Trial Outcomes & Findings for Study on a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Compared to Two Meningococcal Reference Vaccines in European Toddlers (NCT NCT03890367)
NCT ID: NCT03890367
Last Updated: 2025-09-15
Results Overview
Antibody titers against Meningococcal Serogroup C were measured by hSBA.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
707 participants
Primary outcome timeframe
Day 30 (post-vaccination)
Results posted on
2025-09-15
Participant Flow
Study participants were enrolled in 29 active centers in Denmark, Germany and Finland from 12 September 2019 to 03 September 2020.
A total of 707 participants were enrolled and randomized in the study.
Participant milestones
| Measure |
Group 1: MenACYW Conjugate Vaccine
Healthy, toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: Nimenrix® Vaccine
Healthy, toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.
|
Group 3: NeisVac-C® Vaccine
Healthy, toddlers aged 12 to 23 months received a single dose of NeisVac-C® vaccine on Day 0.
|
|---|---|---|---|
|
Overall Study
STARTED
|
232
|
235
|
240
|
|
Overall Study
Safety Analysis Set
|
230
|
232
|
239
|
|
Overall Study
COMPLETED
|
228
|
229
|
239
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
1
|
Reasons for withdrawal
| Measure |
Group 1: MenACYW Conjugate Vaccine
Healthy, toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: Nimenrix® Vaccine
Healthy, toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.
|
Group 3: NeisVac-C® Vaccine
Healthy, toddlers aged 12 to 23 months received a single dose of NeisVac-C® vaccine on Day 0.
|
|---|---|---|---|
|
Overall Study
Withdrawal by parent/guardian
|
1
|
3
|
0
|
|
Overall Study
Protocol deviation
|
2
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
Baseline Characteristics
Study on a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Compared to Two Meningococcal Reference Vaccines in European Toddlers
Baseline characteristics by cohort
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=232 Participants
Healthy, toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: Nimenrix® Vaccine
n=235 Participants
Healthy, toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.
|
Group 3: NeisVac-C® Vaccine
n=240 Participants
Healthy, toddlers aged 12 to 23 months received a single dose of NeisVac-C® vaccine on Day 0.
|
Total
n=707 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
16.5 months
STANDARD_DEVIATION 3.27 • n=5 Participants
|
16.6 months
STANDARD_DEVIATION 3.48 • n=7 Participants
|
16.7 months
STANDARD_DEVIATION 3.45 • n=5 Participants
|
16.6 months
STANDARD_DEVIATION 3.40 • n=4 Participants
|
|
Sex: Female, Male
Female
|
115 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
332 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
117 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
375 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
225 Participants
n=5 Participants
|
226 Participants
n=7 Participants
|
236 Participants
n=5 Participants
|
687 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 30 (post-vaccination)Population: Analysis was performed on hSBA per-protocol analysis set (PPAS) which was a subset that included all participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. The participants who presented protocol deviations were excluded from PPAS. Data for this outcome measure was planned to be collected and analyzed only for Group 1 and 2, and not for Group 3.
Antibody titers against Meningococcal Serogroup C were measured by hSBA.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=214 Participants
Healthy, toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: Nimenrix® Vaccine
n=211 Participants
Healthy, toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.
|
|---|---|---|
|
Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroup C Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Non-inferiority Analysis)
|
99.5 percentage of participants
Interval 97.4 to 100.0
|
89.1 percentage of participants
Interval 84.1 to 93.0
|
PRIMARY outcome
Timeframe: Day 30 (post-vaccination)Population: Analysis was performed on hSBA PPAS which was a subset that included all participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. The participants who presented protocol deviations were excluded from PPAS. Data for this outcome measure was planned to be collected and analyzed only for Group 1 and 2, and not for Group 3.
GMT titers against Meningococcal Serogroup C were measured by hSBA. Titers were expressed in terms of 1/dilution.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=214 Participants
Healthy, toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: Nimenrix® Vaccine
n=211 Participants
Healthy, toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Non-inferiority Analysis)
|
515 titers
Interval 450.0 to 591.0
|
31.6 titers
Interval 26.5 to 37.6
|
PRIMARY outcome
Timeframe: Day 30 (post-vaccination)Population: Analysis was performed on hSBA PPAS which was a subset that included all participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. The participants who presented protocol deviations were excluded from PPAS. Data for this outcome measure was planned to be collected and analyzed only for Group 1 and 2, and not for Group 3.
GMT titers against Meningococcal Serogroup C were measured by hSBA. Titers were expressed in terms of 1/dilution.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=214 Participants
Healthy, toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: Nimenrix® Vaccine
n=211 Participants
Healthy, toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.
|
|---|---|---|
|
GMTs of Antibodies Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Superiority Analysis)
|
515 titers
Interval 450.0 to 591.0
|
31.6 titers
Interval 26.5 to 37.6
|
PRIMARY outcome
Timeframe: Day 30 (post-vaccination)Population: Analysis was performed on hSBA PPAS which was a subset that included all participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. The participants who presented protocol deviations were excluded from PPAS. Data for this outcome measure was planned to be collected and analyzed only for Group 1 and 2, and not for Group 3.
Antibody titers against Meningococcal Serogroup C were measured by hSBA.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=214 Participants
Healthy, toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: Nimenrix® Vaccine
n=211 Participants
Healthy, toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.
|
|---|---|---|
|
Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Superiority Analysis)
|
99.5 percentage of participants
Interval 97.4 to 100.0
|
89.1 percentage of participants
Interval 84.1 to 93.0
|
PRIMARY outcome
Timeframe: Day 30 (post-vaccination)Population: Analysis was performed on rSBA PPAS which was a subset that included all participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. The participants who presented protocol deviations were excluded from PPAS. Data for this outcome measure was planned to be collected and analyzed only for Group 1 and 3, and not for Group 2.
Antibody titers against Meningococcal Serogroup C were measured by rSBA.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=213 Participants
Healthy, toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: Nimenrix® Vaccine
n=215 Participants
Healthy, toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.
|
|---|---|---|
|
Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroup C Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Following Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Non-inferiority Analysis)
|
100 percentage of participants
Interval 98.3 to 100.0
|
100 percentage of participants
Interval 98.3 to 100.0
|
PRIMARY outcome
Timeframe: Day 30 (post-vaccination)Population: Analysis was performed on rSBA PPAS which was a subset that included all participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. The participants who presented protocol deviations were excluded from PPAS. Data for this outcome measure was planned to be collected and analyzed only for Group 1 and 3, and not for Group 2.
GMT titers against Meningococcal Serogroup C were measured by rSBA. Titers were expressed in terms of 1/dilution.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=213 Participants
Healthy, toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: Nimenrix® Vaccine
n=215 Participants
Healthy, toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.
|
|---|---|---|
|
GMTs of Antibodies Against Meningococcal Serogroup C Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Non-inferiority Analysis)
|
2143 titers
Interval 1870.0 to 2456.0
|
1624 titers
Interval 1425.0 to 1850.0
|
PRIMARY outcome
Timeframe: Day 30 (post-vaccination)Population: Analysis was performed on rSBA PPAS which was a subset that included all participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. The participants who presented protocol deviations were excluded from PPAS. Data for this outcome measure was planned to be collected and analyzed only for Group 1 and 3, and not for Group 2.
GMT titers against Meningococcal Serogroup C were measured by rSBA. Titers were expressed in terms of 1/dilution.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=213 Participants
Healthy, toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: Nimenrix® Vaccine
n=215 Participants
Healthy, toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.
|
|---|---|---|
|
GMTs of Antibodies Against Meningococcal Serogroup C Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Superiority Analysis)
|
2143 titers
Interval 1870.0 to 2456.0
|
1624 titers
Interval 1425.0 to 1850.0
|
SECONDARY outcome
Timeframe: Day 30 (post-vaccination)Population: Analysis was performed on rSBA PPAS which was a subset that included all participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. The participants who presented protocol deviations were excluded from PPAS. Data for this outcome measure was planned to be collected and analyzed only for Group 1 and 2, and not for Group 3.
Antibody titers against Meningococcal Serogroup C were measured by rSBA.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=213 Participants
Healthy, toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: Nimenrix® Vaccine
n=210 Participants
Healthy, toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.
|
|---|---|---|
|
Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroup C Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Non-inferiority Analysis)
|
100 percentage of participants
Interval 98.3 to 100.0
|
94.8 percentage of participants
Interval 90.8 to 97.4
|
SECONDARY outcome
Timeframe: Day 30 (post-vaccination)Population: Analysis was performed on rSBA PPAS which was a subset that included all participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. The participants who presented protocol deviations were excluded from PPAS. Data for this outcome measure was planned to be collected and analyzed only for Group 1 and 2, and not for Group 3.
GMT titers against Meningococcal Serogroup C were measured by rSBA. Titers were expressed in terms of 1/dilution.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=213 Participants
Healthy, toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: Nimenrix® Vaccine
n=210 Participants
Healthy, toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.
|
|---|---|---|
|
GMTs of Antibodies Against Meningococcal Serogroup C Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Non-inferiority Analysis)
|
2143 titers
Interval 1870.0 to 2456.0
|
315 titers
Interval 252.0 to 395.0
|
SECONDARY outcome
Timeframe: Day 30 (post-vaccination)Population: Analysis was performed on rSBA PPAS which was a subset that included all participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. The participants who presented protocol deviations were excluded from PPAS. Data for this outcome measure was planned to be collected and analyzed only for Group 1 and 2, and not for Group 3.
GMT titers against Meningococcal Serogroup C were measured by rSBA. Titers were expressed in terms of 1/dilution.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=213 Participants
Healthy, toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: Nimenrix® Vaccine
n=210 Participants
Healthy, toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.
|
|---|---|---|
|
GMTs of Antibodies Against Meningococcal Serogroup C Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Superiority Analysis)
|
2143 titers
Interval 1870.0 to 2456.0
|
315 titers
Interval 252.0 to 395.0
|
SECONDARY outcome
Timeframe: Day 30 (post-vaccination)Population: Analysis was performed on hSBA PPAS which was a subset that included all participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. The participants who presented protocol deviations were excluded from PPAS. Data for this outcome measure was planned to be collected and analyzed only for Group 1 and 3, and not for Group 2.
Antibody titers against Meningococcal Serogroup C were measured by hSBA.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=214 Participants
Healthy, toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: Nimenrix® Vaccine
n=216 Participants
Healthy, toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.
|
|---|---|---|
|
Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Non-inferiority Analysis)
|
99.5 percentage of participants
Interval 97.4 to 100.0
|
99.5 percentage of participants
Interval 97.4 to 100.0
|
SECONDARY outcome
Timeframe: Day 30 (post-vaccination)Population: Analysis was performed on hSBA PPAS which was a subset that included all participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. The participants who presented protocol deviations were excluded from PPAS. Data for this outcome measure was planned to be collected and analyzed only for Group 1 and 3, and not for Group 2.
GMT titers against Meningococcal Serogroup C were measured by hSBA. Titers were expressed in terms of 1/dilution.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=214 Participants
Healthy, toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: Nimenrix® Vaccine
n=216 Participants
Healthy, toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.
|
|---|---|---|
|
GMTs of Antibodies Against Meningococcal Serogroup C Measured by hSBA After Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Non-inferiority Analysis)
|
515 titers
Interval 450.0 to 591.0
|
227 titers
Interval 198.0 to 260.0
|
SECONDARY outcome
Timeframe: Day 30 (post-vaccination)Population: Analysis was performed on hSBA PPAS which was a subset that included all participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. The participants who presented protocol deviations were excluded from PPAS. Data for this outcome measure was planned to be collected and analyzed only for Group 1 and 3, and not for Group 2.
GMT titers against Meningococcal Serogroup C were measured by hSBA. Titers were expressed in terms of 1/dilution.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=214 Participants
Healthy, toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: Nimenrix® Vaccine
n=216 Participants
Healthy, toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.
|
|---|---|---|
|
GMTs of Antibodies Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Superiority Analysis)
|
515 titers
Interval 450.0 to 591.0
|
227 titers
Interval 198.0 to 260.0
|
Adverse Events
Group 1: MenACYW Conjugate Vaccine
Serious events: 1 serious events
Other events: 197 other events
Deaths: 0 deaths
Group 2: Nimenrix® Vaccine
Serious events: 1 serious events
Other events: 192 other events
Deaths: 0 deaths
Group 3: NeisVac-C® Vaccine
Serious events: 2 serious events
Other events: 203 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=230 participants at risk
Healthy, toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: Nimenrix® Vaccine
n=232 participants at risk
Healthy, toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.
|
Group 3: NeisVac-C® Vaccine
n=239 participants at risk
Healthy, toddlers aged 12 to 23 months received a single dose of NeisVac-C® vaccine on Day 0.
|
|---|---|---|---|
|
Infections and infestations
Respiratory Syncytial Virus Infection
|
0.43%
1/230 • Number of events 1 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
0.00%
0/232 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
0.00%
0/239 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
|
Infections and infestations
Respiratory Tract Infection Viral
|
0.00%
0/230 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
0.00%
0/232 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
0.42%
1/239 • Number of events 1 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
|
Injury, poisoning and procedural complications
Foreign Body In Throat
|
0.00%
0/230 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
0.00%
0/232 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
0.42%
1/239 • Number of events 1 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
|
Nervous system disorders
Febrile Convulsion
|
0.00%
0/230 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
0.43%
1/232 • Number of events 1 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
0.42%
1/239 • Number of events 1 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/230 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
0.00%
0/232 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
0.42%
1/239 • Number of events 1 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
Other adverse events
| Measure |
Group 1: MenACYW Conjugate Vaccine
n=230 participants at risk
Healthy, toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.
|
Group 2: Nimenrix® Vaccine
n=232 participants at risk
Healthy, toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.
|
Group 3: NeisVac-C® Vaccine
n=239 participants at risk
Healthy, toddlers aged 12 to 23 months received a single dose of NeisVac-C® vaccine on Day 0.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.2%
12/230 • Number of events 14 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
6.0%
14/232 • Number of events 18 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
5.0%
12/239 • Number of events 12 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
|
Gastrointestinal disorders
Teething
|
9.1%
21/230 • Number of events 22 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
4.7%
11/232 • Number of events 15 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
5.9%
14/239 • Number of events 19 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
|
Gastrointestinal disorders
Toothache
|
7.0%
16/230 • Number of events 20 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
2.6%
6/232 • Number of events 6 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
2.9%
7/239 • Number of events 8 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
|
Gastrointestinal disorders
Vomiting
|
8.7%
20/230 • Number of events 23 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
8.6%
20/232 • Number of events 20 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
6.7%
16/239 • Number of events 16 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
|
General disorders
Crying
|
31.3%
72/230 • Number of events 73 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
31.5%
73/232 • Number of events 73 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
33.9%
81/239 • Number of events 82 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
|
General disorders
Injection Site Erythema
|
37.0%
85/230 • Number of events 85 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
40.9%
95/232 • Number of events 95 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
39.7%
95/239 • Number of events 95 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
|
General disorders
Injection Site Pain
|
41.7%
96/230 • Number of events 96 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
31.5%
73/232 • Number of events 73 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
38.1%
91/239 • Number of events 91 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
|
General disorders
Injection Site Swelling
|
14.3%
33/230 • Number of events 33 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
14.7%
34/232 • Number of events 34 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
17.6%
42/239 • Number of events 42 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
|
General disorders
Pyrexia
|
16.5%
38/230 • Number of events 41 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
18.5%
43/232 • Number of events 45 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
18.8%
45/239 • Number of events 47 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
|
Infections and infestations
Nasopharyngitis
|
9.6%
22/230 • Number of events 22 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
8.2%
19/232 • Number of events 21 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
10.9%
26/239 • Number of events 26 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
|
Infections and infestations
Rhinitis
|
4.3%
10/230 • Number of events 10 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
3.4%
8/232 • Number of events 8 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
5.9%
14/239 • Number of events 15 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
6.5%
15/230 • Number of events 15 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
4.7%
11/232 • Number of events 11 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
5.9%
14/239 • Number of events 14 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
25.7%
59/230 • Number of events 59 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
28.9%
67/232 • Number of events 67 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
28.0%
67/239 • Number of events 67 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
|
Nervous system disorders
Somnolence
|
17.4%
40/230 • Number of events 40 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
17.7%
41/232 • Number of events 41 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
20.5%
49/239 • Number of events 49 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
|
Psychiatric disorders
Irritability
|
43.9%
101/230 • Number of events 103 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
43.5%
101/232 • Number of events 101 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
44.8%
107/239 • Number of events 109 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.8%
11/230 • Number of events 11 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
3.9%
9/232 • Number of events 10 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
5.0%
12/239 • Number of events 13 • Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.
Analysis was performed on Safety Analysis Set which included all participants who had received one dose of study vaccine and were analyzed according to the vaccine they actually received.
|
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