Trial Outcomes & Findings for Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Children Aged 2 to 9 Years (NCT NCT03077438)
NCT ID: NCT03077438
Last Updated: 2022-03-28
Results Overview
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse against serogroups A, C, Y, and W was defined as post-vaccination hSBA titers greater than or equal to (\>=) 1:16 for participants with pre-vaccination hSBA titers less than (\<) 1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers \>=1:8.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1000 participants
Primary outcome timeframe
Day 30 (post-vaccination)
Results posted on
2022-03-28
Participant Flow
Study participants were enrolled in 36 centers in the United States (US) and Puerto Rico from 17 February 2017 to 30 March 2017.
A total of 1000 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and randomized in the study.
Participant milestones
| Measure |
Group 1: MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve participants aged 2 to 9 years received a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine on Day 0.
|
Group 2: MENVEO® Vaccine
Healthy, meningococcal-vaccine naïve participants aged 2 to 9 years received a single dose of Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 (MENVEO®) Conjugate vaccine on Day 0.
|
|---|---|---|
|
Overall Study
STARTED
|
499
|
501
|
|
Overall Study
Safety Analysis Set (SafAS)
|
498
|
494
|
|
Overall Study
COMPLETED
|
487
|
487
|
|
Overall Study
NOT COMPLETED
|
12
|
14
|
Reasons for withdrawal
| Measure |
Group 1: MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve participants aged 2 to 9 years received a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine on Day 0.
|
Group 2: MENVEO® Vaccine
Healthy, meningococcal-vaccine naïve participants aged 2 to 9 years received a single dose of Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 (MENVEO®) Conjugate vaccine on Day 0.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
3
|
5
|
|
Overall Study
Withdrawal by Subject
|
3
|
6
|
|
Overall Study
Lost to Follow-up
|
6
|
3
|
Baseline Characteristics
Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Children Aged 2 to 9 Years
Baseline characteristics by cohort
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=499 Participants
Healthy, meningococcal-vaccine naïve participants aged 2 to 9 years received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: MENVEO® Vaccine
n=501 Participants
Healthy, meningococcal-vaccine naïve participants aged 2 to 9 years received a single dose of MENVEO® Conjugate vaccine on Day 0.
|
Total
n=1000 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
6.0 years
STANDARD_DEVIATION 2.33 • n=5 Participants
|
6.0 years
STANDARD_DEVIATION 2.36 • n=7 Participants
|
6.0 years
STANDARD_DEVIATION 2.34 • n=5 Participants
|
|
Sex: Female, Male
Female
|
245 Participants
n=5 Participants
|
236 Participants
n=7 Participants
|
481 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
254 Participants
n=5 Participants
|
265 Participants
n=7 Participants
|
519 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
66 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
402 Participants
n=5 Participants
|
417 Participants
n=7 Participants
|
819 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
499 Participants
n=5 Participants
|
501 Participants
n=7 Participants
|
1000 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 30 (post-vaccination)Population: Per-protocol analysis set (PPAS) defined for accessing ACYW immune response data for participants who received at least 1 dose of study vaccine and had valid post-vaccination serology result. Participants who presented pre-defined protocol deviations were excluded. 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. The hSBA vaccine seroresponse against serogroups A, C, Y, and W was defined as post-vaccination hSBA titers greater than or equal to (\>=) 1:16 for participants with pre-vaccination hSBA titers less than (\<) 1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers \>=1:8.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=458 Participants
Healthy, meningococcal-vaccine naïve participants aged 2 to 9 years received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: MENVEO® Vaccine
n=460 Participants
Healthy, meningococcal-vaccine naïve participants aged 2 to 9 years received a single dose of MENVEO® Conjugate vaccine on Day 0.
|
|---|---|---|
|
Percentage of Participants Achieving Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine
Serogroup A
|
55.4 percentage of participants
Interval 50.7 to 60.0
|
47.8 percentage of participants
Interval 43.2 to 52.5
|
|
Percentage of Participants Achieving Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine
Serogroup C
|
95.2 percentage of participants
Interval 92.8 to 97.0
|
47.8 percentage of participants
Interval 43.2 to 52.5
|
|
Percentage of Participants Achieving Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine
Serogroup Y
|
91.5 percentage of participants
Interval 88.5 to 93.9
|
79.3 percentage of participants
Interval 75.3 to 82.9
|
|
Percentage of Participants Achieving Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine
Serogroup W
|
78.8 percentage of participants
Interval 74.8 to 82.5
|
64.1 percentage of participants
Interval 59.5 to 68.4
|
SECONDARY outcome
Timeframe: Day 30 (post-vaccination)Population: Analysis was performed on PPAS. 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
n=458 Participants
Healthy, meningococcal-vaccine naïve participants aged 2 to 9 years received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: MENVEO® Vaccine
n=460 Participants
Healthy, meningococcal-vaccine naïve participants aged 2 to 9 years received a single dose of MENVEO® Conjugate vaccine on Day 0.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 9 Years of Age
Serogroup C
|
238 titers (1/dilution)
Interval 209.0 to 270.0
|
17.0 titers (1/dilution)
Interval 14.3 to 20.2
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 9 Years of Age
Serogroup A
|
24.8 titers (1/dilution)
Interval 21.9 to 27.9
|
22.6 titers (1/dilution)
Interval 19.7 to 26.0
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 9 Years of Age
Serogroup Y
|
68.8 titers (1/dilution)
Interval 61.3 to 77.3
|
43.5 titers (1/dilution)
Interval 37.7 to 50.4
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 9 Years of Age
Serogroup W
|
37.5 titers (1/dilution)
Interval 33.7 to 41.8
|
26.2 titers (1/dilution)
Interval 23.0 to 29.9
|
SECONDARY outcome
Timeframe: Day 30 (post-vaccination)Population: Analysis was performed on PPAS. Here 'Overall number of participants analyzed' = number of participants in the PPAS aged 2-5 years, and 'Number analyzed' = participants with available data for each specified category.
Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=229 Participants
Healthy, meningococcal-vaccine naïve participants aged 2 to 9 years received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: MENVEO® Vaccine
n=223 Participants
Healthy, meningococcal-vaccine naïve participants aged 2 to 9 years received a single dose of MENVEO® Conjugate vaccine on Day 0.
|
|---|---|---|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 5 Years of Age
Serogroup C
|
208 titers (1/dilution)
Interval 175.0 to 246.0
|
11.9 titers (1/dilution)
Interval 9.79 to 14.6
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 5 Years of Age
Serogroup A
|
21.6 titers (1/dilution)
Interval 18.2 to 25.5
|
18.9 titers (1/dilution)
Interval 15.5 to 23.0
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 5 Years of Age
Serogroup Y
|
49.8 titers (1/dilution)
Interval 43.0 to 57.6
|
36.1 titers (1/dilution)
Interval 29.2 to 44.7
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 5 Years of Age
Serogroup W
|
28.8 titers (1/dilution)
Interval 24.6 to 33.7
|
20.1 titers (1/dilution)
Interval 16.7 to 24.2
|
SECONDARY outcome
Timeframe: Day 30 (post-vaccination)Population: Analysis was performed on PPAS. Here 'Overall number of participants analyzed' = number of participants in the PPAS aged 6-9 years, and 'Number analyzed' = participants with available data for each specified category.
Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=229 Participants
Healthy, meningococcal-vaccine naïve participants aged 2 to 9 years received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: MENVEO® Vaccine
n=237 Participants
Healthy, meningococcal-vaccine naïve participants aged 2 to 9 years received a single dose of MENVEO® Conjugate vaccine on Day 0.
|
|---|---|---|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 6 to 9 Years of Age
Serogroup W
|
48.9 titers (1/dilution)
Interval 42.5 to 56.3
|
33.6 titers (1/dilution)
Interval 28.2 to 40.1
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 6 to 9 Years of Age
Serogroup A
|
28.4 titers (1/dilution)
Interval 23.9 to 33.8
|
26.8 titers (1/dilution)
Interval 22.0 to 32.6
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 6 to 9 Years of Age
Serogroup C
|
272 titers (1/dilution)
Interval 224.0 to 330.0
|
23.7 titers (1/dilution)
Interval 18.2 to 31.0
|
|
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 6 to 9 Years of Age
Serogroup Y
|
95.1 titers (1/dilution)
Interval 80.2 to 113.0
|
51.8 titers (1/dilution)
Interval 42.5 to 63.2
|
SECONDARY outcome
Timeframe: Day 30 (post-vaccination)Population: Analysis was performed on PPAS. Here 'Overall number of participants analyzed' = number of participants in the PPAS aged 2-5 years, and 'Number analyzed' = participants with available data for each specified category.
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers \>=1:16 for participants with pre-vaccination hSBA titers \<1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers \>=1:8.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=229 Participants
Healthy, meningococcal-vaccine naïve participants aged 2 to 9 years received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: MENVEO® Vaccine
n=223 Participants
Healthy, meningococcal-vaccine naïve participants aged 2 to 9 years received a single dose of MENVEO® Conjugate vaccine on Day 0.
|
|---|---|---|
|
Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 5 Years of Age
Serogroup A
|
52.4 percentage of participants
Interval 45.7 to 59.1
|
44.8 percentage of participants
Interval 38.1 to 51.6
|
|
Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 5 Years of Age
Serogroup C
|
94.3 percentage of participants
Interval 90.5 to 96.9
|
43.2 percentage of participants
Interval 36.6 to 50.0
|
|
Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 5 Years of Age
Serogroup Y
|
88.2 percentage of participants
Interval 83.3 to 92.1
|
77.0 percentage of participants
Interval 70.9 to 82.4
|
|
Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 5 Years of Age
Serogroup W
|
73.8 percentage of participants
Interval 67.6 to 79.4
|
61.3 percentage of participants
Interval 54.5 to 67.7
|
SECONDARY outcome
Timeframe: Day 30 (post-vaccination)Population: Analysis was performed on PPAS. Here 'Overall number of participants analyzed' = number of participants in the PPAS aged 6-9 years, and 'Number analyzed' = participants with available data for each specified category.
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers \>=1:16 for participants with pre-vaccination hSBA titers \<1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers \>=1:8.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=229 Participants
Healthy, meningococcal-vaccine naïve participants aged 2 to 9 years received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: MENVEO® Vaccine
n=237 Participants
Healthy, meningococcal-vaccine naïve participants aged 2 to 9 years received a single dose of MENVEO® Conjugate vaccine on Day 0.
|
|---|---|---|
|
Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 6 to 9 Years Age
Serogroup Y
|
94.8 percentage of participants
Interval 91.0 to 97.3
|
81.4 percentage of participants
Interval 75.9 to 86.2
|
|
Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 6 to 9 Years Age
Serogroup W
|
83.8 percentage of participants
Interval 78.4 to 88.4
|
66.7 percentage of participants
Interval 60.3 to 72.6
|
|
Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 6 to 9 Years Age
Serogroup A
|
58.3 percentage of participants
Interval 51.6 to 64.8
|
50.6 percentage of participants
Interval 44.1 to 57.2
|
|
Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 6 to 9 Years Age
Serogroup C
|
96.1 percentage of participants
Interval 92.7 to 98.2
|
52.1 percentage of participants
Interval 45.5 to 58.6
|
Adverse Events
Group 1: MenACYW Conjugate Vaccine
Serious events: 7 serious events
Other events: 304 other events
Deaths: 0 deaths
Group 2: MENVEO® Vaccine
Serious events: 3 serious events
Other events: 335 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=498 participants at risk
Healthy, meningococcal-vaccine naïve participants aged 2 to 9 years received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: MENVEO® Vaccine
n=494 participants at risk
Healthy, meningococcal-vaccine naïve participants aged 2 to 9 years received a single dose of MENVEO® Conjugate vaccine on Day 0.
|
|---|---|---|
|
Infections and infestations
Osteomyelitis
|
0.20%
1/498 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reaction (SR) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/494 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reaction (SR) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Partial Seizures
|
0.00%
0/498 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reaction (SR) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.20%
1/494 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reaction (SR) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Tethered Cord Syndrome
|
0.20%
1/498 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reaction (SR) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/494 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reaction (SR) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal Hypertrophy
|
0.20%
1/498 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reaction (SR) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.20%
1/494 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reaction (SR) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.20%
1/498 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reaction (SR) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.20%
1/494 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reaction (SR) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Status Asthmaticus
|
0.20%
1/498 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reaction (SR) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/494 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reaction (SR) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar Hypertrophy
|
0.20%
1/498 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reaction (SR) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.20%
1/494 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reaction (SR) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.20%
1/498 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reaction (SR) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/494 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reaction (SR) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Circulatory Collapse
|
0.20%
1/498 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reaction (SR) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/494 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reaction (SR) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
Other adverse events
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=498 participants at risk
Healthy, meningococcal-vaccine naïve participants aged 2 to 9 years received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: MENVEO® Vaccine
n=494 participants at risk
Healthy, meningococcal-vaccine naïve participants aged 2 to 9 years received a single dose of MENVEO® Conjugate vaccine on Day 0.
|
|---|---|---|
|
General disorders
Injection Site Erythema
|
22.1%
110/498 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reaction (SR) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
31.0%
153/494 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reaction (SR) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Injection Site Pain
|
37.8%
188/498 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reaction (SR) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
41.7%
206/494 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reaction (SR) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Injection Site Swelling
|
13.5%
67/498 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reaction (SR) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
21.1%
104/494 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reaction (SR) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Malaise
|
20.7%
103/498 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reaction (SR) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
20.0%
99/494 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reaction (SR) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Pyrexia
|
4.0%
20/498 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reaction (SR) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
5.5%
27/494 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reaction (SR) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Pharyngitis
|
4.8%
24/498 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reaction (SR) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
5.1%
25/494 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reaction (SR) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Pharyngitis Streptococcal
|
3.6%
18/498 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reaction (SR) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
6.9%
34/494 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reaction (SR) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
4.0%
20/498 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reaction (SR) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
5.1%
25/494 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reaction (SR) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
19.9%
99/498 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reaction (SR) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
22.7%
112/494 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reaction (SR) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Headache
|
12.9%
64/498 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reaction (SR) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
12.1%
60/494 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reaction (SR) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.8%
34/498 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reaction (SR) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
6.1%
30/494 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited Reaction (SR) data were collected within 7 days after vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
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