Trial Outcomes & Findings for Study on an Investigational Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Administered as a 5- and/or 10-year Booster Doses in Children and Adolescents Vaccinated 5 or 10 Years Earlier as Toddlers (NCT NCT04936685)
NCT ID: NCT04936685
Last Updated: 2025-07-04
Results Overview
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. hSBA vaccine seroresponse for serogroups A, C, W, and Y is defined as: percentage of participants with a pre-vaccination titer \< 1:8, who had achieved a post-vaccination titer \>= 1:16 or participants with a pre-vaccination titer \>= 1:8, who had achieved a post-vaccination titer at least 4-fold greater than the pre-vaccination titer. The seroresponse sufficiency was demonstrated if the lower limit of 1-sided 97.5% confidence interval (CI) is \> 75%.
ACTIVE_NOT_RECRUITING
PHASE3
209 participants
Baseline (Day 1) and 30 days after the MenACYW conjugate vaccine 5-year booster dose
2025-07-04
Participant Flow
The study was conducted at 26 centers in 4 countries from 23 August 2022 to 06 February 2023.
A total of 209 participants were enrolled in this study. Results has been reported as per the primary completion date of 09 March 2023. Final analysis results will be reported at a later date.
Participant milestones
| Measure |
MenACYW: Group 1
Participants received a first intramuscular (IM) booster dose of 0.5 milliliter (mL) of Meningococcal polysaccharide (Serogroups A, C, Y and W) (MenACYW conjugate vaccine) at Day 1 (visit 1, at child age approximately 5 years post priming dose as toddlers in study MET51) and will receive a second booster dose at Year 5 of the study (visit 3, at adolescent age approximately 5 years post booster dose as children in this study).
|
MenACYW: Group 2
Participants will receive a single IM booster dose of 0.5 mL of MenACYW conjugate vaccine at Year 5 (visit 2) of the study (approximately 10 years post priming dose as toddlers in study MET51).
|
|---|---|---|
|
Overall Study
STARTED
|
93
|
116
|
|
Overall Study
COMPLETED
|
92
|
116
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
MenACYW: Group 1
Participants received a first intramuscular (IM) booster dose of 0.5 milliliter (mL) of Meningococcal polysaccharide (Serogroups A, C, Y and W) (MenACYW conjugate vaccine) at Day 1 (visit 1, at child age approximately 5 years post priming dose as toddlers in study MET51) and will receive a second booster dose at Year 5 of the study (visit 3, at adolescent age approximately 5 years post booster dose as children in this study).
|
MenACYW: Group 2
Participants will receive a single IM booster dose of 0.5 mL of MenACYW conjugate vaccine at Year 5 (visit 2) of the study (approximately 10 years post priming dose as toddlers in study MET51).
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Study on an Investigational Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Administered as a 5- and/or 10-year Booster Doses in Children and Adolescents Vaccinated 5 or 10 Years Earlier as Toddlers
Baseline characteristics by cohort
| Measure |
MenACYW: Group 1
n=93 Participants
Participants had a blood sample before receiving a first IM booster dose of 0.5 mL of MenACYW conjugate vaccine at Day 1 (visit 1, at child age approximately 5 years post priming dose as toddlers in study MET51).
|
MenACYW: Group 2
n=116 Participants
Participants had a blood sample at Day 1 (Visit 1, at child age approximately 5 years post priming dose as toddlers in study MET51).
|
Total
n=209 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
6.28 year
STANDARD_DEVIATION 0.578 • n=5 Participants
|
6.26 year
STANDARD_DEVIATION 0.440 • n=7 Participants
|
6.27 year
STANDARD_DEVIATION 0.505 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
93 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
206 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and 30 days after the MenACYW conjugate vaccine 5-year booster dosePopulation: The Per-Protocol Analysis Sets 1 (PPAS1) is a subset of the Full analysis set (FAS). The FAS consisted of participants who had received the study vaccine and had a valid post-vaccination serology result 5-years after priming vaccination at visit 1. Participants data whose titers meet the hSBA vaccine seroresponse criteria have been reported.
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. hSBA vaccine seroresponse for serogroups A, C, W, and Y is defined as: percentage of participants with a pre-vaccination titer \< 1:8, who had achieved a post-vaccination titer \>= 1:16 or participants with a pre-vaccination titer \>= 1:8, who had achieved a post-vaccination titer at least 4-fold greater than the pre-vaccination titer. The seroresponse sufficiency was demonstrated if the lower limit of 1-sided 97.5% confidence interval (CI) is \> 75%.
Outcome measures
| Measure |
MenACYW: Group 1
n=88 Participants
Participants received a first IM booster dose of 0.5 mL of MenACYW conjugate vaccine at Day 1 (visit 1, at child age approximately 5 years post priming dose as toddlers in study MET51).
|
MenACYW: Group 2
Participants had a blood sample at Day 1 (Visit 1, at child age approximately 5 years post priming dose as toddlers in study MET51).
|
|---|---|---|
|
Group 1: Percentage of Participants With Sufficiency of Serum Bactericidal Assay Using Human Complement (hSBA) Vaccine Seroresponse at 30 Days Post Booster Dose
Serogroup C
|
97.7 percentage of participants
Interval 92.0 to
Seroresponse sufficiency was demonstrated if the lower limit of 1-sided 97.5% CI was \> 75%. Therefore, only 1-sided CI was determined.
|
—
|
|
Group 1: Percentage of Participants With Sufficiency of Serum Bactericidal Assay Using Human Complement (hSBA) Vaccine Seroresponse at 30 Days Post Booster Dose
Serogroup A
|
93.2 percentage of participants
Interval 85.7 to
Seroresponse sufficiency was demonstrated if the lower limit of 1-sided 97.5% CI was \> 75%. Therefore, only 1-sided CI was determined.
|
—
|
|
Group 1: Percentage of Participants With Sufficiency of Serum Bactericidal Assay Using Human Complement (hSBA) Vaccine Seroresponse at 30 Days Post Booster Dose
Serogroup W
|
98.9 percentage of participants
Interval 93.8 to
Seroresponse sufficiency was demonstrated if the lower limit of 1-sided 97.5% CI was \> 75%. Therefore, only 1-sided CI was determined.
|
—
|
|
Group 1: Percentage of Participants With Sufficiency of Serum Bactericidal Assay Using Human Complement (hSBA) Vaccine Seroresponse at 30 Days Post Booster Dose
Serogroup Y
|
98.9 percentage of participants
Interval 93.8 to
Seroresponse sufficiency was demonstrated if the lower limit of 1-sided 97.5% CI was \> 75%. Therefore, only 1-sided CI was determined.
|
—
|
SECONDARY outcome
Timeframe: At Day 1 (approximately 5 year after the administration of a priming dose as toddlers in study MET51)Population: The FAS3 consisted of participants who had a valid baseline serology results (hSBA or rSBA accordingly). Only data from the participants analyzed were reported.
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA and the rSBA and the results were expressed as vaccine seroprotection. Seroprotection rate is defined as percentage of participants with hSBA titer and rSBA titer \>=1.8 who received MenACYW conjugate vaccine 5 years earlier. Antibody persistence of meningococcal serogroups A, C, W, and Y in children at 5 years (Groups 1 and 2).
Outcome measures
| Measure |
MenACYW: Group 1
n=92 Participants
Participants received a first IM booster dose of 0.5 mL of MenACYW conjugate vaccine at Day 1 (visit 1, at child age approximately 5 years post priming dose as toddlers in study MET51).
|
MenACYW: Group 2
n=116 Participants
Participants had a blood sample at Day 1 (Visit 1, at child age approximately 5 years post priming dose as toddlers in study MET51).
|
|---|---|---|
|
Antibody Persistence of Meningococcal (Groups 1 and 2): Percentage of Participants Achieving Titer (Seroprotection) >=1:8 hSBA and Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Titer >=1:8 Approximately 5 Years After the Primary Vaccination
hSBA titer >=1.8, Serogroup A
|
78.3 percentage of participants
Interval 68.4 to 86.2
|
74.1 percentage of participants
Interval 65.2 to 81.8
|
|
Antibody Persistence of Meningococcal (Groups 1 and 2): Percentage of Participants Achieving Titer (Seroprotection) >=1:8 hSBA and Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Titer >=1:8 Approximately 5 Years After the Primary Vaccination
rSBA titer >=1.8, Serogroup A
|
71.7 percentage of participants
Interval 61.4 to 80.6
|
61.7 percentage of participants
Interval 52.2 to 70.6
|
|
Antibody Persistence of Meningococcal (Groups 1 and 2): Percentage of Participants Achieving Titer (Seroprotection) >=1:8 hSBA and Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Titer >=1:8 Approximately 5 Years After the Primary Vaccination
hSBA titer >=1.8, Serogroup C
|
83.7 percentage of participants
Interval 74.5 to 90.6
|
86.2 percentage of participants
Interval 78.6 to 91.9
|
|
Antibody Persistence of Meningococcal (Groups 1 and 2): Percentage of Participants Achieving Titer (Seroprotection) >=1:8 hSBA and Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Titer >=1:8 Approximately 5 Years After the Primary Vaccination
hSBA titer >=1.8, Serogroup W
|
84.8 percentage of participants
Interval 75.8 to 91.4
|
84.5 percentage of participants
Interval 76.6 to 90.5
|
|
Antibody Persistence of Meningococcal (Groups 1 and 2): Percentage of Participants Achieving Titer (Seroprotection) >=1:8 hSBA and Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Titer >=1:8 Approximately 5 Years After the Primary Vaccination
hSBA titer >=1.8, Serogroup Y
|
71.7 percentage of participants
Interval 61.4 to 80.6
|
66.4 percentage of participants
Interval 57.0 to 74.9
|
|
Antibody Persistence of Meningococcal (Groups 1 and 2): Percentage of Participants Achieving Titer (Seroprotection) >=1:8 hSBA and Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Titer >=1:8 Approximately 5 Years After the Primary Vaccination
rSBA titer >=1.8, Serogroup C
|
59.8 percentage of participants
Interval 49.0 to 69.9
|
58.6 percentage of participants
Interval 49.1 to 67.7
|
|
Antibody Persistence of Meningococcal (Groups 1 and 2): Percentage of Participants Achieving Titer (Seroprotection) >=1:8 hSBA and Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Titer >=1:8 Approximately 5 Years After the Primary Vaccination
rSBA titer >=1.8, Serogroup W
|
57.6 percentage of participants
Interval 46.9 to 67.9
|
58.0 percentage of participants
Interval 48.3 to 67.3
|
|
Antibody Persistence of Meningococcal (Groups 1 and 2): Percentage of Participants Achieving Titer (Seroprotection) >=1:8 hSBA and Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Titer >=1:8 Approximately 5 Years After the Primary Vaccination
rSBA titer >=1.8, Serogroup Y
|
62.9 percentage of participants
Interval 52.0 to 72.9
|
60.6 percentage of participants
Interval 50.7 to 69.8
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Day 31 after the administration of a 5-year booster dosePopulation: The PPAS is a subset of the FAS and hSBA and rSBA PPAS1 individually consisted of participants for Group 1 visit 1. Only data from the participants analyzed were reported.
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA and the rSBA and the results were expressed as geometric mean titers.
Outcome measures
| Measure |
MenACYW: Group 1
n=88 Participants
Participants received a first IM booster dose of 0.5 mL of MenACYW conjugate vaccine at Day 1 (visit 1, at child age approximately 5 years post priming dose as toddlers in study MET51).
|
MenACYW: Group 2
Participants had a blood sample at Day 1 (Visit 1, at child age approximately 5 years post priming dose as toddlers in study MET51).
|
|---|---|---|
|
Group 1: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y
Day 31: hSBA, Serogroup C
|
8933 titer
Interval 6252.0 to 12764.0
|
—
|
|
Group 1: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y
Day 1: hSBA, Serogroup Y
|
14.6 titer
Interval 10.8 to 19.7
|
—
|
|
Group 1: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y
Day 31: hSBA, Serogroup Y
|
3727 titer
Interval 2908.0 to 4776.0
|
—
|
|
Group 1: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y
Day 1: hSBA, Serogroup A
|
17.2 titer
Interval 12.6 to 23.3
|
—
|
|
Group 1: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y
Day 31: hSBA, Serogroup A
|
1143 titer
Interval 820.0 to 1594.0
|
—
|
|
Group 1: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y
Day 1: hSBA, Serogroup C
|
36.9 titer
Interval 25.7 to 52.9
|
—
|
|
Group 1: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y
Day 1: hSBA, Serogroup W
|
29.3 titer
Interval 21.7 to 39.7
|
—
|
|
Group 1: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y
Day 31: hSBA, Serogroup W
|
8656 titer
Interval 6393.0 to 11721.0
|
—
|
|
Group 1: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y
Day 1: rSBA, Serogroup A
|
150 titer
Interval 81.7 to 275.0
|
—
|
|
Group 1: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y
Day 31: rSBA, Serogroup A
|
8454 titer
Interval 6869.0 to 10405.0
|
—
|
|
Group 1: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y
Day 1: rSBA, Serogroup C
|
31.5 titer
Interval 18.8 to 52.8
|
—
|
|
Group 1: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y
Day 31: rSBA, Serogroup C
|
20427 titer
Interval 14379.0 to 29018.0
|
—
|
|
Group 1: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y
Day 1: rSBA, Serogroup Y
|
64.5 titer
Interval 35.0 to 119.0
|
—
|
|
Group 1: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y
Day 31: rSBA, Serogroup Y
|
7814 titer
Interval 6111.0 to 9991.0
|
—
|
|
Group 1: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y
Day 1: rSBA, Serogroup W
|
49.7 titer
Interval 26.6 to 93.0
|
—
|
|
Group 1: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y
Day 31: rSBA, Serogroup W
|
23354 titer
Interval 17251.0 to 31615.0
|
—
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) until end of the study (approximately 5.5 years)Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA and the rSBA and the results were expressed as geometric mean titers.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 1) and Day 31 after the administration of a 5-year booster dosePopulation: The PPAS is a subset of the FAS and hSBA PPAS1 consisted of participants for Group 1.
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. hSBA vaccine seroresponse is defined as a post-vaccination titer \>= 1:16 for participants with pre-vaccination hSBA titer \< 1:8, or a post-vaccination titer \>= 4-fold increase at post baseline for participants with pre-vaccination hSBA titer \>= 1:8.
Outcome measures
| Measure |
MenACYW: Group 1
n=88 Participants
Participants received a first IM booster dose of 0.5 mL of MenACYW conjugate vaccine at Day 1 (visit 1, at child age approximately 5 years post priming dose as toddlers in study MET51).
|
MenACYW: Group 2
Participants had a blood sample at Day 1 (Visit 1, at child age approximately 5 years post priming dose as toddlers in study MET51).
|
|---|---|---|
|
Group 1: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8
Day 31: hSBA >=1:8 titer, Serogroup A
|
98.9 percentage of participants
Interval 93.8 to 100.0
|
—
|
|
Group 1: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8
Day 1: hSBA >=1:4 titer, Serogroup A
|
93.2 percentage of participants
Interval 85.7 to 97.5
|
—
|
|
Group 1: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8
Day 31: hSBA >=1:4 titer, Serogroup A
|
100 percentage of participants
Interval 95.9 to 100.0
|
—
|
|
Group 1: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8
Day 1: hSBA >=1:8 titer, Serogroup A
|
78.4 percentage of participants
Interval 68.4 to 86.5
|
—
|
|
Group 1: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8
Day 1: hSBA >=1:4 titer, Serogroup C
|
86.4 percentage of participants
Interval 77.4 to 92.8
|
—
|
|
Group 1: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8
Day 31: hSBA >=1:4 titer, Serogroup C
|
97.7 percentage of participants
Interval 92.0 to 99.7
|
—
|
|
Group 1: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8
Day 1: hSBA >=1:8 titer, Serogroup C
|
84.1 percentage of participants
Interval 74.8 to 91.0
|
—
|
|
Group 1: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8
Day 31: hSBA >=1:8 titer, Serogroup C
|
97.7 percentage of participants
Interval 92.0 to 99.7
|
—
|
|
Group 1: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8
Day 1: hSBA >=1:4 titer, Serogroup Y
|
78.4 percentage of participants
Interval 68.4 to 86.5
|
—
|
|
Group 1: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8
Day 31: hSBA >=1:4 titer, Serogroup Y
|
100 percentage of participants
Interval 95.9 to 100.0
|
—
|
|
Group 1: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8
Day 1: hSBA >=1:8 titer, Serogroup Y
|
73.9 percentage of participants
Interval 63.4 to 82.7
|
—
|
|
Group 1: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8
Day 31: hSBA >=1:8 titer, Serogroup Y
|
100 percentage of participants
Interval 95.9 to 100.0
|
—
|
|
Group 1: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8
Day 1: hSBA >=1:4 titer, Serogroup W
|
95.5 percentage of participants
Interval 88.8 to 98.7
|
—
|
|
Group 1: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8
Day 31: hSBA >=1:4 titer, Serogroup W
|
100 percentage of participants
Interval 95.9 to 100.0
|
—
|
|
Group 1: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8
Day 1: hSBA >=1:8 titer, Serogroup W
|
85.2 percentage of participants
Interval 76.1 to 91.9
|
—
|
|
Group 1: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8
Day 31: hSBA >=1:8 titer, Serogroup W
|
100 percentage of participants
Interval 95.9 to 100.0
|
—
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) until end of the study (approximately 5.5 years)Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. hSBA vaccine seroresponse is defined as a post-vaccination titer \>= 1:16 for participants with pre-vaccination hSBA titer \< 1:8, or a post-vaccination titer \>= 4-fold increase at post baseline for participants with pre-vaccination hSBA titer \>= 1:8.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 1) and Day 31 after the administration of a 5-year booster dosePopulation: The PPAS is a subset of the FAS and rSBA PPAS1 consisted of participants for Group 1. Only data from the participants analyzed were reported.
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the rSBA. rSBA vaccine seroresponse is defined as a post-vaccination titer \>= 1:32 for participants with pre-vaccination rSBA titer \< 1:8, or a post-vaccination titer \>= 4-fold increase at post baseline for participants with pre-vaccination rSBA titer \>= 1:8.
Outcome measures
| Measure |
MenACYW: Group 1
n=88 Participants
Participants received a first IM booster dose of 0.5 mL of MenACYW conjugate vaccine at Day 1 (visit 1, at child age approximately 5 years post priming dose as toddlers in study MET51).
|
MenACYW: Group 2
Participants had a blood sample at Day 1 (Visit 1, at child age approximately 5 years post priming dose as toddlers in study MET51).
|
|---|---|---|
|
Group 1: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128
Day 1: rSBA >=1:8 titer, Serogroup A
|
72.7 percentage of participants
Interval 62.2 to 81.7
|
—
|
|
Group 1: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128
Day 31: rSBA >=1:8 titer, Serogroup A
|
100 percentage of participants
Interval 95.9 to 100.0
|
—
|
|
Group 1: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128
Day 1: rSBA >=1:128 titer, Serogroup A
|
64.8 percentage of participants
Interval 53.9 to 74.7
|
—
|
|
Group 1: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128
Day 31: rSBA >=1:128 titer, Serogroup A
|
100 percentage of participants
Interval 95.9 to 100.0
|
—
|
|
Group 1: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128
Day 1: rSBA >=1:8 titer, Serogroup C
|
62.5 percentage of participants
Interval 51.5 to 72.6
|
—
|
|
Group 1: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128
Day 31: rSBA >=1:8 titer, Serogroup C
|
98.9 percentage of participants
Interval 93.8 to 100.0
|
—
|
|
Group 1: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128
Day 1: rSBA >=1:128 titer, Serogroup C
|
37.5 percentage of participants
Interval 27.4 to 48.5
|
—
|
|
Group 1: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128
Day 31: rSBA >=1:128 titer, Serogroup C
|
98.9 percentage of participants
Interval 93.8 to 100.0
|
—
|
|
Group 1: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128
Day 1: rSBA >=1:8 titer, Serogroup Y
|
63.5 percentage of participants
Interval 52.4 to 73.7
|
—
|
|
Group 1: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128
Day 31: rSBA >=1:8 titer, Serogroup Y
|
98.9 percentage of participants
Interval 93.8 to 100.0
|
—
|
|
Group 1: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128
Day 1: rSBA >=1:128 titer, Serogroup Y
|
56.5 percentage of participants
Interval 45.3 to 67.2
|
—
|
|
Group 1: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128
Day 31: rSBA >=1:128 titer, Serogroup Y
|
98.9 percentage of participants
Interval 93.8 to 100.0
|
—
|
|
Group 1: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128
Day 1: rSBA >=1:8 titer, Serogroup W
|
58.0 percentage of participants
Interval 47.0 to 68.4
|
—
|
|
Group 1: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128
Day 31: rSBA >=1:8 titer, Serogroup W
|
98.9 percentage of participants
Interval 93.8 to 100.0
|
—
|
|
Group 1: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128
Day 1: rSBA >=1:128 titer, Serogroup W
|
50.0 percentage of participants
Interval 39.1 to 60.9
|
—
|
|
Group 1: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128
Day 31: rSBA >=1:128 titer, Serogroup W
|
98.9 percentage of participants
Interval 93.8 to 100.0
|
—
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) until end of the study (approximately 5.5 years)Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the rSBA. rSBA vaccine seroresponse is defined as a post-vaccination titer \>= 1:32 for participants with pre-vaccination rSBA titer \< 1:8, or a post-vaccination titer \>= 4-fold increase at post baseline for participants with pre-vaccination rSBA titer \>= 1:8.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 1) and Day 31 after the administration of a 5-year booster dosePopulation: The PPAS is a subset of the FAS and hSBA PPAS1 consisted of participants for Group 1.
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. hSBA vaccine seroresponse is defined as a post-vaccination titer \>= 1:16 for participants with pre-vaccination hSBA titer \< 1:8, or a post-vaccination titer \>= 4-fold increase at post baseline for participants with pre-vaccination hSBA titer \>= 1:8.
Outcome measures
| Measure |
MenACYW: Group 1
n=88 Participants
Participants received a first IM booster dose of 0.5 mL of MenACYW conjugate vaccine at Day 1 (visit 1, at child age approximately 5 years post priming dose as toddlers in study MET51).
|
MenACYW: Group 2
Participants had a blood sample at Day 1 (Visit 1, at child age approximately 5 years post priming dose as toddlers in study MET51).
|
|---|---|---|
|
Group 1: Percentage of Participants With hSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination
Serogroup A
|
93.2 percentage of participants
Interval 85.7 to 97.5
|
—
|
|
Group 1: Percentage of Participants With hSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination
Serogroup C
|
97.7 percentage of participants
Interval 92.0 to 99.7
|
—
|
|
Group 1: Percentage of Participants With hSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination
Serogroup Y
|
98.9 percentage of participants
Interval 93.8 to 100.0
|
—
|
|
Group 1: Percentage of Participants With hSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination
Serogroup W
|
98.9 percentage of participants
Interval 93.8 to 100.0
|
—
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) until end of the study (approximately 5.5 years)Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. hSBA vaccine seroresponse is defined as a post-vaccination titer \>= 1:16 for participants with pre-vaccination hSBA titer \< 1:8, or a post-vaccination titer \>= 4-fold increase at post baseline for participants with pre-vaccination hSBA titer \>= 1:8.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 1) and Day 31 after the administration of a 5-year booster dosePopulation: The PPAS is a subset of the FAS and rSBA PPAS1 consisted of participants for Group 1. Only data from the participants analyzed were reported.
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the rSBA. rSBA vaccine seroresponse is defined as a post-vaccination titer \>= 1:32 for participants with pre-vaccination rSBA titer \< 1:8, or a post-vaccination titer \>= 4-fold increase at post baseline for participants with pre-vaccination rSBA titer \>= 1:8.
Outcome measures
| Measure |
MenACYW: Group 1
n=88 Participants
Participants received a first IM booster dose of 0.5 mL of MenACYW conjugate vaccine at Day 1 (visit 1, at child age approximately 5 years post priming dose as toddlers in study MET51).
|
MenACYW: Group 2
Participants had a blood sample at Day 1 (Visit 1, at child age approximately 5 years post priming dose as toddlers in study MET51).
|
|---|---|---|
|
Group 1: Percentage of Participants With rSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination
Serogroup C
|
96.6 percentage of participants
Interval 90.4 to 99.3
|
—
|
|
Group 1: Percentage of Participants With rSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination
Serogroup Y
|
91.8 percentage of participants
Interval 83.8 to 96.6
|
—
|
|
Group 1: Percentage of Participants With rSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination
Serogroup W
|
97.7 percentage of participants
Interval 92.0 to 99.7
|
—
|
|
Group 1: Percentage of Participants With rSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination
Serogroup A
|
89.8 percentage of participants
Interval 81.5 to 95.2
|
—
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) until end of the study (approximately 5.5 years)Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the rSBA. rSBA vaccine seroresponse is defined as a post-vaccination titer \>= 1:32 for participants with pre-vaccination rSBA titer \< 1:8, or a post-vaccination titer \>= 4-fold increase at post baseline for participants with pre-vaccination rSBA titer \>= 1:8.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 1) and Day 31 after the administration of a 5-year booster dosePopulation: The PPAS is a subset of the FAS and hSBA PPAS1 consisted of participants for Group 1.
Anti-tetanus antibodies were measured by diphtheria, tetanus, pertussis multiplexed electrochemiluminescent (DTP-ECL) assay, a multiplexed serological assay that allowed for the simultaneous quantification of human antibodies to 6 specific antigens including diphtheria toxoid, tetanus toxoid, and 4 pertussis antigens: pertussis toxin, filamentous hemagglutinin, fimbriae and pertactin. The captured antibodies were then detected using a sulfotag-conjugated anti-human immunoglobulin (Ig)G conjugate.
Outcome measures
| Measure |
MenACYW: Group 1
n=88 Participants
Participants received a first IM booster dose of 0.5 mL of MenACYW conjugate vaccine at Day 1 (visit 1, at child age approximately 5 years post priming dose as toddlers in study MET51).
|
MenACYW: Group 2
Participants had a blood sample at Day 1 (Visit 1, at child age approximately 5 years post priming dose as toddlers in study MET51).
|
|---|---|---|
|
Group 1: Percentage of Participants With >=0.01 International Units (IU)/mL and >=0.1 IU/mL Anti-Tetanus Antibody Concentration
Day 1: >= 0.01 IU/mL
|
100 percentage of participants
Interval 95.9 to 100.0
|
—
|
|
Group 1: Percentage of Participants With >=0.01 International Units (IU)/mL and >=0.1 IU/mL Anti-Tetanus Antibody Concentration
Day 31: >= 0.01 IU/mL
|
100 percentage of participants
Interval 95.9 to 100.0
|
—
|
|
Group 1: Percentage of Participants With >=0.01 International Units (IU)/mL and >=0.1 IU/mL Anti-Tetanus Antibody Concentration
Day 1: >= 0.1 IU/mL
|
95.5 percentage of participants
Interval 88.8 to 98.7
|
—
|
|
Group 1: Percentage of Participants With >=0.01 International Units (IU)/mL and >=0.1 IU/mL Anti-Tetanus Antibody Concentration
Day 31: >= 0.1 IU/mL
|
100 percentage of participants
Interval 95.9 to 100.0
|
—
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) until end of the study (approximately 5.5 years)Anti-tetanus antibodies were measured by diphtheria, tetanus, pertussis multiplexed electrochemiluminescent (DTP-ECL) assay, a multiplexed serological assay that allowed for the simultaneous quantification of human antibodies to 6 specific antigens including diphtheria toxoid, tetanus toxoid, and 4 pertussis antigens: pertussis toxin, filamentous hemagglutinin, fimbriae and pertactin. The captured antibodies were then detected using a sulfotag-conjugated anti-human immunoglobulin (Ig)G conjugate.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 1) and Day 31 after the administration of a 5-year booster dosePopulation: The PPAS is a subset of the FAS and hSBA PPAS1 consisted of participants for Group 1.
Anti-tetanus antibodies were measured by DTP-ECL assay, a multiplexed serological assay that allowed for the simultaneous quantification of human antibodies to 6 specific antigens including diphtheria toxoid, tetanus toxoid, and 4 pertussis antigens: pertussis toxin, filamentous haemagglutinin, fimbriae and pertactin. The captured antibodies were then detected using a sulfotag-conjugated anti-human Ig G conjugate.
Outcome measures
| Measure |
MenACYW: Group 1
n=88 Participants
Participants received a first IM booster dose of 0.5 mL of MenACYW conjugate vaccine at Day 1 (visit 1, at child age approximately 5 years post priming dose as toddlers in study MET51).
|
MenACYW: Group 2
Participants had a blood sample at Day 1 (Visit 1, at child age approximately 5 years post priming dose as toddlers in study MET51).
|
|---|---|---|
|
Group 1: Geometric Mean Concentrations of Anti-Tetanus Antibody Concentration
Day 1
|
2.41 IU/mL
Interval 1.77 to 3.3
|
—
|
|
Group 1: Geometric Mean Concentrations of Anti-Tetanus Antibody Concentration
Day 31
|
13.7 IU/mL
Interval 12.0 to 15.7
|
—
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) until end of the study (approximately 5.5 years)Anti-tetanus antibodies were measured by DTP-ECL assay, a multiplexed serological assay that allowed for the simultaneous quantification of human antibodies to 6 specific antigens including diphtheria toxoid, tetanus toxoid, and 4 pertussis antigens: pertussis toxin, filamentous haemagglutinin, fimbriae and pertactin. The captured antibodies were then detected using a sulfotag-conjugated anti-human Ig G conjugate.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 30 minutes after vaccinationPopulation: The Safety analysis set 1 (SafAS 1) consisted of participants who had received the study vaccine 5 years after priming vaccination (Visit 1) and had any safety data available (Group 1).
An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE is an observed AE that does not fulfill the conditions of solicited reactions (i.e.pre-listed in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination).
Outcome measures
| Measure |
MenACYW: Group 1
n=93 Participants
Participants received a first IM booster dose of 0.5 mL of MenACYW conjugate vaccine at Day 1 (visit 1, at child age approximately 5 years post priming dose as toddlers in study MET51).
|
MenACYW: Group 2
Participants had a blood sample at Day 1 (Visit 1, at child age approximately 5 years post priming dose as toddlers in study MET51).
|
|---|---|---|
|
Group 1: Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 7 days after vaccinationPopulation: The SafAS 1 consisted of participants who had received the study vaccine 5 years after priming vaccination (Visit 1) and had any safety data available (Group 1).
All noxious and unintended responses to a study vaccine related to any dose was considered adverse reactions (AR). A solicited reaction is an "expected" AR (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB. An injection/administration site reaction is an AR at and around the injection/administration site. Injection/administration site reactions are commonly inflammatory reactions. They were considered to be related to the study vaccine administered. Systemic reactions were all ARs that were not injection or administration site reactions and included systemic manifestations such as headache, fever, as well as localized or topical manifestations that are not associated with the vaccination or administration site.
Outcome measures
| Measure |
MenACYW: Group 1
n=92 Participants
Participants received a first IM booster dose of 0.5 mL of MenACYW conjugate vaccine at Day 1 (visit 1, at child age approximately 5 years post priming dose as toddlers in study MET51).
|
MenACYW: Group 2
Participants had a blood sample at Day 1 (Visit 1, at child age approximately 5 years post priming dose as toddlers in study MET51).
|
|---|---|---|
|
Group 1: Number of Participants With Solicited Injection Site Reactions and Systemic Reactions
Solicited injection site reactions
|
67 Participants
|
—
|
|
Group 1: Number of Participants With Solicited Injection Site Reactions and Systemic Reactions
Solicited systemic reactions
|
45 Participants
|
—
|
SECONDARY outcome
Timeframe: Within 30 days after vaccinationPopulation: The SafAS 1 consisted of participants who had received the study vaccine 5 years after priming vaccination (Visit 1) and had any safety data available (Group 1).
An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE is an observed AE that does not fulfill the conditions of solicited reactions (i.e. pre-listed in the CRB in terms of diagnosis and/or onset window post-vaccination). Unsolicited AEs included both serious and non-serious unsolicited AEs.
Outcome measures
| Measure |
MenACYW: Group 1
n=93 Participants
Participants received a first IM booster dose of 0.5 mL of MenACYW conjugate vaccine at Day 1 (visit 1, at child age approximately 5 years post priming dose as toddlers in study MET51).
|
MenACYW: Group 2
Participants had a blood sample at Day 1 (Visit 1, at child age approximately 5 years post priming dose as toddlers in study MET51).
|
|---|---|---|
|
Group 1: Number of Participants With Unsolicited AEs
|
28 Participants
|
—
|
SECONDARY outcome
Timeframe: From the first study vaccine administration up to primary completion date of 09 March 2023, approximately 28 weeksPopulation: The SafAS 1 consisted of participants who had received the study vaccine 5 years after priming vaccination (Visit 1) and had any safety data available (Group 1).
A SAEs is defined as any untoward medical occurrence, at any dose that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, or other important medical event. An AESI (serious or non-serious) is defined as one of scientific and medical concern specific to the Sponsor's study vaccination or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate.
Outcome measures
| Measure |
MenACYW: Group 1
n=93 Participants
Participants received a first IM booster dose of 0.5 mL of MenACYW conjugate vaccine at Day 1 (visit 1, at child age approximately 5 years post priming dose as toddlers in study MET51).
|
MenACYW: Group 2
Participants had a blood sample at Day 1 (Visit 1, at child age approximately 5 years post priming dose as toddlers in study MET51).
|
|---|---|---|
|
Group 1: Number of Participants With Serious AEs (SAEs) and Adverse Event of Special Interest (AESI)
AESI
|
0 Participants
|
—
|
|
Group 1: Number of Participants With Serious AEs (SAEs) and Adverse Event of Special Interest (AESI)
SAE
|
3 Participants
|
—
|
Adverse Events
MenACYW: Group 1
MenACYW: Group 2
Serious adverse events
| Measure |
MenACYW: Group 1
n=93 participants at risk
Participants received a first IM booster dose of 0.5 mL of MenACYW conjugate vaccine at Day 1 (visit 1, at child age approximately 5 years post priming dose as toddlers in study MET51).
|
MenACYW: Group 2
Participants will receive a single IM booster dose of 0.5 mL of MenACYW conjugate vaccine at Year 5 (visit 2) of the study (approximately 10 years post priming dose as toddlers in study MET51).
|
|---|---|---|
|
Infections and infestations
Gastroenteritis
|
1.1%
1/93 • Number of events 1 • From the first study vaccine administration up to primary completion date of 09 March 2023, approximately 28 weeks.
Analysis was performed on SafAS1 population. For 'MenACYW: Group 2', no safety data will be collected as no vaccine administration.
|
—
0/0 • From the first study vaccine administration up to primary completion date of 09 March 2023, approximately 28 weeks.
Analysis was performed on SafAS1 population. For 'MenACYW: Group 2', no safety data will be collected as no vaccine administration.
|
|
Infections and infestations
Giardiasis
|
1.1%
1/93 • Number of events 1 • From the first study vaccine administration up to primary completion date of 09 March 2023, approximately 28 weeks.
Analysis was performed on SafAS1 population. For 'MenACYW: Group 2', no safety data will be collected as no vaccine administration.
|
—
0/0 • From the first study vaccine administration up to primary completion date of 09 March 2023, approximately 28 weeks.
Analysis was performed on SafAS1 population. For 'MenACYW: Group 2', no safety data will be collected as no vaccine administration.
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
1.1%
1/93 • Number of events 1 • From the first study vaccine administration up to primary completion date of 09 March 2023, approximately 28 weeks.
Analysis was performed on SafAS1 population. For 'MenACYW: Group 2', no safety data will be collected as no vaccine administration.
|
—
0/0 • From the first study vaccine administration up to primary completion date of 09 March 2023, approximately 28 weeks.
Analysis was performed on SafAS1 population. For 'MenACYW: Group 2', no safety data will be collected as no vaccine administration.
|
Other adverse events
| Measure |
MenACYW: Group 1
n=93 participants at risk
Participants received a first IM booster dose of 0.5 mL of MenACYW conjugate vaccine at Day 1 (visit 1, at child age approximately 5 years post priming dose as toddlers in study MET51).
|
MenACYW: Group 2
Participants will receive a single IM booster dose of 0.5 mL of MenACYW conjugate vaccine at Year 5 (visit 2) of the study (approximately 10 years post priming dose as toddlers in study MET51).
|
|---|---|---|
|
General disorders
Injection Site Erythema
|
38.7%
36/93 • Number of events 36 • From the first study vaccine administration up to primary completion date of 09 March 2023, approximately 28 weeks.
Analysis was performed on SafAS1 population. For 'MenACYW: Group 2', no safety data will be collected as no vaccine administration.
|
—
0/0 • From the first study vaccine administration up to primary completion date of 09 March 2023, approximately 28 weeks.
Analysis was performed on SafAS1 population. For 'MenACYW: Group 2', no safety data will be collected as no vaccine administration.
|
|
General disorders
Injection Site Pain
|
64.5%
60/93 • Number of events 60 • From the first study vaccine administration up to primary completion date of 09 March 2023, approximately 28 weeks.
Analysis was performed on SafAS1 population. For 'MenACYW: Group 2', no safety data will be collected as no vaccine administration.
|
—
0/0 • From the first study vaccine administration up to primary completion date of 09 March 2023, approximately 28 weeks.
Analysis was performed on SafAS1 population. For 'MenACYW: Group 2', no safety data will be collected as no vaccine administration.
|
|
General disorders
Injection Site Swelling
|
30.1%
28/93 • Number of events 28 • From the first study vaccine administration up to primary completion date of 09 March 2023, approximately 28 weeks.
Analysis was performed on SafAS1 population. For 'MenACYW: Group 2', no safety data will be collected as no vaccine administration.
|
—
0/0 • From the first study vaccine administration up to primary completion date of 09 March 2023, approximately 28 weeks.
Analysis was performed on SafAS1 population. For 'MenACYW: Group 2', no safety data will be collected as no vaccine administration.
|
|
General disorders
Malaise
|
24.7%
23/93 • Number of events 23 • From the first study vaccine administration up to primary completion date of 09 March 2023, approximately 28 weeks.
Analysis was performed on SafAS1 population. For 'MenACYW: Group 2', no safety data will be collected as no vaccine administration.
|
—
0/0 • From the first study vaccine administration up to primary completion date of 09 March 2023, approximately 28 weeks.
Analysis was performed on SafAS1 population. For 'MenACYW: Group 2', no safety data will be collected as no vaccine administration.
|
|
General disorders
Pyrexia
|
15.1%
14/93 • Number of events 14 • From the first study vaccine administration up to primary completion date of 09 March 2023, approximately 28 weeks.
Analysis was performed on SafAS1 population. For 'MenACYW: Group 2', no safety data will be collected as no vaccine administration.
|
—
0/0 • From the first study vaccine administration up to primary completion date of 09 March 2023, approximately 28 weeks.
Analysis was performed on SafAS1 population. For 'MenACYW: Group 2', no safety data will be collected as no vaccine administration.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
31/93 • Number of events 31 • From the first study vaccine administration up to primary completion date of 09 March 2023, approximately 28 weeks.
Analysis was performed on SafAS1 population. For 'MenACYW: Group 2', no safety data will be collected as no vaccine administration.
|
—
0/0 • From the first study vaccine administration up to primary completion date of 09 March 2023, approximately 28 weeks.
Analysis was performed on SafAS1 population. For 'MenACYW: Group 2', no safety data will be collected as no vaccine administration.
|
|
Nervous system disorders
Headache
|
21.5%
20/93 • Number of events 20 • From the first study vaccine administration up to primary completion date of 09 March 2023, approximately 28 weeks.
Analysis was performed on SafAS1 population. For 'MenACYW: Group 2', no safety data will be collected as no vaccine administration.
|
—
0/0 • From the first study vaccine administration up to primary completion date of 09 March 2023, approximately 28 weeks.
Analysis was performed on SafAS1 population. For 'MenACYW: Group 2', no safety data will be collected as no vaccine administration.
|
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 subject 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