Trial Outcomes & Findings for Study on a MenACYW Conjugate Vaccine Administered as a Single Dose in Participants Aged 12 Months and Older in Vietnam (NCT NCT06228586)
NCT ID: NCT06228586
Last Updated: 2025-09-17
Results Overview
Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay utilizing the human complement (hSBA).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
447 participants
Primary outcome timeframe
Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
Results posted on
2025-09-17
Participant Flow
This study was conducted at 4 investigational sites (1 main site and 3 satellite sites) in Vietnam from 18 January 2024 to 31 March 2024.
A total of 447 participants (223 participants aged 12-23 months and 224 participants aged \>=24 months) were enrolled in this study.
Participant milestones
| Measure |
MenACYW Conjugate Vaccine: 12-23 Months of Age
Participants aged 12-23 months received a single dose of 0.5 milliliter (mL) meningococcal polysaccharide (serogroups A, C, W, and Y) tetanus toxoid conjugate vaccine (MenACYW conjugate vaccine) as an intramuscular (IM) injection on Day 1.
|
MenACYW Conjugate Vaccine: 24 Months of Age and Above
Participants aged \>=24 months received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
223
|
224
|
|
Overall Study
Vaccinated
|
223
|
223
|
|
Overall Study
COMPLETED
|
220
|
223
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
MenACYW Conjugate Vaccine: 12-23 Months of Age
Participants aged 12-23 months received a single dose of 0.5 milliliter (mL) meningococcal polysaccharide (serogroups A, C, W, and Y) tetanus toxoid conjugate vaccine (MenACYW conjugate vaccine) as an intramuscular (IM) injection on Day 1.
|
MenACYW Conjugate Vaccine: 24 Months of Age and Above
Participants aged \>=24 months received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 1.
|
|---|---|---|
|
Overall Study
Withdrawal by Participant or Parent/Guardian
|
3
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
MenACYW Conjugate Vaccine: 12-23 Months of Age
n=223 Participants
Participants aged 12-23 months received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 1.
|
MenACYW Conjugate Vaccine: 24 Months of Age and Above
n=224 Participants
Participants aged \>=24 months received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 1.
|
Total
n=447 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
223 Participants
n=223 Participants
|
121 Participants
n=224 Participants
|
344 Participants
n=447 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=223 Participants
|
88 Participants
n=224 Participants
|
88 Participants
n=447 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=223 Participants
|
15 Participants
n=224 Participants
|
15 Participants
n=447 Participants
|
|
Sex: Female, Male
Female
|
118 Participants
n=223 Participants
|
130 Participants
n=224 Participants
|
248 Participants
n=447 Participants
|
|
Sex: Female, Male
Male
|
105 Participants
n=223 Participants
|
94 Participants
n=224 Participants
|
199 Participants
n=447 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)Population: Analysis was performed on the per-protocol analysis set (PPAS) which was a subset of the full analysis set (FAS). The FAS included participants who received the study vaccine and had a valid post-vaccination serology result.
Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay utilizing the human complement (hSBA).
Outcome measures
| Measure |
MenACYW Conjugate Vaccine: 12-23 Months of Age
n=200 Participants
Participants aged 12-23 months received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 1.
|
MenACYW Conjugate Vaccine: 24 Months of Age and Above
n=221 Participants
Participants aged \>=24 months received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 1.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W
Serogroup A: Day 1
|
4.44 titer
Interval 4.0 to 4.92
|
7.58 titer
Interval 6.76 to 8.51
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W
Serogroup A: Day 31
|
39.0 titer
Interval 32.9 to 46.2
|
43.2 titer
Interval 34.6 to 54.1
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W
Serogroup C: Day 1
|
2.61 titer
Interval 2.34 to 2.91
|
5.65 titer
Interval 4.82 to 6.62
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W
Serogroup C: Day 31
|
1226 titer
Interval 1076.0 to 1398.0
|
895 titer
Interval 781.0 to 1026.0
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W
Serogroup Y: Day 1
|
2.86 titer
Interval 2.55 to 3.2
|
4.08 titer
Interval 3.47 to 4.78
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W
Serogroup Y: Day 31
|
132 titer
Interval 112.0 to 156.0
|
288 titer
Interval 244.0 to 340.0
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W
Serogroup W: Day 1
|
2.26 titer
Interval 2.09 to 2.44
|
4.33 titer
Interval 3.81 to 4.92
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W
Serogroup W: Day 31
|
99.4 titer
Interval 85.6 to 115.0
|
166 titer
Interval 139.0 to 198.0
|
PRIMARY outcome
Timeframe: Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)Population: Analysis was performed on the PPAS which was a subset of the FAS. The FAS included participants who received the study vaccine and had a valid post-vaccination serology result.
Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured by hSBA. Percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
MenACYW Conjugate Vaccine: 12-23 Months of Age
n=200 Participants
Participants aged 12-23 months received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 1.
|
MenACYW Conjugate Vaccine: 24 Months of Age and Above
n=221 Participants
Participants aged \>=24 months received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 1.
|
|---|---|---|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement Titers >=4-Fold Rise From Pre-Vaccination to Post-Vaccination
Serogroup A
|
81.5 percentage of participants
Interval 75.4 to 86.6
|
66.5 percentage of participants
Interval 59.9 to 72.7
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement Titers >=4-Fold Rise From Pre-Vaccination to Post-Vaccination
Serogroup C
|
99.5 percentage of participants
Interval 97.2 to 100.0
|
97.7 percentage of participants
Interval 94.8 to 99.3
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement Titers >=4-Fold Rise From Pre-Vaccination to Post-Vaccination
Serogroup Y
|
96.5 percentage of participants
Interval 92.9 to 98.6
|
95.5 percentage of participants
Interval 91.8 to 97.8
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement Titers >=4-Fold Rise From Pre-Vaccination to Post-Vaccination
Serogroup W
|
94.5 percentage of participants
Interval 90.4 to 97.2
|
95.5 percentage of participants
Interval 91.8 to 97.8
|
PRIMARY outcome
Timeframe: Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)Population: Analysis was performed on the PPAS which was a subset of the FAS. The FAS included participants who received the study vaccine and had a valid post-vaccination serology result.
Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured by hSBA. Percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
MenACYW Conjugate Vaccine: 12-23 Months of Age
n=200 Participants
Participants aged 12-23 months received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 1.
|
MenACYW Conjugate Vaccine: 24 Months of Age and Above
n=221 Participants
Participants aged \>=24 months received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 1.
|
|---|---|---|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement Titers >=1:4 and >=1:8
Serogroup A: Day 1: >=1:4
|
79.5 percentage of participants
Interval 73.2 to 84.9
|
94.1 percentage of participants
Interval 90.2 to 96.8
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement Titers >=1:4 and >=1:8
Serogroup A: Day 1: >=1:8
|
25.0 percentage of participants
Interval 19.2 to 31.6
|
59.7 percentage of participants
Interval 52.9 to 66.3
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement Titers >=1:4 and >=1:8
Serogroup A: Day 31: >=1:4
|
97.5 percentage of participants
Interval 94.3 to 99.2
|
89.1 percentage of participants
Interval 84.3 to 92.9
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement Titers >=1:4 and >=1:8
Serogroup A: Day 31: >=1:8
|
93.5 percentage of participants
Interval 89.1 to 96.5
|
84.6 percentage of participants
Interval 79.2 to 89.1
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement Titers >=1:4 and >=1:8
Serogroup C: Day 1: >=1:4
|
16.5 percentage of participants
Interval 11.6 to 22.4
|
64.3 percentage of participants
Interval 57.6 to 70.6
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement Titers >=1:4 and >=1:8
Serogroup C: Day 1: >=1:8
|
8.5 percentage of participants
Interval 5.0 to 13.3
|
38.5 percentage of participants
Interval 32.0 to 45.2
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement Titers >=1:4 and >=1:8
Serogroup C: Day 31: >=1:4
|
100 percentage of participants
Interval 98.2 to 100.0
|
100 percentage of participants
Interval 98.3 to 100.0
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement Titers >=1:4 and >=1:8
Serogroup C: Day 31: >=1:8
|
100 percentage of participants
Interval 98.2 to 100.0
|
100 percentage of participants
Interval 98.3 to 100.0
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement Titers >=1:4 and >=1:8
Serogroup Y: Day 1: >=1:4
|
21.0 percentage of participants
Interval 15.6 to 27.3
|
35.3 percentage of participants
Interval 29.0 to 42.0
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement Titers >=1:4 and >=1:8
Serogroup Y: Day 1: >=1:8
|
15.5 percentage of participants
Interval 10.8 to 21.3
|
26.2 percentage of participants
Interval 20.6 to 32.6
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement Titers >=1:4 and >=1:8
Serogroup Y: Day 31: >=1:4
|
99.5 percentage of participants
Interval 97.2 to 100.0
|
99.1 percentage of participants
Interval 96.8 to 99.9
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement Titers >=1:4 and >=1:8
Serogroup Y: Day 31: >=1:8
|
98.5 percentage of participants
Interval 95.7 to 99.7
|
99.1 percentage of participants
Interval 96.8 to 99.9
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement Titers >=1:4 and >=1:8
Serogroup W: Day 1: >=1:4
|
7.0 percentage of participants
Interval 3.9 to 11.5
|
51.6 percentage of participants
Interval 44.8 to 58.3
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement Titers >=1:4 and >=1:8
Serogroup W: Day 1: >=1:8
|
4.0 percentage of participants
Interval 1.7 to 7.7
|
32.1 percentage of participants
Interval 26.0 to 38.7
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement Titers >=1:4 and >=1:8
Serogroup W: Day 31: >=1:4
|
99.5 percentage of participants
Interval 97.2 to 100.0
|
100 percentage of participants
Interval 98.3 to 100.0
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement Titers >=1:4 and >=1:8
Serogroup W: Day 31: >=1:8
|
98.5 percentage of participants
Interval 95.7 to 99.7
|
100 percentage of participants
Interval 98.3 to 100.0
|
PRIMARY outcome
Timeframe: Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)Population: Analysis was performed on the PPAS which was a subset of the FAS. The FAS included participants who received the study vaccine and had a valid post-vaccination serology result.
Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured by hSBA. hSBA vaccine seroresponse was defined as follows: for a participant with a pre-vaccination titer \<1:8, the post-vaccination titer must be \>=1:16, and for a participant with a pre-vaccination titer \>=1:8, the post-vaccination titer must be at least 4-fold greater than the pre-vaccination titer. Percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
MenACYW Conjugate Vaccine: 12-23 Months of Age
n=200 Participants
Participants aged 12-23 months received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 1.
|
MenACYW Conjugate Vaccine: 24 Months of Age and Above
n=221 Participants
Participants aged \>=24 months received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 1.
|
|---|---|---|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement Vaccine Seroresponse for Serogroups A, C, Y, and W
Serogroup A
|
81.5 percentage of participants
Interval 75.4 to 86.6
|
66.5 percentage of participants
Interval 59.9 to 72.7
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement Vaccine Seroresponse for Serogroups A, C, Y, and W
Serogroup C
|
99.5 percentage of participants
Interval 97.2 to 100.0
|
97.7 percentage of participants
Interval 94.8 to 99.3
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement Vaccine Seroresponse for Serogroups A, C, Y, and W
Serogroup Y
|
96.5 percentage of participants
Interval 92.9 to 98.6
|
95.5 percentage of participants
Interval 91.8 to 97.8
|
|
Percentage of Participants With Serum Bactericidal Assay Using Human Complement Vaccine Seroresponse for Serogroups A, C, Y, and W
Serogroup W
|
94.5 percentage of participants
Interval 90.4 to 97.2
|
95.5 percentage of participants
Interval 91.8 to 97.8
|
PRIMARY outcome
Timeframe: Up to 30 minutes post-vaccination on Day 1Population: The safety analysis set (SafAS) included participants who received the study vaccine and had any safety data available.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the case report form (CRF) in terms of diagnosis and onset window post-vaccination. Immediate events were recorded to capture medically relevant unsolicited systemic AEs (including those related to the study vaccine administered) which occurred within the first 30 minutes after vaccination.
Outcome measures
| Measure |
MenACYW Conjugate Vaccine: 12-23 Months of Age
n=223 Participants
Participants aged 12-23 months received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 1.
|
MenACYW Conjugate Vaccine: 24 Months of Age and Above
n=223 Participants
Participants aged \>=24 months received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 1.
|
|---|---|---|
|
Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From the study vaccine administration (Day 1) up to 7 days post-vaccination, up to Day 8Population: The SafAS included participants who received the study vaccine and had any safety data available.
A solicited reaction was an "expected" adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. An injection site reaction was an AR at and around the injection site considered to be related to the study vaccine administered and were commonly inflammatory reactions. Systemic ARs were all ARs that were not injection site reactions and included systemic manifestations such as headache, fever, as well as localized or topical manifestations.
Outcome measures
| Measure |
MenACYW Conjugate Vaccine: 12-23 Months of Age
n=223 Participants
Participants aged 12-23 months received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 1.
|
MenACYW Conjugate Vaccine: 24 Months of Age and Above
n=223 Participants
Participants aged \>=24 months received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 1.
|
|---|---|---|
|
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions
Solicited injection site reactions
|
29 Participants
|
29 Participants
|
|
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions
Solicited systemic reactions
|
34 Participants
|
24 Participants
|
PRIMARY outcome
Timeframe: From the study vaccine administration (Day 1) up to 30 days post-vaccination (Day 31)Population: The SafAS included participants who received the study vaccine and had any safety data available.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the CRF in terms of diagnosis and onset window post-vaccination.
Outcome measures
| Measure |
MenACYW Conjugate Vaccine: 12-23 Months of Age
n=223 Participants
Participants aged 12-23 months received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 1.
|
MenACYW Conjugate Vaccine: 24 Months of Age and Above
n=223 Participants
Participants aged \>=24 months received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 1.
|
|---|---|---|
|
Number of Participants With Unsolicited Non-Serious Adverse Events
|
48 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: From the study vaccine administration (Day 1) up to 30 days post-vaccination (Day 31)Population: The SafAS included participants who received the study vaccine and had any safety data available.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An SAE was any AE that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was other medically important event. An AESI (serious or non-serious) was one of scientific and medical concern specific to the Sponsor's study vaccine or program, for which ongoing monitoring and rapid communication by the investigator to the Sponsor was appropriate.
Outcome measures
| Measure |
MenACYW Conjugate Vaccine: 12-23 Months of Age
n=223 Participants
Participants aged 12-23 months received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 1.
|
MenACYW Conjugate Vaccine: 24 Months of Age and Above
n=223 Participants
Participants aged \>=24 months received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 1.
|
|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
SAEs
|
3 Participants
|
2 Participants
|
|
Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
AESIs
|
0 Participants
|
0 Participants
|
Adverse Events
MenACYW Conjugate Vaccine: 12-23 Months of Age
Serious events: 3 serious events
Other events: 59 other events
Deaths: 0 deaths
MenACYW Conjugate Vaccine: 24 Months of Age and Above
Serious events: 2 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MenACYW Conjugate Vaccine: 12-23 Months of Age
n=223 participants at risk
Participants aged 12-23 months received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 1.
|
MenACYW Conjugate Vaccine: 24 Months of Age and Above
n=223 participants at risk
Participants aged \>=24 months received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 1.
|
|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/223 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) up to 30 days post-vaccination (Day 31)
Analysis was performed on the SafAS.
|
0.45%
1/223 • Number of events 1 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) up to 30 days post-vaccination (Day 31)
Analysis was performed on the SafAS.
|
|
Infections and infestations
Pneumonia
|
1.3%
3/223 • Number of events 3 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) up to 30 days post-vaccination (Day 31)
Analysis was performed on the SafAS.
|
0.00%
0/223 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) up to 30 days post-vaccination (Day 31)
Analysis was performed on the SafAS.
|
|
Immune system disorders
Anaphylactic Reaction
|
0.45%
1/223 • Number of events 1 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) up to 30 days post-vaccination (Day 31)
Analysis was performed on the SafAS.
|
0.00%
0/223 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) up to 30 days post-vaccination (Day 31)
Analysis was performed on the SafAS.
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.00%
0/223 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) up to 30 days post-vaccination (Day 31)
Analysis was performed on the SafAS.
|
0.45%
1/223 • Number of events 1 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) up to 30 days post-vaccination (Day 31)
Analysis was performed on the SafAS.
|
Other adverse events
| Measure |
MenACYW Conjugate Vaccine: 12-23 Months of Age
n=223 participants at risk
Participants aged 12-23 months received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 1.
|
MenACYW Conjugate Vaccine: 24 Months of Age and Above
n=223 participants at risk
Participants aged \>=24 months received a single dose of 0.5 mL MenACYW conjugate vaccine as an IM injection on Day 1.
|
|---|---|---|
|
Infections and infestations
Upper Respiratory Tract Infection
|
9.9%
22/223 • Number of events 22 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) up to 30 days post-vaccination (Day 31)
Analysis was performed on the SafAS.
|
0.90%
2/223 • Number of events 2 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) up to 30 days post-vaccination (Day 31)
Analysis was performed on the SafAS.
|
|
General disorders
Injection Site Erythema
|
5.8%
13/223 • Number of events 13 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) up to 30 days post-vaccination (Day 31)
Analysis was performed on the SafAS.
|
4.9%
11/223 • Number of events 11 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) up to 30 days post-vaccination (Day 31)
Analysis was performed on the SafAS.
|
|
General disorders
Injection Site Pain
|
11.7%
26/223 • Number of events 26 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) up to 30 days post-vaccination (Day 31)
Analysis was performed on the SafAS.
|
10.3%
23/223 • Number of events 23 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) up to 30 days post-vaccination (Day 31)
Analysis was performed on the SafAS.
|
|
General disorders
Pyrexia
|
7.2%
16/223 • Number of events 16 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) up to 30 days post-vaccination (Day 31)
Analysis was performed on the SafAS.
|
3.1%
7/223 • Number of events 8 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) up to 30 days post-vaccination (Day 31)
Analysis was performed on the SafAS.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
7.6%
17/223 • Number of events 17 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) up to 30 days post-vaccination (Day 31)
Analysis was performed on the SafAS.
|
0.00%
0/223 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) up to 30 days post-vaccination (Day 31)
Analysis was performed on the SafAS.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/223 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) up to 30 days post-vaccination (Day 31)
Analysis was performed on the SafAS.
|
6.7%
15/223 • Number of events 15 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) up to 30 days post-vaccination (Day 31)
Analysis was performed on the SafAS.
|
|
General disorders
Crying
|
5.8%
13/223 • Number of events 13 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) up to 30 days post-vaccination (Day 31)
Analysis was performed on the SafAS.
|
0.00%
0/223 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) up to 30 days post-vaccination (Day 31)
Analysis was performed on the SafAS.
|
|
General disorders
Malaise
|
0.00%
0/223 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) up to 30 days post-vaccination (Day 31)
Analysis was performed on the SafAS.
|
5.8%
13/223 • Number of events 13 • AEs, SAEs and all-cause mortality (deaths) were collected from the study vaccine administration (Day 1) up to 30 days post-vaccination (Day 31)
Analysis was performed on the SafAS.
|
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