Trial Outcomes & Findings for Phase 2 Study Of VLA15, A Vaccine Candidate Against Lyme Borreliosis, In A Healthy Pediatric And Adult Study Population (NCT NCT04801420)
NCT ID: NCT04801420
Last Updated: 2025-11-12
Results Overview
Participants or their legal guardians were required to record any solicited local and systemic adverse events in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema (redness), swelling and induration (hardening). Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever. Two-sided 95% confidence intervals were calculated according to Altman method.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
625 participants
Primary outcome timeframe
From Day 1 to Day 7 after vaccination 1 at Month 0
Results posted on
2025-11-12
Participant Flow
A total of 714 participants were screened of which 89 failed screening and 625 participants were randomized into the study.
Participant milestones
| Measure |
Group 1: VLA15
Participants aged 5 to 65 years received three intramuscular vaccinations of 180 microgram (mcg) VLA15 at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.
|
Group 2: VLA15 + Placebo
Participants aged 5 to 65 years received two intramuscular vaccinations of 180 mcg VLA15 at Month 0 and 6 and a placebo injection at Month 2 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.
|
Group 3: Placebo
Participants aged 5 to 65 years received three intramuscular vaccinations of placebo at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive placebo injection at Month 18, 30 and 42 during the Booster Phase.
|
|---|---|---|---|
|
Overall Study
STARTED
|
208
|
209
|
208
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
208
|
209
|
208
|
Reasons for withdrawal
| Measure |
Group 1: VLA15
Participants aged 5 to 65 years received three intramuscular vaccinations of 180 microgram (mcg) VLA15 at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.
|
Group 2: VLA15 + Placebo
Participants aged 5 to 65 years received two intramuscular vaccinations of 180 mcg VLA15 at Month 0 and 6 and a placebo injection at Month 2 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.
|
Group 3: Placebo
Participants aged 5 to 65 years received three intramuscular vaccinations of placebo at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive placebo injection at Month 18, 30 and 42 during the Booster Phase.
|
|---|---|---|---|
|
Overall Study
Other
|
1
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
7
|
9
|
10
|
|
Overall Study
Moved from study area
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
1
|
4
|
|
Overall Study
Individual stopping criteria reached
|
0
|
1
|
0
|
|
Overall Study
Ongoing in the study
|
195
|
195
|
192
|
Baseline Characteristics
Phase 2 Study Of VLA15, A Vaccine Candidate Against Lyme Borreliosis, In A Healthy Pediatric And Adult Study Population
Baseline characteristics by cohort
| Measure |
Group 1: VLA15
n=208 Participants
Participants aged 5 to 65 years received three intramuscular vaccinations of 180 microgram (mcg) VLA15 at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.
|
Group 2: VLA15 + Placebo
n=209 Participants
Participants aged 5 to 65 years received two intramuscular vaccinations of 180 mcg VLA15 at Month 0 and 6 and a placebo injection at Month 2 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.
|
Group 3: Placebo
n=208 Participants
Participants aged 5 to 65 years received three intramuscular vaccinations of placebo at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive placebo injection at Month 18, 30 and 42 during the Booster Phase.
|
Total
n=625 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
28.7 Years
STANDARD_DEVIATION 19.08 • n=10 Participants
|
28.9 Years
STANDARD_DEVIATION 19.56 • n=10 Participants
|
29.0 Years
STANDARD_DEVIATION 19.72 • n=20 Participants
|
28.9 Years
STANDARD_DEVIATION 19.42 • n=45 Participants
|
|
Sex: Female, Male
Female
|
112 Participants
n=10 Participants
|
108 Participants
n=10 Participants
|
101 Participants
n=20 Participants
|
321 Participants
n=45 Participants
|
|
Sex: Female, Male
Male
|
96 Participants
n=10 Participants
|
101 Participants
n=10 Participants
|
107 Participants
n=20 Participants
|
304 Participants
n=45 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=45 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=10 Participants
|
3 Participants
n=10 Participants
|
6 Participants
n=20 Participants
|
13 Participants
n=45 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
27 Participants
n=10 Participants
|
17 Participants
n=10 Participants
|
24 Participants
n=20 Participants
|
68 Participants
n=45 Participants
|
|
Race/Ethnicity, Customized
White
|
172 Participants
n=10 Participants
|
184 Participants
n=10 Participants
|
176 Participants
n=20 Participants
|
532 Participants
n=45 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
4 Participants
n=10 Participants
|
5 Participants
n=10 Participants
|
2 Participants
n=20 Participants
|
11 Participants
n=45 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 7 after vaccination 1 at Month 0Population: Safety Analysis Set (SAS) included all participants who entered into the study and received at least one vaccination. Participants were analyzed according to the actual treatment received. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, "Number Analyzed" signifies participants evaluable for specified rows.
Participants or their legal guardians were required to record any solicited local and systemic adverse events in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema (redness), swelling and induration (hardening). Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever. Two-sided 95% confidence intervals were calculated according to Altman method.
Outcome measures
| Measure |
Group 1: VLA15
n=190 Participants
Participants aged 5 to 65 years received three intramuscular vaccinations of 180 microgram (mcg) VLA15 at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.
|
Group 2: VLA15 + Placebo
n=187 Participants
Participants aged 5 to 65 years received two intramuscular vaccinations of 180 mcg VLA15 at Month 0 and 6 and a placebo injection at Month 2 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.
|
Group 3: Placebo
n=208 Participants
Participants aged 5 to 65 years received three intramuscular vaccinations of placebo at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive placebo injection at Month 18, 30 and 42 during the Booster Phase.
|
Any VLA15
n=417 Participants
Participants aged 5 to 65 years who received intramuscular vaccinations of 180 mcg VLA15 at either Month 0, 2 or 6 during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination and could not be assigned to Group 1 or 2.
|
All Participants
n=625 Participants
Participants aged 5 to 65 years who received intramuscular vaccination of either 180 mcg VLA15 or placebo during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1
Headache
|
24.9 Percentage of participants
Interval 19.1 to 31.6
|
21.1 Percentage of participants
Interval 15.8 to 27.6
|
19.5 Percentage of participants
Interval 14.6 to 25.5
|
23.5 Percentage of participants
Interval 19.6 to 27.9
|
22.1 Percentage of participants
Interval 19.0 to 25.7
|
|
Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1
Fatigue
|
20.7 Percentage of participants
Interval 15.4 to 27.2
|
17.1 Percentage of participants
Interval 12.3 to 23.3
|
16.4 Percentage of participants
Interval 11.9 to 22.2
|
19.7 Percentage of participants
Interval 16.1 to 24.0
|
18.6 Percentage of participants
Interval 15.7 to 21.9
|
|
Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1
Pain
|
63.0 Percentage of participants
Interval 55.9 to 69.7
|
59.3 Percentage of participants
Interval 52.1 to 66.2
|
12.5 Percentage of participants
Interval 8.6 to 17.8
|
60.4 Percentage of participants
Interval 55.6 to 65.1
|
44.5 Percentage of participants
Interval 40.6 to 48.5
|
|
Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1
Tenderness
|
81.6 Percentage of participants
Interval 75.4 to 86.5
|
84.8 Percentage of participants
Interval 78.9 to 89.3
|
19.5 Percentage of participants
Interval 14.6 to 25.5
|
81.8 Percentage of participants
Interval 77.7 to 85.2
|
61.2 Percentage of participants
Interval 57.3 to 65.0
|
|
Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1
Erythema/redness
|
12.2 Percentage of participants
Interval 8.2 to 17.7
|
14.9 Percentage of participants
Interval 10.5 to 20.8
|
2.5 Percentage of participants
Interval 1.1 to 5.7
|
13.1 Percentage of participants
Interval 10.1 to 16.8
|
9.6 Percentage of participants
Interval 7.5 to 12.2
|
|
Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1
Swelling
|
8.9 Percentage of participants
Interval 5.6 to 14.0
|
8.8 Percentage of participants
Interval 5.5 to 13.9
|
0.5 Percentage of participants
Interval 0.1 to 2.8
|
9.1 Percentage of participants
Interval 6.7 to 12.4
|
6.2 Percentage of participants
Interval 4.6 to 8.5
|
|
Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1
Induration/Hardening
|
10.0 Percentage of participants
Interval 6.4 to 15.3
|
6.6 Percentage of participants
Interval 3.8 to 11.2
|
1.0 Percentage of participants
Interval 0.3 to 3.6
|
8.9 Percentage of participants
Interval 6.4 to 12.1
|
6.2 Percentage of participants
Interval 4.6 to 8.5
|
|
Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1
Muscle pain
|
36.1 Percentage of participants
Interval 29.5 to 43.2
|
34.6 Percentage of participants
Interval 28.1 to 41.8
|
11.0 Percentage of participants
Interval 7.4 to 16.1
|
35.7 Percentage of participants
Interval 31.1 to 40.5
|
27.5 Percentage of participants
Interval 24.0 to 31.2
|
|
Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1
Joint pain
|
9.9 Percentage of participants
Interval 6.4 to 15.2
|
3.9 Percentage of participants
Interval 1.9 to 7.8
|
6.5 Percentage of participants
Interval 3.8 to 10.7
|
7.6 Percentage of participants
Interval 5.4 to 10.6
|
7.2 Percentage of participants
Interval 5.4 to 9.6
|
|
Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1
Nausea
|
3.9 Percentage of participants
Interval 1.9 to 7.9
|
6.1 Percentage of participants
Interval 3.4 to 10.6
|
6.0 Percentage of participants
Interval 3.5 to 10.2
|
5.4 Percentage of participants
Interval 3.5 to 8.1
|
5.6 Percentage of participants
Interval 4.0 to 7.7
|
|
Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1
Vomiting
|
1.1 Percentage of participants
Interval 0.3 to 4.0
|
0.6 Percentage of participants
Interval 0.1 to 3.1
|
1.0 Percentage of participants
Interval 0.3 to 3.6
|
0.8 Percentage of participants
Interval 0.3 to 2.2
|
0.8 Percentage of participants
Interval 0.4 to 2.0
|
|
Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1
Fever
|
1.8 Percentage of participants
Interval 0.6 to 5.1
|
0.0 Percentage of participants
Interval 0.0 to 2.3
|
0.5 Percentage of participants
Interval 0.1 to 3.0
|
1.1 Percentage of participants
Interval 0.4 to 2.8
|
0.9 Percentage of participants
Interval 0.4 to 2.1
|
PRIMARY outcome
Timeframe: From Day 1 to Day 7 after vaccination 2 at Month 2Population: Safety Analysis Set (SAS) included all participants who entered into the study and received at least one vaccination. Participants were analyzed according to the actual treatment received. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, "Number Analyzed" signifies participants evaluable for specified rows.
Participants or their legal guardians were required to record any solicited local and systemic adverse events in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema (redness), swelling and induration (hardening). Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever. Two-sided 95% confidence intervals were calculated according to Altman method.
Outcome measures
| Measure |
Group 1: VLA15
n=190 Participants
Participants aged 5 to 65 years received three intramuscular vaccinations of 180 microgram (mcg) VLA15 at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.
|
Group 2: VLA15 + Placebo
n=181 Participants
Participants aged 5 to 65 years received two intramuscular vaccinations of 180 mcg VLA15 at Month 0 and 6 and a placebo injection at Month 2 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.
|
Group 3: Placebo
n=203 Participants
Participants aged 5 to 65 years received three intramuscular vaccinations of placebo at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive placebo injection at Month 18, 30 and 42 during the Booster Phase.
|
Any VLA15
n=399 Participants
Participants aged 5 to 65 years who received intramuscular vaccinations of 180 mcg VLA15 at either Month 0, 2 or 6 during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination and could not be assigned to Group 1 or 2.
|
All Participants
n=602 Participants
Participants aged 5 to 65 years who received intramuscular vaccination of either 180 mcg VLA15 or placebo during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2
Nausea
|
4.3 Percentage of participants
Interval 2.2 to 8.3
|
3.4 Percentage of participants
Interval 1.6 to 7.2
|
5.7 Percentage of participants
Interval 3.2 to 9.9
|
3.6 Percentage of participants
Interval 2.2 to 6.0
|
4.3 Percentage of participants
Interval 2.9 to 6.3
|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2
Pain
|
56.8 Percentage of participants
Interval 49.6 to 63.7
|
7.9 Percentage of participants
Interval 4.8 to 12.8
|
8.4 Percentage of participants
Interval 5.2 to 13.2
|
32.1 Percentage of participants
Interval 27.6 to 36.8
|
24.3 Percentage of participants
Interval 21.0 to 27.9
|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2
Tenderness
|
81.4 Percentage of participants
Interval 75.2 to 86.3
|
14.7 Percentage of participants
Interval 10.2 to 20.7
|
14.5 Percentage of participants
Interval 10.2 to 20.2
|
47.6 Percentage of participants
Interval 42.7 to 52.5
|
36.7 Percentage of participants
Interval 32.9 to 40.7
|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2
Erythema/redness
|
15.8 Percentage of participants
Interval 11.2 to 21.7
|
0.0 Percentage of participants
Interval 0.0 to 2.1
|
1.6 Percentage of participants
Interval 0.5 to 4.5
|
7.5 Percentage of participants
Interval 5.3 to 10.5
|
5.5 Percentage of participants
Interval 3.9 to 7.7
|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2
Swelling
|
11.4 Percentage of participants
Interval 7.6 to 16.8
|
0.0 Percentage of participants
Interval 0.0 to 2.1
|
0.5 Percentage of participants
Interval 0.1 to 2.9
|
5.4 Percentage of participants
Interval 3.6 to 8.2
|
3.8 Percentage of participants
Interval 2.5 to 5.7
|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2
Induration/Hardening
|
9.2 Percentage of participants
Interval 5.8 to 14.2
|
1.1 Percentage of participants
Interval 0.3 to 4.0
|
0.0 Percentage of participants
Interval 0.0 to 2.0
|
5.4 Percentage of participants
Interval 3.5 to 8.1
|
3.6 Percentage of participants
Interval 2.4 to 5.5
|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2
Headache
|
16.8 Percentage of participants
Interval 12.1 to 22.9
|
12.5 Percentage of participants
Interval 8.4 to 18.2
|
13.0 Percentage of participants
Interval 9.0 to 18.5
|
15.3 Percentage of participants
Interval 12.0 to 19.2
|
14.5 Percentage of participants
Interval 11.9 to 17.6
|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2
Muscle pain
|
23.8 Percentage of participants
Interval 18.2 to 30.4
|
4.0 Percentage of participants
Interval 1.9 to 8.0
|
3.7 Percentage of participants
Interval 1.8 to 7.4
|
14.2 Percentage of participants
Interval 11.1 to 18.0
|
10.7 Percentage of participants
Interval 8.4 to 13.5
|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2
Joint pain
|
4.9 Percentage of participants
Interval 2.6 to 9.0
|
3.4 Percentage of participants
Interval 1.6 to 7.2
|
1.6 Percentage of participants
Interval 0.5 to 4.5
|
4.7 Percentage of participants
Interval 3.0 to 7.3
|
3.6 Percentage of participants
Interval 2.4 to 5.5
|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2
Vomiting
|
1.1 Percentage of participants
Interval 0.3 to 3.9
|
1.7 Percentage of participants
Interval 0.6 to 4.9
|
0.0 Percentage of participants
Interval 0.0 to 2.0
|
1.3 Percentage of participants
Interval 0.6 to 3.0
|
0.9 Percentage of participants
Interval 0.4 to 2.0
|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2
Fatigue
|
13.6 Percentage of participants
Interval 9.4 to 19.3
|
9.1 Percentage of participants
Interval 5.7 to 14.3
|
12.0 Percentage of participants
Interval 8.1 to 17.3
|
11.9 Percentage of participants
Interval 9.1 to 15.6
|
12.0 Percentage of participants
Interval 9.6 to 14.9
|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2
Fever
|
1.7 Percentage of participants
Interval 0.6 to 4.9
|
0.0 Percentage of participants
Interval 0.0 to 2.2
|
0.0 Percentage of participants
Interval 0.0 to 2.1
|
0.8 Percentage of participants
Interval 0.3 to 2.4
|
0.5 Percentage of participants
Interval 0.2 to 1.6
|
PRIMARY outcome
Timeframe: From Day 1 to Day 7 after vaccination 3 at Month 6Population: Safety Analysis Set (SAS) included all participants who entered into the study and received at least one vaccination. Participants were analyzed according to the actual treatment received. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, "Number Analyzed" signifies participants evaluable for specified rows.
Participants or their legal guardians were required to record any solicited local and systemic adverse events in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema (redness), swelling and induration (hardening). Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever. Two-sided 95% confidence intervals were calculated according to Altman method.
Outcome measures
| Measure |
Group 1: VLA15
n=190 Participants
Participants aged 5 to 65 years received three intramuscular vaccinations of 180 microgram (mcg) VLA15 at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.
|
Group 2: VLA15 + Placebo
n=187 Participants
Participants aged 5 to 65 years received two intramuscular vaccinations of 180 mcg VLA15 at Month 0 and 6 and a placebo injection at Month 2 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.
|
Group 3: Placebo
n=191 Participants
Participants aged 5 to 65 years received three intramuscular vaccinations of placebo at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive placebo injection at Month 18, 30 and 42 during the Booster Phase.
|
Any VLA15
n=384 Participants
Participants aged 5 to 65 years who received intramuscular vaccinations of 180 mcg VLA15 at either Month 0, 2 or 6 during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination and could not be assigned to Group 1 or 2.
|
All Participants
n=575 Participants
Participants aged 5 to 65 years who received intramuscular vaccination of either 180 mcg VLA15 or placebo during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3
Pain
|
57.3 Percentage of participants
Interval 50.0 to 64.3
|
62.4 Percentage of participants
Interval 55.1 to 69.1
|
5.6 Percentage of participants
Interval 3.1 to 10.0
|
59.5 Percentage of participants
Interval 54.4 to 64.4
|
41.7 Percentage of participants
Interval 37.6 to 45.9
|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3
Tenderness
|
74.3 Percentage of participants
Interval 67.4 to 80.1
|
83.2 Percentage of participants
Interval 77.1 to 88.0
|
12.8 Percentage of participants
Interval 8.7 to 18.5
|
78.6 Percentage of participants
Interval 74.1 to 82.5
|
57.0 Percentage of participants
Interval 52.8 to 61.1
|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3
Erythema/redness
|
10.7 Percentage of participants
Interval 6.9 to 16.1
|
7.9 Percentage of participants
Interval 4.8 to 12.8
|
1.1 Percentage of participants
Interval 0.3 to 4.0
|
9.7 Percentage of participants
Interval 7.0 to 13.1
|
6.8 Percentage of participants
Interval 5.0 to 9.3
|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3
Swelling
|
7.9 Percentage of participants
Interval 4.8 to 12.8
|
10.2 Percentage of participants
Interval 6.5 to 15.5
|
0.6 Percentage of participants
Interval 0.1 to 3.1
|
9.1 Percentage of participants
Interval 6.6 to 12.6
|
6.3 Percentage of participants
Interval 4.5 to 8.7
|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3
Induration/Hardening
|
7.9 Percentage of participants
Interval 4.8 to 12.8
|
9.0 Percentage of participants
Interval 5.6 to 14.1
|
0.6 Percentage of participants
Interval 0.1 to 3.1
|
8.3 Percentage of participants
Interval 5.9 to 11.6
|
5.7 Percentage of participants
Interval 4.1 to 8.0
|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3
Headache
|
16.6 Percentage of participants
Interval 11.8 to 22.8
|
20.8 Percentage of participants
Interval 15.5 to 27.3
|
8.9 Percentage of participants
Interval 5.5 to 14.0
|
18.6 Percentage of participants
Interval 14.9 to 23.0
|
15.4 Percentage of participants
Interval 12.6 to 18.7
|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3
Muscle pain
|
26.7 Percentage of participants
Interval 20.7 to 33.7
|
29.6 Percentage of participants
Interval 23.4 to 36.7
|
7.8 Percentage of participants
Interval 4.7 to 12.7
|
28.2 Percentage of participants
Interval 23.8 to 33.0
|
21.4 Percentage of participants
Interval 18.2 to 25.1
|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3
Joint pain
|
6.3 Percentage of participants
Interval 3.5 to 10.9
|
3.9 Percentage of participants
Interval 1.9 to 7.9
|
3.3 Percentage of participants
Interval 1.5 to 7.1
|
5.0 Percentage of participants
Interval 3.2 to 7.8
|
4.4 Percentage of participants
Interval 3.0 to 6.5
|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3
Nausea
|
2.3 Percentage of participants
Interval 0.9 to 5.7
|
4.0 Percentage of participants
Interval 1.9 to 7.9
|
2.2 Percentage of participants
Interval 0.9 to 5.6
|
3.1 Percentage of participants
Interval 1.7 to 5.4
|
2.8 Percentage of participants
Interval 1.7 to 4.5
|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3
Vomiting
|
1.1 Percentage of participants
Interval 0.3 to 4.1
|
1.1 Percentage of participants
Interval 0.3 to 4.0
|
0.0 Percentage of participants
Interval 0.0 to 2.1
|
1.1 Percentage of participants
Interval 0.4 to 2.8
|
0.7 Percentage of participants
Interval 0.3 to 1.9
|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3
Fatigue
|
17.7 Percentage of participants
Interval 12.8 to 24.0
|
16.9 Percentage of participants
Interval 12.1 to 23.0
|
11.7 Percentage of participants
Interval 7.8 to 17.2
|
17.2 Percentage of participants
Interval 13.7 to 21.5
|
15.4 Percentage of participants
Interval 12.6 to 18.7
|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3
Fever
|
0.0 Percentage of participants
Interval 0.0 to 2.2
|
1.8 Percentage of participants
Interval 0.6 to 5.1
|
0.6 Percentage of participants
Interval 0.1 to 3.2
|
0.9 Percentage of participants
Interval 0.3 to 2.5
|
0.8 Percentage of participants
Interval 0.3 to 2.0
|
PRIMARY outcome
Timeframe: From Day 1 to Day 7 after vaccination 1, 2 or 3 at Month 0, 2 and 6 respectivelyPopulation: Safety Analysis Set (SAS) included all participants who entered into the study and received at least one vaccination. Participants were analyzed according to the actual treatment received. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table and for each specified row.
Participants or their legal guardians were required to record any solicited local and systemic adverse events in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema (redness), swelling and induration (hardening). Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever. Two-sided 95% confidence intervals were calculated according to Altman method.
Outcome measures
| Measure |
Group 1: VLA15
n=190 Participants
Participants aged 5 to 65 years received three intramuscular vaccinations of 180 microgram (mcg) VLA15 at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.
|
Group 2: VLA15 + Placebo
n=187 Participants
Participants aged 5 to 65 years received two intramuscular vaccinations of 180 mcg VLA15 at Month 0 and 6 and a placebo injection at Month 2 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.
|
Group 3: Placebo
n=208 Participants
Participants aged 5 to 65 years received three intramuscular vaccinations of placebo at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive placebo injection at Month 18, 30 and 42 during the Booster Phase.
|
Any VLA15
n=417 Participants
Participants aged 5 to 65 years who received intramuscular vaccinations of 180 mcg VLA15 at either Month 0, 2 or 6 during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination and could not be assigned to Group 1 or 2.
|
All Participants
n=625 Participants
Participants aged 5 to 65 years who received intramuscular vaccination of either 180 mcg VLA15 or placebo during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase
Tenderness
|
92.6 Percentage of participants
Interval 88.0 to 95.6
|
92.5 Percentage of participants
Interval 87.8 to 95.5
|
28.4 Percentage of participants
Interval 22.7 to 34.8
|
90.6 Percentage of participants
Interval 87.5 to 93.1
|
69.9 Percentage of participants
Interval 66.2 to 73.4
|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase
Joint pain
|
15.3 Percentage of participants
Interval 10.8 to 21.1
|
9.6 Percentage of participants
Interval 6.2 to 14.7
|
8.2 Percentage of participants
Interval 5.2 to 12.7
|
13.2 Percentage of participants
Interval 10.3 to 16.8
|
11.5 Percentage of participants
Interval 9.2 to 14.3
|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase
Fatigue
|
33.2 Percentage of participants
Interval 26.9 to 40.1
|
29.9 Percentage of participants
Interval 23.8 to 36.9
|
28.4 Percentage of participants
Interval 22.7 to 34.8
|
31.4 Percentage of participants
Interval 27.1 to 36.0
|
30.4 Percentage of participants
Interval 26.9 to 34.1
|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase
Pain
|
80.5 Percentage of participants
Interval 74.3 to 85.5
|
77.0 Percentage of participants
Interval 70.5 to 82.5
|
16.8 Percentage of participants
Interval 12.4 to 22.5
|
77.0 Percentage of participants
Interval 72.7 to 80.8
|
57.0 Percentage of participants
Interval 53.0 to 60.8
|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase
Erythema/Redness
|
26.8 Percentage of participants
Interval 21.0 to 33.6
|
18.7 Percentage of participants
Interval 13.8 to 24.9
|
3.4 Percentage of participants
Interval 1.6 to 6.8
|
21.8 Percentage of participants
Interval 18.1 to 26.0
|
15.7 Percentage of participants
Interval 13.0 to 18.7
|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase
Swelling
|
20.5 Percentage of participants
Interval 15.4 to 26.8
|
16.6 Percentage of participants
Interval 11.9 to 22.6
|
1.4 Percentage of participants
Interval 0.5 to 4.2
|
18.0 Percentage of participants
Interval 14.6 to 22.0
|
12.5 Percentage of participants
Interval 10.1 to 15.3
|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase
Induration/Hardening
|
19.5 Percentage of participants
Interval 14.5 to 25.7
|
14.4 Percentage of participants
Interval 10.1 to 20.2
|
1.4 Percentage of participants
Interval 0.5 to 4.2
|
16.5 Percentage of participants
Interval 13.3 to 20.4
|
11.5 Percentage of participants
Interval 9.2 to 14.3
|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase
Headache
|
38.4 Percentage of participants
Interval 31.8 to 45.5
|
36.4 Percentage of participants
Interval 29.8 to 43.5
|
28.8 Percentage of participants
Interval 23.1 to 35.3
|
37.4 Percentage of participants
Interval 32.9 to 42.1
|
34.6 Percentage of participants
Interval 30.9 to 38.4
|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase
Muscle pain
|
45.8 Percentage of participants
Interval 38.9 to 52.9
|
48.1 Percentage of participants
Interval 41.1 to 55.3
|
17.8 Percentage of participants
Interval 13.2 to 23.6
|
46.8 Percentage of participants
Interval 42.0 to 51.6
|
37.1 Percentage of participants
Interval 33.4 to 41.0
|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase
Nausea
|
8.4 Percentage of participants
Interval 5.2 to 13.2
|
11.2 Percentage of participants
Interval 7.5 to 16.6
|
9.6 Percentage of participants
Interval 6.3 to 14.4
|
9.6 Percentage of participants
Interval 7.1 to 12.8
|
9.6 Percentage of participants
Interval 7.5 to 12.2
|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase
Vomiting
|
3.2 Percentage of participants
Interval 1.5 to 6.7
|
3.2 Percentage of participants
Interval 1.5 to 6.8
|
1.0 Percentage of participants
Interval 0.3 to 3.4
|
2.9 Percentage of participants
Interval 1.7 to 5.0
|
2.2 Percentage of participants
Interval 1.3 to 3.7
|
|
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase
Fever
|
3.2 Percentage of participants
Interval 1.5 to 6.7
|
1.6 Percentage of participants
Interval 0.5 to 4.6
|
1.0 Percentage of participants
Interval 0.3 to 3.4
|
2.4 Percentage of participants
Interval 1.3 to 4.4
|
1.9 Percentage of participants
Interval 1.1 to 3.3
|
PRIMARY outcome
Timeframe: Day 208 (Month 7)Population: Per-Protocol Analysis Set (PPAS) consisted of the FAS population excluding those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity). All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, "Number Analyzed" signifies participants with available results for each serotype.
GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay at Day 208 is presented in this outcome measure.
Outcome measures
| Measure |
Group 1: VLA15
n=177 Participants
Participants aged 5 to 65 years received three intramuscular vaccinations of 180 microgram (mcg) VLA15 at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.
|
Group 2: VLA15 + Placebo
n=162 Participants
Participants aged 5 to 65 years received two intramuscular vaccinations of 180 mcg VLA15 at Month 0 and 6 and a placebo injection at Month 2 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.
|
Group 3: Placebo
n=177 Participants
Participants aged 5 to 65 years received three intramuscular vaccinations of placebo at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive placebo injection at Month 18, 30 and 42 during the Booster Phase.
|
Any VLA15
Participants aged 5 to 65 years who received intramuscular vaccinations of 180 mcg VLA15 at either Month 0, 2 or 6 during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination and could not be assigned to Group 1 or 2.
|
All Participants
Participants aged 5 to 65 years who received intramuscular vaccination of either 180 mcg VLA15 or placebo during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination.
|
|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) Against Each Outer Surface Protein A (OspA) Serotype (ST1 to ST6) at Day 208 During the Main Study Phase
ST3
|
586.4 Units per milliliter
Interval 497.4 to 691.4
|
436.2 Units per milliliter
Interval 344.8 to 551.8
|
21.9 Units per milliliter
Interval 20.2 to 23.8
|
—
|
—
|
|
Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) Against Each Outer Surface Protein A (OspA) Serotype (ST1 to ST6) at Day 208 During the Main Study Phase
ST5
|
443.4 Units per milliliter
Interval 375.5 to 523.6
|
239.4 Units per milliliter
Interval 190.5 to 301.0
|
22.4 Units per milliliter
Interval 20.6 to 24.4
|
—
|
—
|
|
Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) Against Each Outer Surface Protein A (OspA) Serotype (ST1 to ST6) at Day 208 During the Main Study Phase
ST6
|
429.7 Units per milliliter
Interval 360.2 to 512.8
|
222.0 Units per milliliter
Interval 177.4 to 277.8
|
24.3 Units per milliliter
Interval 22.1 to 26.7
|
—
|
—
|
|
Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) Against Each Outer Surface Protein A (OspA) Serotype (ST1 to ST6) at Day 208 During the Main Study Phase
ST1
|
333.2 Units per milliliter
Interval 275.2 to 403.4
|
197.3 Units per milliliter
Interval 156.2 to 249.3
|
23.8 Units per milliliter
Interval 21.6 to 26.2
|
—
|
—
|
|
Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) Against Each Outer Surface Protein A (OspA) Serotype (ST1 to ST6) at Day 208 During the Main Study Phase
ST2
|
656.0 Units per milliliter
Interval 560.2 to 768.2
|
460.3 Units per milliliter
Interval 370.6 to 571.8
|
21.9 Units per milliliter
Interval 20.2 to 23.7
|
—
|
—
|
|
Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) Against Each Outer Surface Protein A (OspA) Serotype (ST1 to ST6) at Day 208 During the Main Study Phase
ST4
|
422.8 Units per milliliter
Interval 355.3 to 503.1
|
245.8 Units per milliliter
Interval 196.1 to 308.2
|
23.5 Units per milliliter
Interval 21.3 to 25.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days after booster doseParticipants or their legal guardians were required to record any solicited local and systemic adverse events in the electronic diary. Solicited local AEs included pain, tenderness, erythema (redness), swelling and induration (hardening). Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Day 1 of vaccination up to Day 208 (Month 7)Population: Safety Analysis Set (SAS) included all participants who entered into the study and received at least one vaccination. Participants were analyzed according to the actual treatment received.
SAE was any untoward medical occurrence that at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was another medically important condition. Two-sided 95% confidence intervals were calculated according to Altman method.
Outcome measures
| Measure |
Group 1: VLA15
n=190 Participants
Participants aged 5 to 65 years received three intramuscular vaccinations of 180 microgram (mcg) VLA15 at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.
|
Group 2: VLA15 + Placebo
n=187 Participants
Participants aged 5 to 65 years received two intramuscular vaccinations of 180 mcg VLA15 at Month 0 and 6 and a placebo injection at Month 2 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.
|
Group 3: Placebo
n=208 Participants
Participants aged 5 to 65 years received three intramuscular vaccinations of placebo at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive placebo injection at Month 18, 30 and 42 during the Booster Phase.
|
Any VLA15
n=417 Participants
Participants aged 5 to 65 years who received intramuscular vaccinations of 180 mcg VLA15 at either Month 0, 2 or 6 during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination and could not be assigned to Group 1 or 2.
|
All Participants
n=625 Participants
Participants aged 5 to 65 years who received intramuscular vaccination of either 180 mcg VLA15 or placebo during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Serious Adverse Events (SAEs)
|
0.0 Percentage of participants
Interval 0.0 to 2.0
|
1.1 Percentage of participants
Interval 0.3 to 3.8
|
1.9 Percentage of participants
Interval 0.8 to 4.8
|
0.7 Percentage of participants
Interval 0.2 to 2.1
|
1.1 Percentage of participants
Interval 0.5 to 2.3
|
SECONDARY outcome
Timeframe: From Day 1 of vaccination up to Day 208 (Month 7)Population: Safety Analysis Set (SAS) included all participants who entered into the study and received at least one vaccination. Participants were analyzed according to the actual treatment received.
An AESI (serious or non-serious) was one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor were appropriate. Two-sided 95% confidence intervals were calculated according to Altman method.
Outcome measures
| Measure |
Group 1: VLA15
n=190 Participants
Participants aged 5 to 65 years received three intramuscular vaccinations of 180 microgram (mcg) VLA15 at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.
|
Group 2: VLA15 + Placebo
n=187 Participants
Participants aged 5 to 65 years received two intramuscular vaccinations of 180 mcg VLA15 at Month 0 and 6 and a placebo injection at Month 2 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.
|
Group 3: Placebo
n=208 Participants
Participants aged 5 to 65 years received three intramuscular vaccinations of placebo at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive placebo injection at Month 18, 30 and 42 during the Booster Phase.
|
Any VLA15
n=417 Participants
Participants aged 5 to 65 years who received intramuscular vaccinations of 180 mcg VLA15 at either Month 0, 2 or 6 during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination and could not be assigned to Group 1 or 2.
|
All Participants
n=625 Participants
Participants aged 5 to 65 years who received intramuscular vaccination of either 180 mcg VLA15 or placebo during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Adverse Events of Special Interest (AESIs)
|
0.0 Percentage of participants
Interval 0.0 to 2.0
|
0.5 Percentage of participants
Interval 0.1 to 3.0
|
0.0 Percentage of participants
Interval 0.0 to 1.8
|
1.2 Percentage of participants
Interval 0.5 to 2.8
|
0.8 Percentage of participants
Interval 0.3 to 1.9
|
SECONDARY outcome
Timeframe: From Day 1 to Day 28 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectivelyPopulation: Safety Analysis Set (SAS) included all participants who entered into the study and received at least one vaccination.
An AE was any untoward medical occurrence in a participant administered an investigational product, whether or not related to this treatment. Unsolicited AEs were defined as any solicited local or systemic AE if it had an onset date more than 6 days after vaccination or any other symptom or untoward medical event. Two-sided 95% confidence intervals were calculated according to Altman method.
Outcome measures
| Measure |
Group 1: VLA15
n=190 Participants
Participants aged 5 to 65 years received three intramuscular vaccinations of 180 microgram (mcg) VLA15 at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.
|
Group 2: VLA15 + Placebo
n=187 Participants
Participants aged 5 to 65 years received two intramuscular vaccinations of 180 mcg VLA15 at Month 0 and 6 and a placebo injection at Month 2 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.
|
Group 3: Placebo
n=208 Participants
Participants aged 5 to 65 years received three intramuscular vaccinations of placebo at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive placebo injection at Month 18, 30 and 42 during the Booster Phase.
|
Any VLA15
n=417 Participants
Participants aged 5 to 65 years who received intramuscular vaccinations of 180 mcg VLA15 at either Month 0, 2 or 6 during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination and could not be assigned to Group 1 or 2.
|
All Participants
n=625 Participants
Participants aged 5 to 65 years who received intramuscular vaccination of either 180 mcg VLA15 or placebo during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Unsolicited Adverse Events
|
16.8 Percentage of participants
Interval 12.2 to 22.8
|
25.1 Percentage of participants
Interval 19.5 to 31.8
|
24.5 Percentage of participants
Interval 19.2 to 30.8
|
20.9 Percentage of participants
Interval 17.2 to 25.0
|
22.1 Percentage of participants
Interval 19.0 to 25.5
|
SECONDARY outcome
Timeframe: SAEs, AESIs: From Day 1 of vaccination (vac) up to Day 208 (Month 7), Solicited AEs: From Day 1 to Day 7 after vac 1, 2 and 3 at Month 0, 2 and 6, respectively; Unsolicited AEs: From Day 1 to Day 28 after vac 1, 2 and 3 at Month 0, 2 and 6, respectivelyPopulation: Safety Analysis Set (SAS) included all participants who entered into the study and received at least one vaccination. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, "Number Analyzed" signifies participants evaluable for specified rows.
Percentage of participants with SAEs, AESIs, solicited and unsolicited AEs stratified by age group 18 to 65, 12 to 17 and 5 to 11 years were reported. SAE: any untoward medical occurrence that at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was another medically important condition. AESI: scientific and medical concern specific to the sponsor's product or program. Solicited AE: predefined reactions at injection site or systemic reactions after each vaccination. Unsolicited AEs: any solicited local or systemic AE if it had an onset date more than 6 days after vaccination or any other symptom or untoward medical event. Unsolicited AEs were collected only up to 28 days after any vaccination. Two-sided 95% confidence intervals were calculated according to Altman method.
Outcome measures
| Measure |
Group 1: VLA15
n=190 Participants
Participants aged 5 to 65 years received three intramuscular vaccinations of 180 microgram (mcg) VLA15 at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.
|
Group 2: VLA15 + Placebo
n=187 Participants
Participants aged 5 to 65 years received two intramuscular vaccinations of 180 mcg VLA15 at Month 0 and 6 and a placebo injection at Month 2 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.
|
Group 3: Placebo
n=208 Participants
Participants aged 5 to 65 years received three intramuscular vaccinations of placebo at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive placebo injection at Month 18, 30 and 42 during the Booster Phase.
|
Any VLA15
n=417 Participants
Participants aged 5 to 65 years who received intramuscular vaccinations of 180 mcg VLA15 at either Month 0, 2 or 6 during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination and could not be assigned to Group 1 or 2.
|
All Participants
n=625 Participants
Participants aged 5 to 65 years who received intramuscular vaccination of either 180 mcg VLA15 or placebo during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination.
|
|---|---|---|---|---|---|
|
Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group
SAE: 18 to 65 years
|
0.0 Percentage of participants
Interval 0.0 to 3.8
|
1.1 Percentage of participants
Interval 0.2 to 6.0
|
1.9 Percentage of participants
Interval 0.5 to 6.6
|
0.5 Percentage of participants
Interval 0.1 to 2.6
|
0.9 Percentage of participants
Interval 0.3 to 2.7
|
|
Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group
SAE: 12 to 17 years
|
0.0 Percentage of participants
Interval 0.0 to 8.0
|
0.0 Percentage of participants
Interval 0.0 to 7.4
|
4.0 Percentage of participants
Interval 1.1 to 13.5
|
1.0 Percentage of participants
Interval 0.2 to 5.4
|
2.0 Percentage of participants
Interval 0.7 to 5.7
|
|
Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group
SAE: 5 to 11 years
|
0.0 Percentage of participants
Interval 0.0 to 7.3
|
2.0 Percentage of participants
Interval 0.4 to 10.7
|
0.0 Percentage of participants
Interval 0.0 to 7.0
|
1.0 Percentage of participants
Interval 0.2 to 5.2
|
0.6 Percentage of participants
Interval 0.1 to 3.6
|
|
Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group
AESI: 18 to 65 years
|
0.0 Percentage of participants
Interval 0.0 to 3.8
|
0.0 Percentage of participants
Interval 0.0 to 4.1
|
0.0 Percentage of participants
Interval 0.0 to 3.5
|
0.9 Percentage of participants
Interval 0.3 to 3.4
|
0.6 Percentage of participants
Interval 0.2 to 2.2
|
|
Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group
AESI: 12 to 17 years
|
0.0 Percentage of participants
Interval 0.0 to 8.0
|
0.0 Percentage of participants
Interval 0.0 to 7.4
|
0.0 Percentage of participants
Interval 0.0 to 7.1
|
1.0 Percentage of participants
Interval 0.2 to 5.4
|
0.7 Percentage of participants
Interval 0.1 to 3.7
|
|
Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group
AESI: 5 to 11 years
|
0.0 Percentage of participants
Interval 0.0 to 7.3
|
2.0 Percentage of participants
Interval 0.4 to 10.7
|
0.0 Percentage of participants
Interval 0.0 to 7.0
|
1.9 Percentage of participants
Interval 0.5 to 6.7
|
1.3 Percentage of participants
Interval 0.4 to 4.6
|
|
Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group
Solicited AE: 18 to 65 years
|
94.8 Percentage of participants
Interval 88.5 to 97.8
|
95.6 Percentage of participants
Interval 89.1 to 98.3
|
62.6 Percentage of participants
Interval 53.2 to 71.2
|
93.9 Percentage of participants
Interval 89.8 to 96.4
|
83.4 Percentage of participants
Interval 79.0 to 87.1
|
|
Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group
Solicited AE: 12 to 17 years
|
97.7 Percentage of participants
Interval 88.2 to 99.6
|
93.8 Percentage of participants
Interval 83.2 to 97.9
|
60.0 Percentage of participants
Interval 46.2 to 72.4
|
95.0 Percentage of participants
Interval 88.8 to 97.8
|
83.3 Percentage of participants
Interval 76.6 to 88.4
|
|
Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group
Solicited AE: 5 to 11 years
|
87.8 Percentage of participants
Interval 75.8 to 94.3
|
98.0 Percentage of participants
Interval 89.3 to 99.6
|
64.7 Percentage of participants
Interval 51.0 to 76.4
|
93.3 Percentage of participants
Interval 86.8 to 96.7
|
83.9 Percentage of participants
Interval 77.3 to 88.8
|
|
Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group
Unsolicited AE: 18 to 65 years
|
23.7 Percentage of participants
Interval 16.4 to 33.1
|
30.0 Percentage of participants
Interval 21.5 to 40.1
|
29.0 Percentage of participants
Interval 21.2 to 38.2
|
26.3 Percentage of participants
Interval 20.8 to 32.6
|
27.2 Percentage of participants
Interval 22.6 to 32.3
|
|
Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group
Unsolicited AE: 12 to 17 years
|
18.2 Percentage of participants
Interval 9.5 to 32.0
|
20.8 Percentage of participants
Interval 11.7 to 34.3
|
22.0 Percentage of participants
Interval 12.8 to 35.2
|
19.0 Percentage of participants
Interval 12.5 to 27.8
|
20.0 Percentage of participants
Interval 14.4 to 27.1
|
|
Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group
Unsolicited AE: 5 to 11 years
|
2.0 Percentage of participants
Interval 0.4 to 10.7
|
20.4 Percentage of participants
Interval 11.5 to 33.6
|
17.6 Percentage of participants
Interval 9.6 to 30.3
|
11.5 Percentage of participants
Interval 6.7 to 19.1
|
13.5 Percentage of participants
Interval 9.0 to 19.8
|
SECONDARY outcome
Timeframe: Baseline, Day 85, Day 180 and Day 194GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 85, Day 180, Day 194 and Day 208Seroconversion Rate (SCR) for each OspA serotype specific IgG ST1 to ST6, determined by enzyme linked immunosorbent assay (ELISA). Seroconversion for ELISA was defined as: 1) For participants who were seronegative at screening: percentage of participants with a change from seronegative at screening to seropositive (i.e. antibody titer of \>=40 Units per milliliter \[U/mL\]) at a certain time point. 2) For participants who were seropositive at screening: percentage of participants with a \>= 4-fold rise in OspA IgG antibody titer from screening.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Day 85 and 208GMFR as compared to baseline for IgG against each OspA serotype ST1 to ST6, determined by IgG binding assay at Day 85 and Day 208.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Day 85, Day 180, Day 194 (18 to 65 years only) and Day 208GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay stratified by age group (18 to 65, 12 to 17 and 5 to 11 years).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 85, Day 180, Day 194 (18 to 65 years only) and Day 208SCR for each OspA serotype specific IgG ST1 to ST6, determined by ELISA stratified by age group (18 to 65, 12 to 17 and 5 to 11 years). Seroconversion for ELISA was defined as: 1) For participants who were seronegative at screening: percentage of participants with a change from seronegative at screening to seropositive (i.e. antibody titer of \>=40 Units per milliliter \[U/mL\]) at a certain time point. 2) For participants who were seropositive at screening: percentage of participants with a \>= 4-fold rise in OspA IgG antibody titer from screening.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Day 85, Day 180, Day 194 (18 to 65 years only) and Day 208GMFR as compared to baseline for IgG against each OspA serotype ST1 to ST6, stratified by age group (18 to 65, 12 to 17 and 5 to 11 years) determined by IgG binding assay at Day 85, Day 180, Day 194 (18 to 65 years only) and Day 208.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Month 48Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Month 48Seroconversion for ELISA was defined as: 1) For participants who were seronegative at screening: a change from seronegative at screening to seropositive (i.e. antibody titer of \>=40 U/mL) at a certain time point. 2) For participants who were seropositive at screening: a \>= 4-fold rise in OspA IgG antibody titer from screening.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 19Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Month 48Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Month 48Seroconversion for ELISA was defined as: 1) For participants who were seronegative at screening: a change from seronegative at screening to seropositive (i.e. antibody titer of \>=40 U/mL) at a certain time point. 2) For participants who were seropositive at screening: a \>= 4-fold rise in OspA IgG antibody titer from screening.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Month 48Outcome measures
Outcome data not reported
Adverse Events
Group 1: VLA15
Serious events: 0 serious events
Other events: 178 other events
Deaths: 0 deaths
Group 2: VLA15 + Placebo
Serious events: 2 serious events
Other events: 179 other events
Deaths: 0 deaths
Group 3: Placebo
Serious events: 4 serious events
Other events: 133 other events
Deaths: 0 deaths
Any VLA15
Serious events: 3 serious events
Other events: 391 other events
Deaths: 0 deaths
All Participants
Serious events: 7 serious events
Other events: 524 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: VLA15
n=190 participants at risk
Participants aged 5 to 65 years received three intramuscular vaccinations of 180 microgram (mcg) VLA15 at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.
|
Group 2: VLA15 + Placebo
n=187 participants at risk
Participants aged 5 to 65 years received two intramuscular vaccinations of 180 mcg VLA15 at Month 0 and 6 and a placebo injection at Month 2 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.
|
Group 3: Placebo
n=208 participants at risk
Participants aged 5 to 65 years received three intramuscular vaccinations of placebo at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive placebo injection at Month 18, 30 and 42 during the Booster Phase.
|
Any VLA15
n=417 participants at risk
Participants aged 5 to 65 years who received intramuscular vaccinations of 180 mcg VLA15 at either Month 0, 2 or 6 during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination and could not be assigned to Group 1 or 2.
|
All Participants
n=625 participants at risk
Participants aged 5 to 65 years who received intramuscular vaccination of either 180 mcg VLA15 or placebo during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination.
|
|---|---|---|---|---|---|
|
Psychiatric disorders
Major depression
|
0.00%
0/190 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
0.53%
1/187 • Number of events 1 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
0.00%
0/208 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
0.24%
1/417 • Number of events 1 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
0.16%
1/625 • Number of events 1 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
|
Psychiatric disorders
Reactive attachment disorder of infancy or early childhood
|
0.00%
0/190 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
0.00%
0/187 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
0.48%
1/208 • Number of events 1 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
0.00%
0/417 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
0.16%
1/625 • Number of events 1 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/190 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
0.00%
0/187 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
0.48%
1/208 • Number of events 2 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
0.00%
0/417 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
0.16%
1/625 • Number of events 2 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/190 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
0.00%
0/187 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
0.48%
1/208 • Number of events 1 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
0.00%
0/417 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
0.16%
1/625 • Number of events 1 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/190 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
0.53%
1/187 • Number of events 1 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
0.00%
0/208 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
0.24%
1/417 • Number of events 1 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
0.16%
1/625 • Number of events 1 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/190 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
0.00%
0/187 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
0.00%
0/208 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
0.24%
1/417 • Number of events 1 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
0.16%
1/625 • Number of events 1 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/190 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
0.00%
0/187 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
0.48%
1/208 • Number of events 1 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
0.00%
0/417 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
0.16%
1/625 • Number of events 1 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
Other adverse events
| Measure |
Group 1: VLA15
n=190 participants at risk
Participants aged 5 to 65 years received three intramuscular vaccinations of 180 microgram (mcg) VLA15 at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.
|
Group 2: VLA15 + Placebo
n=187 participants at risk
Participants aged 5 to 65 years received two intramuscular vaccinations of 180 mcg VLA15 at Month 0 and 6 and a placebo injection at Month 2 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18, 30 and 42 during the Booster Phase.
|
Group 3: Placebo
n=208 participants at risk
Participants aged 5 to 65 years received three intramuscular vaccinations of placebo at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive placebo injection at Month 18, 30 and 42 during the Booster Phase.
|
Any VLA15
n=417 participants at risk
Participants aged 5 to 65 years who received intramuscular vaccinations of 180 mcg VLA15 at either Month 0, 2 or 6 during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination and could not be assigned to Group 1 or 2.
|
All Participants
n=625 participants at risk
Participants aged 5 to 65 years who received intramuscular vaccination of either 180 mcg VLA15 or placebo during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination.
|
|---|---|---|---|---|---|
|
General disorders
Injection site pain
|
93.2%
177/190 • Number of events 760 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
94.1%
176/187 • Number of events 561 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
32.2%
67/208 • Number of events 141 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
92.1%
384/417 • Number of events 1385 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
72.2%
451/625 • Number of events 1526 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
|
General disorders
Fatigue
|
33.2%
63/190 • Number of events 93 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
29.4%
55/187 • Number of events 77 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
28.4%
59/208 • Number of events 78 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
30.9%
129/417 • Number of events 186 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
30.1%
188/625 • Number of events 264 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
|
General disorders
Injection site erythema
|
38.9%
74/190 • Number of events 118 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
33.2%
62/187 • Number of events 86 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
8.7%
18/208 • Number of events 23 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
35.3%
147/417 • Number of events 215 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
26.4%
165/625 • Number of events 238 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
|
General disorders
Injection site swelling
|
33.7%
64/190 • Number of events 89 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
29.4%
55/187 • Number of events 67 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
6.2%
13/208 • Number of events 14 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
30.0%
125/417 • Number of events 162 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
22.1%
138/625 • Number of events 176 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
|
General disorders
Injection site induration
|
29.5%
56/190 • Number of events 86 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
26.7%
50/187 • Number of events 61 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
4.8%
10/208 • Number of events 12 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
27.1%
113/417 • Number of events 158 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
19.7%
123/625 • Number of events 170 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
45.8%
87/190 • Number of events 158 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
48.1%
90/187 • Number of events 122 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
17.8%
37/208 • Number of events 43 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
46.8%
195/417 • Number of events 300 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
37.1%
232/625 • Number of events 343 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.3%
29/190 • Number of events 38 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
10.2%
19/187 • Number of events 22 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
8.7%
18/208 • Number of events 23 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
13.7%
57/417 • Number of events 71 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
12.0%
75/625 • Number of events 94 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
|
Nervous system disorders
Headache
|
38.9%
74/190 • Number of events 106 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
36.4%
68/187 • Number of events 98 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
30.3%
63/208 • Number of events 83 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
37.6%
157/417 • Number of events 220 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
35.2%
220/625 • Number of events 303 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
|
Gastrointestinal disorders
Nausea
|
8.4%
16/190 • Number of events 19 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
11.2%
21/187 • Number of events 25 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
9.6%
20/208 • Number of events 27 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
9.6%
40/417 • Number of events 47 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
9.6%
60/625 • Number of events 74 • Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Solicited AEs comprised injection site reactions (pain, tenderness, erythema \[redness\]), induration \[hardening\], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER