Trial Outcomes & Findings for Immunogenicity and Safety of a Booster Dose of a Quadrivalent Meningococcal Conjugate Vaccine in Children (NCT NCT03476135)
NCT ID: NCT03476135
Last Updated: 2022-04-06
Results Overview
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
91 participants
Primary outcome timeframe
Day 0 (pre-vaccination) and Day 30 (post-priming vaccination) in study MET54, and Day 0 (pre-vaccination) and Day 30 (post-booster vaccination) in study MET62
Results posted on
2022-04-06
Participant Flow
The study was conducted at 8 sites in Finland from 27 February 2018 to 10 September 2018.
A total of 91 participants who received a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid (MenACYW) conjugate vaccine or Nimenrix® vaccine in previous study MET54 (NCT03205358) were enrolled in this study (MET62).
Participant milestones
| Measure |
Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)
Participants who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).
|
Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
Participants who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
49
|
|
Overall Study
COMPLETED
|
42
|
49
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)
n=42 Participants
Participants who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).
|
Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
n=49 Participants
Participants who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).
|
Total
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
3.9 years
STANDARD_DEVIATION 0.35 • n=42 Participants
|
3.9 years
STANDARD_DEVIATION 0.33 • n=49 Participants
|
3.9 years
STANDARD_DEVIATION 0.34 • n=91 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=42 Participants
|
30 Participants
n=49 Participants
|
46 Participants
n=91 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=42 Participants
|
19 Participants
n=49 Participants
|
45 Participants
n=91 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Day 0 (pre-vaccination)Population: Analysis was performed on Per-Protocol Analysis Set (PPAS) which included all participants who received at least 1 dose of the study vaccine, had a valid post-vaccination blood sample result and had no certain protocol deviations.
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA.
Outcome measures
| Measure |
Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)
n=40 Participants
Participants who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).
|
Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
n=44 Participants
Participants who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).
|
|---|---|---|
|
Antibody Titers Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine in MET62
Serogroup A
|
12.1 titers (1/dilution)
Interval 8.15 to 18.1
|
16.5 titers (1/dilution)
Interval 11.9 to 22.9
|
|
Antibody Titers Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine in MET62
Serogroup C
|
106 titers (1/dilution)
Interval 73.2 to 153.0
|
11.7 titers (1/dilution)
Interval 7.03 to 19.4
|
|
Antibody Titers Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine in MET62
Serogroup Y
|
30.9 titers (1/dilution)
Interval 24.2 to 39.5
|
17.6 titers (1/dilution)
Interval 13.1 to 23.7
|
|
Antibody Titers Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine in MET62
Serogroup W
|
48.5 titers (1/dilution)
Interval 34.4 to 68.4
|
21.9 titers (1/dilution)
Interval 14.7 to 32.7
|
PRIMARY outcome
Timeframe: Day 30 (post-booster vaccination)Population: Analysis was performed on PPAS.
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA.
Outcome measures
| Measure |
Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)
n=40 Participants
Participants who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).
|
Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
n=44 Participants
Participants who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).
|
|---|---|---|
|
Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine in MET62
Serogroup A
|
763 titers (1/dilution)
Interval 521.0 to 1117.0
|
659 titers (1/dilution)
Interval 427.0 to 1017.0
|
|
Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine in MET62
Serogroup C
|
5894 titers (1/dilution)
Interval 4325.0 to 8031.0
|
1592 titers (1/dilution)
Interval 1165.0 to 2174.0
|
|
Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine in MET62
Serogroup Y
|
2013 titers (1/dilution)
Interval 1451.0 to 2792.0
|
2806 titers (1/dilution)
Interval 2066.0 to 3813.0
|
|
Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine in MET62
Serogroup W
|
2656 titers (1/dilution)
Interval 1601.0 to 4406.0
|
3444 titers (1/dilution)
Interval 2387.0 to 4970.0
|
PRIMARY outcome
Timeframe: Day 0 (pre-vaccination)Population: Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by rSBA.
Outcome measures
| Measure |
Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)
n=39 Participants
Participants who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).
|
Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
n=44 Participants
Participants who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).
|
|---|---|---|
|
Antibody Titers Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine in MET62
Serogroup A
|
135 titers (1/dilution)
Interval 58.0 to 314.0
|
281 titers (1/dilution)
Interval 131.0 to 606.0
|
|
Antibody Titers Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine in MET62
Serogroup C
|
102 titers (1/dilution)
Interval 60.9 to 169.0
|
11.9 titers (1/dilution)
Interval 6.14 to 22.9
|
|
Antibody Titers Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine in MET62
Serogroup Y
|
119 titers (1/dilution)
Interval 65.0 to 219.0
|
126 titers (1/dilution)
Interval 69.1 to 230.0
|
|
Antibody Titers Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine in MET62
Serogroup W
|
113 titers (1/dilution)
Interval 54.6 to 234.0
|
126 titers (1/dilution)
Interval 63.6 to 250.0
|
PRIMARY outcome
Timeframe: Day 30 (post-booster vaccination)Population: Analysis was performed on PPAS.
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by rSBA.
Outcome measures
| Measure |
Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)
n=40 Participants
Participants who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).
|
Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
n=44 Participants
Participants who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).
|
|---|---|---|
|
Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine in MET62
Serogroup A
|
4240 titers (1/dilution)
Interval 3352.0 to 5365.0
|
5702 titers (1/dilution)
Interval 4575.0 to 7107.0
|
|
Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine in MET62
Serogroup C
|
8629 titers (1/dilution)
Interval 6573.0 to 11328.0
|
4871 titers (1/dilution)
Interval 3750.0 to 6327.0
|
|
Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine in MET62
Serogroup Y
|
5499 titers (1/dilution)
Interval 4502.0 to 6717.0
|
7814 titers (1/dilution)
Interval 6465.0 to 9445.0
|
|
Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine in MET62
Serogroup W
|
16103 titers (1/dilution)
Interval 12691.0 to 20431.0
|
19793 titers (1/dilution)
Interval 15538.0 to 25214.0
|
PRIMARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 30 (post-priming vaccination) in study MET54, and Day 0 (pre-vaccination) and Day 30 (post-booster vaccination) in study MET62Population: Analysis in both MET54 and MET62 was performed on Full Analysis Set for Persistence (FASP) which included all participants who had a valid pre-vaccination blood sample result. Here, 'Number analyzed' = participants with available data for each specified category.
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA.
Outcome measures
| Measure |
Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)
n=42 Participants
Participants who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).
|
Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
n=49 Participants
Participants who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).
|
|---|---|---|
|
Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62
Serogroup A: Day 0 (MET54)
|
3.68 titers (1/dilution)
Interval 3.12 to 4.33
|
3.67 titers (1/dilution)
Interval 3.15 to 4.29
|
|
Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62
Serogroup A: Day 30 (MET54)
|
83.3 titers (1/dilution)
Interval 63.9 to 109.0
|
49.6 titers (1/dilution)
Interval 32.1 to 76.7
|
|
Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62
Serogroup A: Day 0 (MET62)
|
11.9 titers (1/dilution)
Interval 8.11 to 17.4
|
14.7 titers (1/dilution)
Interval 10.7 to 20.2
|
|
Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62
Serogroup A: Day 30 (MET62)
|
755 titers (1/dilution)
Interval 520.0 to 1097.0
|
629 titers (1/dilution)
Interval 418.0 to 948.0
|
|
Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62
Serogroup C: Day 0 (MET54)
|
2.48 titers (1/dilution)
Interval 2.04 to 3.01
|
2.30 titers (1/dilution)
Interval 2.12 to 2.5
|
|
Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62
Serogroup C: Day 30 (MET54)
|
594 titers (1/dilution)
Interval 445.0 to 793.0
|
29.4 titers (1/dilution)
Interval 20.1 to 43.1
|
|
Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62
Serogroup C: Day 0 (MET62)
|
103 titers (1/dilution)
Interval 71.7 to 149.0
|
11.6 titers (1/dilution)
Interval 7.28 to 18.3
|
|
Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62
Serogroup C: Day 30 (MET62)
|
5744 titers (1/dilution)
Interval 4230.0 to 7800.0
|
1618 titers (1/dilution)
Interval 1204.0 to 2172.0
|
|
Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62
Serogroup Y: Day 0 (MET54)
|
2.17 titers (1/dilution)
Interval 1.95 to 2.42
|
2.27 titers (1/dilution)
Interval 2.05 to 2.52
|
|
Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62
Serogroup Y: Day 30 (MET54)
|
105 titers (1/dilution)
Interval 73.9 to 149.0
|
75.8 titers (1/dilution)
Interval 54.2 to 106.0
|
|
Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62
Serogroup Y: Day 0 (MET62)
|
32.5 titers (1/dilution)
Interval 24.8 to 42.7
|
18.2 titers (1/dilution)
Interval 13.8 to 24.0
|
|
Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62
Serogroup Y: Day 30 (MET62)
|
2048 titers (1/dilution)
Interval 1486.0 to 2823.0
|
2710 titers (1/dilution)
Interval 2022.0 to 3633.0
|
|
Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62
Serogroup W: Day 0 (MET54)
|
2.00 titers (1/dilution)
The 95% confidence interval was not computable as the standard deviation of the sample was 0, since all participants had the same value.
|
2.12 titers (1/dilution)
Interval 2.0 to 2.24
|
|
Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62
Serogroup W: Day 30 (MET54)
|
71.8 titers (1/dilution)
Interval 53.3 to 96.7
|
40.1 titers (1/dilution)
Interval 30.6 to 52.6
|
|
Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62
Serogroup W: Day 0 (MET62)
|
50.0 titers (1/dilution)
Interval 35.9 to 69.5
|
21.2 titers (1/dilution)
Interval 14.6 to 30.9
|
|
Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62
Serogroup W: Day 30 (MET62)
|
2776 titers (1/dilution)
Interval 1682.0 to 4584.0
|
3235 titers (1/dilution)
Interval 2278.0 to 4594.0
|
PRIMARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 30 (post-priming vaccination) in study MET54, and Day 0 (pre-vaccination) and Day 30 (post-booster vaccination) in study MET62Population: Analysis in both MET54 and MET62 was performed on FASP. Here, 'Number analyzed' = participants with available data for each specified category.
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by rSBA.
Outcome measures
| Measure |
Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)
n=42 Participants
Participants who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).
|
Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
n=49 Participants
Participants who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).
|
|---|---|---|
|
Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62
Serogroup A: Day 0 (MET54)
|
12.3 titers (1/dilution)
Interval 5.25 to 28.8
|
4.88 titers (1/dilution)
Interval 2.74 to 8.69
|
|
Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62
Serogroup A: Day 30 (MET54)
|
3198 titers (1/dilution)
Interval 2559.0 to 3996.0
|
7633 titers (1/dilution)
Interval 5879.0 to 9909.0
|
|
Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62
Serogroup A: Day 0 (MET62)
|
124 titers (1/dilution)
Interval 54.0 to 283.0
|
239 titers (1/dilution)
Interval 113.0 to 503.0
|
|
Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62
Serogroup A: Day 30 (MET62)
|
4096 titers (1/dilution)
Interval 3223.0 to 5205.0
|
5341 titers (1/dilution)
Interval 4275.0 to 6674.0
|
|
Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62
Serogroup C: Day 0 (MET54)
|
2.21 titers (1/dilution)
Interval 1.81 to 2.7
|
2.15 titers (1/dilution)
Interval 1.86 to 2.47
|
|
Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62
Serogroup C: Day 30 (MET54)
|
2711 titers (1/dilution)
Interval 2156.0 to 3409.0
|
414 titers (1/dilution)
Interval 283.0 to 607.0
|
|
Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62
Serogroup C: Day 0 (MET62)
|
94.4 titers (1/dilution)
Interval 55.9 to 160.0
|
11.2 titers (1/dilution)
Interval 6.11 to 20.6
|
|
Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62
Serogroup C: Day 30 (MET62)
|
8474 titers (1/dilution)
Interval 6483.0 to 11075.0
|
4817 titers (1/dilution)
Interval 3759.0 to 6175.0
|
|
Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62
Serogroup Y: Day 0 (MET54)
|
2.88 titers (1/dilution)
Interval 1.87 to 4.42
|
4.29 titers (1/dilution)
Interval 2.48 to 7.44
|
|
Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62
Serogroup Y: Day 30 (MET54)
|
2667 titers (1/dilution)
Interval 2063.0 to 3447.0
|
2836 titers (1/dilution)
Interval 2127.0 to 3781.0
|
|
Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62
Serogroup Y: Day 0 (MET62)
|
120 titers (1/dilution)
Interval 67.1 to 213.0
|
123 titers (1/dilution)
Interval 67.6 to 223.0
|
|
Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62
Serogroup Y: Day 30 (MET62)
|
5553 titers (1/dilution)
Interval 4565.0 to 6755.0
|
7498 titers (1/dilution)
Interval 6213.0 to 9049.0
|
|
Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62
Serogroup W: Day 0 (MET54)
|
2.00 titers (1/dilution)
The 95% confidence interval was not computable as the standard deviation of the sample was 0, since all participants had the same value.
|
2.24 titers (1/dilution)
Interval 1.78 to 2.81
|
|
Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62
Serogroup W: Day 30 (MET54)
|
5793 titers (1/dilution)
Interval 4346.0 to 7720.0
|
4214 titers (1/dilution)
Interval 3162.0 to 5616.0
|
|
Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62
Serogroup W: Day 0 (MET62)
|
106 titers (1/dilution)
Interval 51.6 to 219.0
|
113 titers (1/dilution)
Interval 57.9 to 219.0
|
|
Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62
Serogroup W: Day 30 (MET62)
|
15839 titers (1/dilution)
Interval 12530.0 to 20023.0
|
18710 titers (1/dilution)
Interval 14737.0 to 23753.0
|
PRIMARY outcome
Timeframe: Day 0 (pre-vaccination)Population: Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
Anti-tetanus antibodies were measured by electrochemiluminescent (ECL) assay.
Outcome measures
| Measure |
Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)
n=39 Participants
Participants who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).
|
Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
n=44 Participants
Participants who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).
|
|---|---|---|
|
Antibody Concentrations Against Tetanus Toxoid Before a Booster Dose of MenACYW Conjugate Vaccine in MET62
|
3.12 International unit per milliliter(IU/mL)
Interval 2.05 to 4.75
|
3.02 International unit per milliliter(IU/mL)
Interval 2.11 to 4.31
|
PRIMARY outcome
Timeframe: Day 30 (post-booster vaccination)Population: Analysis was performed on PPAS.
Anti-tetanus antibodies were measured by ECL assay.
Outcome measures
| Measure |
Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)
n=40 Participants
Participants who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).
|
Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
n=44 Participants
Participants who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).
|
|---|---|---|
|
Antibody Concentrations Against Tetanus Toxoid After a Booster Dose of MenACYW Conjugate Vaccine in MET62
|
10.4 IU/mL
Interval 8.41 to 12.8
|
9.36 IU/mL
Interval 7.61 to 11.5
|
PRIMARY outcome
Timeframe: Within 30 minutes after vaccinationPopulation: Analysis was performed on safety analysis set which included participants who had received at least one dose of the study vaccine and had any safety data available.
Immediate events captured medically relevant unsolicited systemic adverse events (AEs) that occurred within the first 30 minutes after vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. Systemic AEs were all AEs that were not injection or administration site reactions.
Outcome measures
| Measure |
Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)
n=42 Participants
Participants who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).
|
Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
n=49 Participants
Participants who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).
|
|---|---|---|
|
Number of Participants With Immediate Adverse Event After Vaccination in MET62
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Within 7 days after vaccinationPopulation: Analysis was performed on safety analysis set.
A solicited reaction (SR) was an adverse reaction (AR) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB. Solicited injection site reactions: pain, erythema, and swelling. Solicited systemic reactions: fever, headache, malaise and, myalgia.
Outcome measures
| Measure |
Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)
n=42 Participants
Participants who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).
|
Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
n=49 Participants
Participants who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).
|
|---|---|---|
|
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions in MET62
Pain
|
26 Participants
|
35 Participants
|
|
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions in MET62
Erythema
|
22 Participants
|
27 Participants
|
|
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions in MET62
Swelling
|
16 Participants
|
19 Participants
|
|
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions in MET62
Fever
|
3 Participants
|
4 Participants
|
|
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions in MET62
Headache
|
8 Participants
|
14 Participants
|
|
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions in MET62
Malaise
|
13 Participants
|
15 Participants
|
|
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions in MET62
Myalgia
|
14 Participants
|
21 Participants
|
PRIMARY outcome
Timeframe: Within 30 days after vaccinationPopulation: Analysis was performed on safety analysis set.
An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRB in terms of diagnosis and/or onset window post-vaccination.
Outcome measures
| Measure |
Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)
n=42 Participants
Participants who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).
|
Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
n=49 Participants
Participants who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).
|
|---|---|---|
|
Number of Participants With Unsolicited Adverse Event After Vaccination in MET62
|
22 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: Within 30 days after vaccinationPopulation: Analysis was performed on safety analysis set.
A SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was an important medical event.
Outcome measures
| Measure |
Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)
n=42 Participants
Participants who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).
|
Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
n=49 Participants
Participants who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).
|
|---|---|---|
|
Number of Participants With a Serious Adverse Event (SAE) After Vaccination in MET62
|
0 Participants
|
0 Participants
|
Adverse Events
Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
Serious events: 0 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)
n=42 participants at risk
Participants who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).
|
Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
n=49 participants at risk
Participants who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).
|
|---|---|---|
|
General disorders
Injection Site Erythema
|
52.4%
22/42 • Number of events 22 • SR were collected up to Day 7 after each vaccination, non-serious unsolicited AEs were collected up to Day 30 after each vaccination. SAEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB. An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRB in terms of diagnosis and/or onset window post-vaccination. Analysis was performed on safety analysis set.
|
55.1%
27/49 • Number of events 27 • SR were collected up to Day 7 after each vaccination, non-serious unsolicited AEs were collected up to Day 30 after each vaccination. SAEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB. An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRB in terms of diagnosis and/or onset window post-vaccination. Analysis was performed on safety analysis set.
|
|
General disorders
Injection Site Pain
|
61.9%
26/42 • Number of events 26 • SR were collected up to Day 7 after each vaccination, non-serious unsolicited AEs were collected up to Day 30 after each vaccination. SAEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB. An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRB in terms of diagnosis and/or onset window post-vaccination. Analysis was performed on safety analysis set.
|
71.4%
35/49 • Number of events 35 • SR were collected up to Day 7 after each vaccination, non-serious unsolicited AEs were collected up to Day 30 after each vaccination. SAEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB. An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRB in terms of diagnosis and/or onset window post-vaccination. Analysis was performed on safety analysis set.
|
|
General disorders
Injection Site Swelling
|
38.1%
16/42 • Number of events 16 • SR were collected up to Day 7 after each vaccination, non-serious unsolicited AEs were collected up to Day 30 after each vaccination. SAEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB. An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRB in terms of diagnosis and/or onset window post-vaccination. Analysis was performed on safety analysis set.
|
38.8%
19/49 • Number of events 19 • SR were collected up to Day 7 after each vaccination, non-serious unsolicited AEs were collected up to Day 30 after each vaccination. SAEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB. An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRB in terms of diagnosis and/or onset window post-vaccination. Analysis was performed on safety analysis set.
|
|
General disorders
Malaise
|
31.0%
13/42 • Number of events 13 • SR were collected up to Day 7 after each vaccination, non-serious unsolicited AEs were collected up to Day 30 after each vaccination. SAEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB. An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRB in terms of diagnosis and/or onset window post-vaccination. Analysis was performed on safety analysis set.
|
30.6%
15/49 • Number of events 15 • SR were collected up to Day 7 after each vaccination, non-serious unsolicited AEs were collected up to Day 30 after each vaccination. SAEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB. An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRB in terms of diagnosis and/or onset window post-vaccination. Analysis was performed on safety analysis set.
|
|
General disorders
Pyrexia
|
7.1%
3/42 • Number of events 3 • SR were collected up to Day 7 after each vaccination, non-serious unsolicited AEs were collected up to Day 30 after each vaccination. SAEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB. An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRB in terms of diagnosis and/or onset window post-vaccination. Analysis was performed on safety analysis set.
|
8.2%
4/49 • Number of events 4 • SR were collected up to Day 7 after each vaccination, non-serious unsolicited AEs were collected up to Day 30 after each vaccination. SAEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB. An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRB in terms of diagnosis and/or onset window post-vaccination. Analysis was performed on safety analysis set.
|
|
Infections and infestations
Otitis Media
|
2.4%
1/42 • Number of events 1 • SR were collected up to Day 7 after each vaccination, non-serious unsolicited AEs were collected up to Day 30 after each vaccination. SAEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB. An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRB in terms of diagnosis and/or onset window post-vaccination. Analysis was performed on safety analysis set.
|
6.1%
3/49 • Number of events 3 • SR were collected up to Day 7 after each vaccination, non-serious unsolicited AEs were collected up to Day 30 after each vaccination. SAEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB. An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRB in terms of diagnosis and/or onset window post-vaccination. Analysis was performed on safety analysis set.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
16.7%
7/42 • Number of events 7 • SR were collected up to Day 7 after each vaccination, non-serious unsolicited AEs were collected up to Day 30 after each vaccination. SAEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB. An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRB in terms of diagnosis and/or onset window post-vaccination. Analysis was performed on safety analysis set.
|
8.2%
4/49 • Number of events 4 • SR were collected up to Day 7 after each vaccination, non-serious unsolicited AEs were collected up to Day 30 after each vaccination. SAEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB. An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRB in terms of diagnosis and/or onset window post-vaccination. Analysis was performed on safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
14/42 • Number of events 14 • SR were collected up to Day 7 after each vaccination, non-serious unsolicited AEs were collected up to Day 30 after each vaccination. SAEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB. An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRB in terms of diagnosis and/or onset window post-vaccination. Analysis was performed on safety analysis set.
|
42.9%
21/49 • Number of events 21 • SR were collected up to Day 7 after each vaccination, non-serious unsolicited AEs were collected up to Day 30 after each vaccination. SAEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB. An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRB in terms of diagnosis and/or onset window post-vaccination. Analysis was performed on safety analysis set.
|
|
Nervous system disorders
Headache
|
23.8%
10/42 • Number of events 11 • SR were collected up to Day 7 after each vaccination, non-serious unsolicited AEs were collected up to Day 30 after each vaccination. SAEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB. An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRB in terms of diagnosis and/or onset window post-vaccination. Analysis was performed on safety analysis set.
|
28.6%
14/49 • Number of events 14 • SR were collected up to Day 7 after each vaccination, non-serious unsolicited AEs were collected up to Day 30 after each vaccination. SAEs were collected throughout the trial (up to 30 days after vaccination).
SR was an AR observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB. An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRB in terms of diagnosis and/or onset window post-vaccination. Analysis was performed on safety analysis set.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable participant matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
- Publication restrictions are in place
Restriction type: OTHER