Trial Outcomes & Findings for Comparison of GlaxoSmithKline (GSK)134612 in Subjects With Increased Risk for Meningococcal Disease Versus Healthy Subjects (NCT NCT01641042)

Last Updated: 2017-10-18

Results Overview

Vaccine response was defined as: rSBA antibody titers greater than or equal to (≥) 1:32, for initially seronegative subjects \[i.e. pre-vaccination rSBA antibody titers below (\<) 1:8\] and at least a 4-fold increase in rSBA antibody titers from pre to post-vaccination, for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titers ≥ 1:8).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

86 participants

Primary outcome timeframe

One month after the first vaccine dose (at Month 1)

Results posted on

2017-10-18

Participant Flow

During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

Participant milestones

Participant milestones
Measure	Nimenrix At-Risk Group Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.	Nimenrix Healthy Group Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Overall Study STARTED	43	43
Overall Study COMPLETED	43	43
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of GlaxoSmithKline (GSK)134612 in Subjects With Increased Risk for Meningococcal Disease Versus Healthy Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nimenrix At-Risk Group n=43 Participants Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.	Nimenrix Healthy Group n=43 Participants Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.	Total n=86 Participants Total of all reporting groups
Age, Continuous	12.0 Years STANDARD_DEVIATION 4.4 • n=5 Participants	11.5 Years STANDARD_DEVIATION 3.6 • n=7 Participants	11.75 Years STANDARD_DEVIATION 4.00 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	22 Participants n=7 Participants	42 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	21 Participants n=7 Participants	44 Participants n=5 Participants
Race/Ethnicity, Customized African Heritage/African American	11 Participants n=5 Participants	2 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized White-Caucasian/European Heritage	32 Participants n=5 Participants	38 Participants n=7 Participants	70 Participants n=5 Participants

PRIMARY outcome

Timeframe: One month after the first vaccine dose (at Month 1)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.

Outcome measures

Outcome measures
Measure	Nimenrix At-Risk Group n=40 Participants Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.	Nimenrix Healthy Group n=40 Participants Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Number of Subjects With a Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY) Antibodies rSBA-MenA	40 Participants	39 Participants
Number of Subjects With a Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY) Antibodies rSBA-MenC	37 Participants	39 Participants
Number of Subjects With a Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY) Antibodies rSBA-MenW-135	40 Participants	39 Participants
Number of Subjects With a Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY) Antibodies rSBA-MenY	39 Participants	40 Participants

PRIMARY outcome

Timeframe: One month after the first vaccine dose (at Month 1)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.

Vaccine response was defined as: hSBA antibody titers ≥ 1:8, for initially seronegative subjects (i.e. pre-vaccination rSBA antibody titers \< 1:4) and at least a 4-fold increase in hSBA antibody titers from pre to post-vaccination, for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titers ≥ 1:4).

Outcome measures

Outcome measures
Measure	Nimenrix At-Risk Group n=38 Participants Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.	Nimenrix Healthy Group n=38 Participants Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Number of Subjects With a Vaccine Response for Serum Bactericidal Assay Using Human Complement Against N. Meningitides Serogroups A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135, hSBA-MenY) Antibodies hSBA-MenA	23 Participants	23 Participants
Number of Subjects With a Vaccine Response for Serum Bactericidal Assay Using Human Complement Against N. Meningitides Serogroups A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135, hSBA-MenY) Antibodies hSBA-MenC	27 Participants	20 Participants
Number of Subjects With a Vaccine Response for Serum Bactericidal Assay Using Human Complement Against N. Meningitides Serogroups A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135, hSBA-MenY) Antibodies hSBA-MenW-135	20 Participants	21 Participants
Number of Subjects With a Vaccine Response for Serum Bactericidal Assay Using Human Complement Against N. Meningitides Serogroups A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135, hSBA-MenY) Antibodies hSBA-MenY	23 Participants	29 Participants

SECONDARY outcome

Timeframe: One month after the second vaccine dose (At Month 3)

Vaccine response was defined as: rSBA antibody titers ≥ 1:32, for initially seronegative subjects (i.e. pre-vaccination rSBA antibody titers \< 1:8) and at least a 4-fold increase in rSBA antibody titers from pre to post-vaccination, for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titers ≥ 1:8).

Outcome measures

Outcome measures
Measure	Nimenrix At-Risk Group n=39 Participants Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.	Nimenrix Healthy Group n=39 Participants Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies rSBA-MenA	39 Participants	39 Participants
Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies rSBA-MenC	39 Participants	39 Participants
Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies rSBA-MenW-135	39 Participants	39 Participants
Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies rSBA-MenY	39 Participants	39 Participants

SECONDARY outcome

Timeframe: One month after the second vaccine dose (At Month 3)

Outcome measures

Outcome measures
Measure	Nimenrix At-Risk Group n=37 Participants Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.	Nimenrix Healthy Group n=37 Participants Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Number of Subjects With a Vaccine Response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies hSBA-MenA	28 Participants	24 Participants
Number of Subjects With a Vaccine Response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies hSBA-MenC	34 Participants	29 Participants
Number of Subjects With a Vaccine Response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies hSBA-MenW-135	29 Participants	24 Participants
Number of Subjects With a Vaccine Response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies hSBA-MenY	27 Participants	27 Participants

SECONDARY outcome

Timeframe: At pre-primary vaccination (Month 0), at post first vaccine dose (Month 1) and post second vaccine dose (Month 3)

The cut-off value for the assay was ≥ 1:8.

Outcome measures

Outcome measures
Measure	Nimenrix At-Risk Group n=40 Participants Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.	Nimenrix Healthy Group n=40 Participants Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenA; Month 0	7 Participants	2 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenA; Month 1	40 Participants	40 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenA; Month 3	39 Participants	39 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenC; Month 0	10 Participants	5 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenC; Month 1	37 Participants	39 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenC; Month 3	39 Participants	39 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenW-135; Month 0	5 Participants	3 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenW-135; Month 1	40 Participants	39 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenW-135; Month 3	39 Participants	39 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenY; Month 0	9 Participants	8 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenY; Month 1	40 Participants	40 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenY; Month 3	39 Participants	39 Participants

SECONDARY outcome

Timeframe: Pre-primary vaccination at Month 0, post first vaccine dose at Month 1 and post second vaccine dose at Month 3

The cut-off value for the assay was ≥ 1:128.

Outcome measures

Outcome measures
Measure	Nimenrix At-Risk Group n=40 Participants Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.	Nimenrix Healthy Group n=40 Participants Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenA; Month 0	6 Participants	1 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenA; Month 1	40 Participants	40 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenA; Month 3	39 Participants	39 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenC; Month 0	3 Participants	4 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenC; Month 1	37 Participants	39 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenC; Month 3	38 Participants	38 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenW-135; Month 0	4 Participants	2 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenW-135; Month 1	40 Participants	39 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenW-135; Month 3	38 Participants	39 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenY; Month 0	8 Participants	8 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenY; Month 1	40 Participants	40 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values rSBA-MenY; Month 3	39 Participants	39 Participants

SECONDARY outcome

Timeframe: At pre-primary vaccination (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)

Antibody titers were measured in geometric mean titers (GMTs), calculated on all subjects.

Outcome measures

Outcome measures
Measure	Nimenrix At-Risk Group n=40 Participants Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.	Nimenrix Healthy Group n=40 Participants Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Meningococcal Antigens rSBA-MenA; Month 0	8.6 Titers Interval 4.8 to 15.3	4.8 Titers Interval 3.6 to 6.3
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Meningococcal Antigens rSBA-MenA; Month 1	2012.8 Titers Interval 1414.0 to 2865.3	4025.6 Titers Interval 3065.1 to 5287.2
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Meningococcal Antigens rSBA-MenA; Month 3	2820.1 Titers Interval 1899.0 to 4187.9	3553.1 Titers Interval 2640.3 to 4781.5
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Meningococcal Antigens rSBA-MenC; Month 0	9 Titers Interval 5.4 to 15.0	6.3 Titers Interval 4.2 to 9.3
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Meningococcal Antigens rSBA-MenC; Month 1	1374.8 Titers Interval 693.4 to 2725.7	2233.4 Titers Interval 1197.4 to 4165.6
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Meningococcal Antigens rSBA-MenC; Month 3	1684.3 Titers Interval 1097.8 to 2584.1	1684.3 Titers Interval 1087.8 to 2608.1
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Meningococcal Antigens rSBA-MenW-135; Month 0	7 Titers Interval 4.2 to 11.7	5.1 Titers Interval 3.8 to 6.9
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Meningococcal Antigens rSBA-MenW-135; Month 1	3050.9 Titers Interval 2029.8 to 4585.5	4167.6 Titers Interval 2620.0 to 6629.2
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Meningococcal Antigens rSBA-MenW-135; Month 3	5844.3 Titers Interval 4046.3 to 8441.3	6981.1 Titers Interval 5467.9 to 8913.0
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Meningococcal Antigens rSBA-MenY; Month 0	10.6 Titers Interval 5.7 to 19.7	9.7 Titers Interval 5.4 to 17.3
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Meningococcal Antigens rSBA-MenY; Month 1	4624.2 Titers Interval 3125.5 to 6841.6	7009 Titers Interval 5175.6 to 9491.9
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Meningococcal Antigens rSBA-MenY; Month 3	5640.2 Titers Interval 4142.5 to 7679.5	6618.6 Titers Interval 4875.6 to 8984.6

SECONDARY outcome

Timeframe: Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)

The cut-off value for the assay was ≥ 1:4.

Outcome measures

Outcome measures
Measure	Nimenrix At-Risk Group n=40 Participants Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.	Nimenrix Healthy Group n=40 Participants Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenA; Month 0	14 Participants	12 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenA; Month 1	29 Participants	28 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenA; Month 3	35 Participants	29 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenC; Month 0	21 Participants	23 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenC; Month 1	34 Participants	36 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenC; Month 3	38 Participants	39 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenW-135; Month 0	20 Participants	16 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenW-135; Month 1	34 Participants	39 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenW-135; Month 3	39 Participants	38 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenY; Month 0	24 Participants	25 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenY; Month 1	37 Participants	40 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenY; Month 3	39 Participants	39 Participants

SECONDARY outcome

Timeframe: Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)

The cut-off value for the assay ≥ 1:8.

Outcome measures

Outcome measures
Measure	Nimenrix At-Risk Group n=40 Participants Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.	Nimenrix Healthy Group n=40 Participants Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenC; Month 1	34 Participants	36 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenA; Month 0	13 Participants	12 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenA; Month 1	29 Participants	28 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenA; Month 3	35 Participants	29 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenC; Month 0	20 Participants	22 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenC; Month 3	38 Participants	39 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenW-135; Month 0	20 Participants	16 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenW-135; Month 1	34 Participants	39 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenW-135; Month 3	39 Participants	38 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenY; Month 0	24 Participants	25 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenY; Month 1	37 Participants	40 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values hSBA-MenY; Month 3	39 Participants	39 Participants

SECONDARY outcome

Timeframe: Pre-primary vaccination at Month 0, post first vaccine dose at Month 1 and post second vaccine dose at Month 3

Antibody titers were measured in Geometric mean titers (GMTs), calculated on all subjects.

Outcome measures

Outcome measures
Measure	Nimenrix At-Risk Group n=40 Participants Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.	Nimenrix Healthy Group n=40 Participants Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens hSBA-MenA; Month 0	5.5 Titres Interval 3.4 to 8.9	4.2 Titres Interval 2.9 to 6.1
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens hSBA-MenA; Month 1	105.9 Titres Interval 47.6 to 235.6	68.7 Titres Interval 32.6 to 144.5
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens hSBA-MenA; Month 3	235.1 Titres Interval 136.2 to 405.9	90.3 Titres Interval 44.8 to 182.1
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens hSBA-MenC; Month 0	12.9 Titres Interval 6.5 to 25.7	10.9 Titres Interval 6.3 to 18.6
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens hSBA-MenC; Month 1	812.9 Titres Interval 283.5 to 2330.9	196.7 Titres Interval 84.6 to 457.2
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens hSBA-MenC; Month 3	1472.1 Titres Interval 733.6 to 2954.0	764.6 Titres Interval 404.8 to 1444.5
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens hSBA-MenW-135; Month 0	21.7 Titres Interval 9.9 to 47.7	13.6 Titres Interval 6.4 to 28.5
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens hSBA-MenW-135; Month 1	283.7 Titres Interval 137.4 to 585.6	263.7 Titres Interval 187.3 to 371.2
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens hSBA-MenW-135; Month 3	884.5 Titres Interval 567.2 to 1379.2	590.8 Titres Interval 443.0 to 787.8
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens hSBA-MenY; Month 0	37 Titres Interval 16.7 to 82.4	32 Titres Interval 15.5 to 65.8
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens hSBA-MenY; Month 1	743.6 Titres Interval 352.9 to 1566.7	661.7 Titres Interval 460.2 to 951.6
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens hSBA-MenY; Month 3	1415.1 Titres Interval 905.2 to 2212.2	800.7 Titres Interval 638.1 to 1004.7

SECONDARY outcome

Timeframe: Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)

The cut-off value for the assay was ≥ 0.3 micrograms per milliliter (μg/m).

Outcome measures

Outcome measures
Measure	Nimenrix At-Risk Group n=33 Participants Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.	Nimenrix Healthy Group n=34 Participants Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Values anti-PSA; Month 0	28 Participants	30 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Values anti-PSA; Month 1	29 Participants	34 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Values anti-PSA; Month 3	33 Participants	32 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Values anti-PSC; Month 0	15 Participants	4 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Values anti-PSC; Month 1	29 Participants	34 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Values anti-PSC; Month 3	33 Participants	32 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Values anti-PSW-135; Month 0	21 Participants	19 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Values anti-PSW-135; Month 1	29 Participants	34 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Values anti-PSW-135; Month 3	33 Participants	32 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Values anti-PSY; Month 0	7 Participants	5 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Values anti-PSY; Month 1	10 Participants	13 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Values anti-PSY; Month 3	10 Participants	11 Participants

SECONDARY outcome

Timeframe: Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)

The cut-off value for the assay was ≥ 2.0 μg/mL.

Outcome measures

Outcome measures
Measure	Nimenrix At-Risk Group n=33 Participants Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.	Nimenrix Healthy Group n=34 Participants Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentration ≥ the Cut-off Values anti-PSA; Month 0	12 Participants	9 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentration ≥ the Cut-off Values anti-PSA; Month 1	29 Participants	34 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentration ≥ the Cut-off Values anti-PSA; Month 3	33 Participants	32 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentration ≥ the Cut-off Values anti-PSC; Month 0	3 Participants	2 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentration ≥ the Cut-off Values anti-PSC; Month 1	26 Participants	32 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentration ≥ the Cut-off Values anti-PSC; Month 3	30 Participants	27 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentration ≥ the Cut-off Values anti-PSW-135; Month 0	4 Participants	2 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentration ≥ the Cut-off Values anti-PSW-135; Month 1	28 Participants	33 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentration ≥ the Cut-off Values anti-PSW-135; Month 3	33 Participants	32 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentration ≥ the Cut-off Values anti-PSY; Month 0	3 Participants	3 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentration ≥ the Cut-off Values anti-PSY; Month 1	10 Participants	13 Participants
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentration ≥ the Cut-off Values anti-PSY; Month 3	10 Participants	11 Participants

SECONDARY outcome

Timeframe: Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)

Antibody titers were measured in geometric mean concentrations (GMCs), calculated on all subjects.

Outcome measures

Outcome measures
Measure	Nimenrix At-Risk Group n=33 Participants Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.	Nimenrix Healthy Group n=34 Participants Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens anti-PSA; Month 0	1.9 Titers Interval 1.5 to 2.4	1.4 Titers Interval 1.1 to 1.8
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens anti-PSA; Month 1	17.4 Titers Interval 11.7 to 25.8	16.2 Titers Interval 11.3 to 23.3
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens anti-PSA; Month 3	14.2 Titers Interval 10.5 to 19.3	10.7 Titers Interval 8.0 to 14.3
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens anti-PSC; Month 0	0.4 Titers Interval 0.2 to 0.6	0.2 Titers Interval 0.1 to 0.3
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens anti-PSC; Month 1	8.3 Titers Interval 5.6 to 12.5	8.4 Titers Interval 5.9 to 11.8
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens anti-PSC; Month 3	6 Titers Interval 4.4 to 8.1	5.8 Titers Interval 4.2 to 8.0
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens anti-PSW-135; Month 0	0.6 Titers Interval 0.3 to 1.1	0.4 Titers Interval 0.3 to 0.6
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens anti-PSW-135; Month 1	14.9 Titers Interval 8.4 to 26.3	13.3 Titers Interval 9.2 to 19.4
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens anti-PSW-135; Month 3	19 Titers Interval 12.8 to 28.2	14 Titers Interval 9.9 to 19.8
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens anti-PSY; Month 0	2.9 Titers Interval 1.1 to 7.9	2.5 Titers Interval 1.0 to 6.1
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens anti-PSY; Month 1	20.4 Titers Interval 6.3 to 66.2	17.3 Titers Interval 11.2 to 26.8
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens anti-PSY; Month 3	30 Titers Interval 10.4 to 86.5	12.5 Titers Interval 9.4 to 16.7

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) post-vaccination period following each dose and across doses

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and with their symptom sheet filled in.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.

Outcome measures

Outcome measures
Measure	Nimenrix At-Risk Group n=3 Participants Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.	Nimenrix Healthy Group n=3 Participants Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years Any Pain, Dose 1	2 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years Grade 3 Pain, Dose 1	0 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years Any Redness, Dose 1	2 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years Grade 3 Redness, Dose 1	0 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years Any Swelling, Dose 1	2 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years Grade 3 Swelling, Dose 1	0 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years Any Pain, Dose 2	1 Participants	1 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years Grade 3 Pain, Dose 2	0 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years Any Redness, Dose 2	0 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years Grade 3 Redness, Dose 2	0 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years Any Swelling, Dose 2	0 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years Grade 3 Swelling, Dose 2	0 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years Any Pain, Across Doses	2 Participants	1 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years Grade 3 Pain, Across Doses	0 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years Any Redness, Across Doses	2 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years Grade 3 Redness, Across Doses	0 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years Any Swelling, Across Doses	2 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years Grade 3 Swelling, Across Doses	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) post-vaccination period following each dose and across doses

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and with their symptom sheet filled in.

Assessed solicited local symptoms were pain, redness and swelling. Any was defined as occurrence of the symptom regardless of intensity grade. Grade 3 pain was defined as cried when limb was moved/spontaneously painful. Grade 3 redness/swelling was defined as redness/swelling spreading beyond 30 millimeters (mm) of injection site.

Outcome measures

Outcome measures
Measure	Nimenrix At-Risk Group n=40 Participants Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.	Nimenrix Healthy Group n=39 Participants Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years Any Pain, Dose 1	28 Participants	23 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years Grade 3 Pain, Dose 1	2 Participants	1 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years Any Redness, Dose 1	7 Participants	13 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years Grade 3 Redness, Dose 1	0 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years Any Swelling, Dose 1	12 Participants	8 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years Grade 3 Swelling, Dose 1	2 Participants	2 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years Any Pain, Dose 2	29 Participants	24 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years Grade 3 Pain, Dose 2	3 Participants	1 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years Any Redness, Dose 2	12 Participants	8 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years Grade 3 Redness, Dose 2	1 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years Any Swelling, Dose 2	12 Participants	10 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years Grade 3 Swelling, Dose 2	3 Participants	2 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years Any Pain, Across Doses	32 Participants	28 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years Grade 3 Pain, Across Doses	4 Participants	2 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years Any Redness, Across Doses	14 Participants	14 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years Grade 3 Redness, Across Doses	1 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years Any Swelling, Across Doses	18 Participants	12 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years Grade 3 Swelling, Across Doses	4 Participants	3 Participants

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) post-vaccination period following each dose and across doses

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and with their symptom sheet filled in.

Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptoms = symptoms which prevented normal everyday activities. Grade 3 fever = oral temperature \>39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	Nimenrix At-Risk Group n=3 Participants Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.	Nimenrix Healthy Group n=3 Participants Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years Any Drowsiness, Dose 1	3 Participants	1 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years Grade 3 Drowsiness, Dose 1	1 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years Related Drowsiness, Dose 1	3 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years Any Irritability, Dose 1	2 Participants	1 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years Grade 3 Irritability, Dose 1	1 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years Related Irritability, Dose 1	2 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years Any Loss of appetite, Dose 1	2 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years Grade 3 Loss of appetite, Dose 1	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years Related Loss of appetite, Dose 1	2 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years Any Fever, Dose 1	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years Grade 3 Fever, Dose 1	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years Related Fever, Dose 1	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years Any Drowsiness, Dose 2	0 Participants	1 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years Grade 3 Drowsiness, Dose 2	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years Related Drowsiness, Dose 2	0 Participants	1 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years Any Irritability, Dose 2	0 Participants	1 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years Grade 3 Irritability, Dose 2	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years Related Irritability, Dose 2	0 Participants	1 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years Any Loss of appetite, Dose 2	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years Grade 3 Loss of appetite, Dose 2	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years Related Loss of appetite, Dose 2	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years Any Fever, Dose 2	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years Grade 3 Fever, Dose 2	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years Related Fever, Dose 2	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years Any Drowsiness, Across doses	3 Participants	2 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years Grade 3 Drowsiness, Across doses	1 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years Related Drowsiness, Across doses	3 Participants	1 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years Any Irritability, Across doses	2 Participants	2 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years Grade 3 Irritability, Across doses	1 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years Related Irritability, Across doses	2 Participants	1 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years Any Loss of appetite, Across doses	2 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years Grade 3 Loss of appetite, Across doses	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years Related Loss of appetite, Across doses	2 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years Any Fever, Across doses	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years Grade 3 Fever, Across doses	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years Related Fever, Across doses	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) post-vaccination period following each dose and across doses

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and with their symptom sheet filled in.

Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache and fever. Gastrointestinal symptoms include nausea, vomiting, diarrhoea and/or abdominal pain. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptoms = symptoms which prevented normal everyday activities. Grade 3 fever = oral temperature \>39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	Nimenrix At-Risk Group n=40 Participants Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.	Nimenrix Healthy Group n=39 Participants Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years Any Fatigue, Dose 1	18 Participants	12 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years Grade 3 Fatigue, Dose 1	1 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years Related Fatigue, Dose 1	17 Participants	12 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years Any Gastrointestinal, Dose 1	5 Participants	3 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years Grade 3 Gastrointestinal, Dose 1	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years Related Gastrointestinal, Dose 1	4 Participants	3 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years Any Headache, Dose 1	12 Participants	9 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years Grade 3 Headache, Dose 1	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years Related Headache, Dose 1	9 Participants	9 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years Any Fever, Dose 1	3 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years Grade 3 Fever, Dose 1	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years Related Fever, Dose 1	2 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years Any Fatigue, Dose 2	13 Participants	7 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years Grade 3 Fatigue, Dose 2	0 Participants	1 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years Related Fatigue, Dose 2	13 Participants	6 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years Any Gastrointestinal, Dose 2	1 Participants	6 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years Grade 3 Gastrointestinal, Dose 2	0 Participants	2 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years Related Gastrointestinal, Dose 2	1 Participants	3 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years Any Headache, Dose 2	7 Participants	5 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years Grade 3 Headache, Dose 2	0 Participants	1 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years Related Headache, Dose 2	6 Participants	4 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years Any Fever, Dose 2	1 Participants	2 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years Grade 3 Fever, Dose 2	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years Related Fever, Dose 2	1 Participants	1 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years Any Fatigue, Across doses	21 Participants	14 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years Grade 3 Fatigue, Across doses	1 Participants	1 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years Related Fatigue, Across doses	21 Participants	14 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years Any Gastrointestinal, Across doses	6 Participants	8 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years Grade 3 Gastrointestinal, Across doses	0 Participants	2 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years Related Gastrointestinal, Across doses	5 Participants	5 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years Any Headache, Across doses	16 Participants	10 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years Grade 3 Headache, Across doses	0 Participants	1 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years Related Headache, Across doses	14 Participants	10 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years Any Fever, Across doses	4 Participants	2 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years Grade 3 Fever, Across doses	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years Related Fever, Across doses	3 Participants	1 Participants

SECONDARY outcome

Timeframe: From Month 0 until the end of the Extended Safety Follow-Up [ESFU] (at Month 8)

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.

NOCIs include autoimmune disorders, asthma, type 1 diabetes and allergies.

Outcome measures

Outcome measures
Measure	Nimenrix At-Risk Group n=43 Participants Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.	Nimenrix Healthy Group n=43 Participants Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During the 31-day (Days 0-30) post first vaccination period

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.

An unsolicited adverse event (AE) covers any untoward medical occurrence in a clinical subject investigation temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an AE reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE.

Outcome measures

Outcome measures
Measure	Nimenrix At-Risk Group n=43 Participants Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.	Nimenrix Healthy Group n=43 Participants Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)	7 Participants	7 Participants

SECONDARY outcome

Timeframe: During the 31-day (Days 0-30) post second vaccination period

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.

An unsolicited AE covers any untoward medical occurrence in a clinical subject investigation temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an AE reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE.

Outcome measures

Outcome measures
Measure	Nimenrix At-Risk Group n=43 Participants Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.	Nimenrix Healthy Group n=43 Participants Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Number of Subjects Reporting Any Unsolicited AEs	3 Participants	8 Participants

SECONDARY outcome

Timeframe: From Month 0 until the end of the ESFU (at Month 8)

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Outcome measures
Measure	Nimenrix At-Risk Group n=43 Participants Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.	Nimenrix Healthy Group n=43 Participants Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Number of Subjects With Serious Adverse Events (SAEs)	4 Participants	1 Participants

Adverse Events

Nimenrix At-risk Group

Serious events: 4 serious events

Other events: 38 other events

Deaths: 0 deaths

Nimenrix Healthy Group

Serious events: 1 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Nimenrix At-risk Group n=43 participants at risk Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.	Nimenrix Healthy Group n=43 participants at risk Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Blood and lymphatic system disorders Sickle cell anaemia with crisis	2.3% 1/43 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: from Month 0 up to the end of the ESFU Phase (at Month 8).	0.00% 0/43 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: from Month 0 up to the end of the ESFU Phase (at Month 8).
Infections and infestations Cystitis escherichia	2.3% 1/43 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: from Month 0 up to the end of the ESFU Phase (at Month 8).	0.00% 0/43 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: from Month 0 up to the end of the ESFU Phase (at Month 8).
Infections and infestations Pneumococcal bacteraemia	2.3% 1/43 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: from Month 0 up to the end of the ESFU Phase (at Month 8).	0.00% 0/43 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: from Month 0 up to the end of the ESFU Phase (at Month 8).
Infections and infestations Salmonellosis	2.3% 1/43 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: from Month 0 up to the end of the ESFU Phase (at Month 8).	0.00% 0/43 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: from Month 0 up to the end of the ESFU Phase (at Month 8).
Injury, poisoning and procedural complications Joint injury	0.00% 0/43 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: from Month 0 up to the end of the ESFU Phase (at Month 8).	2.3% 1/43 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: from Month 0 up to the end of the ESFU Phase (at Month 8).

Other adverse events

Other adverse events
Measure	Nimenrix At-risk Group n=43 participants at risk Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.	Nimenrix Healthy Group n=43 participants at risk Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Skin and subcutaneous tissue disorders Erythema	37.2% 16/43 • Number of events 21 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: from Month 0 up to the end of the ESFU Phase (at Month 8).	32.6% 14/43 • Number of events 21 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: from Month 0 up to the end of the ESFU Phase (at Month 8).
General disorders Fatigue	48.8% 21/43 • Number of events 31 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: from Month 0 up to the end of the ESFU Phase (at Month 8).	32.6% 14/43 • Number of events 19 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: from Month 0 up to the end of the ESFU Phase (at Month 8).
Gastrointestinal disorders Gastrointestinal disorder	14.0% 6/43 • Number of events 6 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: from Month 0 up to the end of the ESFU Phase (at Month 8).	18.6% 8/43 • Number of events 9 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: from Month 0 up to the end of the ESFU Phase (at Month 8).
Nervous system disorders Headache	37.2% 16/43 • Number of events 19 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: from Month 0 up to the end of the ESFU Phase (at Month 8).	23.3% 10/43 • Number of events 14 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: from Month 0 up to the end of the ESFU Phase (at Month 8).
General disorders Pain	79.1% 34/43 • Number of events 60 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: from Month 0 up to the end of the ESFU Phase (at Month 8).	67.4% 29/43 • Number of events 48 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: from Month 0 up to the end of the ESFU Phase (at Month 8).
General disorders Pyrexia	11.6% 5/43 • Number of events 5 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: from Month 0 up to the end of the ESFU Phase (at Month 8).	4.7% 2/43 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: from Month 0 up to the end of the ESFU Phase (at Month 8).
Nervous system disorders Somnolence	7.0% 3/43 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: from Month 0 up to the end of the ESFU Phase (at Month 8).	4.7% 2/43 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: from Month 0 up to the end of the ESFU Phase (at Month 8).
General disorders Swelling	46.5% 20/43 • Number of events 26 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: from Month 0 up to the end of the ESFU Phase (at Month 8).	27.9% 12/43 • Number of events 18 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: from Month 0 up to the end of the ESFU Phase (at Month 8).

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER