Trial Outcomes & Findings for The Long-term Antibody Persistence of MenACWY-TT Vaccine (PF-06866681) Versus Meningitec(Registered) or Mencevax(Registered) ACWY in Healthy Adolescents and Adults and a Booster Dose of MenACWY-TT Administered 10 Years Post Primary Vaccination (NCT NCT01962207)
NCT ID: NCT01962207
Last Updated: 2019-06-07
Results Overview
Serogroups included Neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
243 participants
Primary outcome timeframe
6 years after primary vaccination (Year 1 of study MENACWY-TT-100)
Results posted on
2019-06-07
Participant Flow
In this study, participants from the study MENACWY-TT-027 \[NCT00427908\] were followed up for assessment of persistence of immune response and safety. And those who consented received booster vaccination and were followed up for another 6 months.
Participant milestones
| Measure |
MenACWY-TT Vaccine: Less Than (<) 2 Years
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenCCRM (Meningitec) Vaccine: Less Than 2 Years
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years
Persistence phase was followed up by booster phase. Persistence phase: Participants with \>=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
|---|---|---|---|---|
|
Persistence Phase (5 Years)
STARTED
|
76
|
23
|
115
|
29
|
|
Persistence Phase (5 Years)
COMPLETED
|
47
|
10
|
71
|
17
|
|
Persistence Phase (5 Years)
NOT COMPLETED
|
29
|
13
|
44
|
12
|
|
Booster Phase (6 Months)
STARTED
|
67
|
16
|
77
|
21
|
|
Booster Phase (6 Months)
COMPLETED
|
67
|
16
|
77
|
21
|
|
Booster Phase (6 Months)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
MenACWY-TT Vaccine: Less Than (<) 2 Years
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenCCRM (Meningitec) Vaccine: Less Than 2 Years
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years
Persistence phase was followed up by booster phase. Persistence phase: Participants with \>=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
|---|---|---|---|---|
|
Persistence Phase (5 Years)
Lost to Follow-up
|
2
|
1
|
5
|
2
|
|
Persistence Phase (5 Years)
Migrated/moved from study area
|
2
|
0
|
4
|
0
|
|
Persistence Phase (5 Years)
Withdrawal by Subject
|
4
|
5
|
18
|
4
|
|
Persistence Phase (5 Years)
Eligibility criteria not fulfilled
|
0
|
0
|
3
|
1
|
|
Persistence Phase (5 Years)
Adverse Event
|
0
|
0
|
1
|
0
|
|
Persistence Phase (5 Years)
Missed at least 1 persistence visit
|
21
|
7
|
13
|
5
|
Baseline Characteristics
The Long-term Antibody Persistence of MenACWY-TT Vaccine (PF-06866681) Versus Meningitec(Registered) or Mencevax(Registered) ACWY in Healthy Adolescents and Adults and a Booster Dose of MenACWY-TT Administered 10 Years Post Primary Vaccination
Baseline characteristics by cohort
| Measure |
MenACWY-TT Vaccine: Less Than (<) 2 Years
n=76 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenCCRM (Meningitec) Vaccine: Less Than 2 Years
n=23 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years
n=115 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \>=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
n=29 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
Total
n=243 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
8.2 years
STANDARD_DEVIATION 0.7 • n=5 Participants
|
8.2 years
STANDARD_DEVIATION 0.7 • n=7 Participants
|
12.5 years
STANDARD_DEVIATION 2.6 • n=5 Participants
|
12.1 years
STANDARD_DEVIATION 2.9 • n=4 Participants
|
10.7 years
STANDARD_DEVIATION 3.0 • n=21 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
122 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
121 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
76 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
243 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White - Arabic/North African heritage
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White - Caucasian/European heritage
|
75 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
238 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 6 years after primary vaccination (Year 1 of study MENACWY-TT-100)Population: All eligible participants who received primary vaccination with MenACWY-TT, Meningitec, or Mencevax ACWY during study MenACWY-TT-027 and had available assay results for at least 1 tested antigen. Here, "Overall Number of Participants Analyzed" (N) signifies number of participants evaluable for this measure.
Serogroups included Neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY).
Outcome measures
| Measure |
MenACWY-TT Vaccine: Less Than (<) 2 Years
n=54 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenCCRM (Meningitec) Vaccine: Less Than 2 Years
n=16 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years
n=98 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \>=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
n=24 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
|---|---|---|---|---|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titers >=1:8 and >=1:128 For Each of the 4 Serogroups After 6 Years of Primary Vaccination
rSBA-MenA: >=1:8
|
51.9 percentage of participants
Interval 37.8 to 65.7
|
18.8 percentage of participants
Interval 4.0 to 45.6
|
79.6 percentage of participants
Interval 70.3 to 87.1
|
12.5 percentage of participants
Interval 2.7 to 32.4
|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titers >=1:8 and >=1:128 For Each of the 4 Serogroups After 6 Years of Primary Vaccination
rSBA-MenC: >=1:8
|
77.8 percentage of participants
Interval 64.4 to 88.0
|
75.0 percentage of participants
Interval 47.6 to 92.7
|
82.7 percentage of participants
Interval 73.7 to 89.6
|
79.2 percentage of participants
Interval 57.8 to 92.9
|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titers >=1:8 and >=1:128 For Each of the 4 Serogroups After 6 Years of Primary Vaccination
rSBA-MenW-135: >=1:8
|
33.3 percentage of participants
Interval 21.1 to 47.5
|
12.5 percentage of participants
Interval 1.6 to 38.3
|
73.5 percentage of participants
Interval 63.6 to 81.9
|
12.5 percentage of participants
Interval 2.7 to 32.4
|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titers >=1:8 and >=1:128 For Each of the 4 Serogroups After 6 Years of Primary Vaccination
rSBA-MenY: >=1:8
|
38.9 percentage of participants
Interval 25.9 to 53.1
|
37.5 percentage of participants
Interval 15.2 to 64.6
|
71.4 percentage of participants
Interval 61.4 to 80.1
|
20.8 percentage of participants
Interval 7.1 to 42.2
|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titers >=1:8 and >=1:128 For Each of the 4 Serogroups After 6 Years of Primary Vaccination
rSBA-MenA: >=1:28
|
16.7 percentage of participants
Interval 7.9 to 29.3
|
6.3 percentage of participants
Interval 0.2 to 30.2
|
55.1 percentage of participants
Interval 44.7 to 65.2
|
8.3 percentage of participants
Interval 1.0 to 27.0
|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titers >=1:8 and >=1:128 For Each of the 4 Serogroups After 6 Years of Primary Vaccination
rSBA-MenC: >=1:28
|
70.4 percentage of participants
Interval 56.4 to 82.0
|
56.3 percentage of participants
Interval 29.9 to 80.2
|
68.4 percentage of participants
Interval 58.2 to 77.4
|
62.5 percentage of participants
Interval 40.6 to 81.2
|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titers >=1:8 and >=1:128 For Each of the 4 Serogroups After 6 Years of Primary Vaccination
rSBA-MenW-135: >=1:28
|
29.6 percentage of participants
Interval 18.0 to 43.6
|
6.3 percentage of participants
Interval 0.2 to 30.2
|
73.5 percentage of participants
Interval 63.6 to 81.9
|
12.5 percentage of participants
Interval 2.7 to 32.4
|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titers >=1:8 and >=1:128 For Each of the 4 Serogroups After 6 Years of Primary Vaccination
rSBA-MenY: >=1:28
|
33.3 percentage of participants
Interval 21.1 to 47.5
|
31.3 percentage of participants
Interval 11.0 to 58.7
|
65.3 percentage of participants
Interval 55.0 to 74.6
|
20.8 percentage of participants
Interval 7.1 to 42.2
|
PRIMARY outcome
Timeframe: 7 years after primary vaccination (Year 2 of study MENACWY-TT-100)Population: All eligible participants who received primary vaccination with MenACWY-TT, Meningitec or Mencevax ACWY in Study MenACWY-TT-027, had available assay results for at least 1 tested antigen. "N": number of participants evaluable for this measure. "Number analyzed": participants analyzed for specified serogroup titers cut off.
Serogroups included MenA, MenC, MenW-135 and MenY.
Outcome measures
| Measure |
MenACWY-TT Vaccine: Less Than (<) 2 Years
n=60 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenCCRM (Meningitec) Vaccine: Less Than 2 Years
n=21 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years
n=104 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \>=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
n=27 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
|---|---|---|---|---|
|
Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 7 Years of Primary Vaccination
rSBA-MenA: >=1:8
|
58.3 percentage of participants
Interval 44.9 to 70.9
|
9.5 percentage of participants
Interval 1.2 to 30.4
|
74.0 percentage of participants
Interval 64.5 to 82.1
|
18.5 percentage of participants
Interval 6.3 to 38.1
|
|
Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 7 Years of Primary Vaccination
rSBA-MenC: >=1:8
|
78.3 percentage of participants
Interval 65.8 to 87.9
|
71.4 percentage of participants
Interval 47.8 to 88.7
|
84.2 percentage of participants
Interval 75.6 to 90.7
|
81.5 percentage of participants
Interval 61.9 to 93.7
|
|
Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 7 Years of Primary Vaccination
rSBA-MenW-135: >=1:8
|
26.7 percentage of participants
Interval 16.1 to 39.7
|
9.5 percentage of participants
Interval 1.2 to 30.4
|
73.5 percentage of participants
Interval 63.9 to 81.8
|
11.1 percentage of participants
Interval 2.4 to 29.2
|
|
Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 7 Years of Primary Vaccination
rSBA-MenY: >=1:8
|
35.0 percentage of participants
Interval 23.1 to 48.4
|
28.6 percentage of participants
Interval 11.3 to 52.2
|
75.5 percentage of participants
Interval 66.0 to 83.5
|
14.8 percentage of participants
Interval 4.2 to 33.7
|
|
Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 7 Years of Primary Vaccination
rSBA-MenA: >=1:28
|
21.7 percentage of participants
Interval 12.1 to 34.2
|
9.5 percentage of participants
Interval 1.2 to 30.4
|
44.2 percentage of participants
Interval 34.5 to 54.3
|
11.1 percentage of participants
Interval 2.4 to 29.2
|
|
Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 7 Years of Primary Vaccination
rSBA-MenC: >=1:28
|
61.7 percentage of participants
Interval 48.2 to 73.9
|
52.4 percentage of participants
Interval 29.8 to 74.3
|
61.4 percentage of participants
Interval 51.2 to 70.9
|
66.7 percentage of participants
Interval 46.0 to 83.5
|
|
Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 7 Years of Primary Vaccination
rSBA-MenW-135: >=1:28
|
23.3 percentage of participants
Interval 13.4 to 36.0
|
9.5 percentage of participants
Interval 1.2 to 30.4
|
69.6 percentage of participants
Interval 59.7 to 78.3
|
7.4 percentage of participants
Interval 0.9 to 24.3
|
|
Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 7 Years of Primary Vaccination
rSBA-MenY: >=1:28
|
33.3 percentage of participants
Interval 21.7 to 46.7
|
28.6 percentage of participants
Interval 11.3 to 52.2
|
69.6 percentage of participants
Interval 59.7 to 78.3
|
14.8 percentage of participants
Interval 4.2 to 33.7
|
PRIMARY outcome
Timeframe: 8 years after primary vaccination (Year 3 of study MENACWY-TT-100)Population: All eligible participants who received primary vaccination with MenACWY-TT, Meningitec or Mencevax ACWY in Study MenACWY-TT-027 and had available assay results for at least 1 tested antigen. "N": number of participants evaluable for this measure.
Serogroups included MenA, MenC, MenW-135 and MenY.
Outcome measures
| Measure |
MenACWY-TT Vaccine: Less Than (<) 2 Years
n=65 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenCCRM (Meningitec) Vaccine: Less Than 2 Years
n=22 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years
n=100 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \>=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
n=25 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
|---|---|---|---|---|
|
Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 8 Years of Primary Vaccination
rSBA-MenA: >=1:8
|
47.7 percentage of participants
Interval 35.1 to 60.5
|
4.5 percentage of participants
Interval 0.1 to 22.8
|
70.0 percentage of participants
Interval 60.0 to 78.8
|
24.0 percentage of participants
Interval 9.4 to 45.1
|
|
Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 8 Years of Primary Vaccination
rSBA-MenC: >=1:8
|
78.5 percentage of participants
Interval 66.5 to 87.7
|
77.3 percentage of participants
Interval 54.6 to 92.2
|
85.0 percentage of participants
Interval 76.5 to 91.4
|
88.0 percentage of participants
Interval 68.8 to 97.5
|
|
Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 8 Years of Primary Vaccination
rSBA-MenW-135: >=1:8
|
29.2 percentage of participants
Interval 18.6 to 41.8
|
13.6 percentage of participants
Interval 2.9 to 34.9
|
76.0 percentage of participants
Interval 66.4 to 84.0
|
20.0 percentage of participants
Interval 6.8 to 40.7
|
|
Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 8 Years of Primary Vaccination
rSBA-MenY: >=1:8
|
40.0 percentage of participants
Interval 28.0 to 52.9
|
40.9 percentage of participants
Interval 20.7 to 63.6
|
79.0 percentage of participants
Interval 69.7 to 86.5
|
24.0 percentage of participants
Interval 9.4 to 45.1
|
|
Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 8 Years of Primary Vaccination
rSBA-MenA: >=1:28
|
23.1 percentage of participants
Interval 13.5 to 35.2
|
4.5 percentage of participants
Interval 0.1 to 22.8
|
45.0 percentage of participants
Interval 35.0 to 55.3
|
12.0 percentage of participants
Interval 2.5 to 31.2
|
|
Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 8 Years of Primary Vaccination
rSBA-MenC: >=1:28
|
64.6 percentage of participants
Interval 51.8 to 76.1
|
50.0 percentage of participants
Interval 28.2 to 71.8
|
61.0 percentage of participants
Interval 50.7 to 70.6
|
64.0 percentage of participants
Interval 42.5 to 82.0
|
|
Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 8 Years of Primary Vaccination
rSBA-MenW-135: >=1:28
|
27.7 percentage of participants
Interval 17.3 to 40.2
|
9.1 percentage of participants
Interval 1.1 to 29.2
|
76.0 percentage of participants
Interval 66.4 to 84.0
|
20.0 percentage of participants
Interval 6.8 to 40.7
|
|
Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 8 Years of Primary Vaccination
rSBA-MenY: >=1:28
|
38.5 percentage of participants
Interval 26.7 to 51.4
|
40.9 percentage of participants
Interval 20.7 to 63.6
|
73.0 percentage of participants
Interval 63.2 to 81.4
|
20.0 percentage of participants
Interval 6.8 to 40.7
|
PRIMARY outcome
Timeframe: 9 years after primary vaccination (Year 4 of study MENACWY-TT-100)Population: All eligible participants who received primary vaccination with MenACWY-TT, Meningitec or Mencevax ACWY in Study MenACWY-TT-027, had available assay results for at least 1 tested antigen. "N": number of participants evaluable for this measure. "Number analyzed": participants analyzed for specified serogroup titers cut off.
Serogroups included MenA, MenC, MenW-135 and MenY.
Outcome measures
| Measure |
MenACWY-TT Vaccine: Less Than (<) 2 Years
n=64 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenCCRM (Meningitec) Vaccine: Less Than 2 Years
n=21 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years
n=93 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \>=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
n=25 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
|---|---|---|---|---|
|
Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 9 Years of Primary Vaccination
rSBA-MenA >=1:8
|
67.2 percentage of participants
Interval 54.3 to 78.4
|
4.8 percentage of participants
Interval 0.1 to 23.8
|
79.6 percentage of participants
Interval 69.9 to 87.2
|
24.0 percentage of participants
Interval 9.4 to 45.1
|
|
Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 9 Years of Primary Vaccination
rSBA-MenC >=1:8
|
81.3 percentage of participants
Interval 69.5 to 89.9
|
85.7 percentage of participants
Interval 63.7 to 97.0
|
86.0 percentage of participants
Interval 77.3 to 92.3
|
84.0 percentage of participants
Interval 63.9 to 95.5
|
|
Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 9 Years of Primary Vaccination
rSBA-MenW-135 >=1:8
|
32.8 percentage of participants
Interval 21.6 to 45.7
|
9.5 percentage of participants
Interval 1.2 to 30.4
|
76.1 percentage of participants
Interval 66.1 to 84.4
|
16.0 percentage of participants
Interval 4.5 to 36.1
|
|
Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 9 Years of Primary Vaccination
rSBA-MenY >=1:8
|
42.2 percentage of participants
Interval 29.9 to 55.2
|
47.6 percentage of participants
Interval 25.7 to 70.2
|
66.7 percentage of participants
Interval 56.1 to 76.1
|
20.0 percentage of participants
Interval 6.8 to 40.7
|
|
Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 9 Years of Primary Vaccination
rSBA-MenA >=1:28
|
31.3 percentage of participants
Interval 20.2 to 44.1
|
4.8 percentage of participants
Interval 0.1 to 23.8
|
57.0 percentage of participants
Interval 46.3 to 67.2
|
16.0 percentage of participants
Interval 4.5 to 36.1
|
|
Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 9 Years of Primary Vaccination
rSBA-MenC >=1:28
|
65.6 percentage of participants
Interval 52.7 to 77.1
|
57.1 percentage of participants
Interval 34.0 to 78.2
|
64.5 percentage of participants
Interval 53.9 to 74.2
|
68.0 percentage of participants
Interval 46.5 to 85.1
|
|
Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 9 Years of Primary Vaccination
rSBA-MenW-135 >=1:28
|
26.6 percentage of participants
Interval 16.3 to 39.1
|
9.5 percentage of participants
Interval 1.2 to 30.4
|
71.7 percentage of participants
Interval 61.4 to 80.6
|
16.0 percentage of participants
Interval 4.5 to 36.1
|
|
Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 9 Years of Primary Vaccination
rSBA-MenY >=1:28
|
34.4 percentage of participants
Interval 22.9 to 47.3
|
38.1 percentage of participants
Interval 18.1 to 61.6
|
58.1 percentage of participants
Interval 47.4 to 68.2
|
16.0 percentage of participants
Interval 4.5 to 36.1
|
PRIMARY outcome
Timeframe: 10 years after primary vaccination (Year 4 of study MENACWY-TT-100)Population: All eligible participants who received primary vaccination with MenACWY-TT, Meningitec or Mencevax ACWY in Study MenACWY-TT-027, had available assay results for at least 1 tested antigen. "N": number of participants evaluable for this measure. "Number analyzed": participants analyzed for specified serogroup titers cut off.
Serogroups included MenA, MenC, MenW-135 and MenY.
Outcome measures
| Measure |
MenACWY-TT Vaccine: Less Than (<) 2 Years
n=64 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenCCRM (Meningitec) Vaccine: Less Than 2 Years
n=17 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years
n=82 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \>=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
n=21 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
|---|---|---|---|---|
|
Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 10 Years of Primary Vaccination
rSBA-MenA >=1:8
|
65.6 percentage of participants
Interval 52.7 to 77.1
|
17.6 percentage of participants
Interval 3.8 to 43.4
|
88.9 percentage of participants
Interval 80.0 to 94.8
|
28.6 percentage of participants
Interval 11.3 to 52.2
|
|
Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 10 Years of Primary Vaccination
rSBA-MenC >=1:8
|
82.8 percentage of participants
Interval 71.3 to 91.1
|
88.2 percentage of participants
Interval 63.6 to 98.5
|
84.1 percentage of participants
Interval 74.4 to 91.3
|
81.0 percentage of participants
Interval 58.1 to 94.6
|
|
Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 10 Years of Primary Vaccination
rSBA-MenW-135 >=1:8
|
31.3 percentage of participants
Interval 20.2 to 44.1
|
0.0 percentage of participants
Interval 0.0 to 19.5
|
67.1 percentage of participants
Interval 55.8 to 77.1
|
23.8 percentage of participants
Interval 8.2 to 47.2
|
|
Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 10 Years of Primary Vaccination
rSBA-MenY >=1:8
|
43.8 percentage of participants
Interval 31.4 to 56.7
|
35.3 percentage of participants
Interval 14.2 to 61.7
|
65.9 percentage of participants
Interval 54.6 to 76.0
|
23.8 percentage of participants
Interval 8.2 to 47.2
|
|
Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 10 Years of Primary Vaccination
rSBA-MenA >=1:28
|
26.6 percentage of participants
Interval 16.3 to 39.1
|
5.9 percentage of participants
Interval 0.1 to 28.7
|
49.4 percentage of participants
Interval 38.1 to 60.7
|
14.3 percentage of participants
Interval 3.0 to 36.3
|
|
Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 10 Years of Primary Vaccination
rSBA-MenC >=1:28
|
64.1 percentage of participants
Interval 51.1 to 75.7
|
58.8 percentage of participants
Interval 32.9 to 81.6
|
65.9 percentage of participants
Interval 54.6 to 76.0
|
66.7 percentage of participants
Interval 43.0 to 85.4
|
|
Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 10 Years of Primary Vaccination
rSBA-MenW-135 >=1:28
|
28.1 percentage of participants
Interval 17.6 to 40.8
|
0.0 percentage of participants
Interval 0.0 to 19.5
|
65.9 percentage of participants
Interval 54.6 to 76.0
|
23.8 percentage of participants
Interval 8.2 to 47.2
|
|
Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 10 Years of Primary Vaccination
rSBA-MenY >=1:28
|
35.9 percentage of participants
Interval 24.3 to 48.9
|
29.4 percentage of participants
Interval 10.3 to 56.0
|
59.8 percentage of participants
Interval 48.3 to 70.4
|
19.0 percentage of participants
Interval 5.4 to 41.9
|
PRIMARY outcome
Timeframe: 6 Years after primary vaccination (Year 1 of study MENACWY-TT-100)Population: All eligible participants who received primary vaccination with MenACWY-TT, Meningitec or Mencevax ACWY in Study MenACWY-TT-027 and had available assay results for at least 1 tested antigen. "N": number of participants evaluable for this measure.
Serogroups included MenA, MenC, MenW-135 and MenY.
Outcome measures
| Measure |
MenACWY-TT Vaccine: Less Than (<) 2 Years
n=54 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenCCRM (Meningitec) Vaccine: Less Than 2 Years
n=16 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years
n=98 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \>=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
n=24 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
|---|---|---|---|---|
|
Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 6 Years of Primary Vaccination
rSBA-MenA
|
16.0 titers
Interval 9.8 to 26.1
|
5.9 titers
Interval 3.1 to 11.3
|
107.3 titers
Interval 66.0 to 174.3
|
5.8 titers
Interval 3.5 to 9.6
|
|
Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 6 Years of Primary Vaccination
rSBA-MenC
|
161.3 titers
Interval 84.7 to 307.1
|
103.1 titers
Interval 31.9 to 333.3
|
192.9 titers
Interval 121.0 to 307.5
|
98.7 titers
Interval 42.2 to 230.7
|
|
Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 6 Years of Primary Vaccination
rSBA-MenW-135
|
18.0 titers
Interval 9.8 to 32.9
|
6.2 titers
Interval 3.1 to 12.3
|
265.2 titers
Interval 154.9 to 454.1
|
7.6 titers
Interval 3.7 to 15.6
|
|
Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 6 Years of Primary Vaccination
rSBA-MenY
|
21.5 titers
Interval 11.5 to 40.1
|
21.7 titers
Interval 5.9 to 79.0
|
136.4 titers
Interval 82.6 to 225.3
|
11.6 titers
Interval 4.7 to 28.7
|
PRIMARY outcome
Timeframe: 7 years after primary vaccination (Year 2 of study MENACWY-TT-100)Population: All eligible participants who received primary vaccination with MenACWY-TT, Meningitec or Mencevax ACWY in Study MenACWY-TT-027, had available assay results for at least 1 tested antigen. "N": number of participants evaluable for this measure. "Number analyzed": participants analyzed for specified serogroup.
Serogroups included MenA, MenC, MenW-135 and MenY.
Outcome measures
| Measure |
MenACWY-TT Vaccine: Less Than (<) 2 Years
n=60 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenCCRM (Meningitec) Vaccine: Less Than 2 Years
n=21 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years
n=104 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \>=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
n=27 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
|---|---|---|---|---|
|
Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 7 Years of Primary Vaccination
rSBA-MenA
|
20.4 titers
Interval 12.1 to 34.4
|
6.1 titers
Interval 3.3 to 11.4
|
65.3 titers
Interval 40.5 to 105.4
|
7.4 titers
Interval 4.0 to 13.8
|
|
Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 7 Years of Primary Vaccination
rSBA-MenC
|
104.0 titers
Interval 58.0 to 186.3
|
54.3 titers
Interval 18.5 to 158.9
|
139.0 titers
Interval 87.8 to 220.0
|
101.6 titers
Interval 42.1 to 245.0
|
|
Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 7 Years of Primary Vaccination
rSBA-MenW-135
|
13.0 titers
Interval 7.6 to 22.3
|
6.8 titers
Interval 3.0 to 15.3
|
206.0 titers
Interval 120.9 to 350.9
|
6.3 titers
Interval 3.7 to 10.9
|
|
Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 7 Years of Primary Vaccination
rSBA-MenY
|
19.9 titers
Interval 11.0 to 36.1
|
18.3 titers
Interval 5.8 to 57.6
|
152.7 titers
Interval 96.1 to 242.6
|
8.2 titers
Interval 4.1 to 16.5
|
PRIMARY outcome
Timeframe: 8 years after primary vaccination (Year 3 of study MENACWY-TT-100)Population: All eligible participants who received primary vaccination with MenACWY-TT, Meningitec or Mencevax ACWY in Study MenACWY-TT-027, had available assay results for at least 1 tested antigen. "N": number of participants evaluable for this measure.
Serogroups included MenA, MenC, MenW-135 and MenY.
Outcome measures
| Measure |
MenACWY-TT Vaccine: Less Than (<) 2 Years
n=65 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenCCRM (Meningitec) Vaccine: Less Than 2 Years
n=22 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years
n=100 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \>=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
n=25 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
|---|---|---|---|---|
|
Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 8 Years of Primary Vaccination
rSBA-MenW-135
|
15.3 titers
Interval 9.0 to 26.3
|
6.4 titers
Interval 3.3 to 12.4
|
252.5 titers
Interval 154.3 to 413.2
|
11.8 titers
Interval 4.7 to 29.8
|
|
Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 8 Years of Primary Vaccination
rSBA-MenY
|
26.1 titers
Interval 14.4 to 47.5
|
33.0 titers
Interval 9.8 to 111.0
|
181.0 titers
Interval 115.0 to 284.9
|
10.9 titers
Interval 4.8 to 24.6
|
|
Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 8 Years of Primary Vaccination
rSBA-MenA
|
15.8 titers
Interval 9.8 to 25.6
|
4.8 titers
Interval 3.3 to 7.2
|
51.3 titers
Interval 31.5 to 83.4
|
7.8 titers
Interval 4.2 to 14.3
|
|
Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 8 Years of Primary Vaccination
rSBA-MenC
|
110.2 titers
Interval 65.9 to 184.3
|
64.0 titers
Interval 26.0 to 157.4
|
140.1 titers
Interval 91.3 to 214.9
|
121.1 titers
Interval 52.2 to 281.1
|
PRIMARY outcome
Timeframe: 9 years after primary vaccination (Year 4 of study MENACWY-TT-100)Population: All eligible participants who received primary vaccination with MenACWY-TT, Meningitec or Mencevax ACWY in Study MenACWY-TT-027, had available assay results for at least 1 tested antigen. "N": number of participants evaluable for this measure. "Number analyzed": participants analyzed for specified serogroup.
Serogroups included MenA, MenC, MenW-135 and MenY.
Outcome measures
| Measure |
MenACWY-TT Vaccine: Less Than (<) 2 Years
n=64 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenCCRM (Meningitec) Vaccine: Less Than 2 Years
n=21 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years
n=93 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \>=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
n=25 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
|---|---|---|---|---|
|
Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 9 Years of Primary Vaccination
rSBA-MenA
|
28.4 titers
Interval 16.5 to 48.9
|
5.2 titers
Interval 3.0 to 9.0
|
118.8 titers
Interval 71.1 to 198.6
|
10.9 titers
Interval 4.5 to 26.2
|
|
Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 9 Years of Primary Vaccination
rSBA-MenC
|
166.0 titers
Interval 92.3 to 298.7
|
92.0 titers
Interval 32.7 to 259.1
|
176.4 titers
Interval 106.8 to 291.3
|
164.3 titers
Interval 66.5 to 405.8
|
|
Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 9 Years of Primary Vaccination
rSBA-MenW-135
|
17.3 titers
Interval 9.7 to 30.8
|
6.6 titers
Interval 3.2 to 13.6
|
274.0 titers
Interval 155.8 to 481.7
|
9.7 titers
Interval 4.0 to 23.3
|
|
Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 9 Years of Primary Vaccination
rSBA-MenY
|
23.1 titers
Interval 13.0 to 41.2
|
32.0 titers
Interval 10.6 to 96.3
|
106.2 titers
Interval 61.5 to 183.4
|
10.0 titers
Interval 4.4 to 22.9
|
PRIMARY outcome
Timeframe: 10 years after primary vaccination (Year 5 of study MENACWY-TT-100)Population: All eligible participants who received primary vaccination with MenACWY-TT, Meningitec or Mencevax ACWY in Study MenACWY-TT-027, had available assay results for at least 1 tested antigen. "N": number of participants evaluable for this measure. "Number analyzed": participants analyzed for specified serogroup.
Serogroups included MenA, MenC, MenW-135 and MenY.
Outcome measures
| Measure |
MenACWY-TT Vaccine: Less Than (<) 2 Years
n=64 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenCCRM (Meningitec) Vaccine: Less Than 2 Years
n=17 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years
n=82 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \>=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
n=21 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
|---|---|---|---|---|
|
Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 10 Years of Primary Vaccination
rSBA-MenA
|
29.3 titers
Interval 16.8 to 51.3
|
5.8 titers
Interval 3.2 to 10.6
|
106.0 titers
Interval 63.7 to 176.4
|
9.1 titers
Interval 4.0 to 20.7
|
|
Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 10 Years of Primary Vaccination
rSBA-MenC
|
132.2 titers
Interval 74.5 to 234.6
|
81.7 titers
Interval 29.2 to 229.2
|
175.0 titers
Interval 104.7 to 292.4
|
105.0 titers
Interval 37.2 to 296.4
|
|
Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 10 Years of Primary Vaccination
rSBA-MenW-135
|
16.7 titers
Interval 9.5 to 29.3
|
4.0 titers
The confidence interval was not estimable due to the lack of variability of antibody titer.
|
187.2 titers
Interval 101.0 to 347.1
|
14.0 titers
Interval 4.8 to 41.2
|
|
Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 10 Years of Primary Vaccination
rSBA-MenY
|
25.8 titers
Interval 14.0 to 47.3
|
22.2 titers
Interval 5.8 to 84.2
|
90.5 titers
Interval 51.5 to 159.2
|
12.7 titers
Interval 4.2 to 38.1
|
SECONDARY outcome
Timeframe: 6, 7, 8, 9 and 10 years after primary vaccination (Year 1, 2, 3, 4 and 5 of study MENACWY-TT-100)Population: All eligible participants who received primary vaccination with MenACWY-TT, Meningitec or Mencevax ACWY in Study MenACWY-TT-027, had available assay results for at least 1 tested antigen. "N": number of participants evaluable for this measure. "Number analyzed": participants analyzed for specified serogroup titers cut off.
Serogroups included MenA, MenC, MenW-135 and MenY.
Outcome measures
| Measure |
MenACWY-TT Vaccine: Less Than (<) 2 Years
n=64 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenCCRM (Meningitec) Vaccine: Less Than 2 Years
n=22 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years
n=100 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \>=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
n=27 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
|---|---|---|---|---|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 5 of study MENACWY-TT-10: hSBA-MenC>=1:8
|
91.9 percentage of participants
Interval 82.2 to 97.3
|
93.8 percentage of participants
Interval 69.8 to 99.8
|
91.1 percentage of participants
Interval 82.6 to 96.4
|
100.0 percentage of participants
Interval 83.9 to 100.0
|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 1 of study MENACWY-TT-10: hSBA-MenW-135 >=1:8
|
70.2 percentage of participants
Interval 55.1 to 82.7
|
13.3 percentage of participants
Interval 1.7 to 40.5
|
81.5 percentage of participants
Interval 72.1 to 88.9
|
30.4 percentage of participants
Interval 13.2 to 52.9
|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 2 of study MENACWY-TT-10: hSBA-MenW-135 >=1:8
|
60.3 percentage of participants
Interval 46.6 to 73.0
|
20.0 percentage of participants
Interval 5.7 to 43.7
|
79.6 percentage of participants
Interval 70.3 to 87.1
|
18.5 percentage of participants
Interval 6.3 to 38.1
|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 5 of study MENACWY-TT-10: hSBA-MenW-135 >=1:8
|
44.4 percentage of participants
Interval 30.9 to 58.6
|
21.4 percentage of participants
Interval 4.7 to 50.8
|
61.2 percentage of participants
Interval 48.5 to 72.9
|
26.3 percentage of participants
Interval 9.1 to 51.2
|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 1 of study MENACWY-TT-10: hSBA-MenY >=1:8
|
31.7 percentage of participants
Interval 18.1 to 48.1
|
7.1 percentage of participants
Interval 0.2 to 33.9
|
65.2 percentage of participants
Interval 54.3 to 75.0
|
25.0 percentage of participants
Interval 9.8 to 46.7
|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 2 of study MENACWY-TT-10: hSBA-MenY >=1:8
|
51.8 percentage of participants
Interval 38.0 to 65.3
|
33.3 percentage of participants
Interval 14.6 to 57.0
|
75.0 percentage of participants
Interval 65.3 to 83.1
|
40.7 percentage of participants
Interval 22.4 to 61.2
|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 5 of study MENACWY-TT-10: hSBA-MenY >=1:8
|
41.4 percentage of participants
Interval 28.6 to 55.1
|
40.0 percentage of participants
Interval 16.3 to 67.7
|
72.6 percentage of participants
Interval 60.9 to 82.4
|
44.4 percentage of participants
Interval 21.5 to 69.2
|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 1 of study MENACWY-TT-100: hSBA-MenA >=1:4
|
34.1 percentage of participants
Interval 20.5 to 49.9
|
28.6 percentage of participants
Interval 8.4 to 58.1
|
42.2 percentage of participants
Interval 31.9 to 53.1
|
42.9 percentage of participants
Interval 21.8 to 66.0
|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 2 of study MENACWY-TT-10: hSBA-MenA >=1:4
|
26.7 percentage of participants
Interval 16.1 to 39.7
|
14.3 percentage of participants
Interval 3.0 to 36.3
|
26.3 percentage of participants
Interval 17.9 to 36.1
|
26.9 percentage of participants
Interval 11.6 to 47.8
|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 3 of study MENACWY-TT-10: hSBA-MenA >=1:4
|
32.8 percentage of participants
Interval 21.6 to 45.7
|
27.3 percentage of participants
Interval 10.7 to 50.2
|
28.9 percentage of participants
Interval 20.1 to 39.0
|
40.0 percentage of participants
Interval 21.1 to 61.3
|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 4 of study MENACWY-TT-10: hSBA-MenA >=1:4
|
39.7 percentage of participants
Interval 27.6 to 52.8
|
30.0 percentage of participants
Interval 11.9 to 54.3
|
43.0 percentage of participants
Interval 32.4 to 54.2
|
30.4 percentage of participants
Interval 13.2 to 52.9
|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 5 of study MENACWY-TT-10: hSBA-MenA >=1:4
|
31.1 percentage of participants
Interval 19.9 to 44.3
|
25.0 percentage of participants
Interval 7.3 to 52.4
|
34.8 percentage of participants
Interval 23.7 to 47.2
|
33.3 percentage of participants
Interval 14.6 to 57.0
|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 1 of study MENACWY-TT-10: hSBA-MenC >=1:4
|
92.5 percentage of participants
Interval 81.8 to 97.9
|
93.8 percentage of participants
Interval 69.8 to 99.8
|
93.8 percentage of participants
Interval 87.0 to 97.7
|
100.0 percentage of participants
Interval 85.8 to 100.0
|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 2 of study MENACWY-TT-10: hSBA-MenC >=1:4
|
89.8 percentage of participants
Interval 79.2 to 96.2
|
100.0 percentage of participants
Interval 83.2 to 100.0
|
88.5 percentage of participants
Interval 80.4 to 94.1
|
92.3 percentage of participants
Interval 74.9 to 99.1
|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 3 of study MENACWY-TT-10: hSBA-MenC >=1:4
|
92.2 percentage of participants
Interval 82.7 to 97.4
|
95.5 percentage of participants
Interval 77.2 to 99.9
|
89.6 percentage of participants
Interval 81.7 to 94.9
|
96.0 percentage of participants
Interval 79.6 to 99.9
|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 4 of study MENACWY-TT-10: hSBA-MenC >=1:4
|
90.5 percentage of participants
Interval 80.4 to 96.4
|
95.0 percentage of participants
Interval 75.1 to 99.9
|
86.7 percentage of participants
Interval 77.9 to 92.9
|
91.7 percentage of participants
Interval 73.0 to 99.0
|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 5 of study MENACWY-TT-10: hSBA-MenC >=1:4
|
91.9 percentage of participants
Interval 82.2 to 97.3
|
93.8 percentage of participants
Interval 69.8 to 99.8
|
91.1 percentage of participants
Interval 82.6 to 96.4
|
100.0 percentage of participants
Interval 83.9 to 100.0
|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 1 of study MENACWY-TT-10: hSBA-MenW-135>=1:4
|
70.2 percentage of participants
Interval 55.1 to 82.7
|
13.3 percentage of participants
Interval 1.7 to 40.5
|
81.5 percentage of participants
Interval 72.1 to 88.9
|
30.4 percentage of participants
Interval 13.2 to 52.9
|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 2 of study MENACWY-TT-10: hSBA-MenW-135>=1:4
|
60.3 percentage of participants
Interval 46.6 to 73.0
|
20.0 percentage of participants
Interval 5.7 to 43.7
|
79.6 percentage of participants
Interval 70.3 to 87.1
|
18.5 percentage of participants
Interval 6.3 to 38.1
|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 3 of study MENACWY-TT-10: hSBA-MenW-135>=1:4
|
39.1 percentage of participants
Interval 27.1 to 52.1
|
19.0 percentage of participants
Interval 5.4 to 41.9
|
56.4 percentage of participants
Interval 45.8 to 66.6
|
12.0 percentage of participants
Interval 2.5 to 31.2
|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 4 of study MENACWY-TT-10: hSBA-MenW-135>=1:4
|
44.8 percentage of participants
Interval 31.7 to 58.5
|
18.8 percentage of participants
Interval 4.0 to 45.6
|
68.4 percentage of participants
Interval 56.9 to 78.4
|
9.5 percentage of participants
Interval 1.2 to 30.4
|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 5 of study MENACWY-TT-10: hSBA-MenW-135>=1:4
|
44.4 percentage of participants
Interval 30.9 to 58.6
|
21.4 percentage of participants
Interval 4.7 to 50.8
|
61.2 percentage of participants
Interval 48.5 to 72.9
|
26.3 percentage of participants
Interval 9.1 to 51.2
|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 1 of study MENACWY-TT-10: hSBA-MenY>=1:4
|
31.7 percentage of participants
Interval 18.1 to 48.1
|
7.1 percentage of participants
Interval 0.2 to 33.9
|
65.2 percentage of participants
Interval 54.3 to 75.0
|
25.0 percentage of participants
Interval 9.8 to 46.7
|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 2 of study MENACWY-TT-10: hSBA-MenY>=1:4
|
51.8 percentage of participants
Interval 38.0 to 65.3
|
33.3 percentage of participants
Interval 14.6 to 57.0
|
75.0 percentage of participants
Interval 65.3 to 83.1
|
40.7 percentage of participants
Interval 22.4 to 61.2
|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 3 of study MENACWY-TT-10: hSBA-MenY>=1:4
|
50.8 percentage of participants
Interval 37.9 to 63.6
|
38.1 percentage of participants
Interval 18.1 to 61.6
|
72.0 percentage of participants
Interval 61.8 to 80.9
|
34.8 percentage of participants
Interval 16.4 to 57.3
|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 4 of study MENACWY-TT-10: hSBA-MenY>=1:4
|
32.8 percentage of participants
Interval 21.3 to 46.0
|
26.3 percentage of participants
Interval 9.1 to 51.2
|
67.9 percentage of participants
Interval 56.8 to 77.6
|
27.3 percentage of participants
Interval 10.7 to 50.2
|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 5 of study MENACWY-TT-10: hSBA-MenY>=1:4
|
41.4 percentage of participants
Interval 28.6 to 55.1
|
40.0 percentage of participants
Interval 16.3 to 67.7
|
72.6 percentage of participants
Interval 60.9 to 82.4
|
44.4 percentage of participants
Interval 21.5 to 69.2
|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 1 of study MENACWY-TT-10: hSBA-MenA>=1:8
|
31.8 percentage of participants
Interval 18.6 to 47.6
|
28.6 percentage of participants
Interval 8.4 to 58.1
|
41.1 percentage of participants
Interval 30.8 to 52.0
|
33.3 percentage of participants
Interval 14.6 to 57.0
|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 2 of study MENACWY-TT-10: hSBA-MenA>=1:8
|
25.0 percentage of participants
Interval 14.7 to 37.9
|
14.3 percentage of participants
Interval 3.0 to 36.3
|
26.3 percentage of participants
Interval 17.9 to 36.1
|
23.1 percentage of participants
Interval 9.0 to 43.6
|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 3 of study MENACWY-TT-10: hSBA-MenA>=1:8
|
32.8 percentage of participants
Interval 21.6 to 45.7
|
27.3 percentage of participants
Interval 10.7 to 50.2
|
28.9 percentage of participants
Interval 20.1 to 39.0
|
36.0 percentage of participants
Interval 18.0 to 57.5
|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 4 of study MENACWY-TT-10: hSBA-MenA>=1:8
|
30.2 percentage of participants
Interval 19.2 to 43.0
|
20.0 percentage of participants
Interval 5.7 to 43.7
|
43.0 percentage of participants
Interval 32.4 to 54.2
|
26.1 percentage of participants
Interval 10.2 to 48.4
|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 5 of study MENACWY-TT-10: hSBA-MenA>=1:8
|
26.2 percentage of participants
Interval 15.8 to 39.1
|
18.8 percentage of participants
Interval 4.0 to 45.6
|
33.3 percentage of participants
Interval 22.4 to 45.7
|
28.6 percentage of participants
Interval 11.3 to 52.2
|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 1 of study MENACWY-TT-10: hSBA-MenC>=1:8
|
92.5 percentage of participants
Interval 81.8 to 97.9
|
93.8 percentage of participants
Interval 69.8 to 99.8
|
93.8 percentage of participants
Interval 87.0 to 97.7
|
100.0 percentage of participants
Interval 85.8 to 100.0
|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 2 of study MENACWY-TT-10: hSBA-MenC>=1:8
|
89.8 percentage of participants
Interval 79.2 to 96.2
|
100.0 percentage of participants
Interval 83.2 to 100.0
|
88.5 percentage of participants
Interval 80.4 to 94.1
|
92.3 percentage of participants
Interval 74.9 to 99.1
|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 3 of study MENACWY-TT-10: hSBA-MenC>=1:8
|
92.2 percentage of participants
Interval 82.7 to 97.4
|
95.5 percentage of participants
Interval 77.2 to 99.9
|
89.6 percentage of participants
Interval 81.7 to 94.9
|
96.0 percentage of participants
Interval 79.6 to 99.9
|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 4 of study MENACWY-TT-10: hSBA-MenC>=1:8
|
90.5 percentage of participants
Interval 80.4 to 96.4
|
95.0 percentage of participants
Interval 75.1 to 99.9
|
85.6 percentage of participants
Interval 76.6 to 92.1
|
91.7 percentage of participants
Interval 73.0 to 99.0
|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 3 of study MENACWY-TT-10: hSBA-MenW-135 >=1:8
|
39.1 percentage of participants
Interval 27.1 to 52.1
|
19.0 percentage of participants
Interval 5.4 to 41.9
|
56.4 percentage of participants
Interval 45.8 to 66.6
|
12.0 percentage of participants
Interval 2.5 to 31.2
|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 4 of study MENACWY-TT-10: hSBA-MenW-135 >=1:8
|
44.8 percentage of participants
Interval 31.7 to 58.5
|
18.8 percentage of participants
Interval 4.0 to 45.6
|
67.1 percentage of participants
Interval 55.6 to 77.3
|
9.5 percentage of participants
Interval 1.2 to 30.4
|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 3 of study MENACWY-TT-10: hSBA-MenY >=1:8
|
50.8 percentage of participants
Interval 37.9 to 63.6
|
38.1 percentage of participants
Interval 18.1 to 61.6
|
72.0 percentage of participants
Interval 61.8 to 80.9
|
34.8 percentage of participants
Interval 16.4 to 57.3
|
|
Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 4 of study MENACWY-TT-10: hSBA-MenY >=1:8
|
32.8 percentage of participants
Interval 21.3 to 46.0
|
26.3 percentage of participants
Interval 9.1 to 51.2
|
67.9 percentage of participants
Interval 56.8 to 77.6
|
27.3 percentage of participants
Interval 10.7 to 50.2
|
SECONDARY outcome
Timeframe: 6, 7, 8, 9 and 10 years after primary vaccination (Year 1, 2, 3, 4 and 5 of study MENACWY-TT-100)Population: All eligible participants who received primary vaccination with MenACWY-TT, Meningitec or Mencevax ACWY in Study MenACWY-TT-027, had available assay results for at least 1 tested antigen. "N": number of participants evaluable for this measure. "Number analyzed": participants analyzed for specified serogroup.
Serogroups included MenA, MenC, MenW-135 and MenY.
Outcome measures
| Measure |
MenACWY-TT Vaccine: Less Than (<) 2 Years
n=64 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenCCRM (Meningitec) Vaccine: Less Than 2 Years
n=22 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years
n=100 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \>=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
n=27 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
|---|---|---|---|---|
|
Persistence Phase: Geometric Mean Titers as Measured by hSBA for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 3 of study MENACWY-TT-100: hSBA-MenA
|
5.0 titers
Interval 3.5 to 7.1
|
3.7 titers
Interval 2.2 to 6.1
|
4.6 titers
Interval 3.4 to 6.0
|
6.7 titers
Interval 3.2 to 14.0
|
|
Persistence Phase: Geometric Mean Titers as Measured by hSBA for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 4 of study MENACWY-TT-100: hSBA-MenA
|
4.8 titers
Interval 3.5 to 6.6
|
3.4 titers
Interval 2.2 to 5.2
|
6.6 titers
Interval 4.8 to 9.0
|
4.5 titers
Interval 2.4 to 8.8
|
|
Persistence Phase: Geometric Mean Titers as Measured by hSBA for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 5 of study MENACWY-TT-100: hSBA-MenA
|
4.2 titers
Interval 3.1 to 5.9
|
3.1 titers
Interval 2.0 to 4.8
|
4.6 titers
Interval 3.4 to 6.2
|
5.4 titers
Interval 2.5 to 11.7
|
|
Persistence Phase: Geometric Mean Titers as Measured by hSBA for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 1 of study MENACWY-TT-100: hSBA-MenC
|
542.5 titers
Interval 284.8 to 1033.5
|
230.0 titers
Interval 84.3 to 628.1
|
427.2 titers
Interval 260.7 to 700.0
|
234.8 titers
Interval 122.2 to 451.1
|
|
Persistence Phase: Geometric Mean Titers as Measured by hSBA for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 2 of study MENACWY-TT-100: hSBA-MenC
|
368.1 titers
Interval 191.9 to 706.0
|
223.6 titers
Interval 105.8 to 472.7
|
342.7 titers
Interval 200.7 to 585.4
|
169.2 titers
Interval 67.3 to 425.2
|
|
Persistence Phase: Geometric Mean Titers as Measured by hSBA for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 4 of study MENACWY-TT-100: hSBA-MenW-135
|
8.5 titers
Interval 5.3 to 13.5
|
3.7 titers
Interval 1.6 to 8.4
|
23.1 titers
Interval 14.7 to 36.1
|
2.8 titers
Interval 1.7 to 4.4
|
|
Persistence Phase: Geometric Mean Titers as Measured by hSBA for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 1 of study MENACWY-TT-100: hSBA-MenA
|
4.7 titers
Interval 3.2 to 7.1
|
3.5 titers
Interval 2.1 to 5.8
|
6.5 titers
Interval 4.8 to 8.8
|
5.9 titers
Interval 3.0 to 11.7
|
|
Persistence Phase: Geometric Mean Titers as Measured by hSBA for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 2 of study MENACWY-TT-100: hSBA-MenA
|
3.8 titers
Interval 2.9 to 5.2
|
2.8 titers
Interval 1.8 to 4.2
|
4.5 titers
Interval 3.4 to 6.0
|
4.7 titers
Interval 2.4 to 9.0
|
|
Persistence Phase: Geometric Mean Titers as Measured by hSBA for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 3 of study MENACWY-TT-100: hSBA-MenC
|
378.2 titers
Interval 210.7 to 679.0
|
203.4 titers
Interval 73.8 to 560.9
|
365.5 titers
Interval 214.1 to 624.1
|
273.8 titers
Interval 103.8 to 722.1
|
|
Persistence Phase: Geometric Mean Titers as Measured by hSBA for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 4 of study MENACWY-TT-100: hSBA-MenC
|
319.0 titers
Interval 172.7 to 589.0
|
217.2 titers
Interval 82.8 to 569.9
|
190.4 titers
Interval 112.1 to 323.4
|
125.7 titers
Interval 51.2 to 308.8
|
|
Persistence Phase: Geometric Mean Titers as Measured by hSBA for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 5 of study MENACWY-TT-100: hSBA-MenC
|
362.2 titers
Interval 207.2 to 633.4
|
112.4 titers
Interval 41.2 to 307.0
|
199.3 titers
Interval 118.4 to 335.7
|
119.1 titers
Interval 50.2 to 282.5
|
|
Persistence Phase: Geometric Mean Titers as Measured by hSBA for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 1 of study MENACWY-TT-100: hSBA-MenW-135
|
31.8 titers
Interval 17.5 to 57.8
|
3.3 titers
Interval 1.6 to 6.8
|
62.5 titers
Interval 42.0 to 93.1
|
7.0 titers
Interval 2.9 to 16.9
|
|
Persistence Phase: Geometric Mean Titers as Measured by hSBA for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 2 of study MENACWY-TT-100: hSBA-MenW-135
|
19.5 titers
Interval 11.6 to 32.7
|
4.9 titers
Interval 1.9 to 12.5
|
50.5 titers
Interval 34.5 to 74.1
|
4.0 titers
Interval 2.1 to 7.3
|
|
Persistence Phase: Geometric Mean Titers as Measured by hSBA for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 3 of study MENACWY-TT-100: hSBA-MenW-135
|
8.0 titers
Interval 5.1 to 12.6
|
4.1 titers
Interval 1.9 to 8.6
|
20.4 titers
Interval 13.0 to 32.2
|
3.3 titers
Interval 1.8 to 6.0
|
|
Persistence Phase: Geometric Mean Titers as Measured by hSBA for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 5 of study MENACWY-TT-100: hSBA-MenW-135
|
7.6 titers
Interval 4.8 to 11.8
|
3.8 titers
Interval 1.7 to 8.2
|
17.4 titers
Interval 10.8 to 28.0
|
4.2 titers
Interval 2.2 to 8.0
|
|
Persistence Phase: Geometric Mean Titers as Measured by hSBA for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 1 of study MENACWY-TT-100: hSBA-MenY
|
7.9 titers
Interval 4.1 to 15.2
|
3.1 titers
Interval 1.2 to 7.6
|
40.3 titers
Interval 23.9 to 68.1
|
7.3 titers
Interval 2.7 to 19.8
|
|
Persistence Phase: Geometric Mean Titers as Measured by hSBA for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 2 of study MENACWY-TT-100: hSBA-MenY
|
15.8 titers
Interval 9.0 to 27.7
|
6.9 titers
Interval 2.9 to 16.6
|
54.4 titers
Interval 35.0 to 84.4
|
10.5 titers
Interval 4.4 to 25.0
|
|
Persistence Phase: Geometric Mean Titers as Measured by hSBA for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 3 of study MENACWY-TT-100: hSBA-MenY
|
11.6 titers
Interval 7.3 to 18.6
|
8.7 titers
Interval 3.5 to 21.5
|
43.7 titers
Interval 27.5 to 69.5
|
8.8 titers
Interval 3.4 to 22.5
|
|
Persistence Phase: Geometric Mean Titers as Measured by hSBA for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 4 of study MENACWY-TT-100: hSBA-MenY
|
7.3 titers
Interval 4.4 to 11.9
|
5.8 titers
Interval 2.3 to 15.0
|
35.5 titers
Interval 21.5 to 58.8
|
6.2 titers
Interval 2.5 to 15.3
|
|
Persistence Phase: Geometric Mean Titers as Measured by hSBA for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Year 5 of study MENACWY-TT-100: hSBA-MenY
|
8.6 titers
Interval 5.3 to 14.2
|
8.5 titers
Interval 2.8 to 25.7
|
36.8 titers
Interval 22.4 to 60.7
|
13.9 titers
Interval 4.2 to 46.0
|
SECONDARY outcome
Timeframe: 1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)Population: All eligible participants who received primary vaccination in study MenACWY-TT-027 and booster vaccination in MenACWY-TT-100, had available assay results for 1 month post booster vaccination blood sample. "N": number of participants evaluable for this measure. "Number analyzed": participants analyzed for specified serogroup titers cut off.
Serogroups included MenA, MenC, MenW-135 and MenY.
Outcome measures
| Measure |
MenACWY-TT Vaccine: Less Than (<) 2 Years
n=62 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenCCRM (Meningitec) Vaccine: Less Than 2 Years
n=16 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years
n=74 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \>=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
n=17 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
|---|---|---|---|---|
|
Booster Phase: Percentage of Participants With rSBA Titers >=1:8 and >=1:128 For Each of the 4 Serogroups at 1 Month After Booster Vaccination
rSBA-MenC: >= 1:8
|
100.0 percentage of participants
Interval 94.2 to 100.0
|
100.0 percentage of participants
Interval 79.4 to 100.0
|
100.0 percentage of participants
Interval 95.1 to 100.0
|
100.0 percentage of participants
Interval 80.5 to 100.0
|
|
Booster Phase: Percentage of Participants With rSBA Titers >=1:8 and >=1:128 For Each of the 4 Serogroups at 1 Month After Booster Vaccination
rSBA-MenA: >= 1:8
|
98.4 percentage of participants
Interval 91.3 to 100.0
|
100.0 percentage of participants
Interval 79.4 to 100.0
|
95.9 percentage of participants
Interval 88.6 to 99.2
|
100.0 percentage of participants
Interval 80.5 to 100.0
|
|
Booster Phase: Percentage of Participants With rSBA Titers >=1:8 and >=1:128 For Each of the 4 Serogroups at 1 Month After Booster Vaccination
rSBA-MenW-135: >= 1:8
|
100.0 percentage of participants
Interval 94.2 to 100.0
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
100.0 percentage of participants
Interval 95.1 to 100.0
|
94.1 percentage of participants
Interval 71.3 to 99.9
|
|
Booster Phase: Percentage of Participants With rSBA Titers >=1:8 and >=1:128 For Each of the 4 Serogroups at 1 Month After Booster Vaccination
rSBA-MenY >= 1:8
|
98.4 percentage of participants
Interval 91.3 to 100.0
|
100.0 percentage of participants
Interval 79.4 to 100.0
|
100.0 percentage of participants
Interval 95.1 to 100.0
|
100.0 percentage of participants
Interval 80.5 to 100.0
|
|
Booster Phase: Percentage of Participants With rSBA Titers >=1:8 and >=1:128 For Each of the 4 Serogroups at 1 Month After Booster Vaccination
rSBA-MenA: >= 1:28
|
98.4 percentage of participants
Interval 91.3 to 100.0
|
100.0 percentage of participants
Interval 79.4 to 100.0
|
95.9 percentage of participants
Interval 88.6 to 99.2
|
100.0 percentage of participants
Interval 80.5 to 100.0
|
|
Booster Phase: Percentage of Participants With rSBA Titers >=1:8 and >=1:128 For Each of the 4 Serogroups at 1 Month After Booster Vaccination
rSBA-MenC: >= 1:28
|
100.0 percentage of participants
Interval 94.2 to 100.0
|
100.0 percentage of participants
Interval 79.4 to 100.0
|
100.0 percentage of participants
Interval 95.1 to 100.0
|
100.0 percentage of participants
Interval 80.5 to 100.0
|
|
Booster Phase: Percentage of Participants With rSBA Titers >=1:8 and >=1:128 For Each of the 4 Serogroups at 1 Month After Booster Vaccination
rSBA-MenW-135: >= 1:28
|
100.0 percentage of participants
Interval 94.2 to 100.0
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
100.0 percentage of participants
Interval 95.1 to 100.0
|
94.1 percentage of participants
Interval 71.3 to 99.9
|
|
Booster Phase: Percentage of Participants With rSBA Titers >=1:8 and >=1:128 For Each of the 4 Serogroups at 1 Month After Booster Vaccination
rSBA-MenY >= 1:28
|
98.4 percentage of participants
Interval 91.3 to 100.0
|
100.0 percentage of participants
Interval 79.4 to 100.0
|
100.0 percentage of participants
Interval 95.1 to 100.0
|
100.0 percentage of participants
Interval 80.5 to 100.0
|
SECONDARY outcome
Timeframe: 1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)Population: All eligible participants who received primary vaccination in study MenACWY-TT-027 and booster vaccination in this study (MenACWY-TT-100) and had available assay results for the 1 month post booster vaccination blood sample. "N": number of participants evaluable for this measure.
Serogroups included MenA, MenC, MenW-135 and MenY.
Outcome measures
| Measure |
MenACWY-TT Vaccine: Less Than (<) 2 Years
n=62 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenCCRM (Meningitec) Vaccine: Less Than 2 Years
n=16 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years
n=74 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \>=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
n=17 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
|---|---|---|---|---|
|
Booster Phase: Geometric Mean Titers as Measured by rSBA For Each of the 4 Serogroups 1 Month After Booster Vaccination
rSBA-MenA
|
5122.3 titers
Interval 3725.6 to 7042.6
|
4871.0 titers
Interval 2465.1 to 9624.9
|
4626.4 titers
Interval 3040.6 to 7039.4
|
6414.2 titers
Interval 3878.5 to 10607.8
|
|
Booster Phase: Geometric Mean Titers as Measured by rSBA For Each of the 4 Serogroups 1 Month After Booster Vaccination
rSBA-MenC
|
7163.5 titers
Interval 5478.0 to 9367.7
|
5792.6 titers
Interval 3630.6 to 9242.2
|
4020.0 titers
Interval 3319.0 to 4869.1
|
15101.0 titers
Interval 7099.3 to 32121.5
|
|
Booster Phase: Geometric Mean Titers as Measured by rSBA For Each of the 4 Serogroups 1 Month After Booster Vaccination
rSBA-MenW-135
|
25911.2 titers
Interval 19119.7 to 35115.2
|
17970.4 titers
Interval 11666.4 to 27680.7
|
27944.4 titers
Interval 22213.8 to 35153.3
|
10462.5 titers
Interval 3253.5 to 33645.5
|
|
Booster Phase: Geometric Mean Titers as Measured by rSBA For Each of the 4 Serogroups 1 Month After Booster Vaccination
rSBA-MenY
|
7660.5 titers
Interval 5262.9 to 11150.3
|
6316.9 titers
Interval 3223.8 to 12377.5
|
7529.7 titers
Interval 5827.5 to 9729.2
|
6959.2 titers
Interval 3636.7 to 13317.1
|
SECONDARY outcome
Timeframe: 1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)Population: All eligible participants who received primary vaccination in study MenACWY-TT-027 and booster vaccination in this study (MenACWY-TT-100), had available assay results for 1 month post booster vaccination blood sample. "N": number of participants evaluable for this measure. "Number analyzed": participants analyzed for specified serogroup.
Serogroups included MenA, MenC, MenW-135 and MenY. rSBA booster response to meningococcal antigens (A,C, W-135 and Y) is defined as: rSBA antibody titer \>= 1:32 one month after vaccination, and at least 4-fold increase in rSBA titers one month after vaccination.
Outcome measures
| Measure |
MenACWY-TT Vaccine: Less Than (<) 2 Years
n=62 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenCCRM (Meningitec) Vaccine: Less Than 2 Years
n=16 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years
n=74 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \>=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
n=17 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
|---|---|---|---|---|
|
Booster Phase: Percentage of Participants With rSBA Booster Response at 1 Month After Booster Vaccination
rSBA-MenC
|
82.3 percentage of participants
Interval 70.5 to 90.8
|
93.8 percentage of participants
Interval 69.8 to 99.8
|
75.7 percentage of participants
Interval 64.3 to 84.9
|
94.1 percentage of participants
Interval 71.3 to 99.9
|
|
Booster Phase: Percentage of Participants With rSBA Booster Response at 1 Month After Booster Vaccination
rSBA-MenA
|
90.3 percentage of participants
Interval 80.1 to 96.4
|
100.0 percentage of participants
Interval 79.4 to 100.0
|
87.7 percentage of participants
Interval 77.9 to 94.2
|
94.1 percentage of participants
Interval 71.3 to 99.9
|
|
Booster Phase: Percentage of Participants With rSBA Booster Response at 1 Month After Booster Vaccination
rSBA-MenW-135
|
100.0 percentage of participants
Interval 94.2 to 100.0
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
100.0 percentage of participants
Interval 95.1 to 100.0
|
88.2 percentage of participants
Interval 63.6 to 98.5
|
|
Booster Phase: Percentage of Participants With rSBA Booster Response at 1 Month After Booster Vaccination
rSBA-MenY
|
95.2 percentage of participants
Interval 86.5 to 99.0
|
87.5 percentage of participants
Interval 61.7 to 98.4
|
93.2 percentage of participants
Interval 84.9 to 97.8
|
100.0 percentage of participants
Interval 80.5 to 100.0
|
SECONDARY outcome
Timeframe: 1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)Population: All eligible participants: received primary vaccination in study MenACWY-TT-027, booster vaccination in study MenACWY-TT-100, had available assay results for 1 month post booster vaccination blood sample. "N": number of participants evaluable for this measure. "Number analyzed": participants analyzed for specified serogroup titers cut off.
Serogroups included MenA, MenC, MenW-135 and MenY.
Outcome measures
| Measure |
MenACWY-TT Vaccine: Less Than (<) 2 Years
n=62 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenCCRM (Meningitec) Vaccine: Less Than 2 Years
n=16 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years
n=74 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \>=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
n=17 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
|---|---|---|---|---|
|
Booster Phase: Percentage of Participants With hSBA Titers >=1:4 and >=1:8 For Each of the 4 Serogroups at 1 Month After Booster Vaccination
hSBA-MenA: >=1:4
|
100.0 percentage of participants
Interval 94.2 to 100.0
|
87.5 percentage of participants
Interval 61.7 to 98.4
|
100.0 percentage of participants
Interval 95.1 to 100.0
|
100.0 percentage of participants
Interval 80.5 to 100.0
|
|
Booster Phase: Percentage of Participants With hSBA Titers >=1:4 and >=1:8 For Each of the 4 Serogroups at 1 Month After Booster Vaccination
hSBA-MenC: >=1:4
|
100.0 percentage of participants
Interval 93.9 to 100.0
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
100.0 percentage of participants
Interval 94.9 to 100.0
|
94.1 percentage of participants
Interval 71.3 to 99.9
|
|
Booster Phase: Percentage of Participants With hSBA Titers >=1:4 and >=1:8 For Each of the 4 Serogroups at 1 Month After Booster Vaccination
hSBA-MenW-135: >=1:4
|
100.0 percentage of participants
Interval 94.2 to 100.0
|
100.0 percentage of participants
Interval 75.3 to 100.0
|
100.0 percentage of participants
Interval 95.1 to 100.0
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
|
Booster Phase: Percentage of Participants With hSBA Titers >=1:4 and >=1:8 For Each of the 4 Serogroups at 1 Month After Booster Vaccination
hSBA-MenY: >=1:4
|
100.0 percentage of participants
Interval 94.1 to 100.0
|
93.3 percentage of participants
Interval 68.1 to 99.8
|
100.0 percentage of participants
Interval 95.1 to 100.0
|
100.0 percentage of participants
Interval 80.5 to 100.0
|
|
Booster Phase: Percentage of Participants With hSBA Titers >=1:4 and >=1:8 For Each of the 4 Serogroups at 1 Month After Booster Vaccination
hSBA-MenA: >=1:8
|
100.0 percentage of participants
Interval 94.2 to 100.0
|
87.5 percentage of participants
Interval 61.7 to 98.4
|
100.0 percentage of participants
Interval 95.1 to 100.0
|
100.0 percentage of participants
Interval 80.5 to 100.0
|
|
Booster Phase: Percentage of Participants With hSBA Titers >=1:4 and >=1:8 For Each of the 4 Serogroups at 1 Month After Booster Vaccination
hSBA-MenC: >=1:8
|
100.0 percentage of participants
Interval 93.9 to 100.0
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
100.0 percentage of participants
Interval 94.9 to 100.0
|
94.1 percentage of participants
Interval 71.3 to 99.9
|
|
Booster Phase: Percentage of Participants With hSBA Titers >=1:4 and >=1:8 For Each of the 4 Serogroups at 1 Month After Booster Vaccination
hSBA-MenW-135: >=1:8
|
100.0 percentage of participants
Interval 94.2 to 100.0
|
100.0 percentage of participants
Interval 75.3 to 100.0
|
100.0 percentage of participants
Interval 95.1 to 100.0
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
|
Booster Phase: Percentage of Participants With hSBA Titers >=1:4 and >=1:8 For Each of the 4 Serogroups at 1 Month After Booster Vaccination
hSBA-MenY: >=1:8
|
100.0 percentage of participants
Interval 94.1 to 100.0
|
93.3 percentage of participants
Interval 68.1 to 99.8
|
100.0 percentage of participants
Interval 95.1 to 100.0
|
100.0 percentage of participants
Interval 80.5 to 100.0
|
SECONDARY outcome
Timeframe: 1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)Population: All eligible participants: received primary vaccination in study MenACWY-TT-027, booster vaccination in study MenACWY-TT-100, had available assay results for 1 month post booster vaccination blood sample. "N": number of participants evaluable for this measure. "Number analyzed": participants analyzed for specified serogroup titers cut off.
Serogroups included MenA, MenC, MenW-135 and MenY.
Outcome measures
| Measure |
MenACWY-TT Vaccine: Less Than (<) 2 Years
n=62 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenCCRM (Meningitec) Vaccine: Less Than 2 Years
n=16 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years
n=74 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \>=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
n=17 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
|---|---|---|---|---|
|
Booster Phase: Geometric Mean Titers Using hSBA For Each of the 4 Serogroups at 1 Month After Booster Vaccination
hSBA-MenA
|
1534.2 titers
Interval 1112.1 to 2116.6
|
90.0 titers
Interval 35.7 to 227.1
|
1213.0 titers
Interval 993.9 to 1480.5
|
211.1 titers
Interval 130.9 to 340.3
|
|
Booster Phase: Geometric Mean Titers Using hSBA For Each of the 4 Serogroups at 1 Month After Booster Vaccination
hSBA-MenC
|
33959.8 titers
Interval 23890.2 to 48273.5
|
42559.2 titers
Interval 20106.2 to 90086.2
|
15543.5 titers
Interval 11734.9 to 20588.3
|
44794.4 titers
Interval 10111.6 to 198440.4
|
|
Booster Phase: Geometric Mean Titers Using hSBA For Each of the 4 Serogroups at 1 Month After Booster Vaccination
hSBA-MenW-135
|
11924.8 titers
Interval 8715.6 to 16315.7
|
258.1 titers
Interval 155.7 to 427.8
|
6965.2 titers
Interval 5274.3 to 9198.3
|
199.6 titers
Interval 101.0 to 394.7
|
|
Booster Phase: Geometric Mean Titers Using hSBA For Each of the 4 Serogroups at 1 Month After Booster Vaccination
hSBA-MenY
|
12154.3 titers
Interval 9660.9 to 15291.1
|
407.8 titers
Interval 129.9 to 1280.3
|
11127.4 titers
Interval 8909.2 to 13898.0
|
453.9 titers
Interval 214.6 to 959.8
|
SECONDARY outcome
Timeframe: 1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)Population: All eligible participants: received primary vaccination in study MenACWY-TT-027, booster vaccination in study MenACWY-TT-100, had available assay results for 1 month post booster vaccination blood sample. "N": number of participants evaluable for this measure. "Number analyzed": participants analyzed for specified serogroup.
Serogroups included MenA, MenC, MenW-135 and MenY. hSBA booster response to meningococcal antigens (A,C, W-135 and Y) is defined as: hSBA antibody titer \>= 1:8 one month after vaccination, and at least 4-fold increase in hSBA titers one month after vaccination.
Outcome measures
| Measure |
MenACWY-TT Vaccine: Less Than (<) 2 Years
n=59 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenCCRM (Meningitec) Vaccine: Less Than 2 Years
n=15 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years
n=70 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \>=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
n=17 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
|---|---|---|---|---|
|
Booster Phase: Percentage of Participants With hSBA Booster Response at 1 Month After Booster Vaccination
hSBA-MenA
|
98.3 percentage of participants
Interval 90.9 to 100.0
|
93.3 percentage of participants
Interval 68.1 to 99.8
|
100.0 percentage of participants
Interval 94.1 to 100.0
|
88.2 percentage of participants
Interval 63.6 to 98.5
|
|
Booster Phase: Percentage of Participants With hSBA Booster Response at 1 Month After Booster Vaccination
hSBA-MenC
|
86.0 percentage of participants
Interval 74.2 to 93.7
|
92.9 percentage of participants
Interval 66.1 to 99.8
|
85.7 percentage of participants
Interval 75.3 to 92.9
|
94.1 percentage of participants
Interval 71.3 to 99.9
|
|
Booster Phase: Percentage of Participants With hSBA Booster Response at 1 Month After Booster Vaccination
hSBA-MenW-135
|
100.0 percentage of participants
Interval 93.2 to 100.0
|
90.9 percentage of participants
Interval 58.7 to 99.8
|
96.6 percentage of participants
Interval 88.3 to 99.6
|
100.0 percentage of participants
Interval 76.8 to 100.0
|
|
Booster Phase: Percentage of Participants With hSBA Booster Response at 1 Month After Booster Vaccination
hSBA-MenY
|
100.0 percentage of participants
Interval 93.6 to 100.0
|
71.4 percentage of participants
Interval 41.9 to 91.6
|
98.5 percentage of participants
Interval 91.7 to 100.0
|
78.6 percentage of participants
Interval 49.2 to 95.3
|
SECONDARY outcome
Timeframe: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination)Population: All the participants enrolled in the study.
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. AEs related to "lack of vaccine efficacy" were as judged by the investigator.
Outcome measures
| Measure |
MenACWY-TT Vaccine: Less Than (<) 2 Years
n=76 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenCCRM (Meningitec) Vaccine: Less Than 2 Years
n=23 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years
n=115 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \>=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
n=29 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
|---|---|---|---|---|
|
Persistence Phase: Percentage of Participants With Serious Adverse Events (SAEs) Related to Vaccination or Any Adverse Event (AE) Related to Lack of Vaccine Efficacy
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 4 days post booster vaccinationPopulation: Analysis population included all participants who received a booster dose of study vaccine MenACWY-TT in the booster stage. "Number analyzed": participants analyzed for specified category.
Solicited general events: fatigue, gastrointestinal (GI) events (nausea, vomiting, diarrhea and/or abdominal pain, headache (0= normal, 1=mild/easily tolerated, 2=moderate/interfered with normal activity, 3=severe/prevented normal activity) and fever (\>=37.5°C for oral/axillary/tympanic route, \>=38.0°C for rectal route). Solicited local events: pain (0=none, 1=mild, not interfered/prevented normal activity, 2=moderate, painful when limb moved/interfered with normal activity, 3=severe, significant pain at rest/prevented normal activity), redness and swelling at injection site (record greatest surface diameter in millimeter (mm) as 0 to \<=20 mm, \>20 to \<=50 mm, \>50 mm). Participants may be represented in more than 1 category. Only categories with at least 1 participant reported. 'Medical advice' signifies medical advice received to resolve any event. 'Related'=relationship to study vaccine assessed by investigator.
Outcome measures
| Measure |
MenACWY-TT Vaccine: Less Than (<) 2 Years
n=67 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenCCRM (Meningitec) Vaccine: Less Than 2 Years
n=16 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years
n=77 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \>=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
n=21 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
|---|---|---|---|---|
|
Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination
All pain
|
59.7 percentage of participants
|
56.3 percentage of participants
|
59.5 percentage of participants
|
61.9 percentage of participants
|
|
Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination
Pain: Grade 1
|
43.3 percentage of participants
|
37.5 percentage of participants
|
40.5 percentage of participants
|
42.9 percentage of participants
|
|
Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination
Pain: Grade 2
|
16.4 percentage of participants
|
18.8 percentage of participants
|
16.2 percentage of participants
|
19.0 percentage of participants
|
|
Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination
Severe pain: Grade 3
|
0.0 percentage of participants
|
0.0 percentage of participants
|
2.7 percentage of participants
|
0.0 percentage of participants
|
|
Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination
All redness
|
35.8 percentage of participants
|
43.8 percentage of participants
|
36.5 percentage of participants
|
23.8 percentage of participants
|
|
Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination
Redness: 0 to <=20 mm
|
28.4 percentage of participants
|
25.0 percentage of participants
|
31.1 percentage of participants
|
14.3 percentage of participants
|
|
Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination
Redness: >50 mm
|
6.0 percentage of participants
|
0.0 percentage of participants
|
2.7 percentage of participants
|
9.5 percentage of participants
|
|
Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination
All swelling
|
17.9 percentage of participants
|
6.3 percentage of participants
|
23.0 percentage of participants
|
14.3 percentage of participants
|
|
Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination
Swelling: 0 to <=20 mm
|
14.9 percentage of participants
|
0.0 percentage of participants
|
16.2 percentage of participants
|
0.0 percentage of participants
|
|
Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination
Swelling: >20 to <=50 mm
|
1.5 percentage of participants
|
6.3 percentage of participants
|
1.4 percentage of participants
|
4.8 percentage of participants
|
|
Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination
Swelling: >50 mm
|
1.5 percentage of participants
|
0.0 percentage of participants
|
5.4 percentage of participants
|
9.5 percentage of participants
|
|
Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination
Fatigue: Grade 1
|
20.9 percentage of participants
|
12.5 percentage of participants
|
16.2 percentage of participants
|
14.3 percentage of participants
|
|
Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination
Fatigue: Grade 2
|
9.0 percentage of participants
|
0.0 percentage of participants
|
6.8 percentage of participants
|
9.5 percentage of participants
|
|
Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination
Fatigue: Related fatigue
|
31.3 percentage of participants
|
12.5 percentage of participants
|
29.7 percentage of participants
|
23.8 percentage of participants
|
|
Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination
All fever
|
1.5 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination
Fever: Grade 2
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination
Fever: Grade 3
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination
Fever: Related
|
1.5 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination
Fever: Grade 3 related
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination
All gastrointestinal event (GI)
|
9.0 percentage of participants
|
0.0 percentage of participants
|
17.6 percentage of participants
|
14.3 percentage of participants
|
|
Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination
GI: Grade 1
|
7.5 percentage of participants
|
0.0 percentage of participants
|
13.5 percentage of participants
|
4.8 percentage of participants
|
|
Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination
GI: Grade 2
|
1.5 percentage of participants
|
0.0 percentage of participants
|
2.7 percentage of participants
|
9.5 percentage of participants
|
|
Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination
GI: Grade 3
|
0.0 percentage of participants
|
0.0 percentage of participants
|
1.4 percentage of participants
|
0.0 percentage of participants
|
|
Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination
GI: Related
|
7.5 percentage of participants
|
0.0 percentage of participants
|
17.6 percentage of participants
|
14.3 percentage of participants
|
|
Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination
GI: Grade 3 related
|
0.0 percentage of participants
|
0.0 percentage of participants
|
1.4 percentage of participants
|
0.0 percentage of participants
|
|
Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination
All headache
|
20.9 percentage of participants
|
31.3 percentage of participants
|
27.0 percentage of participants
|
23.8 percentage of participants
|
|
Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination
Headache: Grade 1
|
14.9 percentage of participants
|
18.8 percentage of participants
|
18.9 percentage of participants
|
19.0 percentage of participants
|
|
Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination
Headache: Grade 2
|
6.0 percentage of participants
|
12.5 percentage of participants
|
6.8 percentage of participants
|
4.8 percentage of participants
|
|
Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination
Headache: Grade 3
|
0.0 percentage of participants
|
0.0 percentage of participants
|
1.4 percentage of participants
|
0.0 percentage of participants
|
|
Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination
Headache: Grade 3 related
|
0.0 percentage of participants
|
0.0 percentage of participants
|
1.4 percentage of participants
|
0.0 percentage of participants
|
|
Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination
Headache: Medical advice
|
0.0 percentage of participants
|
0.0 percentage of participants
|
1.4 percentage of participants
|
0.0 percentage of participants
|
|
Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination
Redness: >20 to <=50 mm
|
1.5 percentage of participants
|
18.8 percentage of participants
|
2.7 percentage of participants
|
0.0 percentage of participants
|
|
Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination
All fatigue
|
31.3 percentage of participants
|
12.5 percentage of participants
|
29.7 percentage of participants
|
23.8 percentage of participants
|
|
Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination
Fatigue: Grade 3
|
1.5 percentage of participants
|
0.0 percentage of participants
|
6.8 percentage of participants
|
0.0 percentage of participants
|
|
Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination
Fatigue: Grade 3 Related
|
1.5 percentage of participants
|
0.0 percentage of participants
|
6.8 percentage of participants
|
0.0 percentage of participants
|
|
Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination
Fever: Grade 1
|
1.5 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination
Headache: Related
|
17.9 percentage of participants
|
31.3 percentage of participants
|
24.3 percentage of participants
|
23.8 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 31 days post booster vaccinationPopulation: Analysis population included all participants who received a booster dose of study vaccine MenACWY-TT in the booster stage.
An AE was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An unsolicited AE covers any untoward medical occurrence in a clinical investigation participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Outcome measures
| Measure |
MenACWY-TT Vaccine: Less Than (<) 2 Years
n=67 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenCCRM (Meningitec) Vaccine: Less Than 2 Years
n=16 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years
n=77 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \>=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
n=21 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
|---|---|---|---|---|
|
Booster Phase: Percentage of Participants With Unsolicited Adverse Events up to 31 Days Post Booster Vaccination
|
23.9 percentage of participants
|
31.3 percentage of participants
|
35.1 percentage of participants
|
52.4 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 6 months post booster vaccinationPopulation: Analysis population included all participants who received a booster dose of study vaccine MenACWY-TT in the booster stage.
An AE was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. 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.
Outcome measures
| Measure |
MenACWY-TT Vaccine: Less Than (<) 2 Years
n=67 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenCCRM (Meningitec) Vaccine: Less Than 2 Years
n=16 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years
n=77 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \>=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
n=21 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
|---|---|---|---|---|
|
Booster Phase: Percentage of Participants With Serious Adverse Events (SAEs) Up to 6 Months Post Booster Vaccination
|
0.0 percentage of participants
|
0.0 percentage of participants
|
1.3 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 6 months post booster vaccinationPopulation: Analysis population included all participants who received a booster dose of study vaccine MenACWY-TT in the booster stage.
New onset chronic illness included autoimmune disorders, asthma, type I diabetes, allergies.
Outcome measures
| Measure |
MenACWY-TT Vaccine: Less Than (<) 2 Years
n=67 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenCCRM (Meningitec) Vaccine: Less Than 2 Years
n=16 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years
n=77 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \>=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
n=21 Participants
Persistence phase was followed up by booster phase. Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
|
|---|---|---|---|---|
|
Booster Phase: Percentage of Participants With New Onset Chronic Illness Up to 6 Months Post Booster Vaccination
|
0.0 percentage of participants
|
0.0 percentage of participants
|
1.3 percentage of participants
|
4.8 percentage of participants
|
Adverse Events
Persistence Phase: MenACWY-TT Vaccine (Less Than [<] 2 Years)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Persistence Phase:MenCCRM (Meningitec) Vaccine(<2 Years)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Persistence Phase: MenACWY-TT Vaccine (>=2 Years)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Persistence Phase: MenPS (Mencevax ACWY) Vaccine (< 2 Years)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Booster Phase: MenACWY-TT Vaccine (Less Than 2 Years)
Serious events: 0 serious events
Other events: 53 other events
Deaths: 0 deaths
Booster Phase: MenCCRM (Meningitec) Vaccine (<2 Years)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Booster Phase: MenACWY-TT Vaccine (>= 2 Years)
Serious events: 1 serious events
Other events: 65 other events
Deaths: 0 deaths
Booster Phase: MenPS (Mencevax ACWY) Vaccine (<2 Years)
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Persistence Phase: MenACWY-TT Vaccine (Less Than [<] 2 Years)
n=76 participants at risk
Participants with \<2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study they were evaluated for long-term persistence for a maximum duration of 5 years (6, 7, 8, 9 and 10 years post primary vaccination in MENACWY-TT-027).
|
Persistence Phase:MenCCRM (Meningitec) Vaccine(<2 Years)
n=23 participants at risk
Participants with \<2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study they were evaluated for long-term persistence for a maximum duration of 5 years (6, 7, 8, 9 and 10 years post primary vaccination in MENACWY-TT-027).
|
Persistence Phase: MenACWY-TT Vaccine (>=2 Years)
n=115 participants at risk
Participants with \>=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study they were evaluated for long-term persistence for a maximum duration of 5 years (6, 7, 8, 9 and 10 years post primary vaccination in MENACWY-TT-027).
|
Persistence Phase: MenPS (Mencevax ACWY) Vaccine (< 2 Years)
n=29 participants at risk
Participants with \<2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study they were evaluated for long term persistence for a maximum duration of 5 years (6, 7, 8, 9 and 10 years post primary vaccination in MENACWY-TT-027).
|
Booster Phase: MenACWY-TT Vaccine (Less Than 2 Years)
n=67 participants at risk
Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study they were evaluated for long-term persistence for a maximum duration of 5 years (6, 7, 8, 9 and 10 years post primary vaccination in MENACWY-TT-027). Booster phase: Participants received a single 0.5 mL booster dose of MenACWY-TT intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months.
|
Booster Phase: MenCCRM (Meningitec) Vaccine (<2 Years)
n=16 participants at risk
Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study they were evaluated for long-term persistence for a maximum duration of 5 years (6, 7, 8, 9 and 10 years post primary vaccination in MENACWY-TT-027). Booster phase: Participants received a single 0.5 mL booster dose of MenACWY-TT intramuscularly in this study, 10 years post primary vaccination, and were followed up for 6 months.
|
Booster Phase: MenACWY-TT Vaccine (>= 2 Years)
n=77 participants at risk
Persistence phase: Participants with \>=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study they were evaluated for long-term persistence for a maximum duration of 5 years (6, 7, 8, 9 and 10 years post primary vaccination in MENACWY-TT-027). Booster phase: Participants received a single 0.5 mL booster dose of MenACWY-TT in this study, 10 years post primary vaccination, and were followed up for 6 months.
|
Booster Phase: MenPS (Mencevax ACWY) Vaccine (<2 Years)
n=21 participants at risk
Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study they were evaluated for long term persistence for a maximum duration of 5 years (6, 7, 8, 9 and 10 years post primary vaccination in MENACWY-TT-027). Booster phase: Participants received a single 0.5 mL booster dose of MenACWY-TT in this study, 10 years post primary vaccination, and were followed up for 6 months.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
1.3%
1/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
Other adverse events
| Measure |
Persistence Phase: MenACWY-TT Vaccine (Less Than [<] 2 Years)
n=76 participants at risk
Participants with \<2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study they were evaluated for long-term persistence for a maximum duration of 5 years (6, 7, 8, 9 and 10 years post primary vaccination in MENACWY-TT-027).
|
Persistence Phase:MenCCRM (Meningitec) Vaccine(<2 Years)
n=23 participants at risk
Participants with \<2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study they were evaluated for long-term persistence for a maximum duration of 5 years (6, 7, 8, 9 and 10 years post primary vaccination in MENACWY-TT-027).
|
Persistence Phase: MenACWY-TT Vaccine (>=2 Years)
n=115 participants at risk
Participants with \>=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study they were evaluated for long-term persistence for a maximum duration of 5 years (6, 7, 8, 9 and 10 years post primary vaccination in MENACWY-TT-027).
|
Persistence Phase: MenPS (Mencevax ACWY) Vaccine (< 2 Years)
n=29 participants at risk
Participants with \<2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study they were evaluated for long term persistence for a maximum duration of 5 years (6, 7, 8, 9 and 10 years post primary vaccination in MENACWY-TT-027).
|
Booster Phase: MenACWY-TT Vaccine (Less Than 2 Years)
n=67 participants at risk
Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study they were evaluated for long-term persistence for a maximum duration of 5 years (6, 7, 8, 9 and 10 years post primary vaccination in MENACWY-TT-027). Booster phase: Participants received a single 0.5 mL booster dose of MenACWY-TT intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months.
|
Booster Phase: MenCCRM (Meningitec) Vaccine (<2 Years)
n=16 participants at risk
Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study they were evaluated for long-term persistence for a maximum duration of 5 years (6, 7, 8, 9 and 10 years post primary vaccination in MENACWY-TT-027). Booster phase: Participants received a single 0.5 mL booster dose of MenACWY-TT intramuscularly in this study, 10 years post primary vaccination, and were followed up for 6 months.
|
Booster Phase: MenACWY-TT Vaccine (>= 2 Years)
n=77 participants at risk
Persistence phase: Participants with \>=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study they were evaluated for long-term persistence for a maximum duration of 5 years (6, 7, 8, 9 and 10 years post primary vaccination in MENACWY-TT-027). Booster phase: Participants received a single 0.5 mL booster dose of MenACWY-TT in this study, 10 years post primary vaccination, and were followed up for 6 months.
|
Booster Phase: MenPS (Mencevax ACWY) Vaccine (<2 Years)
n=21 participants at risk
Persistence phase: Participants with \<2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study they were evaluated for long term persistence for a maximum duration of 5 years (6, 7, 8, 9 and 10 years post primary vaccination in MENACWY-TT-027). Booster phase: Participants received a single 0.5 mL booster dose of MenACWY-TT in this study, 10 years post primary vaccination, and were followed up for 6 months.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
1.3%
1/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
4.8%
1/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
1.5%
1/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
Gastrointestinal disorders
Coeliac disease
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
4.8%
1/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
Gastrointestinal disorders
Gastrointestinal symptoms
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
9.0%
6/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
16.9%
13/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
14.3%
3/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
1.3%
1/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
General disorders
Axillary pain
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
1.5%
1/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
4.8%
1/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
General disorders
Fatigue 1
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
31.3%
21/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
12.5%
2/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
28.6%
22/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
23.8%
5/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
General disorders
Fatigue
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
6.2%
1/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
4.8%
1/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
General disorders
Injection site bruising
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
3.0%
2/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
General disorders
Injection site erythema (redness)
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
35.8%
24/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
43.8%
7/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
35.1%
27/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
23.8%
5/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
General disorders
Injection site hypoaesthesia
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
1.3%
1/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
General disorders
Injection site pain (pain at injection site)
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
59.7%
40/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
56.2%
9/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
57.1%
44/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
61.9%
13/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
General disorders
Injection site pruritus
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
1.5%
1/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
6.2%
1/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
1.3%
1/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
General disorders
Injection site swelling (swelling)
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
17.9%
12/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
6.2%
1/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
22.1%
17/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
14.3%
3/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
General disorders
Pyrexia
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
3.0%
2/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
12.5%
2/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
1.3%
1/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
1.3%
1/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
1.5%
1/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
Infections and infestations
Ear infection
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
1.3%
1/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
2.6%
2/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
4.8%
1/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
1.3%
1/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
1.3%
1/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
6.2%
1/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
1.3%
1/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
4.8%
1/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
Infections and infestations
Otitis media
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
1.3%
1/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
6.2%
1/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
4.8%
1/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
3.0%
2/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
4.8%
1/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
1.3%
1/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
Infections and infestations
Skin infection
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
4.8%
1/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
1.3%
1/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
1.5%
1/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
6.2%
1/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
9.1%
7/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
9.5%
2/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
6.2%
1/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
1.5%
1/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
1.5%
1/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
1.3%
1/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
1.3%
1/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
4.8%
1/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
4.8%
1/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
1.5%
1/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
4.8%
1/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
1.5%
1/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
Nervous system disorders
Headache 1
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
20.9%
14/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
31.2%
5/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
26.0%
20/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
23.8%
5/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
Nervous system disorders
Headache
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
6.0%
4/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
6.2%
1/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
3.9%
3/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
1.3%
1/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
Nervous system disorders
Migraine
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
4.8%
1/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
1.5%
1/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
1.3%
1/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
4.8%
1/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
1.5%
1/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
2.6%
2/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
1.3%
1/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
1.3%
1/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
1.5%
1/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
1.5%
1/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
2.6%
2/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
1.5%
1/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/76 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/23 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/115 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/29 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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.
|
1.5%
1/67 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/16 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/77 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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%
0/21 • For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
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