Trial Outcomes & Findings for Study to Evaluate the Long-term Antibody Persistence of GlaxoSmithKline (GSK) Biologicals' MenACWY-TT Vaccine (GSK134612) Versus Mencevax ACWY in Healthy Adolescents and Adults and Booster Response to MenACWY-TT Vaccine Administered at 10 Years Post-primary Vaccination (NCT NCT01934140)

NCT ID: NCT01934140

Last Updated: 2019-08-28

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

311 participants

Primary outcome timeframe

After 6 years of primary vaccination

Results posted on

2019-08-28

Participant Flow

Enrollment for this study (MENACWY-TT-99) started at Year 6 post primary vaccination in study 107386 \[NCT00356369\]. However, as approval was not obtained from authorities until after end of Year 6, hence no planned activities was done for Year 6.

In this study, participants from the study 107386 \[NCT00356369\] were followed up for assessment of persistence of immune response. And those who consented received booster vaccination and were followed up for another 6 months.

Participant milestones

Participant milestones
Measure	ACWY-TT Group Persistence phase was followed up by booster phase. Persistence phase: Participants received a single 0.5 millilitre (mL) dose of meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study 107386 \[NCT00356369\]. Then, in this study (MENACWY-TT-99), they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible participants from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in 107386 \[NCT00356369\], and were followed up for 6 months after booster vaccination.	MenPS Group Persistence phase was followed up by booster phase. Persistence phase: Participants received a single 0.5 mL dose of Mencevax ACWY vaccine intramuscularly, as primary vaccination in study 107386 \[NCT00356369\]. Then, in this study (MENACWY-TT-99) they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible participants from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination, and were followed up for 6 months after booster vaccination.
Persistence Phase (Year 6-10) STARTED	235	76
Persistence Phase (Year 6-10) COMPLETED	152	51
Persistence Phase (Year 6-10) NOT COMPLETED	83	25
Booster Phase (6 Months) STARTED	164	56
Booster Phase (6 Months) Vaccinated	164	56
Booster Phase (6 Months) COMPLETED	159	53
Booster Phase (6 Months) NOT COMPLETED	5	3

Reasons for withdrawal

Reasons for withdrawal
Measure	ACWY-TT Group Persistence phase was followed up by booster phase. Persistence phase: Participants received a single 0.5 millilitre (mL) dose of meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study 107386 \[NCT00356369\]. Then, in this study (MENACWY-TT-99), they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible participants from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in 107386 \[NCT00356369\], and were followed up for 6 months after booster vaccination.	MenPS Group Persistence phase was followed up by booster phase. Persistence phase: Participants received a single 0.5 mL dose of Mencevax ACWY vaccine intramuscularly, as primary vaccination in study 107386 \[NCT00356369\]. Then, in this study (MENACWY-TT-99) they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible participants from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination, and were followed up for 6 months after booster vaccination.
Persistence Phase (Year 6-10) Other	24	6
Persistence Phase (Year 6-10) Lost to Follow-up	5	2
Persistence Phase (Year 6-10) Migrated/moved from study area	31	10
Persistence Phase (Year 6-10) Eligibility criteria not fulfilled	2	0
Persistence Phase (Year 6-10) Missed at least 1 persistence visit	21	7
Booster Phase (6 Months) Lost to Follow-up	1	0
Booster Phase (6 Months) Missed at least 1 booster visit	2	1
Booster Phase (6 Months) Migrated/moved from study area	2	2

Baseline Characteristics

Study to Evaluate the Long-term Antibody Persistence of GlaxoSmithKline (GSK) Biologicals' MenACWY-TT Vaccine (GSK134612) Versus Mencevax ACWY in Healthy Adolescents and Adults and Booster Response to MenACWY-TT Vaccine Administered at 10 Years Post-primary Vaccination

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ACWY-TT Group n=235 Participants Persistence phase was followed up by booster phase. Persistence phase: Participants received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study 107386 \[NCT00356369\]. Then, in this study (MENACWY-TT-99), they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible participants from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in 107386 \[NCT00356369\], and were followed up for 6 months after booster vaccination.	MenPS Group n=76 Participants Persistence phase was followed up by booster phase. Persistence phase: Participants received a single 0.5 mL dose of Mencevax ACWY vaccine intramuscularly, as primary vaccination in study 107386 \[NCT00356369\]. Then, in this study (MENACWY-TT-99) they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible participants from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination, and were followed up for 6 months after booster vaccination.	Total n=311 Participants Total of all reporting groups
Age, Continuous	25.3 years STANDARD_DEVIATION 8.2 • n=93 Participants	25.2 years STANDARD_DEVIATION 8.4 • n=4 Participants	25.2 years STANDARD_DEVIATION 8.2 • n=27 Participants
Sex: Female, Male Female	108 Participants n=93 Participants	40 Participants n=4 Participants	148 Participants n=27 Participants
Sex: Female, Male Male	127 Participants n=93 Participants	36 Participants n=4 Participants	163 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	235 Participants n=93 Participants	76 Participants n=4 Participants	311 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	235 Participants n=93 Participants	76 Participants n=4 Participants	311 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants

PRIMARY outcome

Timeframe: After 6 years of primary vaccination

Population: Data was not collected and analyzed for this outcome measure because approval was not obtained from the authorities for Year 6 activities.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: After 7 years of primary vaccination

Population: All eligible participants who received primary vaccination with MenACWY-TT or Mencevax ACWY during study 107386 \[NCT00356369\], 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 MenA, MenC, MenW-135 and MenY.

Outcome measures

Outcome measures
Measure	ACWY-TT Group n=206 Participants Persistence phase was followed up by booster phase. Persistence phase: Participants received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study 107386 \[NCT00356369\]. Then, in this study (MENACWY-TT-99), they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible participants from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in 107386 \[NCT00356369\], and were followed up for 6 months after booster vaccination.	MenPS Group n=65 Participants Persistence phase was followed up by booster phase. Persistence phase: Participants received a single 0.5 mL dose of Mencevax ACWY vaccine intramuscularly, as primary vaccination in study 107386 \[NCT00356369\]. Then, in this study (MENACWY-TT-99) they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible participants from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination, 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	88.3 percentage of participants Interval 83.2 to 92.4	67.7 percentage of participants Interval 54.9 to 78.8
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	82.5 percentage of participants Interval 76.6 to 87.4	76.9 percentage of participants Interval 64.8 to 86.5
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: >=1:8	60.7 percentage of participants Interval 53.7 to 67.4	23.1 percentage of participants Interval 13.5 to 35.2
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	80.1 percentage of participants Interval 74.0 to 85.3	46.2 percentage of participants Interval 33.7 to 59.0
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: >=1:128	73.8 percentage of participants Interval 67.2 to 79.7	46.2 percentage of participants Interval 33.7 to 59.0
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: >=1:128	61.7 percentage of participants Interval 54.6 to 68.3	61.5 percentage of participants Interval 48.6 to 73.3
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-MenW-135: >=1:128	52.4 percentage of participants Interval 45.4 to 59.4	16.9 percentage of participants Interval 8.8 to 28.3
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: >=1:128	76.7 percentage of participants Interval 70.3 to 82.3	38.5 percentage of participants Interval 26.7 to 51.4

PRIMARY outcome

Timeframe: After 8 years of primary vaccination

Population: All eligible participants who received primary vaccination with MenACWY-TT or Mencevax ACWY during study 107386 \[NCT00356369\], had available assay results for at least 1 tested antigen. Here, "N" signifies number of participants evaluable for this measure and "Number analyzed" (n): participants analyzed for specified serogroup.

Serogroups included MenA, MenC, MenW-135 and MenY.

Outcome measures

Outcome measures
Measure	ACWY-TT Group n=208 Participants Persistence phase was followed up by booster phase. Persistence phase: Participants received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study 107386 \[NCT00356369\]. Then, in this study (MENACWY-TT-99), they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible participants from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in 107386 \[NCT00356369\], and were followed up for 6 months after booster vaccination.	MenPS Group n=67 Participants Persistence phase was followed up by booster phase. Persistence phase: Participants received a single 0.5 mL dose of Mencevax ACWY vaccine intramuscularly, as primary vaccination in study 107386 \[NCT00356369\]. Then, in this study (MENACWY-TT-99) they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible participants from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination, 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-MenC: >=1:8	86.3 percentage of participants Interval 80.8 to 90.7	80.6 percentage of participants Interval 69.1 to 89.2
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-MenA: >=1:8	76.0 percentage of participants Interval 69.6 to 81.6	56.7 percentage of participants Interval 44.0 to 68.8
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	66.2 percentage of participants Interval 59.3 to 72.6	23.9 percentage of participants Interval 14.3 to 35.9
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	76.2 percentage of participants Interval 69.8 to 81.9	40.3 percentage of participants Interval 28.5 to 53.0
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-MenA: >=1:128	60.6 percentage of participants Interval 53.6 to 67.3	40.3 percentage of participants Interval 28.5 to 53.0
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-MenC: >=1:128	68.1 percentage of participants Interval 61.3 to 74.5	64.2 percentage of participants Interval 51.5 to 75.5
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: >=1:128	60.9 percentage of participants Interval 53.9 to 67.6	16.4 percentage of participants Interval 8.5 to 27.5
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-MenY: >=1:128	70.9 percentage of participants Interval 64.2 to 77.0	37.3 percentage of participants Interval 25.8 to 50.0

PRIMARY outcome

Timeframe: After 9 years of primary vaccination

Population: All eligible participants who received primary vaccination with MenACWY-TT or Mencevax ACWY during study 107386 \[NCT00356369\], had available assay results for at least 1 tested antigen. Here, "N" signifies number of participants evaluable for this measure.

Serogroups included MenA, MenC, MenW-135 and MenY.

Outcome measures

Outcome measures
Measure	ACWY-TT Group n=190 Participants Persistence phase was followed up by booster phase. Persistence phase: Participants received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study 107386 \[NCT00356369\]. Then, in this study (MENACWY-TT-99), they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible participants from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in 107386 \[NCT00356369\], and were followed up for 6 months after booster vaccination.	MenPS Group n=61 Participants Persistence phase was followed up by booster phase. Persistence phase: Participants received a single 0.5 mL dose of Mencevax ACWY vaccine intramuscularly, as primary vaccination in study 107386 \[NCT00356369\]. Then, in this study (MENACWY-TT-99) they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible participants from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination, 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	82.6 percentage of participants Interval 76.5 to 87.7	65.6 percentage of participants Interval 52.3 to 77.3
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	89.5 percentage of participants Interval 84.2 to 93.5	90.2 percentage of participants Interval 79.8 to 96.3
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	55.8 percentage of participants Interval 48.4 to 63.0	9.8 percentage of participants Interval 3.7 to 20.2
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	89.5 percentage of participants Interval 84.2 to 93.5	57.4 percentage of participants Interval 44.1 to 70.0
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: >=1:128	75.3 percentage of participants Interval 68.5 to 81.2	59.0 percentage of participants Interval 45.7 to 71.4
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: >=1:128	66.8 percentage of participants Interval 59.7 to 73.5	67.2 percentage of participants Interval 54.0 to 78.7
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-MenW-135: >=1:128	50.5 percentage of participants Interval 43.2 to 57.8	9.8 percentage of participants Interval 3.7 to 20.2
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: >=1:128	86.3 percentage of participants Interval 80.6 to 90.9	50.8 percentage of participants Interval 37.7 to 63.9

PRIMARY outcome

Timeframe: After 10 years of primary vaccination

Population: All eligible participants who received primary vaccination with MenACWY-TT or Mencevax ACWY during study 107386 \[NCT00356369\], had available assay results for at least 1 tested antigen. Here, "N" signifies number of participants evaluable for this measure and "n": participants analyzed for specified serogroup.

Serogroups included MenA, MenC, MenW-135 and MenY.

Outcome measures

Outcome measures
Measure	ACWY-TT Group n=162 Participants Persistence phase was followed up by booster phase. Persistence phase: Participants received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study 107386 \[NCT00356369\]. Then, in this study (MENACWY-TT-99), they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible participants from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in 107386 \[NCT00356369\], and were followed up for 6 months after booster vaccination.	MenPS Group n=54 Participants Persistence phase was followed up by booster phase. Persistence phase: Participants received a single 0.5 mL dose of Mencevax ACWY vaccine intramuscularly, as primary vaccination in study 107386 \[NCT00356369\]. Then, in this study (MENACWY-TT-99) they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible participants from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination, 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	76.5 percentage of participants Interval 69.3 to 82.8	70.4 percentage of participants Interval 56.4 to 82.0
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	90.7 percentage of participants Interval 85.1 to 94.7	88.9 percentage of participants Interval 77.4 to 95.8
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	70.2 percentage of participants Interval 62.5 to 77.1	24.1 percentage of participants Interval 13.5 to 37.6
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-MenY: >=1:8	87.0 percentage of participants Interval 80.8 to 91.7	64.8 percentage of participants Interval 50.6 to 77.3
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-MenA: >=1:128	67.9 percentage of participants Interval 60.1 to 75.0	57.4 percentage of participants Interval 43.2 to 70.8
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: >=1:128	72.7 percentage of participants Interval 65.1 to 79.4	68.5 percentage of participants Interval 54.4 to 80.5
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: >=1:128	64.6 percentage of participants Interval 56.7 to 72.0	22.2 percentage of participants Interval 12.0 to 35.6
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-MenY: >=1:128	83.2 percentage of participants Interval 76.5 to 88.6	53.7 percentage of participants Interval 39.6 to 67.4

PRIMARY outcome

Timeframe: After 6 years of primary vaccination

Population: Data was not collected and analyzed for this outcome measure because approval was not obtained from the authorities for Year 6 activities.

Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers expressed as the reciprocal of the highest serum last dilution resulting in at least 50 percentage (%) reduction of meningococcal colony-forming units.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: After 7 years of primary vaccination

Population: All eligible participants who received primary vaccination with MenACWY-TT or Mencevax ACWY during study 107386 \[NCT00356369\], had available assay results for at least 1 tested antigen. Here, "N" signifies number of participants evaluable for this measure.

Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers expressed as the reciprocal of the highest serum last dilution resulting in at least 50 % reduction of meningococcal colony-forming units.

Outcome measures

Outcome measures
Measure	ACWY-TT Group n=206 Participants Persistence phase was followed up by booster phase. Persistence phase: Participants received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study 107386 \[NCT00356369\]. Then, in this study (MENACWY-TT-99), they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible participants from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in 107386 \[NCT00356369\], and were followed up for 6 months after booster vaccination.	MenPS Group n=65 Participants Persistence phase was followed up by booster phase. Persistence phase: Participants received a single 0.5 mL dose of Mencevax ACWY vaccine intramuscularly, as primary vaccination in study 107386 \[NCT00356369\]. Then, in this study (MENACWY-TT-99) they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible participants from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination, and were followed up for 6 months after booster vaccination.
Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 7 Years of Primary Vaccination rSBA-MenA	220.8 titers Interval 167.2 to 291.5	54.5 titers Interval 31.1 to 95.8
Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 7 Years of Primary Vaccination rSBA-MenC	105.3 titers Interval 79.7 to 139.1	156.7 titers Interval 82.7 to 297.1
Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 7 Years of Primary Vaccination rSBA-MenW-135	83.2 titers Interval 57.0 to 121.5	10.0 titers Interval 6.3 to 15.9
Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 7 Years of Primary Vaccination rSBA-MenY	270.2 titers Interval 195.2 to 373.8	32.7 titers Interval 17.8 to 60.1

PRIMARY outcome

Timeframe: After 8 years of primary vaccination

Population: All eligible participants who received primary vaccination with MenACWY-TT or Mencevax ACWY during study 107386 \[NCT00356369\], had available assay results for at least 1 tested antigen. Here, "N" signifies number of participants evaluable for this measure and "n": participants analyzed for specified serogroup.

Outcome measures

Outcome measures
Measure	ACWY-TT Group n=208 Participants Persistence phase was followed up by booster phase. Persistence phase: Participants received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study 107386 \[NCT00356369\]. Then, in this study (MENACWY-TT-99), they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible participants from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in 107386 \[NCT00356369\], and were followed up for 6 months after booster vaccination.	MenPS Group n=67 Participants Persistence phase was followed up by booster phase. Persistence phase: Participants received a single 0.5 mL dose of Mencevax ACWY vaccine intramuscularly, as primary vaccination in study 107386 \[NCT00356369\]. Then, in this study (MENACWY-TT-99) they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible participants from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination, and were followed up for 6 months after booster vaccination.
Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 8 Years of Primary Vaccination rSBA-MenA	104.8 titers Interval 77.1 to 142.4	44.1 titers Interval 24.3 to 80.0
Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 8 Years of Primary Vaccination rSBA-MenC	155.4 titers Interval 118.3 to 204.0	240.6 titers Interval 125.4 to 461.8
Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 8 Years of Primary Vaccination rSBA-MenW-135	119.7 titers Interval 82.8 to 173.1	10.8 titers Interval 6.7 to 17.5
Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 8 Years of Primary Vaccination rSBA-MenY	181.6 titers Interval 130.2 to 253.3	26.0 titers Interval 14.5 to 46.6

PRIMARY outcome

Timeframe: After 9 years of primary vaccination

Population: All eligible participants who received primary vaccination with MenACWY-TT or Mencevax ACWY during study 107386 \[NCT00356369\], had available assay results for at least 1 tested antigen.Here, "N" signifies number of participants evaluable for this measure.

Outcome measures

Outcome measures
Measure	ACWY-TT Group n=190 Participants Persistence phase was followed up by booster phase. Persistence phase: Participants received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study 107386 \[NCT00356369\]. Then, in this study (MENACWY-TT-99), they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible participants from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in 107386 \[NCT00356369\], and were followed up for 6 months after booster vaccination.	MenPS Group n=61 Participants Persistence phase was followed up by booster phase. Persistence phase: Participants received a single 0.5 mL dose of Mencevax ACWY vaccine intramuscularly, as primary vaccination in study 107386 \[NCT00356369\]. Then, in this study (MENACWY-TT-99) they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible participants from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination, and were followed up for 6 months after booster vaccination.
Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 9 Years of Primary Vaccination rSBA-MenA	227.8 titers Interval 165.0 to 314.5	81.2 titers Interval 44.2 to 149.4
Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 9 Years of Primary Vaccination rSBA-MenC	173.3 titers Interval 129.9 to 231.1	264.9 titers Interval 147.7 to 474.9
Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 9 Years of Primary Vaccination rSBA-MenW-135	71.7 titers Interval 48.0 to 107.0	6.7 titers Interval 4.5 to 10.0
Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 9 Years of Primary Vaccination rSBA-MenY	460.6 titers Interval 346.2 to 612.7	57.8 titers Interval 30.6 to 109.2

PRIMARY outcome

Timeframe: After 10 years of primary vaccination

Population: All eligible participants who received primary vaccination with MenACWY-TT or Mencevax ACWY during study 107386 \[NCT00356369\], had available assay results for at least 1 tested antigen. Here, "N" signifies number of participants evaluable for this measure and "n": participants analyzed for specified serogroup.

Outcome measures

Outcome measures
Measure	ACWY-TT Group n=162 Participants Persistence phase was followed up by booster phase. Persistence phase: Participants received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study 107386 \[NCT00356369\]. Then, in this study (MENACWY-TT-99), they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible participants from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in 107386 \[NCT00356369\], and were followed up for 6 months after booster vaccination.	MenPS Group n=54 Participants Persistence phase was followed up by booster phase. Persistence phase: Participants received a single 0.5 mL dose of Mencevax ACWY vaccine intramuscularly, as primary vaccination in study 107386 \[NCT00356369\]. Then, in this study (MENACWY-TT-99) they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible participants from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination, and were followed up for 6 months after booster vaccination.
Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 10 Years of Primary Vaccination rSBA-MenA	142.5 titers Interval 100.4 to 202.1	73.7 titers Interval 40.9 to 132.8
Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 10 Years of Primary Vaccination rSBA-MenC	181.4 titers Interval 134.6 to 244.4	234.0 titers Interval 122.3 to 447.9
Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 10 Years of Primary Vaccination rSBA-MenW-135	161.5 titers Interval 104.8 to 248.9	11.9 titers Interval 6.8 to 21.0
Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 10 Years of Primary Vaccination rSBA-MenY	387.0 titers Interval 274.1 to 546.4	63.2 titers Interval 33.4 to 119.6

SECONDARY outcome

Timeframe: 1 month after booster vaccination

Population: All eligible participants who received primary vaccination in study107386 \[NCT00356369\], received booster dose of vaccine in study MENACWY-099; for whom assay results are available for antibodies against at least 1 study vaccine antigen component for blood sample taken 1 month after vaccination. N=number of participants evaluable for this measure.

Serogroups included MenA, MenC, MenW-135 and MenY.

Outcome measures

Outcome measures
Measure	ACWY-TT Group n=155 Participants Persistence phase was followed up by booster phase. Persistence phase: Participants received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study 107386 \[NCT00356369\]. Then, in this study (MENACWY-TT-99), they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible participants from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in 107386 \[NCT00356369\], and were followed up for 6 months after booster vaccination.	MenPS Group n=52 Participants Persistence phase was followed up by booster phase. Persistence phase: Participants received a single 0.5 mL dose of Mencevax ACWY vaccine intramuscularly, as primary vaccination in study 107386 \[NCT00356369\]. Then, in this study (MENACWY-TT-99) they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible participants from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination, 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-MenA: >=1:8	100.0 percentage of participants Interval 97.6 to 100.0	100.0 percentage of participants Interval 93.2 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: >=1:8	100.0 percentage of participants Interval 97.6 to 100.0	98.1 percentage of participants Interval 89.7 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 97.6 to 100.0	98.1 percentage of participants Interval 89.7 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-MenY: >=1:8	100.0 percentage of participants Interval 97.6 to 100.0	100.0 percentage of participants Interval 93.2 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: >=1:128	100.0 percentage of participants Interval 97.6 to 100.0	100.0 percentage of participants Interval 93.2 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: >=1:128	100.0 percentage of participants Interval 97.6 to 100.0	96.2 percentage of participants Interval 86.8 to 99.5
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: >=1:128	100.0 percentage of participants Interval 97.6 to 100.0	98.1 percentage of participants Interval 89.7 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-MenY: >=1:128	100.0 percentage of participants Interval 97.6 to 100.0	100.0 percentage of participants Interval 93.2 to 100.0

SECONDARY outcome

Timeframe: 1 month after booster vaccination

Outcome measures

Outcome measures
Measure	ACWY-TT Group n=155 Participants Persistence phase was followed up by booster phase. Persistence phase: Participants received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study 107386 \[NCT00356369\]. Then, in this study (MENACWY-TT-99), they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible participants from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in 107386 \[NCT00356369\], and were followed up for 6 months after booster vaccination.	MenPS Group n=52 Participants Persistence phase was followed up by booster phase. Persistence phase: Participants received a single 0.5 mL dose of Mencevax ACWY vaccine intramuscularly, as primary vaccination in study 107386 \[NCT00356369\]. Then, in this study (MENACWY-TT-99) they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible participants from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination, and were followed up for 6 months after booster vaccination.
Booster Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups at 1 Month After Booster Vaccination rSBA-MenA	4059.5 titers Interval 3383.8 to 4870.2	3584.8 titers Interval 2750.7 to 4672.0
Booster Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups at 1 Month After Booster Vaccination rSBA-MenC	13823.5 titers Interval 10839.7 to 17628.7	3444.3 titers Interval 1998.5 to 5936.0
Booster Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups at 1 Month After Booster Vaccination rSBA-MenW-135	23431.0 titers Interval 17351.4 to 31640.7	5792.6 titers Interval 3585.9 to 9357.4
Booster Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups at 1 Month After Booster Vaccination rSBA-MenY	8958.4 titers Interval 7601.6 to 10557.5	5137.8 titers Interval 3528.2 to 7481.6

SECONDARY outcome

Timeframe: 1 month after booster vaccination

Population: All eligible participants: received primary vaccination in study 107386\[NCT00356369\] and booster dose in study MENACWY-099;assay results available for antibodies against at least 1 study vaccine antigen component in blood sample taken 1 month post vaccination. N=participants evaluable for measure, n=participants analyzed for specified serogroups.

Serogroups included MenA, MenC, MenW-135 and MenY. rSBA booster vaccine responses for serogroups A, C, W-135 and Y defined as: for initially seronegative participants (pre-vaccination titer below the cut-off of 1:8) had rSBA antibody titers \>= 1:32, 1 month after vaccination, and for initially seropositive participants (pre-vaccination titer \>= 1:8) had rSBA antibody titers at least 4 times the pre-vaccination antibody titers, 1 month after vaccination. Data reported below is including both seropositive and seronegative participants.

Outcome measures

Outcome measures
Measure	ACWY-TT Group n=155 Participants Persistence phase was followed up by booster phase. Persistence phase: Participants received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study 107386 \[NCT00356369\]. Then, in this study (MENACWY-TT-99), they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible participants from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in 107386 \[NCT00356369\], and were followed up for 6 months after booster vaccination.	MenPS Group n=52 Participants Persistence phase was followed up by booster phase. Persistence phase: Participants received a single 0.5 mL dose of Mencevax ACWY vaccine intramuscularly, as primary vaccination in study 107386 \[NCT00356369\]. Then, in this study (MENACWY-TT-99) they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible participants from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination, 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-MenA	87.7 percentage of participants Interval 81.5 to 92.5	88.5 percentage of participants Interval 76.6 to 95.6
Booster Phase: Percentage of Participants With rSBA Booster Response at 1 Month After Booster Vaccination rSBA-MenC	90.9 percentage of participants Interval 85.2 to 94.9	75.0 percentage of participants Interval 61.1 to 86.0
Booster Phase: Percentage of Participants With rSBA Booster Response at 1 Month After Booster Vaccination rSBA-MenW-135	94.2 percentage of participants Interval 89.2 to 97.3	96.2 percentage of participants Interval 86.8 to 99.5
Booster Phase: Percentage of Participants With rSBA Booster Response at 1 Month After Booster Vaccination rSBA-MenY	83.8 percentage of participants Interval 77.0 to 89.2	92.3 percentage of participants Interval 81.5 to 97.9

SECONDARY outcome

Timeframe: 1 month after booster vaccination

Tetanus toxoid (TT) was used as carrier in tetravalent meningococcal ACWY conjugate vaccine. Percentage of participants with anti-TT concentration \>=0.1 IU/mL, \>=1.0 IU/mL were summarized.

Outcome measures

Outcome measures
Measure	ACWY-TT Group n=155 Participants Persistence phase was followed up by booster phase. Persistence phase: Participants received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study 107386 \[NCT00356369\]. Then, in this study (MENACWY-TT-99), they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible participants from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in 107386 \[NCT00356369\], and were followed up for 6 months after booster vaccination.	MenPS Group n=52 Participants Persistence phase was followed up by booster phase. Persistence phase: Participants received a single 0.5 mL dose of Mencevax ACWY vaccine intramuscularly, as primary vaccination in study 107386 \[NCT00356369\]. Then, in this study (MENACWY-TT-99) they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible participants from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination, and were followed up for 6 months after booster vaccination.
Booster Phase: Percentage of Participants With Antibodies Against-Tetanus Toxoid (Anti-TT) Concentrations >=0.1 International Units Per Millilitre (IU/mL), >=1.0 IU/mL at 1 Month After Booster Vaccination Anti-TT >=1.0 IU/mL	94.8 percentage of participants Interval 90.1 to 97.7	88.5 percentage of participants Interval 76.6 to 95.6
Booster Phase: Percentage of Participants With Antibodies Against-Tetanus Toxoid (Anti-TT) Concentrations >=0.1 International Units Per Millilitre (IU/mL), >=1.0 IU/mL at 1 Month After Booster Vaccination Anti-TT >=0.1 IU/mL	99.4 percentage of participants Interval 96.5 to 100.0	98.1 percentage of participants Interval 89.7 to 100.0

SECONDARY outcome

Timeframe: 1 month after booster vaccination

TT was used as carrier in tetravalent meningococcal ACWY conjugate vaccine. Percentage of participants with anti-TT concentration \>=0.1 IU/mL, \>=1.0 IU/mL were summarized.

Outcome measures

Outcome measures
Measure	ACWY-TT Group n=155 Participants Persistence phase was followed up by booster phase. Persistence phase: Participants received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study 107386 \[NCT00356369\]. Then, in this study (MENACWY-TT-99), they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible participants from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in 107386 \[NCT00356369\], and were followed up for 6 months after booster vaccination.	MenPS Group n=52 Participants Persistence phase was followed up by booster phase. Persistence phase: Participants received a single 0.5 mL dose of Mencevax ACWY vaccine intramuscularly, as primary vaccination in study 107386 \[NCT00356369\]. Then, in this study (MENACWY-TT-99) they were evaluated for long-term persistence of immune response for 4 years (7, 8, 9 and 10 years post primary vaccination). Booster phase: All eligible participants from persistence phase who provided informed consent to enroll in booster phase, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination, and were followed up for 6 months after booster vaccination.
Booster Phase: Geometric Mean Concentrations (GMCs) of Antibodies Against-Tetanus Toxoid (Anti-TT) at 1 Month After Booster Vaccination	7.163 IU/mL Interval 5.958 to 8.613	7.650 IU/mL Interval 4.888 to 11.973

SECONDARY outcome

Timeframe: Up to 4 days post booster vaccination

Population: All eligible participants who received primary vaccination in study 107386 \[NCT00356369\] and received booster dose of vaccine in study MENACWY-099. "n" participants analyzed for specified categories.

Solicited local events:1)pain(Grade \[G\] : 0=none,1=mild,neither interfered nor prevented normal activities,2=moderate, painful when limb moved; interfered with normal activities,3=severe, significant pain at rest,prevented normal activities),2)redness, and 3)swelling (record greatest surface diameter in millimetre\[mm\] as 0 to less than or equal to\[\<=\]20 mm, greater than\[\>\]20 to \<=50 mm,\>50 mm). If to resolve any event medical advice taken, results reported as Medical Advice. Solicited general events: 1) fatigue, 2) gastrointestinal(GI) events(nausea, vomiting, diarrhea and/or abdominal pain,3) headache(G : 0=normal, 1=mild, easily tolerated,2=moderate, interfered with normal activity,3=severe, prevented normal activity), and 4)fever (G: 0=less than\[\<\] 37.5 degree Celsius\[°C\], 1= 37.5 degree C to 38.0degree C, 2= 38.1 degreeC to 39.0 degree C,3 =\>39.0 degree C). 'Related'=relationship to study vaccine assessed by investigator.Medical advice=medical advice received to resolve any event.