Trial Outcomes & Findings for A Phase 2 Clinical Trial of VLA1553 in Healthy Children Aged 1 to 11 Years (NCT NCT06106581)
NCT ID: NCT06106581
Last Updated: 2026-08-13
Results Overview
Frequency and severity of solicited injection site and solicited systemic reactions within 14 days post-vaccination.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
304 participants
Primary outcome timeframe
within 14 days post-vaccination
Results posted on
2026-08-13
Participant Flow
Participant milestones
| Measure |
VLA1553 Half Dose
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
|---|---|---|---|
|
Overall Study
STARTED
|
119
|
124
|
61
|
|
Overall Study
COMPLETED
|
115
|
122
|
60
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
1
|
Reasons for withdrawal
| Measure |
VLA1553 Half Dose
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
|
Overall Study
participant was out of town and was not back within the time window
|
0
|
1
|
0
|
Baseline Characteristics
A Phase 2 Clinical Trial of VLA1553 in Healthy Children Aged 1 to 11 Years
Baseline characteristics by cohort
| Measure |
VLA1553 Half Dose
n=119 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose
n=124 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control
n=61 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
Total
n=304 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
5.0 years
STANDARD_DEVIATION 3.05 • n=1 Participants
|
5.0 years
STANDARD_DEVIATION 3.05 • n=1 Participants
|
5.1 years
STANDARD_DEVIATION 3.37 • n=1 Participants
|
5.0 years
STANDARD_DEVIATION 3.11 • n=2 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=1 Participants
|
65 Participants
n=1 Participants
|
29 Participants
n=1 Participants
|
146 Participants
n=2 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=1 Participants
|
59 Participants
n=1 Participants
|
32 Participants
n=1 Participants
|
158 Participants
n=2 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=1 Participants
|
2 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
2 Participants
n=2 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
42 Participants
n=1 Participants
|
34 Participants
n=1 Participants
|
12 Participants
n=1 Participants
|
88 Participants
n=2 Participants
|
|
Race/Ethnicity, Customized
White
|
0 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=2 Participants
|
|
Race/Ethnicity, Customized
Other
|
77 Participants
n=1 Participants
|
87 Participants
n=1 Participants
|
49 Participants
n=1 Participants
|
213 Participants
n=2 Participants
|
PRIMARY outcome
Timeframe: within 14 days post-vaccinationPopulation: Safety Population
Frequency and severity of solicited injection site and solicited systemic reactions within 14 days post-vaccination.
Outcome measures
| Measure |
VLA1553 Half Dose - 7-11 Years
n=40 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 7-11 Years
n=43 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 7-11 Years
n=21 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 3-6 Years
n=40 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 3-6 Years
n=40 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 3-6 Years
n=20 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 1-2 Years
n=39 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 1-2 Years
n=41 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 1-2 Years
n=20 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Injection Site Reactions
|
12 Participants
|
8 Participants
|
7 Participants
|
6 Participants
|
7 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: within 14 days post-vaccinationPopulation: Safety Population
Outcome measures
| Measure |
VLA1553 Half Dose - 7-11 Years
n=40 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 7-11 Years
n=43 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 7-11 Years
n=21 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 3-6 Years
n=40 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 3-6 Years
n=40 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 3-6 Years
n=20 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 1-2 Years
n=39 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 1-2 Years
n=41 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 1-2 Years
n=20 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
|---|---|---|---|---|---|---|---|---|---|
|
Severity of Solicited Injection Site Reactions
Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Severity of Solicited Injection Site Reactions
Grade 2
|
5 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Severity of Solicited Injection Site Reactions
Grade 1
|
9 Participants
|
7 Participants
|
6 Participants
|
6 Participants
|
7 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Severity of Solicited Injection Site Reactions
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: within 14 days post-vaccinationPopulation: Safety Population
Outcome measures
| Measure |
VLA1553 Half Dose - 7-11 Years
n=40 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 7-11 Years
n=43 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 7-11 Years
n=21 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 3-6 Years
n=40 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 3-6 Years
n=40 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 3-6 Years
n=20 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 1-2 Years
n=39 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 1-2 Years
n=41 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 1-2 Years
n=20 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Systemic Reactions
|
11 Participants
|
17 Participants
|
3 Participants
|
10 Participants
|
10 Participants
|
4 Participants
|
9 Participants
|
15 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: within 14 days post-vaccinationPopulation: Safety Population
Outcome measures
| Measure |
VLA1553 Half Dose - 7-11 Years
n=40 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 7-11 Years
n=43 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 7-11 Years
n=21 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 3-6 Years
n=40 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 3-6 Years
n=40 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 3-6 Years
n=20 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 1-2 Years
n=39 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 1-2 Years
n=41 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 1-2 Years
n=20 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
|---|---|---|---|---|---|---|---|---|---|
|
Severity of Solicited Systemic Reactions
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Severity of Solicited Systemic Reactions
Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Severity of Solicited Systemic Reactions
Grade 2
|
8 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Severity of Solicited Systemic Reactions
Grade 1
|
6 Participants
|
15 Participants
|
3 Participants
|
10 Participants
|
9 Participants
|
1 Participants
|
7 Participants
|
13 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: within 28 days post-vaccinationPopulation: Safety Population
Outcome measures
| Measure |
VLA1553 Half Dose - 7-11 Years
n=40 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 7-11 Years
n=43 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 7-11 Years
n=21 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 3-6 Years
n=40 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 3-6 Years
n=40 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 3-6 Years
n=20 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 1-2 Years
n=39 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 1-2 Years
n=41 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 1-2 Years
n=20 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Any Adverse Event (AE)
|
22 Participants
|
23 Participants
|
11 Participants
|
20 Participants
|
16 Participants
|
6 Participants
|
16 Participants
|
20 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: within 28 days post-vaccinationPopulation: Safety Population
In the Outcome measure "Severity of any AE", subjects may be represented in more than one AE category. Therefore, the total number of subjects with any AE may be lower than the sum of the numbers of subjects in the individual AE categories (solicited / unsolicited AE).
Outcome measures
| Measure |
VLA1553 Half Dose - 7-11 Years
n=40 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 7-11 Years
n=43 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 7-11 Years
n=21 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 3-6 Years
n=40 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 3-6 Years
n=40 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 3-6 Years
n=20 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 1-2 Years
n=39 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 1-2 Years
n=41 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 1-2 Years
n=20 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
|---|---|---|---|---|---|---|---|---|---|
|
Severity of Any Adverse Event (AE)
any solicited AE
|
17 Participants
|
20 Participants
|
9 Participants
|
14 Participants
|
12 Participants
|
4 Participants
|
10 Participants
|
15 Participants
|
3 Participants
|
|
Severity of Any Adverse Event (AE)
solicited AE - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Severity of Any Adverse Event (AE)
solicited AE - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Severity of Any Adverse Event (AE)
solicited AE - Grade 2
|
11 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Severity of Any Adverse Event (AE)
solicited AE - Grade 1
|
6 Participants
|
16 Participants
|
7 Participants
|
14 Participants
|
7 Participants
|
1 Participants
|
7 Participants
|
11 Participants
|
2 Participants
|
|
Severity of Any Adverse Event (AE)
any unsolicited AE
|
10 Participants
|
13 Participants
|
6 Participants
|
12 Participants
|
11 Participants
|
5 Participants
|
12 Participants
|
13 Participants
|
6 Participants
|
|
Severity of Any Adverse Event (AE)
unsolicited AE - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Severity of Any Adverse Event (AE)
unsolicited AE - Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Severity of Any Adverse Event (AE)
unsolicited AE - Grade 2
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Severity of Any Adverse Event (AE)
unsolicited AE - Grade 1
|
7 Participants
|
13 Participants
|
5 Participants
|
11 Participants
|
9 Participants
|
5 Participants
|
11 Participants
|
13 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: until Month 6 (Day 180) and Month 12 (Day 365) post-vaccinationPopulation: Safety Population
Outcome measures
| Measure |
VLA1553 Half Dose - 7-11 Years
n=40 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 7-11 Years
n=43 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 7-11 Years
n=21 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 3-6 Years
n=40 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 3-6 Years
n=40 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 3-6 Years
n=20 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 1-2 Years
n=39 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 1-2 Years
n=41 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 1-2 Years
n=20 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With of Unsolicited AE
Month 12 - Day 365
|
25 Participants
|
31 Participants
|
12 Participants
|
30 Participants
|
24 Participants
|
16 Participants
|
29 Participants
|
33 Participants
|
17 Participants
|
|
Number of Participants With of Unsolicited AE
Month 6 - Day 180
|
25 Participants
|
25 Participants
|
11 Participants
|
27 Participants
|
20 Participants
|
13 Participants
|
27 Participants
|
28 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: until Month 6 (Day 180) and Month 12 (Day 365) post-vaccinationPopulation: Safety Population
Outcome measures
| Measure |
VLA1553 Half Dose - 7-11 Years
n=40 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 7-11 Years
n=43 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 7-11 Years
n=21 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 3-6 Years
n=40 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 3-6 Years
n=40 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 3-6 Years
n=20 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 1-2 Years
n=39 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 1-2 Years
n=41 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 1-2 Years
n=20 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
|---|---|---|---|---|---|---|---|---|---|
|
Severity of Unsolicited AE
Month 6 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Severity of Unsolicited AE
Month 6 - Grade 3
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Severity of Unsolicited AE
Month 6 - Grade 2
|
8 Participants
|
4 Participants
|
3 Participants
|
8 Participants
|
4 Participants
|
2 Participants
|
8 Participants
|
7 Participants
|
4 Participants
|
|
Severity of Unsolicited AE
Month 6 - Grade 1
|
16 Participants
|
19 Participants
|
8 Participants
|
18 Participants
|
16 Participants
|
11 Participants
|
16 Participants
|
19 Participants
|
10 Participants
|
|
Severity of Unsolicited AE
Month 12 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Severity of Unsolicited AE
Month 12 - Grade 3
|
1 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Severity of Unsolicited AE
Month 12 - Grade 2
|
10 Participants
|
5 Participants
|
4 Participants
|
9 Participants
|
8 Participants
|
5 Participants
|
11 Participants
|
16 Participants
|
6 Participants
|
|
Severity of Unsolicited AE
Month 12 - Grade 1
|
14 Participants
|
22 Participants
|
7 Participants
|
19 Participants
|
16 Participants
|
11 Participants
|
15 Participants
|
15 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: until Month 6 (Day 180) and Month 12 (Day 365) post-vaccinationPopulation: Safety Population
Outcome measures
| Measure |
VLA1553 Half Dose - 7-11 Years
n=40 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 7-11 Years
n=43 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 7-11 Years
n=21 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 3-6 Years
n=40 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 3-6 Years
n=40 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 3-6 Years
n=20 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 1-2 Years
n=39 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 1-2 Years
n=41 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 1-2 Years
n=20 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Any Serious Adverse Event (SAE)
Month 6 - Day 180
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Any Serious Adverse Event (SAE)
Month 12 - ay 365
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 2 to 21 days post-vaccinationPopulation: Safety Population
Early onset AESI were defined as: 1. Fever (≥ 38.0 °c / 100.4 °f,) AND 2. symptoms suggesting acute (poly)arthralgia/arthritis, myalgia, neurological symptoms (e.g., for meningoencephalitis, acute encephalitis, headache, seizures), back pain, lymphadenopathy, cardiac or ocular symptoms (e.g., for uveitis and retinitis); OR one or more of the following signs and symptoms: macular to maculopapular rash (sometimes with cutaneous pruritus \[foot plant\]), pigmentary changes, bullous rash/ skin blistering, purpura, ecchymosis and 3. Onset of symptoms 2 to 21 days after vaccination AND 4. Duration of event ≥ 3 days.
Outcome measures
| Measure |
VLA1553 Half Dose - 7-11 Years
n=119 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 7-11 Years
n=124 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 7-11 Years
n=61 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 3-6 Years
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 3-6 Years
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 3-6 Years
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 1-2 Years
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 1-2 Years
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 1-2 Years
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Any Early Onset Adverse Event of Special Interest (AESI)
|
3 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 to 21 days post-vaccinationPopulation: Safety Population
Outcome measures
| Measure |
VLA1553 Half Dose - 7-11 Years
n=119 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 7-11 Years
n=124 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 7-11 Years
n=61 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 3-6 Years
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 3-6 Years
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 3-6 Years
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 1-2 Years
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 1-2 Years
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 1-2 Years
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
|---|---|---|---|---|---|---|---|---|---|
|
Severity of Any Early Onset Adverse Event of Special Interest (AESI)
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Severity of Any Early Onset Adverse Event of Special Interest (AESI)
Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Severity of Any Early Onset Adverse Event of Special Interest (AESI)
Grade 2
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Severity of Any Early Onset Adverse Event of Special Interest (AESI)
Grade 1
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Starting 22 days post-vaccination until end of trial, 12 months post-vaccinationPopulation: Safety Population
Outcome measures
| Measure |
VLA1553 Half Dose - 7-11 Years
n=119 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 7-11 Years
n=124 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 7-11 Years
n=61 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 3-6 Years
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 3-6 Years
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 3-6 Years
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 1-2 Years
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 1-2 Years
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 1-2 Years
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Any Late Onset Adverse Event of Special Interest (AESI)
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Starting 22 days post-vaccination until end of trial, 12 months post-vaccinationPopulation: Safety Population
Outcome measures
| Measure |
VLA1553 Half Dose - 7-11 Years
n=119 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 7-11 Years
n=124 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 7-11 Years
n=61 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 3-6 Years
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 3-6 Years
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 3-6 Years
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 1-2 Years
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 1-2 Years
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 1-2 Years
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
|---|---|---|---|---|---|---|---|---|---|
|
Severity of Any Late Onset Adverse Event of Special Interest (AESI)
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Severity of Any Late Onset Adverse Event of Special Interest (AESI)
Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Severity of Any Late Onset Adverse Event of Special Interest (AESI)
Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Severity of Any Late Onset Adverse Event of Special Interest (AESI)
Grade 1
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: on Days 1, 4, 8 and 15 and beyond as applicablePopulation: Viremia subset of the Safety Analysis Population including 124 participants.
Number of participants with viremic results, including quantifiable results and results below LLOQ, by visit and by pooled trial arm. Day 29 was only tested, if Day 15 was tested positive. Viremia is measured in genome copy equivalents per milliliter (GCE/mL). All quantifiable results and results below LLOQ (\< 3214.4 GCE/mL), but above the LOD, are considered "viremic". A result of "not detected" or below LOD (\<1071,4 GCE/mL) is included as "non-viremic".
Outcome measures
| Measure |
VLA1553 Half Dose - 7-11 Years
n=50 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 7-11 Years
n=53 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 7-11 Years
n=21 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 3-6 Years
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 3-6 Years
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 3-6 Years
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 1-2 Years
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 1-2 Years
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 1-2 Years
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
|---|---|---|---|---|---|---|---|---|---|
|
Assessment of Viremia on Days 1, 4, 8 and 15
Visit 1 - Day 1 : Quantifiable
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Assessment of Viremia on Days 1, 4, 8 and 15
Visit 1 - Day 1 : Below LLOQ
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Assessment of Viremia on Days 1, 4, 8 and 15
Visit 2 - Day 4 : Quantifiable
|
12 Participants
|
23 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Assessment of Viremia on Days 1, 4, 8 and 15
Visit 2 - Day 4 : Below LLOQ
|
6 Participants
|
10 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Assessment of Viremia on Days 1, 4, 8 and 15
Visit 3 - Day 8 : Quantifiable
|
10 Participants
|
8 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Assessment of Viremia on Days 1, 4, 8 and 15
Visit 3 - Day 8 : Below LLOQ
|
6 Participants
|
5 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Assessment of Viremia on Days 1, 4, 8 and 15
Visit 4 - Day 15 : Quantifiable
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Assessment of Viremia on Days 1, 4, 8 and 15
Visit 4 - Day 15 : Below LLOQ
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Assessment of Viremia on Days 1, 4, 8 and 15
Visit 5 - Day 29 : Quantifiable
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Assessment of Viremia on Days 1, 4, 8 and 15
Visit 5 - Day 29 : Below LLOQ
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: on Day 1, Day 15, Day 29, Day 85, Day 180 and Month 12 post-vaccinationPopulation: Immunogenicity Population - seronegative at baseline (μPRNT50 ≤ 40)
Immune Response provided by Geometric Mean Titers (GMTs) in Baseline Seronegative Participants pooled by Trial Arm up to 12 months post vaccination.
Outcome measures
| Measure |
VLA1553 Half Dose - 7-11 Years
n=109 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 7-11 Years
n=116 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 7-11 Years
n=53 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 3-6 Years
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 3-6 Years
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 3-6 Years
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 1-2 Years
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 1-2 Years
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 1-2 Years
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
|---|---|---|---|---|---|---|---|---|---|
|
Immune Response in Baseline Seronegative Participants as Measured by CHIKV-specific Neutralizing Antibody Titers
Visit 1 - Day 1
|
10.1 titer
Interval 9.9 to 10.3
|
10.0 titer
Interval 10.0 to 10.0
|
10.3 titer
Interval 9.9 to 10.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immune Response in Baseline Seronegative Participants as Measured by CHIKV-specific Neutralizing Antibody Titers
Visit 4 - Day 15
|
1046.1 titer
Interval 726.6 to 1506.0
|
1949.9 titer
Interval 1513.7 to 2511.8
|
10.2 titer
Interval 9.8 to 10.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immune Response in Baseline Seronegative Participants as Measured by CHIKV-specific Neutralizing Antibody Titers
Visit 5 - Day 29
|
1845.4 titer
Interval 1300.3 to 2618.8
|
2860.6 titer
Interval 2267.8 to 3608.3
|
10.3 titer
Interval 9.9 to 10.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immune Response in Baseline Seronegative Participants as Measured by CHIKV-specific Neutralizing Antibody Titers
Visit 6 - Day 85
|
630.8 titer
Interval 465.8 to 854.4
|
1031.5 titer
Interval 830.6 to 1281.0
|
10.0 titer
Interval 10.0 to 10.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immune Response in Baseline Seronegative Participants as Measured by CHIKV-specific Neutralizing Antibody Titers
Visit 7 - Day 180
|
514.2 titer
Interval 383.2 to 690.0
|
813.7 titer
Interval 658.5 to 1005.4
|
10.0 titer
Interval 10.0 to 10.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immune Response in Baseline Seronegative Participants as Measured by CHIKV-specific Neutralizing Antibody Titers
Visit 8 - Day 365
|
798.7 titer
Interval 573.4 to 1112.5
|
1355.7 titer
Interval 1071.5 to 1715.2
|
10.5 titer
Interval 9.9 to 11.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: on Day 1, Day 15, Day 29, Day 85, Day 180 and Month 12 post-vaccinationPopulation: Per Protocol Population
Immune Response provided by Geometric Mean Titers (GMTs) by Visit, by Age Group and Trial Arm up to 12 months post vaccination.
Outcome measures
| Measure |
VLA1553 Half Dose - 7-11 Years
n=29 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 7-11 Years
n=36 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 7-11 Years
n=13 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 3-6 Years
n=40 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 3-6 Years
n=39 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 3-6 Years
n=20 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 1-2 Years
n=38 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 1-2 Years
n=40 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 1-2 Years
n=20 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
|---|---|---|---|---|---|---|---|---|---|
|
Immune Response as Measured by CHIKV-specific Neutralizing Antibody Titers by Age Group and Trial Arm.
Visit 1 - Day 1
|
10.0 titer
Interval 10.0 to 10.0
|
10.0 titer
Interval 10.0 to 10.0
|
10.7 titer
Interval 9.3 to 12.3
|
10.3 titer
Interval 9.7 to 10.8
|
10.0 titer
Interval 10.0 to 10.0
|
10.0 titer
Interval 10.0 to 10.0
|
10.0 titer
Interval 10.0 to 10.0
|
10.0 titer
Interval 10.0 to 10.0
|
10.4 titer
Interval 9.6 to 11.1
|
|
Immune Response as Measured by CHIKV-specific Neutralizing Antibody Titers by Age Group and Trial Arm.
Visit 4 - Day 15
|
836.0 titer
Interval 443.2 to 1576.7
|
2214.5 titer
Interval 1716.3 to 2857.2
|
10.0 titer
Interval 10.0 to 10.0
|
1437.4 titer
Interval 836.1 to 2471.1
|
2275.4 titer
Interval 1518.3 to 3410.3
|
10.0 titer
Interval 10.0 to 10.0
|
960.3 titer
Interval 462.7 to 1993.1
|
1474.5 titer
Interval 808.7 to 2688.8
|
10.7 titer
Interval 9.3 to 12.3
|
|
Immune Response as Measured by CHIKV-specific Neutralizing Antibody Titers by Age Group and Trial Arm.
Visit 5 - Day 29
|
1979.1 titer
Interval 941.9 to 4158.4
|
3443.6 titer
Interval 2957.0 to 4010.3
|
10.0 titer
Interval 10.0 to 10.0
|
2170.2 titer
Interval 1304.9 to 3609.2
|
3134.8 titer
Interval 2108.4 to 4660.7
|
10.0 titer
Interval 10.0 to 10.0
|
1439.2 titer
Interval 730.0 to 2837.1
|
2161.7 titer
Interval 1235.0 to 3783.7
|
11.0 titer
Interval 9.6 to 12.5
|
|
Immune Response as Measured by CHIKV-specific Neutralizing Antibody Titers by Age Group and Trial Arm.
Visit 6 - Day 85
|
634.5 titer
Interval 347.7 to 1157.7
|
1240.8 titer
Interval 1003.9 to 1533.6
|
10.0 titer
Interval 10.0 to 10.0
|
763.4 titer
Interval 497.7 to 1170.9
|
1073.7 titer
Interval 763.8 to 1509.2
|
10.0 titer
Interval 10.0 to 10.0
|
517.5 titer
Interval 277.9 to 963.8
|
831.1 titer
Interval 500.1 to 1381.1
|
10.0 titer
Interval 10.0 to 10.0
|
|
Immune Response as Measured by CHIKV-specific Neutralizing Antibody Titers by Age Group and Trial Arm.
Visit 7 - Day 180
|
573.8 titer
Interval 315.9 to 1042.1
|
835.4 titer
Interval 648.3 to 1076.7
|
10.0 titer
Interval 10.0 to 10.0
|
468.0 titer
Interval 313.2 to 699.4
|
872.4 titer
Interval 635.4 to 1197.8
|
10.0 titer
Interval 10.0 to 10.0
|
506.0 titer
Interval 272.4 to 940.0
|
820.1 titer
Interval 517.8 to 1298.9
|
10.0 titer
Interval 10.0 to 10.0
|
|
Immune Response as Measured by CHIKV-specific Neutralizing Antibody Titers by Age Group and Trial Arm.
Visit 8 - Day 365
|
693.3 titer
Interval 376.4 to 1277.2
|
1451.0 titer
Interval 1102.4 to 1909.9
|
10.7 titer
Interval 9.3 to 12.3
|
858.6 titer
Interval 524.5 to 1405.4
|
1382.2 titer
Interval 975.0 to 1959.5
|
10.0 titer
Interval 10.0 to 10.0
|
814.0 titer
Interval 400.4 to 1654.7
|
1242.6 titer
Interval 703.3 to 2195.8
|
10.8 titer
Interval 9.6 to 12.2
|
SECONDARY outcome
Timeframe: on Day 1, Day 15, Day 29, Day 85, Day 180 and Month 12 post-vaccinationPopulation: Per Protocol Population
Immune Response provided by Geometric Mean Titers (GMTs) by Visit, pooled by Trial Arm up to 12 months post vaccination.
Outcome measures
| Measure |
VLA1553 Half Dose - 7-11 Years
n=107 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 7-11 Years
n=115 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 7-11 Years
n=53 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 3-6 Years
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 3-6 Years
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 3-6 Years
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 1-2 Years
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 1-2 Years
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 1-2 Years
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
|---|---|---|---|---|---|---|---|---|---|
|
Immune Response Measured by CHIKV-specific Neutralizing Antibody Titers Pooled by Dose
Visit 1 - Day 1
|
10.1 titer
Interval 9.9 to 10.3
|
10.0 titer
Interval 10.0 to 10.0
|
10.3 titer
Interval 9.9 to 10.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immune Response Measured by CHIKV-specific Neutralizing Antibody Titers Pooled by Dose
Visit 4 - Day 15
|
1073.6 titer
Interval 748.1 to 1540.7
|
1944.8 titer
Interval 1506.5 to 2510.8
|
10.2 titer
Interval 9.8 to 10.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immune Response Measured by CHIKV-specific Neutralizing Antibody Titers Pooled by Dose
Visit 5 - Day 29
|
1829.3 titer
Interval 1280.8 to 2612.8
|
2843.6 titer
Interval 2247.1 to 3598.5
|
10.3 titer
Interval 9.9 to 10.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immune Response Measured by CHIKV-specific Neutralizing Antibody Titers Pooled by Dose
Visit 6 - Day 85
|
631.4 titer
Interval 463.5 to 860.2
|
1025.9 titer
Interval 824.8 to 1276.2
|
10.0 titer
Interval 10.0 to 10.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immune Response Measured by CHIKV-specific Neutralizing Antibody Titers Pooled by Dose
Visit 7 - Day 180
|
508.5 titer
Interval 377.1 to 685.8
|
842.5 titer
Interval 689.1 to 1030.1
|
10.0 titer
Interval 10.0 to 10.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immune Response Measured by CHIKV-specific Neutralizing Antibody Titers Pooled by Dose
Visit 8 - Day 365
|
794.5 titer
Interval 566.8 to 1113.7
|
1353.4 titer
Interval 1067.5 to 1715.8
|
10.5 titer
Interval 9.9 to 11.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at Day 15, Day 29, Day 85, Day 180 and Month 12Population: Immunogenicity Population - seronegative at baseline (μPRNT50 ≤ 40)
Percentage of participants seronegative at baseline with Seroconversion (defined as \>4-fold titer change compared to baseline) by Visit Pooled by Trial Arm
Outcome measures
| Measure |
VLA1553 Half Dose - 7-11 Years
n=109 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 7-11 Years
n=116 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 7-11 Years
n=53 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 3-6 Years
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 3-6 Years
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 3-6 Years
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 1-2 Years
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 1-2 Years
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 1-2 Years
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Seronegative at Baseline With Seroconversion as Compared to Baseline
Visit 4 - Day 15
|
95 Participants
|
110 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Seronegative at Baseline With Seroconversion as Compared to Baseline
Visit 5 - Day 29
|
98 Participants
|
111 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Seronegative at Baseline With Seroconversion as Compared to Baseline
Visit 6 - Day 85
|
94 Participants
|
110 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Seronegative at Baseline With Seroconversion as Compared to Baseline
Visit 7 - Day 180
|
96 Participants
|
111 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Seronegative at Baseline With Seroconversion as Compared to Baseline
Visit 8 - Day 365
|
95 Participants
|
110 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at Day 15, Day 29, Day 85, Day 180 and Month 12Population: Immunogenicity Population - seropositive at baseline (μPRNT50 \> 40)
Percentage of participants seropositive at baseline with Seroconversion (defined as \>4-fold titer change compared to baseline) by Visit Pooled by Trial Arm.
Outcome measures
| Measure |
VLA1553 Half Dose - 7-11 Years
n=9 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 7-11 Years
n=7 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 7-11 Years
n=8 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 3-6 Years
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 3-6 Years
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 3-6 Years
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 1-2 Years
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 1-2 Years
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 1-2 Years
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Seropositive at Baseline With Seroconversion as Compared to Baseline
Visit 4 - Day 15
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Seropositive at Baseline With Seroconversion as Compared to Baseline
Visit 5 - Day 29
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Seropositive at Baseline With Seroconversion as Compared to Baseline
Visit 6 - Day 85
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Seropositive at Baseline With Seroconversion as Compared to Baseline
Visit 7 - Day 180
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Seropositive at Baseline With Seroconversion as Compared to Baseline
Visit 8 - Day 365
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at Day 15, Day 29, Day 85, Day 180 and Month 12Population: Per Protocol Population
Percentage of participants with Seroconversion (defined as \>4-fold titer change compared to baseline) by Visit by Age Group and Trial Arm.
Outcome measures
| Measure |
VLA1553 Half Dose - 7-11 Years
n=29 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 7-11 Years
n=36 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 7-11 Years
n=13 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 3-6 Years
n=40 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 3-6 Years
n=39 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 3-6 Years
n=20 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 1-2 Years
n=38 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 1-2 Years
n=40 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 1-2 Years
n=20 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroconversion as Compared to Baseline Stratified by Age Stratum
Visit 4 - Day 15
|
26 Participants
|
36 Participants
|
0 Participants
|
36 Participants
|
38 Participants
|
0 Participants
|
31 Participants
|
35 Participants
|
0 Participants
|
|
Percentage of Participants With Seroconversion as Compared to Baseline Stratified by Age Stratum
Visit 5 - Day 29
|
26 Participants
|
36 Participants
|
0 Participants
|
37 Participants
|
38 Participants
|
0 Participants
|
33 Participants
|
35 Participants
|
0 Participants
|
|
Percentage of Participants With Seroconversion as Compared to Baseline Stratified by Age Stratum
Visit 6 - Day 85
|
26 Participants
|
35 Participants
|
0 Participants
|
35 Participants
|
38 Participants
|
0 Participants
|
30 Participants
|
36 Participants
|
0 Participants
|
|
Percentage of Participants With Seroconversion as Compared to Baseline Stratified by Age Stratum
Visit 7 - Day 180
|
26 Participants
|
36 Participants
|
0 Participants
|
38 Participants
|
38 Participants
|
0 Participants
|
30 Participants
|
36 Participants
|
0 Participants
|
|
Percentage of Participants With Seroconversion as Compared to Baseline Stratified by Age Stratum
Visit 8 - Day 365
|
26 Participants
|
36 Participants
|
0 Participants
|
37 Participants
|
38 Participants
|
0 Participants
|
30 Participants
|
35 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: at Day 15, Day 29, Day 85, Day 180 and Month 12Population: Per Protocol Population
Percentage of participants with Seroconversion (defined as \>4-fold titer change compared to baseline) by Visit Pooled by Trial Arm
Outcome measures
| Measure |
VLA1553 Half Dose - 7-11 Years
n=107 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 7-11 Years
n=115 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 7-11 Years
n=53 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 3-6 Years
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 3-6 Years
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 3-6 Years
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 1-2 Years
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 1-2 Years
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 1-2 Years
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroconversion as Compared to Baseline by Dose
Visit 8 - Day 365
|
93 Participants
|
109 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Seroconversion as Compared to Baseline by Dose
Visit 4 - Day 15
|
93 Participants
|
109 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Seroconversion as Compared to Baseline by Dose
Visit 5 - Day 29
|
96 Participants
|
109 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Seroconversion as Compared to Baseline by Dose
Visit 6 - Day 85
|
91 Participants
|
109 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Seroconversion as Compared to Baseline by Dose
Visit 7 - Day 180
|
94 Participants
|
110 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: on Day 15, Day 29, Day 85, Day 180 and Month 12 post-vaccinationPopulation: Immunogenicity Population -Seronegative at Baseline (μPRNT50 ≤ 40)
Percentage of Participants with Seroresponse for CHIKV-Specific Neutralizing Antibody Titers (defined as PRNT50 ≥150) by Visit Pooled by Trial Arm.
Outcome measures
| Measure |
VLA1553 Half Dose - 7-11 Years
n=109 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 7-11 Years
n=116 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 7-11 Years
n=53 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 3-6 Years
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 3-6 Years
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 3-6 Years
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 1-2 Years
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 1-2 Years
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 1-2 Years
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Seronegative at Baseline With a Seroresponse (Defined as PRNT50 ≥150 for Baseline Negative Participants) by Dose
Visit 4 - Day 15
|
94 Participants
|
110 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Seronegative at Baseline With a Seroresponse (Defined as PRNT50 ≥150 for Baseline Negative Participants) by Dose
Visit 5 - Day 29
|
97 Participants
|
111 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Seronegative at Baseline With a Seroresponse (Defined as PRNT50 ≥150 for Baseline Negative Participants) by Dose
Visit 6 - Day 85
|
92 Participants
|
110 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Seronegative at Baseline With a Seroresponse (Defined as PRNT50 ≥150 for Baseline Negative Participants) by Dose
Visit 7 - Day 180
|
95 Participants
|
111 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Seronegative at Baseline With a Seroresponse (Defined as PRNT50 ≥150 for Baseline Negative Participants) by Dose
Visit 8 - Day 365
|
92 Participants
|
109 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: on Day 15, Day 29, Day 85, Day 180 and Month 12 post-vaccinationPopulation: Per Protocol Population
Percentage of Participants with Seroresponse for CHIKV-Specific Neutralizing Antibody Titers (defined as PRNT50 ≥150) by Visit by Age Group and Trial Arm.
Outcome measures
| Measure |
VLA1553 Half Dose - 7-11 Years
n=29 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 7-11 Years
n=36 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 7-11 Years
n=13 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 3-6 Years
n=40 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 3-6 Years
n=39 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 3-6 Years
n=20 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 1-2 Years
n=38 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 1-2 Years
n=40 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 1-2 Years
n=20 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Seroresponse Stratified by Age Stratum
Visit 6 - Day 85
|
26 Participants
|
35 Participants
|
0 Participants
|
34 Participants
|
38 Participants
|
0 Participants
|
30 Participants
|
36 Participants
|
0 Participants
|
|
Percentage of Participants With a Seroresponse Stratified by Age Stratum
Visit 4 - Day 15
|
26 Participants
|
36 Participants
|
0 Participants
|
36 Participants
|
38 Participants
|
0 Participants
|
30 Participants
|
35 Participants
|
0 Participants
|
|
Percentage of Participants With a Seroresponse Stratified by Age Stratum
Visit 5 - Day 29
|
26 Participants
|
36 Participants
|
0 Participants
|
37 Participants
|
38 Participants
|
0 Participants
|
32 Participants
|
35 Participants
|
0 Participants
|
|
Percentage of Participants With a Seroresponse Stratified by Age Stratum
Visit 7 - Day 180
|
26 Participants
|
36 Participants
|
0 Participants
|
37 Participants
|
38 Participants
|
0 Participants
|
30 Participants
|
36 Participants
|
0 Participants
|
|
Percentage of Participants With a Seroresponse Stratified by Age Stratum
Visit 8 - Day 365
|
26 Participants
|
35 Participants
|
0 Participants
|
36 Participants
|
38 Participants
|
0 Participants
|
28 Participants
|
35 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: on Day 15, Day 29, Day 85, Day 180 and Month 12 post-vaccinationPopulation: Per Protocol Population
Percentage of Participants with Seroresponse for CHIKV-Specific Neutralizing Antibody Titers (defined as PRNT50 ≥150) by Visit Pooled by Trial Arm.
Outcome measures
| Measure |
VLA1553 Half Dose - 7-11 Years
n=107 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 7-11 Years
n=115 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 7-11 Years
n=53 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 3-6 Years
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 3-6 Years
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 3-6 Years
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 1-2 Years
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 1-2 Years
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 1-2 Years
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Seroresponse Stratified by Dose
Visit 5 - Day 29
|
95 Participants
|
109 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Seroresponse Stratified by Dose
Visit 6 - Day 85
|
90 Participants
|
109 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Seroresponse Stratified by Dose
Visit 7 - Day 180
|
93 Participants
|
110 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Seroresponse Stratified by Dose
Visit 8 - Day 365
|
90 Participants
|
108 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Seroresponse Stratified by Dose
Visit 4 - Day 15
|
92 Participants
|
109 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at Days 15, 29, 85, 180 and at Month 12 post-vaccinationPopulation: Immunogenicity Population -Seronegative at Baseline (μPRNT50 ≤ 40)
Fold Change for CHIKV-Specific Neutralizing Antibody Titers in seronegative Participants by Visit Pooled by Trial Arm.
Outcome measures
| Measure |
VLA1553 Half Dose - 7-11 Years
n=109 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 7-11 Years
n=116 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 7-11 Years
n=53 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 3-6 Years
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 3-6 Years
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 3-6 Years
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 1-2 Years
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 1-2 Years
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 1-2 Years
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
|---|---|---|---|---|---|---|---|---|---|
|
Fold Change of CHIKV-specific Neutralizing Antibody Titers as Compared to Baseline in Participants Seronegative at Baseline
Visit 4 - Day 15
|
103.6 fold change
Interval 71.9 to 149.3
|
195.0 fold change
Interval 151.4 to 251.2
|
1.0 fold change
Interval 0.9 to 1.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Fold Change of CHIKV-specific Neutralizing Antibody Titers as Compared to Baseline in Participants Seronegative at Baseline
Visit 5 - Day 29
|
182.8 fold change
Interval 128.7 to 259.7
|
286.1 fold change
Interval 226.8 to 360.8
|
1.0 fold change
Interval 0.9 to 1.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Fold Change of CHIKV-specific Neutralizing Antibody Titers as Compared to Baseline in Participants Seronegative at Baseline
Visit 6 - Day 85
|
62.5 fold change
Interval 46.1 to 84.6
|
103.1 fold change
Interval 83.1 to 128.1
|
1.0 fold change
Interval 0.9 to 1.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Fold Change of CHIKV-specific Neutralizing Antibody Titers as Compared to Baseline in Participants Seronegative at Baseline
Visit 7 - Day 180
|
50.9 fold change
Interval 37.9 to 68.4
|
81.4 fold change
Interval 65.9 to 100.5
|
1.0 fold change
Interval 0.9 to 1.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Fold Change of CHIKV-specific Neutralizing Antibody Titers as Compared to Baseline in Participants Seronegative at Baseline
Visit 8 - Day 365
|
79.1 fold change
Interval 56.7 to 110.3
|
135.6 fold change
Interval 107.2 to 171.5
|
1.0 fold change
Interval 0.9 to 1.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at Days 15, 29, 85, 180 and at Month 12 post-vaccinationPopulation: Immunogenicity Population -Seropositive at Baseline (μPRNT50 \>40)
Fold Change for CHIKV-Specific Neutralizing Antibody Titers in seropositive Participants by Visit Pooled by Trial Arm.
Outcome measures
| Measure |
VLA1553 Half Dose - 7-11 Years
n=9 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 7-11 Years
n=7 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 7-11 Years
n=8 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 3-6 Years
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 3-6 Years
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 3-6 Years
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 1-2 Years
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 1-2 Years
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 1-2 Years
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
|---|---|---|---|---|---|---|---|---|---|
|
Fold Change of CHIKV-specific Neutralizing Antibody Titers as Compared to Baseline in Seropositive Participants
Visit 4 - Day 15
|
0.9 fold change
Interval 0.7 to 1.1
|
1.4 fold change
Interval 0.8 to 2.5
|
1.1 fold change
Interval 0.6 to 2.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Fold Change of CHIKV-specific Neutralizing Antibody Titers as Compared to Baseline in Seropositive Participants
Visit 5 - Day 29
|
0.8 fold change
Interval 0.6 to 1.1
|
1.9 fold change
Interval 1.4 to 2.7
|
1.2 fold change
Interval 0.9 to 1.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Fold Change of CHIKV-specific Neutralizing Antibody Titers as Compared to Baseline in Seropositive Participants
Visit 6 - Day 85
|
0.8 fold change
Interval 0.6 to 1.2
|
1.9 fold change
Interval 1.4 to 2.6
|
1.4 fold change
Interval 0.9 to 2.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Fold Change of CHIKV-specific Neutralizing Antibody Titers as Compared to Baseline in Seropositive Participants
Visit 7 - Day 180
|
1.2 fold change
Interval 0.8 to 1.8
|
1.1 fold change
Interval 0.7 to 1.6
|
1.2 fold change
Interval 0.6 to 2.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Fold Change of CHIKV-specific Neutralizing Antibody Titers as Compared to Baseline in Seropositive Participants
Visit 8 - Day 365
|
0.9 fold change
Interval 0.6 to 1.3
|
1.2 fold change
Interval 0.6 to 2.4
|
1.4 fold change
Interval 0.8 to 2.2
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at Days 15, 29, 85, 180 and at Month 12 post-vaccinationPopulation: Per Protocol Population
Fold Change for CHIKV-Specific Neutralizing Antibody Titers by Visit by Age Group and Trial Arm.
Outcome measures
| Measure |
VLA1553 Half Dose - 7-11 Years
n=29 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 7-11 Years
n=36 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 7-11 Years
n=13 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 3-6 Years
n=40 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 3-6 Years
n=39 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 3-6 Years
n=20 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 1-2 Years
n=38 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 1-2 Years
n=40 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 1-2 Years
n=20 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
|---|---|---|---|---|---|---|---|---|---|
|
Fold Change of CHIKV-specific Neutralizing Antibody Titers as Compared to Baseline Stratified by Age Stratum
Visit 4 - Day 15
|
83.6 fold change
Interval 44.3 to 157.7
|
221.4 fold change
Interval 171.6 to 285.7
|
0.9 fold change
Interval 0.8 to 1.1
|
140.0 fold change
Interval 80.9 to 242.2
|
227.5 fold change
Interval 151.8 to 341.0
|
1.0 fold change
Interval 1.0 to 1.0
|
96.0 fold change
Interval 46.3 to 199.3
|
147.5 fold change
Interval 80.9 to 268.9
|
1.0 fold change
Interval 0.9 to 1.2
|
|
Fold Change of CHIKV-specific Neutralizing Antibody Titers as Compared to Baseline Stratified by Age Stratum
Visit 5 - Day 29
|
197.9 fold change
Interval 94.2 to 415.8
|
344.4 fold change
Interval 295.7 to 401.0
|
0.9 fold change
Interval 0.8 to 1.1
|
211.5 fold change
Interval 126.3 to 354.2
|
313.5 fold change
Interval 210.8 to 466.1
|
1.0 fold change
Interval 1.0 to 1.0
|
143.9 fold change
Interval 73.0 to 283.7
|
216.2 fold change
Interval 123.5 to 378.4
|
1.1 fold change
Interval 0.9 to 1.2
|
|
Fold Change of CHIKV-specific Neutralizing Antibody Titers as Compared to Baseline Stratified by Age Stratum
Visit 6 - Day 85
|
63.4 fold change
Interval 34.8 to 115.8
|
124.1 fold change
Interval 100.4 to 153.4
|
0.9 fold change
Interval 0.8 to 1.1
|
74.2 fold change
Interval 48.3 to 114.2
|
107.4 fold change
Interval 76.4 to 150.9
|
1.0 fold change
Interval 1.0 to 1.0
|
51.7 fold change
Interval 27.8 to 96.4
|
83.1 fold change
Interval 50.0 to 138.1
|
1.0 fold change
Interval 0.9 to 1.2
|
|
Fold Change of CHIKV-specific Neutralizing Antibody Titers as Compared to Baseline Stratified by Age Stratum
Visit 7 - Day 180
|
57.4 fold change
Interval 31.6 to 104.2
|
83.5 fold change
Interval 64.8 to 107.7
|
0.9 fold change
Interval 0.8 to 1.1
|
45.6 fold change
Interval 30.4 to 68.4
|
87.2 fold change
Interval 63.5 to 119.8
|
1.0 fold change
Interval 1.0 to 1.0
|
50.6 fold change
Interval 27.2 to 94.0
|
82.0 fold change
Interval 51.8 to 129.9
|
1.0 fold change
Interval 0.9 to 1.0
|
|
Fold Change of CHIKV-specific Neutralizing Antibody Titers as Compared to Baseline Stratified by Age Stratum
Visit 8 - Day 365
|
69.3 fold change
Interval 37.6 to 127.7
|
145.1 fold change
Interval 110.2 to 191.0
|
1.0 fold change
Interval 0.8 to 1.2
|
83.7 fold change
Interval 50.8 to 137.9
|
138.2 fold change
Interval 97.5 to 195.9
|
1.0 fold change
Interval 1.0 to 1.0
|
81.4 fold change
Interval 40.0 to 165.5
|
124.3 fold change
Interval 70.3 to 219.6
|
1.0 fold change
Interval 0.9 to 1.2
|
SECONDARY outcome
Timeframe: at Days 15, 29, 85, 180 and at Month 12 post-vaccinationPopulation: Per Protocol Population
Fold Change for CHIKV-Specific Neutralizing Antibody Titers by Visit Pooled by Trial Arm.
Outcome measures
| Measure |
VLA1553 Half Dose - 7-11 Years
n=107 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 7-11 Years
n=115 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 7-11 Years
n=53 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 3-6 Years
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 3-6 Years
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 3-6 Years
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 1-2 Years
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 1-2 Years
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 1-2 Years
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
|---|---|---|---|---|---|---|---|---|---|
|
Fold Change of CHIKV-specific Neutralizing Antibody Titers as Compared to Baseline Stratified by Dose
Visit 4 - Day 15
|
106.3 fold change
Interval 74.0 to 152.7
|
194.5 fold change
Interval 150.6 to 251.1
|
1.0 fold change
Interval 0.9 to 1.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Fold Change of CHIKV-specific Neutralizing Antibody Titers as Compared to Baseline Stratified by Dose
Visit 5 - Day 29
|
181.2 fold change
Interval 126.7 to 259.1
|
284.4 fold change
Interval 224.7 to 359.9
|
1.0 fold change
Interval 0.9 to 1.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Fold Change of CHIKV-specific Neutralizing Antibody Titers as Compared to Baseline Stratified by Dose
Visit 6 - Day 85
|
62.5 fold change
Interval 45.9 to 85.2
|
102.6 fold change
Interval 82.5 to 127.6
|
1.0 fold change
Interval 0.9 to 1.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Fold Change of CHIKV-specific Neutralizing Antibody Titers as Compared to Baseline Stratified by Dose
Visit 7 - Day 180
|
50.4 fold change
Interval 37.3 to 68.0
|
84.3 fold change
Interval 68.9 to 103.0
|
1.0 fold change
Interval 0.9 to 1.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Fold Change of CHIKV-specific Neutralizing Antibody Titers as Compared to Baseline Stratified by Dose
Visit 8 - Day 365
|
78.7 fold change
Interval 56.0 to 110.4
|
135.3 fold change
Interval 106.7 to 171.6
|
1.0 fold change
Interval 0.9 to 1.1
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at Day 15, Day 29, Day 85, Day 180 and Month 12Population: Immunogenicity Population -Seronegative at Baseline (μPRNT50 ≤ 40)
Percentage of Participants Reaching a 4-/8-/16-/64-Fold Change in Titers by Visit Pooled by Trial Arm.
Outcome measures
| Measure |
VLA1553 Half Dose - 7-11 Years
n=109 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 7-11 Years
n=116 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 7-11 Years
n=53 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 3-6 Years
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 3-6 Years
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 3-6 Years
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 1-2 Years
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 1-2 Years
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 1-2 Years
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Seronegative at Baseline Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline
Visit 4 - Day 15: 4-fold change
|
95 Participants
|
110 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Seronegative at Baseline Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline
Visit 4 - Day 15: 8-fold change
|
95 Participants
|
110 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Seronegative at Baseline Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline
Visit 4 - Day 15: 16-fold change
|
94 Participants
|
110 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Seronegative at Baseline Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline
Visit 4 - Day 15: 64-fold change
|
83 Participants
|
103 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Seronegative at Baseline Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline
Visit 5 - Day 29: 4-fold change
|
98 Participants
|
111 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Seronegative at Baseline Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline
Visit 5 - Day 29: 8-fold change
|
97 Participants
|
111 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Seronegative at Baseline Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline
Visit 5 - Day 29: 16-fold change
|
97 Participants
|
111 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Seronegative at Baseline Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline
Visit 5 - Day 29: 64-fold change
|
95 Participants
|
111 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Seronegative at Baseline Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline
Visit 6 - Day 85: 4-fold change
|
94 Participants
|
110 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Seronegative at Baseline Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline
Visit 6 - Day 85: 8-fold change
|
94 Participants
|
110 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Seronegative at Baseline Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline
Visit 6 - Day 85: 16-fold change
|
92 Participants
|
110 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Seronegative at Baseline Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline
Visit 6 - Day 85: 64-fold change
|
74 Participants
|
93 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Seronegative at Baseline Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline
Visit 7 - Day 180: 4-fold change
|
96 Participants
|
111 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Seronegative at Baseline Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline
Visit 7 - Day 180: 8-fold change
|
95 Participants
|
111 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Seronegative at Baseline Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline
Visit 7 - Day 180: 16-fold change
|
94 Participants
|
111 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Seronegative at Baseline Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline
Visit 7 - Day 180: 64-fold change
|
59 Participants
|
85 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Seronegative at Baseline Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline
Visit 8 - Day 365: 4-fold change
|
95 Participants
|
110 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Seronegative at Baseline Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline
Visit 8 - Day 365: 8-fold change
|
94 Participants
|
110 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Seronegative at Baseline Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline
Visit 8 - Day 365: 16-fold change
|
91 Participants
|
109 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Seronegative at Baseline Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline
Visit 8 - Day 365: 64-fold change
|
74 Participants
|
100 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at Day 15, Day 29, Day 85, Day 180 and Month 12Population: Per Protocol Population
Percentage of Participants Reaching a 4-/8-/16-/64-Fold Change in Titers by Visit by Age Group and Trial Arm.
Outcome measures
| Measure |
VLA1553 Half Dose - 7-11 Years
n=29 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 7-11 Years
n=36 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 7-11 Years
n=13 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 3-6 Years
n=40 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 3-6 Years
n=39 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 3-6 Years
n=20 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 1-2 Years
n=38 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 1-2 Years
n=40 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 1-2 Years
n=20 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline Stratified by Age Stratum
Visit 4 - Day 15: 4-fold change
|
26 Participants
|
36 Participants
|
0 Participants
|
36 Participants
|
38 Participants
|
0 Participants
|
31 Participants
|
35 Participants
|
0 Participants
|
|
Percentage of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline Stratified by Age Stratum
Visit 4 - Day 15: 8-fold change
|
26 Participants
|
36 Participants
|
0 Participants
|
36 Participants
|
38 Participants
|
0 Participants
|
31 Participants
|
35 Participants
|
0 Participants
|
|
Percentage of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline Stratified by Age Stratum
Visit 4 - Day 15: 16-fold change
|
26 Participants
|
36 Participants
|
0 Participants
|
36 Participants
|
38 Participants
|
0 Participants
|
30 Participants
|
35 Participants
|
0 Participants
|
|
Percentage of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline Stratified by Age Stratum
Visit 4 - Day 15: 64-fold change
|
22 Participants
|
34 Participants
|
0 Participants
|
32 Participants
|
35 Participants
|
0 Participants
|
28 Participants
|
33 Participants
|
0 Participants
|
|
Percentage of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline Stratified by Age Stratum
Visit 5 - Day 29: 4-fold change
|
26 Participants
|
36 Participants
|
0 Participants
|
37 Participants
|
38 Participants
|
0 Participants
|
33 Participants
|
35 Participants
|
0 Participants
|
|
Percentage of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline Stratified by Age Stratum
Visit 5 - Day 29: 8-fold change
|
26 Participants
|
36 Participants
|
0 Participants
|
37 Participants
|
38 Participants
|
0 Participants
|
32 Participants
|
35 Participants
|
0 Participants
|
|
Percentage of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline Stratified by Age Stratum
Visit 5 - Day 29: 16-fold change
|
26 Participants
|
36 Participants
|
0 Participants
|
37 Participants
|
38 Participants
|
0 Participants
|
32 Participants
|
35 Participants
|
0 Participants
|
|
Percentage of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline Stratified by Age Stratum
Visit 5 - Day 29: 64-fold change
|
25 Participants
|
36 Participants
|
0 Participants
|
36 Participants
|
38 Participants
|
0 Participants
|
32 Participants
|
35 Participants
|
0 Participants
|
|
Percentage of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline Stratified by Age Stratum
Visit 6 - Day 85: 4-fold change
|
26 Participants
|
35 Participants
|
0 Participants
|
35 Participants
|
38 Participants
|
0 Participants
|
30 Participants
|
36 Participants
|
0 Participants
|
|
Percentage of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline Stratified by Age Stratum
Visit 6 - Day 85: 8-fold change
|
26 Participants
|
35 Participants
|
0 Participants
|
34 Participants
|
38 Participants
|
0 Participants
|
30 Participants
|
36 Participants
|
0 Participants
|
|
Percentage of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline Stratified by Age Stratum
Visit 6 - Day 85: 16-fold change
|
26 Participants
|
35 Participants
|
0 Participants
|
34 Participants
|
38 Participants
|
0 Participants
|
30 Participants
|
36 Participants
|
0 Participants
|
|
Percentage of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline Stratified by Age Stratum
Visit 6 - Day 85: 64-fold change
|
22 Participants
|
30 Participants
|
0 Participants
|
26 Participants
|
31 Participants
|
0 Participants
|
24 Participants
|
31 Participants
|
0 Participants
|
|
Percentage of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline Stratified by Age Stratum
Visit 7 - Day 180: 4-fold change
|
26 Participants
|
36 Participants
|
0 Participants
|
38 Participants
|
38 Participants
|
0 Participants
|
30 Participants
|
36 Participants
|
0 Participants
|
|
Percentage of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline Stratified by Age Stratum
Visit 7 - Day 180: 8-fold change
|
26 Participants
|
36 Participants
|
0 Participants
|
37 Participants
|
38 Participants
|
0 Participants
|
30 Participants
|
36 Participants
|
0 Participants
|
|
Percentage of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline Stratified by Age Stratum
Visit 7 - Day 180: 16-fold change
|
26 Participants
|
36 Participants
|
0 Participants
|
36 Participants
|
38 Participants
|
0 Participants
|
30 Participants
|
36 Participants
|
0 Participants
|
|
Percentage of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline Stratified by Age Stratum
Visit 7 - Day 180: 64-fold change
|
19 Participants
|
25 Participants
|
0 Participants
|
18 Participants
|
28 Participants
|
0 Participants
|
21 Participants
|
31 Participants
|
0 Participants
|
|
Percentage of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline Stratified by Age Stratum
Visit 8 - Day 365: 4-fold change
|
26 Participants
|
36 Participants
|
0 Participants
|
37 Participants
|
38 Participants
|
0 Participants
|
30 Participants
|
35 Participants
|
0 Participants
|
|
Percentage of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline Stratified by Age Stratum
Visit 8 - Day 365: 8-fold change
|
26 Participants
|
36 Participants
|
0 Participants
|
37 Participants
|
38 Participants
|
0 Participants
|
29 Participants
|
35 Participants
|
0 Participants
|
|
Percentage of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline Stratified by Age Stratum
Visit 8 - Day 365: 16-fold change
|
26 Participants
|
35 Participants
|
0 Participants
|
35 Participants
|
38 Participants
|
0 Participants
|
28 Participants
|
35 Participants
|
0 Participants
|
|
Percentage of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline Stratified by Age Stratum
Visit 8 - Day 365: 64-fold change
|
21 Participants
|
32 Participants
|
0 Participants
|
25 Participants
|
33 Participants
|
0 Participants
|
26 Participants
|
34 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: at Day 15, Day 29, Day 85, Day 180 and Month 12Population: Per Protocol Population
Percentage of Participants Reaching a 4-/8-/16-/64-Fold Change in Titers by Visit Pooled by Trial Arm.
Outcome measures
| Measure |
VLA1553 Half Dose - 7-11 Years
n=107 Participants
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 7-11 Years
n=115 Participants
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 7-11 Years
n=53 Participants
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 3-6 Years
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 3-6 Years
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 3-6 Years
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 1-2 Years
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 1-2 Years
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 1-2 Years
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline by Dose
Visit 8 - Day 365: 16-fold change
|
89 Participants
|
108 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline by Dose
Visit 4 - Day 15: 4-fold change
|
93 Participants
|
109 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline by Dose
Visit 4 - Day 15: 8-fold change
|
93 Participants
|
109 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline by Dose
Visit 4 - Day 15: 16-fold change
|
92 Participants
|
109 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline by Dose
Visit 4 - Day 15: 64-fold change
|
82 Participants
|
102 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline by Dose
Visit 5 - Day 29: 4-fold change
|
96 Participants
|
109 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline by Dose
Visit 5 - Day 29: 8-fold change
|
95 Participants
|
109 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline by Dose
Visit 5 - Day 29: 16-fold change
|
95 Participants
|
109 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline by Dose
Visit 5 - Day 29: 64-fold change
|
93 Participants
|
109 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline by Dose
Visit 6 - Day 85: 4-fold change
|
91 Participants
|
109 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline by Dose
Visit 6 - Day 85: 8-fold change
|
91 Participants
|
109 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline by Dose
Visit 6 - Day 85: 16-fold change
|
90 Participants
|
109 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline by Dose
Visit 6 - Day 85: 64-fold change
|
72 Participants
|
92 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline by Dose
Visit 7 - Day 180: 4-fold change
|
94 Participants
|
110 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline by Dose
Visit 7 - Day 180: 8-fold change
|
93 Participants
|
110 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline by Dose
Visit 7 - Day 180: 16-fold change
|
92 Participants
|
110 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline by Dose
Visit 7 - Day 180: 64-fold change
|
58 Participants
|
84 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline by Dose
Visit 8 - Day 365: 4-fold change
|
93 Participants
|
109 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline by Dose
Visit 8 - Day 365: 8-fold change
|
92 Participants
|
109 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline by Dose
Visit 8 - Day 365: 64-fold change
|
72 Participants
|
99 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
VLA1553 Half Dose - 7-11 Years
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
VLA1553 Full Dose - 7-11 Years
Serious events: 2 serious events
Other events: 32 other events
Deaths: 0 deaths
Control - 7-11 Years
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
VLA1553 Half Dose - 3-6 Years
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
VLA1553 Full Dose - 3-6 Years
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Control - 3-6 Years
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
VLA1553 Half Dose - 1-2 Years
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
VLA1553 Full Dose - 1-2 Years
Serious events: 2 serious events
Other events: 32 other events
Deaths: 0 deaths
Control - 1-2 Years
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VLA1553 Half Dose - 7-11 Years
n=40 participants at risk
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 7-11 Years
n=43 participants at risk
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 7-11 Years
n=21 participants at risk
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 3-6 Years
n=40 participants at risk
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 3-6 Years
n=40 participants at risk
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 3-6 Years
n=20 participants at risk
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 1-2 Years
n=39 participants at risk
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 1-2 Years
n=41 participants at risk
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 1-2 Years
n=20 participants at risk
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Cellulitis
|
2.5%
1/40 • Number of events 1 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/43 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/21 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/40 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/40 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/20 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/39 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/41 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/20 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/40 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/43 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/21 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
2.5%
1/40 • Number of events 1 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/40 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/20 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/39 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/41 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/20 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
|
Infections and infestations
Pneumonia
|
0.00%
0/40 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/43 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/21 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/40 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/40 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/20 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/39 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/41 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
5.0%
1/20 • Number of events 1 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
0.00%
0/40 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
2.3%
1/43 • Number of events 1 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/21 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/40 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/40 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/20 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/39 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
2.4%
1/41 • Number of events 1 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/20 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/40 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
2.3%
1/43 • Number of events 1 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/21 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/40 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/40 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/20 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/39 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/41 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/20 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/40 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/43 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/21 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/40 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/40 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/20 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/39 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
2.4%
1/41 • Number of events 1 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/20 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
Other adverse events
| Measure |
VLA1553 Half Dose - 7-11 Years
n=40 participants at risk
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 7-11 Years
n=43 participants at risk
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 7-11 Years
n=21 participants at risk
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 3-6 Years
n=40 participants at risk
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 3-6 Years
n=40 participants at risk
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 3-6 Years
n=20 participants at risk
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
VLA1553 Half Dose - 1-2 Years
n=39 participants at risk
VLA1553 Half dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
|
VLA1553 Full Dose - 1-2 Years
n=41 participants at risk
VLA1553 Full dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
|
Control - 1-2 Years
n=20 participants at risk
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
|
|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Pyrexia
|
17.5%
7/40 • Number of events 8 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
14.0%
6/43 • Number of events 6 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
4.8%
1/21 • Number of events 1 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
20.0%
8/40 • Number of events 9 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
15.0%
6/40 • Number of events 6 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
20.0%
4/20 • Number of events 4 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
23.1%
9/39 • Number of events 9 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
17.1%
7/41 • Number of events 8 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
5.0%
1/20 • Number of events 1 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
|
Infections and infestations
Nasopharyngitis
|
42.5%
17/40 • Number of events 27 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
41.9%
18/43 • Number of events 29 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
28.6%
6/21 • Number of events 10 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
47.5%
19/40 • Number of events 28 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
35.0%
14/40 • Number of events 29 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
50.0%
10/20 • Number of events 17 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
61.5%
24/39 • Number of events 48 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
65.9%
27/41 • Number of events 68 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
55.0%
11/20 • Number of events 25 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
|
Infections and infestations
Viral infection
|
0.00%
0/40 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
2.3%
1/43 • Number of events 1 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
23.8%
5/21 • Number of events 7 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
7.5%
3/40 • Number of events 5 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
7.5%
3/40 • Number of events 4 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
15.0%
3/20 • Number of events 3 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
7.7%
3/39 • Number of events 5 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
9.8%
4/41 • Number of events 4 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
5.0%
1/20 • Number of events 1 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
|
General disorders
Injection site pain
|
30.0%
12/40 • Number of events 18 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
18.6%
8/43 • Number of events 11 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
28.6%
6/21 • Number of events 10 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
12.5%
5/40 • Number of events 6 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
17.5%
7/40 • Number of events 10 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/20 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
5.1%
2/39 • Number of events 2 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
2.4%
1/41 • Number of events 1 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
5.0%
1/20 • Number of events 1 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
|
Gastrointestinal disorders
Diarrhoea
|
2.5%
1/40 • Number of events 1 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
7.0%
3/43 • Number of events 3 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/21 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
5.0%
2/40 • Number of events 2 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
2.5%
1/40 • Number of events 1 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
10.0%
2/20 • Number of events 2 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
7.7%
3/39 • Number of events 3 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
17.1%
7/41 • Number of events 11 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
25.0%
5/20 • Number of events 7 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
1/40 • Number of events 1 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
7.0%
3/43 • Number of events 4 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/21 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
10.0%
4/40 • Number of events 4 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
10.0%
4/40 • Number of events 4 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
10.0%
2/20 • Number of events 2 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
7.7%
3/39 • Number of events 3 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
12.2%
5/41 • Number of events 5 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
5.0%
1/20 • Number of events 2 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
|
Nervous system disorders
Headache
|
35.0%
14/40 • Number of events 18 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
34.9%
15/43 • Number of events 17 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
23.8%
5/21 • Number of events 6 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
12.5%
5/40 • Number of events 5 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
17.5%
7/40 • Number of events 7 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
15.0%
3/20 • Number of events 3 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/39 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/41 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
0.00%
0/20 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
10.0%
4/40 • Number of events 4 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
7.0%
3/43 • Number of events 4 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
4.8%
1/21 • Number of events 1 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
5.0%
2/40 • Number of events 5 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
5.0%
2/40 • Number of events 3 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
15.0%
3/20 • Number of events 5 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
12.8%
5/39 • Number of events 5 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
19.5%
8/41 • Number of events 8 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
20.0%
4/20 • Number of events 7 • - Up to 14 days post-vaccination: solicited local and systemic Adverse Events - Up to Month 6 and Month 12 post-vaccination: Unsolicited AEs - Up to Month 6 and Month 12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till trial end: late onset AESI
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place