be provided with a copy of the Manuscript (unless the Manuscript is an abstract, presentation, or poster: not less than 30 days prior to the earlier of Publication or submission for Publication). Site shall delay Publication/ submission for Publication of the Manuscript, as the case may be, for an additional 120 days to allow patent applications to be filed.
- Publication restrictions are in place
Restriction type: OTHER