Trial Outcomes & Findings for Persistence of Antibodies After Meningococcal Vaccine PF-06866681 in Healthy Children (NCT NCT01900899)
NCT ID: NCT01900899
Last Updated: 2019-06-17
Results Overview
Serogroups included MenA, MenC, MenW-135 and MenY.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
184 participants
Primary outcome timeframe
24 months after booster Vaccination
Results posted on
2019-06-17
Participant Flow
In this study, participants from the study MENACWY-TT-039 (NCT01900899) and MENACWY-TT-048 EXT (NCT01900899) were followed up for persistence of immune response and safety for a maximum duration of 6 years.
Participant milestones
| Measure |
MenACWY-TT Vaccine
Participants who received single 0.5 milliliter (mL) dose of meningococcal A, C, W-135, Y-tetanus toxoid conjugate (MenACWY-TT) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years.
|
MenCCRM Vaccine
Participants who received single 0.5 mL dose of meningococcal serogroup C CRM197 conjugated (MenCCRM) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years.
|
|---|---|---|
|
Overall Study
STARTED
|
159
|
25
|
|
Overall Study
COMPLETED
|
150
|
24
|
|
Overall Study
NOT COMPLETED
|
9
|
1
|
Reasons for withdrawal
| Measure |
MenACWY-TT Vaccine
Participants who received single 0.5 milliliter (mL) dose of meningococcal A, C, W-135, Y-tetanus toxoid conjugate (MenACWY-TT) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years.
|
MenCCRM Vaccine
Participants who received single 0.5 mL dose of meningococcal serogroup C CRM197 conjugated (MenCCRM) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
1
|
|
Overall Study
Migrated from study area
|
2
|
0
|
Baseline Characteristics
Persistence of Antibodies After Meningococcal Vaccine PF-06866681 in Healthy Children
Baseline characteristics by cohort
| Measure |
MenACWY-TT Vaccine
n=159 Participants
Participants who received single 0.5 mL dose of meningococcal A, C, W-135, Y-tetanus toxoid conjugate (MenACWY-TT) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years.
|
MenCCRM Vaccine
n=25 Participants
Participants who received single 0.5 mL dose of meningococcal serogroup C CRM197 conjugated (MenCCRM) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years.
|
Total
n=184 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
90.2 months
STANDARD_DEVIATION 6.06 • n=5 Participants
|
89.6 months
STANDARD_DEVIATION 5.56 • n=7 Participants
|
90.1 months
STANDARD_DEVIATION 5.99 • n=5 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race: White-Caucasian
|
158 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race: Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity: American hispanic
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity: Non American hispanic
|
159 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
183 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 months after booster VaccinationPopulation: All eligible participants who received primary and booster vaccination with MenACWY-TT or Meningitec vaccine in studies MENACWY-TT-039 and MENACWY-TT-048 EXT and had available assay results for at least 1 tested antigen. N (overall number of participants analyzed)=number of participants evaluable for this outcome measure.
Serogroups included MenA, MenC, MenW-135 and MenY.
Outcome measures
| Measure |
MenACWY-TT Vaccine
n=123 Participants
Participants who received single 0.5 mL dose of meningococcal A, C, W-135, Y-tetanus toxoid conjugate (MenACWY-TT) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years.
|
MenCCRM Vaccine
n=21 Participants
Participants who received single 0.5 mL dose of meningococcal serogroup C CRM197 conjugated (MenCCRM) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years.
|
|---|---|---|
|
Percentage of Participants With rSBA-Antibody Titers Greater Than or Equal to (>=) 1:8 For Each of the 4 Serogroups at 24 Months After Booster Vaccination
rSBA-MenA
|
98.4 percentage of participants
Interval 94.2 to 99.8
|
23.8 percentage of participants
Interval 8.2 to 47.2
|
|
Percentage of Participants With rSBA-Antibody Titers Greater Than or Equal to (>=) 1:8 For Each of the 4 Serogroups at 24 Months After Booster Vaccination
rSBA-MenC
|
97.6 percentage of participants
Interval 93.0 to 99.5
|
100.0 percentage of participants
Interval 83.9 to 100.0
|
|
Percentage of Participants With rSBA-Antibody Titers Greater Than or Equal to (>=) 1:8 For Each of the 4 Serogroups at 24 Months After Booster Vaccination
rSBA-MenW-135
|
96.7 percentage of participants
Interval 91.9 to 99.1
|
9.5 percentage of participants
Interval 1.2 to 30.4
|
|
Percentage of Participants With rSBA-Antibody Titers Greater Than or Equal to (>=) 1:8 For Each of the 4 Serogroups at 24 Months After Booster Vaccination
rSBA-MenY
|
100.0 percentage of participants
Interval 97.0 to 100.0
|
33.3 percentage of participants
Interval 14.6 to 57.0
|
PRIMARY outcome
Timeframe: 36 months after booster VaccinationPopulation: All eligible participants who received primary and booster vaccination with MenACWY-TT or Meningitec vaccine in studies MENACWY-TT-039 and MENACWY-TT-048 EXT and had available assay results for at least 1 tested antigen. Here, N signifies number of participants evaluable for this outcome measure.
Serogroups included MenA, MenC, MenW-135 and MenY.
Outcome measures
| Measure |
MenACWY-TT Vaccine
n=135 Participants
Participants who received single 0.5 mL dose of meningococcal A, C, W-135, Y-tetanus toxoid conjugate (MenACWY-TT) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years.
|
MenCCRM Vaccine
n=22 Participants
Participants who received single 0.5 mL dose of meningococcal serogroup C CRM197 conjugated (MenCCRM) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years.
|
|---|---|---|
|
Percentage of Participants With rSBA-Antibody Titers >= 1:8 For Each of the 4 Serogroups at 36 Months After Booster Vaccination
rSBA-MenA
|
95.6 percentage of participants
Interval 90.6 to 98.4
|
18.2 percentage of participants
Interval 5.2 to 40.3
|
|
Percentage of Participants With rSBA-Antibody Titers >= 1:8 For Each of the 4 Serogroups at 36 Months After Booster Vaccination
rSBA-MenC
|
88.1 percentage of participants
Interval 81.5 to 93.1
|
77.3 percentage of participants
Interval 54.6 to 92.2
|
|
Percentage of Participants With rSBA-Antibody Titers >= 1:8 For Each of the 4 Serogroups at 36 Months After Booster Vaccination
rSBA-MenW-135
|
97.8 percentage of participants
Interval 93.6 to 99.5
|
9.1 percentage of participants
Interval 1.1 to 29.2
|
|
Percentage of Participants With rSBA-Antibody Titers >= 1:8 For Each of the 4 Serogroups at 36 Months After Booster Vaccination
rSBA-MenY
|
94.8 percentage of participants
Interval 89.6 to 97.9
|
36.4 percentage of participants
Interval 17.2 to 59.3
|
PRIMARY outcome
Timeframe: 48 months after booster VaccinationPopulation: All eligible participants who received primary and booster vaccination with MenACWY-TT/ Meningitec vaccine in studies MENACWY-TT-039 and MENACWY-TT-048 EXT and had available assay results for at least 1 tested antigen. Here, N=number of participants evaluable for this outcome measure.
Serogroups included MenA, MenC, MenW-135 and MenY.
Outcome measures
| Measure |
MenACWY-TT Vaccine
n=139 Participants
Participants who received single 0.5 mL dose of meningococcal A, C, W-135, Y-tetanus toxoid conjugate (MenACWY-TT) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years.
|
MenCCRM Vaccine
n=23 Participants
Participants who received single 0.5 mL dose of meningococcal serogroup C CRM197 conjugated (MenCCRM) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years.
|
|---|---|---|
|
Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 48 Months After Booster Vaccination
rSBA-MenA
|
95.0 percentage of participants
Interval 89.9 to 98.0
|
26.1 percentage of participants
Interval 10.2 to 48.4
|
|
Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 48 Months After Booster Vaccination
rSBA-MenC
|
88.5 percentage of participants
Interval 82.0 to 93.3
|
100.0 percentage of participants
Interval 85.2 to 100.0
|
|
Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 48 Months After Booster Vaccination
rSBA-MenW-135
|
87.0 percentage of participants
Interval 80.2 to 92.1
|
17.4 percentage of participants
Interval 5.0 to 38.8
|
|
Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 48 Months After Booster Vaccination
rSBA-MenY
|
95.0 percentage of participants
Interval 89.9 to 98.0
|
43.5 percentage of participants
Interval 23.2 to 65.5
|
PRIMARY outcome
Timeframe: 60 months after booster VaccinationPopulation: All eligible participants who received primary and booster vaccination with MenACWY-TT/ Meningitec vaccine in studies MENACWY-TT-039 and MENACWY-TT-048 EXT and had available assay results for at least 1 tested antigen. Here, N=number of participants evaluable for this outcome measure.
Serogroups included MenA, MenC, MenW-135 and MenY.
Outcome measures
| Measure |
MenACWY-TT Vaccine
n=137 Participants
Participants who received single 0.5 mL dose of meningococcal A, C, W-135, Y-tetanus toxoid conjugate (MenACWY-TT) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years.
|
MenCCRM Vaccine
n=23 Participants
Participants who received single 0.5 mL dose of meningococcal serogroup C CRM197 conjugated (MenCCRM) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years.
|
|---|---|---|
|
Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 60 Months After Booster Vaccination
rSBA-MenA
|
89.8 percentage of participants
Interval 83.4 to 94.3
|
0.0 percentage of participants
Interval 0.0 to 14.8
|
|
Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 60 Months After Booster Vaccination
rSBA-MenC
|
80.3 percentage of participants
Interval 72.6 to 86.6
|
78.3 percentage of participants
Interval 56.3 to 92.5
|
|
Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 60 Months After Booster Vaccination
rSBA-MenW-135
|
88.3 percentage of participants
Interval 81.7 to 93.2
|
13.0 percentage of participants
Interval 2.8 to 33.6
|
|
Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 60 Months After Booster Vaccination
rSBA-MenY
|
92.7 percentage of participants
Interval 87.0 to 96.4
|
26.1 percentage of participants
Interval 10.2 to 48.4
|
PRIMARY outcome
Timeframe: 72 months after booster VaccinationPopulation: All eligible participants who received primary and booster vaccination with MenACWY-TT/ Meningitec vaccine in studies MENACWY-TT-039 and MENACWY-TT-048 EXT and had available assay results for at least 1 tested antigen. Here, N=number of participants evaluable for this outcome measure.
Serogroups included MenA, MenC, MenW-135 and MenY.
Outcome measures
| Measure |
MenACWY-TT Vaccine
n=134 Participants
Participants who received single 0.5 mL dose of meningococcal A, C, W-135, Y-tetanus toxoid conjugate (MenACWY-TT) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years.
|
MenCCRM Vaccine
n=23 Participants
Participants who received single 0.5 mL dose of meningococcal serogroup C CRM197 conjugated (MenCCRM) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years.
|
|---|---|---|
|
Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 72 Months After Booster Vaccination
rSBA-MenA
|
92.5 percentage of participants
Interval 86.7 to 96.4
|
8.7 percentage of participants
Interval 1.1 to 28.0
|
|
Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 72 Months After Booster Vaccination
rSBA-MenC
|
71.6 percentage of participants
Interval 63.2 to 79.1
|
65.2 percentage of participants
Interval 42.7 to 83.6
|
|
Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 72 Months After Booster Vaccination
rSBA-MenW-135
|
85.8 percentage of participants
Interval 78.7 to 91.2
|
13.0 percentage of participants
Interval 2.8 to 33.6
|
|
Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 72 Months After Booster Vaccination
rSBA-MenY
|
94.0 percentage of participants
Interval 88.6 to 97.4
|
13.0 percentage of participants
Interval 2.8 to 33.6
|
SECONDARY outcome
Timeframe: 24, 36, 48, 60 and 72 months after booster VaccinationPopulation: All eligible participants who received primary and booster vaccination with MenACWY-TT/ Meningitec vaccine in studies MENACWY-TT-039 and MENACWY-TT-048 EXT and had available assay results for at least 1 tested antigen. N=number of participants evaluable for this outcome measure. 'Number Analyzed' = participants evaluable for specified categories.
Serogroups included MenA, MenC, MenW-135 and MenY.
Outcome measures
| Measure |
MenACWY-TT Vaccine
n=139 Participants
Participants who received single 0.5 mL dose of meningococcal A, C, W-135, Y-tetanus toxoid conjugate (MenACWY-TT) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years.
|
MenCCRM Vaccine
n=23 Participants
Participants who received single 0.5 mL dose of meningococcal serogroup C CRM197 conjugated (MenCCRM) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years.
|
|---|---|---|
|
Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups
Month 24: rSBA-MenA-1:128
|
95.1 percentage of participants
Interval 89.7 to 98.2
|
14.3 percentage of participants
Interval 3.0 to 36.3
|
|
Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups
Month 24: rSBA-MenC-1:128
|
74.8 percentage of participants
Interval 66.2 to 82.2
|
85.7 percentage of participants
Interval 63.7 to 97.0
|
|
Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups
Month 24: rSBA-MenW-135-1:128
|
94.3 percentage of participants
Interval 88.6 to 97.7
|
9.5 percentage of participants
Interval 1.2 to 30.4
|
|
Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups
Month 24: rSBA-MenY-1:128
|
94.3 percentage of participants
Interval 88.6 to 97.7
|
33.3 percentage of participants
Interval 14.6 to 57.0
|
|
Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups
Month 36: rSBA-MenA-1:128
|
83.0 percentage of participants
Interval 75.5 to 88.9
|
13.6 percentage of participants
Interval 2.9 to 34.9
|
|
Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups
Month 36: rSBA-MenC-1:128
|
46.7 percentage of participants
Interval 38.0 to 55.4
|
40.9 percentage of participants
Interval 20.7 to 63.6
|
|
Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups
Month 36: rSBA-MenW-135-1:128
|
88.1 percentage of participants
Interval 81.5 to 93.1
|
9.1 percentage of participants
Interval 1.1 to 29.2
|
|
Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups
Month 36: rSBA-MenY-1:128
|
84.4 percentage of participants
Interval 77.2 to 90.1
|
36.4 percentage of participants
Interval 17.2 to 59.3
|
|
Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups
Month 48: rSBA-MenA-1:128
|
83.5 percentage of participants
Interval 76.2 to 89.2
|
17.4 percentage of participants
Interval 5.0 to 38.8
|
|
Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups
Month 48: rSBA-MenC-1:128
|
46.0 percentage of participants
Interval 37.6 to 54.7
|
47.8 percentage of participants
Interval 26.8 to 69.4
|
|
Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups
Month 48: rSBA-MenW-135-1:128
|
73.9 percentage of participants
Interval 65.8 to 81.0
|
17.4 percentage of participants
Interval 5.0 to 38.8
|
|
Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups
Month 48: rSBA-MenY-1:128
|
82.0 percentage of participants
Interval 74.6 to 88.0
|
43.5 percentage of participants
Interval 23.2 to 65.5
|
|
Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups
Month 60: rSBA-MenA-1:128
|
73.0 percentage of participants
Interval 64.7 to 80.2
|
0.0 percentage of participants
Interval 0.0 to 14.8
|
|
Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups
Month 60: rSBA-MenC-1:128
|
47.4 percentage of participants
Interval 38.9 to 56.1
|
43.5 percentage of participants
Interval 23.2 to 65.5
|
|
Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups
Month 60: rSBA-MenW-135-1:128
|
69.3 percentage of participants
Interval 60.9 to 76.9
|
13.0 percentage of participants
Interval 2.8 to 33.6
|
|
Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups
Month 60: rSBA-MenY-1:128
|
77.4 percentage of participants
Interval 69.4 to 84.1
|
21.7 percentage of participants
Interval 7.5 to 43.7
|
|
Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups
Month 72: rSBA-MenA-1:128
|
78.4 percentage of participants
Interval 70.4 to 85.0
|
8.7 percentage of participants
Interval 1.1 to 28.0
|
|
Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups
Month 72: rSBA-MenC-1:128
|
40.3 percentage of participants
Interval 31.9 to 49.1
|
34.8 percentage of participants
Interval 16.4 to 57.3
|
|
Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups
Month 72: rSBA-MenW-135-1:128
|
67.2 percentage of participants
Interval 58.5 to 75.0
|
13.0 percentage of participants
Interval 2.8 to 33.6
|
|
Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups
Month 72: rSBA-MenY-1:128
|
75.4 percentage of participants
Interval 67.2 to 82.4
|
13.0 percentage of participants
Interval 2.8 to 33.6
|
SECONDARY outcome
Timeframe: 24, 36, 48, 60 and 72 months after booster VaccinationPopulation: All eligible participants who received primary and booster vaccination with MenACWY-TT/ Meningitec vaccine in studies MENACWY-TT-039 and MENACWY-TT-048 EXT and had available assay results for at least 1 tested antigen. N=number of participants evaluable for this outcome measure. 'Number Analyzed' = participants evaluable for specified categories.
Serogroups included MenA, MenC, MenW-135 and MenY.
Outcome measures
| Measure |
MenACWY-TT Vaccine
n=139 Participants
Participants who received single 0.5 mL dose of meningococcal A, C, W-135, Y-tetanus toxoid conjugate (MenACWY-TT) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years.
|
MenCCRM Vaccine
n=23 Participants
Participants who received single 0.5 mL dose of meningococcal serogroup C CRM197 conjugated (MenCCRM) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years.
|
|---|---|---|
|
Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Month 24: rSBA-MenA
|
1071.2 titers
Interval 821.9 to 1396.2
|
9.1 titers
Interval 3.9 to 21.6
|
|
Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Month 24: rSBA-MenC
|
174.5 titers
Interval 137.5 to 221.5
|
224.3 titers
Interval 134.1 to 375.4
|
|
Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Month 24: rSBA-MenW-135
|
859.9 titers
Interval 641.6 to 1152.3
|
6.6 titers
Interval 3.2 to 13.4
|
|
Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Month 24: rSBA-MenY
|
734.4 titers
Interval 584.6 to 922.5
|
18.9 titers
Interval 6.6 to 53.7
|
|
Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Month 36: rSBA-MenA
|
376.3 titers
Interval 280.7 to 504.3
|
8.8 titers
Interval 3.9 to 19.6
|
|
Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Month 36: rSBA-MenC
|
70.6 titers
Interval 53.3 to 93.3
|
54.7 titers
Interval 25.0 to 119.5
|
|
Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Month 36: rSBA-MenW-135
|
544.5 titers
Interval 418.0 to 709.4
|
6.4 titers
Interval 3.3 to 12.7
|
|
Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Month 36: rSBA-MenY
|
416.9 titers
Interval 313.3 to 554.9
|
20.6 titers
Interval 7.6 to 56.1
|
|
Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Month 48: rSBA-MenA
|
413.2 titers
Interval 310.3 to 550.2
|
10.8 titers
Interval 4.7 to 24.7
|
|
Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Month 48: rSBA-MenC
|
69.0 titers
Interval 52.5 to 90.7
|
62.1 titers
Interval 32.1 to 120.3
|
|
Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Month 48: rSBA-MenW-135
|
224.7 titers
Interval 158.6 to 318.2
|
9.3 titers
Interval 4.1 to 21.1
|
|
Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Month 48: rSBA-MenY
|
335.1 titers
Interval 254.7 to 440.9
|
28.4 titers
Interval 10.3 to 77.8
|
|
Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Month 60: rSBA-MenA
|
229.0 titers
Interval 163.0 to 321.9
|
4.0 titers
CI was not estimable due to the lack of variability of geometric means.
|
|
Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Month 60: rSBA-MenC
|
66.0 titers
Interval 48.1 to 90.5
|
47.3 titers
Interval 19.0 to 117.9
|
|
Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Month 60: rSBA-MenW-135
|
184.3 titers
Interval 130.3 to 260.6
|
8.0 titers
Interval 3.6 to 17.8
|
|
Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Month 60: rSBA-MenY
|
265.2 titers
Interval 190.9 to 368.4
|
13.0 titers
Interval 5.2 to 32.3
|
|
Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Month 72: rSBA-MenA
|
297.4 titers
Interval 214.4 to 412.5
|
5.7 titers
Interval 3.4 to 9.6
|
|
Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Month 72: rSBA-MenC
|
39.6 titers
Interval 28.6 to 54.6
|
33.0 titers
Interval 14.7 to 74.2
|
|
Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Month 72: rSBA-MenW-135
|
171.9 titers
Interval 117.5 to 251.4
|
7.3 titers
Interval 3.7 to 14.6
|
|
Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Month 72: rSBA-MenY
|
260.0 titers
Interval 188.6 to 358.5
|
8.8 titers
Interval 3.5 to 21.8
|
SECONDARY outcome
Timeframe: Baseline up to the Month 72 after booster vaccination (up to 6 years)Population: All eligible participants who received primary and booster vaccination with MenACWY-TT or Meningitec vaccine in studies MENACWY-TT-039 and MENACWY-TT-048 EXT and had available assay results for at least 1 tested antigen.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 72 months after last dose of study drug that were absent before treatment or that worsened relative to pretreatment state.
Outcome measures
| Measure |
MenACWY-TT Vaccine
n=159 Participants
Participants who received single 0.5 mL dose of meningococcal A, C, W-135, Y-tetanus toxoid conjugate (MenACWY-TT) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years.
|
MenCCRM Vaccine
n=25 Participants
Participants who received single 0.5 mL dose of meningococcal serogroup C CRM197 conjugated (MenCCRM) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Serious Adverse Events (SAEs)
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 24, 36, 48, 60 and 72 months after booster VaccinationPopulation: All eligible participants who received primary and booster vaccination with MenACWY-TT/ Meningitec vaccine in studies MENACWY-TT-039 and MENACWY-TT-048 EXT and had available assay results for at least 1 tested antigen. N=number of participants evaluable for this outcome measure. 'Number Analyzed' = participants evaluable for specified categories.
Serogroups included MenA, MenC, MenW-135 and MenY.
Outcome measures
| Measure |
MenACWY-TT Vaccine
n=137 Participants
Participants who received single 0.5 mL dose of meningococcal A, C, W-135, Y-tetanus toxoid conjugate (MenACWY-TT) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years.
|
MenCCRM Vaccine
n=23 Participants
Participants who received single 0.5 mL dose of meningococcal serogroup C CRM197 conjugated (MenCCRM) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years.
|
|---|---|---|
|
Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
Month 60: hSBA-MenA>=1:4
|
53.3 percentage of participants
Interval 44.6 to 62.0
|
0.0 percentage of participants
Interval 0.0 to 14.8
|
|
Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
Month 60: hSBA-MenC>=1:4
|
99.3 percentage of participants
Interval 96.0 to 100.0
|
100.0 percentage of participants
Interval 85.2 to 100.0
|
|
Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
Month 48: hSBA-MenY>=1:4
|
97.0 percentage of participants
Interval 92.4 to 99.2
|
28.6 percentage of participants
Interval 11.3 to 52.2
|
|
Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
Month 48: hSBA-MenC>=1:4
|
98.5 percentage of participants
Interval 94.7 to 99.8
|
100.0 percentage of participants
Interval 84.6 to 100.0
|
|
Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
Month 48: hSBA-MenW-135>=1:4
|
100.0 percentage of participants
Interval 97.3 to 100.0
|
4.3 percentage of participants
Interval 0.1 to 21.9
|
|
Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
Month 24: hSBA-MenA>=1:4
|
70.0 percentage of participants
Interval 61.0 to 78.0
|
14.3 percentage of participants
Interval 3.0 to 36.3
|
|
Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
Month 24: hSBA-MenC>=1:4
|
100.0 percentage of participants
Interval 97.0 to 100.0
|
100.0 percentage of participants
Interval 83.9 to 100.0
|
|
Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
Month 24: hSBA-MenW-135>=1:4
|
100.0 percentage of participants
Interval 97.0 to 100.0
|
15.0 percentage of participants
Interval 3.2 to 37.9
|
|
Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
Month 24: hSBA-MenY>=1:4
|
100.0 percentage of participants
Interval 97.0 to 100.0
|
28.6 percentage of participants
Interval 11.3 to 52.2
|
|
Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
Month 36: hSBA-MenA>=1:4
|
77.4 percentage of participants
Interval 69.4 to 84.2
|
14.3 percentage of participants
Interval 3.0 to 36.3
|
|
Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
Month 36: hSBA-MenC>=1:4
|
100.0 percentage of participants
Interval 97.2 to 100.0
|
100.0 percentage of participants
Interval 84.6 to 100.0
|
|
Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
Month 36: hSBA-MenW-135>=1:4
|
100.0 percentage of participants
Interval 97.3 to 100.0
|
18.2 percentage of participants
Interval 5.2 to 40.3
|
|
Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
Month 36: hSBA-MenY>=1:4
|
99.3 percentage of participants
Interval 95.9 to 100.0
|
40.0 percentage of participants
Interval 19.1 to 63.9
|
|
Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
Month 48: hSBA-MenA>=1:4
|
72.9 percentage of participants
Interval 64.3 to 80.3
|
34.8 percentage of participants
Interval 16.4 to 57.3
|
|
Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
Month 60: hSBA-MenW-135>=1:4
|
100.0 percentage of participants
Interval 97.3 to 100.0
|
4.5 percentage of participants
Interval 0.1 to 22.8
|
|
Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
Month 60: hSBA-MenY>=1:4
|
97.8 percentage of participants
Interval 93.7 to 99.5
|
40.9 percentage of participants
Interval 20.7 to 63.6
|
|
Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
Month 72: hSBA-MenA>=1:4
|
58.5 percentage of participants
Interval 49.5 to 67.0
|
13.0 percentage of participants
Interval 2.8 to 33.6
|
|
Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
Month 72: hSBA-MenC>=1:4
|
98.5 percentage of participants
Interval 94.6 to 99.8
|
100.0 percentage of participants
Interval 85.2 to 100.0
|
|
Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
Month 72: hSBA-MenW-135>=1:4
|
98.5 percentage of participants
Interval 94.7 to 99.8
|
9.5 percentage of participants
Interval 1.2 to 30.4
|
|
Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
Month 72: hSBA-MenY>=1:4
|
97.7 percentage of participants
Interval 93.5 to 99.5
|
33.3 percentage of participants
Interval 14.6 to 57.0
|
|
Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
Month 24: hSBA-MenA>=1:8
|
70.0 percentage of participants
Interval 61.0 to 78.0
|
14.3 percentage of participants
Interval 3.0 to 36.3
|
|
Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
Month 24: hSBA-MenC>=1:8
|
99.2 percentage of participants
Interval 95.5 to 100.0
|
100.0 percentage of participants
Interval 83.9 to 100.0
|
|
Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
Month 24: hSBA-MenW-135>=1:8
|
100.0 percentage of participants
Interval 97.0 to 100.0
|
15.0 percentage of participants
Interval 3.2 to 37.9
|
|
Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
Month 24: hSBA-MenY>=1:8
|
100.0 percentage of participants
Interval 97.0 to 100.0
|
28.6 percentage of participants
Interval 11.3 to 52.2
|
|
Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
Month 36: hSBA-MenA>=1:8
|
77.4 percentage of participants
Interval 69.4 to 84.2
|
9.5 percentage of participants
Interval 1.2 to 30.4
|
|
Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
Month 36: hSBA-MenC>=1:8
|
99.2 percentage of participants
Interval 95.8 to 100.0
|
100.0 percentage of participants
Interval 84.6 to 100.0
|
|
Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
Month 36: hSBA-MenW-135>=1:8
|
100.0 percentage of participants
Interval 97.3 to 100.0
|
18.2 percentage of participants
Interval 5.2 to 40.3
|
|
Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
Month 36: hSBA-MenY>=1:8
|
99.3 percentage of participants
Interval 95.9 to 100.0
|
40.0 percentage of participants
Interval 19.1 to 63.9
|
|
Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
Month 48: hSBA-MenA>=1:8
|
71.3 percentage of participants
Interval 62.7 to 78.9
|
34.8 percentage of participants
Interval 16.4 to 57.3
|
|
Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
Month 48: hSBA-MenC>=1:8
|
97.7 percentage of participants
Interval 93.5 to 99.5
|
100.0 percentage of participants
Interval 84.6 to 100.0
|
|
Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
Month 48: hSBA-MenW-135>=1:8
|
100.0 percentage of participants
Interval 97.3 to 100.0
|
4.3 percentage of participants
Interval 0.1 to 21.9
|
|
Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
Month 48: hSBA-MenY>=1:8
|
97.0 percentage of participants
Interval 92.4 to 99.2
|
28.6 percentage of participants
Interval 11.3 to 52.2
|
|
Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
Month 60: hSBA-MenA>=1:8
|
53.3 percentage of participants
Interval 44.6 to 62.0
|
0.0 percentage of participants
Interval 0.0 to 14.8
|
|
Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
Month 60: hSBA-MenC>=1:8
|
99.3 percentage of participants
Interval 96.0 to 100.0
|
100.0 percentage of participants
Interval 85.2 to 100.0
|
|
Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
Month 60: hSBA-MenW-135>=1:8
|
100.0 percentage of participants
Interval 97.3 to 100.0
|
4.5 percentage of participants
Interval 0.1 to 22.8
|
|
Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
Month 60: hSBA-MenY>=1:8
|
97.8 percentage of participants
Interval 93.7 to 99.5
|
40.9 percentage of participants
Interval 20.7 to 63.6
|
|
Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
Month 72: hSBA-MenA>=1:8
|
58.5 percentage of participants
Interval 49.5 to 67.0
|
13.0 percentage of participants
Interval 2.8 to 33.6
|
|
Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
Month 72: hSBA-MenC>=1:8
|
97.7 percentage of participants
Interval 93.4 to 99.5
|
95.7 percentage of participants
Interval 78.1 to 99.9
|
|
Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
Month 72: hSBA-MenW-135>=1:8
|
98.5 percentage of participants
Interval 94.7 to 99.8
|
9.5 percentage of participants
Interval 1.2 to 30.4
|
|
Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
Month 72: hSBA-MenY>=1:8
|
97.7 percentage of participants
Interval 93.5 to 99.5
|
33.3 percentage of participants
Interval 14.6 to 57.0
|
SECONDARY outcome
Timeframe: 24, 36, 48, 60 and 72 months after booster VaccinationPopulation: All eligible participants who received primary and booster vaccination with MenACWY-TT/ Meningitec vaccine in studies MENACWY-TT-039 and MENACWY-TT-048 EXT and had available assay results for at least 1 tested antigen. N=number of participants evaluable for this outcome measure. 'Number Analyzed' = participants evaluable for specified categories.
Serogroups included MenA, MenC, MenW-135 and MenY.
Outcome measures
| Measure |
MenACWY-TT Vaccine
n=137 Participants
Participants who received single 0.5 mL dose of meningococcal A, C, W-135, Y-tetanus toxoid conjugate (MenACWY-TT) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years.
|
MenCCRM Vaccine
n=23 Participants
Participants who received single 0.5 mL dose of meningococcal serogroup C CRM197 conjugated (MenCCRM) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years.
|
|---|---|---|
|
Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Month 72: hSBA-MenA
|
14.4 titers
Interval 10.5 to 19.7
|
2.8 titers
Interval 1.9 to 4.0
|
|
Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Month 24: hSBA-MenA
|
33.2 titers
Interval 22.9 to 48.3
|
2.9 titers
Interval 1.9 to 4.4
|
|
Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Month 24: hSBA-MenC
|
510.08 titers
Interval 389.8 to 669.3
|
424.9 titers
Interval 188.3 to 958.9
|
|
Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Month 24: hSBA-MenW-135
|
991.3 titers
Interval 852.0 to 1153.5
|
3.4 titers
Interval 1.9 to 6.1
|
|
Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Month 24: hSBA-MenY
|
575.4 titers
Interval 488.3 to 678.1
|
4.6 titers
Interval 2.5 to 8.5
|
|
Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Month 36: hSBA-MenA
|
44.6 titers
Interval 32.2 to 61.7
|
2.6 titers
Interval 1.9 to 3.5
|
|
Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Month 36: hSBA-MenC
|
343.3 titers
Interval 270.2 to 436.2
|
226.7 titers
Interval 135.5 to 379.4
|
|
Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Month 36: hSBA-MenW-135
|
738.8 titers
Interval 640.6 to 852.0
|
3.5 titers
Interval 2.0 to 6.1
|
|
Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Month 36: hSBA-MenY
|
691.9 titers
Interval 579.8 to 825.6
|
7.4 titers
Interval 3.4 to 16.2
|
|
Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Month 48: hSBA-MenA
|
27.7 titers
Interval 20.2 to 38.1
|
4.2 titers
Interval 2.6 to 6.6
|
|
Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Month 48: hSBA-MenC
|
232.3 titers
Interval 176.6 to 305.6
|
182.6 titers
Interval 109.9 to 303.3
|
|
Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Month 48: hSBA-MenW-135
|
600.0 titers
Interval 506.0 to 711.5
|
2.3 titers
Interval 1.7 to 3.0
|
|
Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Month 48: hSBA-MenY
|
495.0 titers
Interval 393.4 to 622.7
|
5.0 titers
Interval 2.5 to 8.5
|
|
Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Month 60: hSBA-MenA
|
13.2 titers
Interval 9.6 to 18.3
|
2.0 titers
CI was not estimable due to the lack of variability of geometric means.
|
|
Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Month 60: hSBA-MenC
|
337.1 titers
Interval 261.3 to 434.9
|
241.3 titers
Interval 138.7 to 419.8
|
|
Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Month 60: hSBA-MenW-135
|
326.8 titers
Interval 275.6 to 387.5
|
2.4 titers
Interval 1.6 to 3.6
|
|
Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Month 60: hSBA-MenY
|
398.7 titers
Interval 320.8 to 495.4
|
7.6 titers
Interval 3.5 to 16.4
|
|
Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Month 72: hSBA-MenC
|
259.1 titers
Interval 194.7 to 344.7
|
169.4 titers
Interval 94.1 to 304.8
|
|
Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Month 72: hSBA-MenW-135
|
314.4 titers
Interval 255.1 to 387.6
|
2.5 titers
Interval 1.8 to 3.4
|
|
Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Month 72: hSBA-MenY
|
315.6 titers
Interval 252.7 to 394.0
|
8.0 titers
Interval 3.1 to 20.8
|
Adverse Events
MenACWY-TT Vaccine
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
MenCCRM Vaccine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MenACWY-TT Vaccine
n=159 participants at risk
Participants who received single 0.5 mL dose of meningococcal A, C, W-135, Y-tetanus toxoid conjugate (MenACWY-TT) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years.
|
MenCCRM Vaccine
n=25 participants at risk
Participants who received single 0.5 mL dose of meningococcal serogroup C CRM197 conjugated (MenCCRM) vaccine as primary vaccination in study MENACWY-TT-039 and as booster dose in study MENACWY-TT-048 EXT, intramuscularly with a follow up period of 4 years, were observed in this study for a maximum duration of 6 years.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Juvenile idiopathic arthritis
|
0.63%
1/159 • Baseline up to the Month 72 after booster vaccination (up to 6 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/25 • Baseline up to the Month 72 after booster vaccination (up to 6 years)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER