Trial Outcomes & Findings for Persistence and Booster Study of GSK Biologicals' Meningococcal Vaccine (GSK134612) in Healthy Children (NCT NCT01266993)

NCT ID: NCT01266993

Last Updated: 2020-11-23

Results Overview

The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 271 participants
• Primary outcome timeframe: At Month 32, post-primary vaccination
• Results posted on: 2020-11-23

Participant Flow

Out of 282 subjects participating to the study, 271 participated to Month 32-44 period, 261 to Month 44-56, 260 to Month 56-68, and 282 to Month 68-69 booster period. Out of 282 subjects participating to Month 68-69 booster period, 41 subjects had a subject number allocated but received no vaccine dose, hence only 241 started this phase.

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

Measure	Nimenrix Group Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.	Menjugate Group Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
Persistence Phase (Month 32-44) STARTED	199	72
Persistence Phase (Month 32-44) COMPLETED	199	72
Persistence Phase (Month 32-44) NOT COMPLETED	0	0
Persistence Phase (Month 44-56) STARTED	193	68
Persistence Phase (Month 44-56) COMPLETED	193	68
Persistence Phase (Month 44-56) NOT COMPLETED	0	0
Persistence Phase (Month 56-68) STARTED	193	67
Persistence Phase (Month 56-68) COMPLETED	193	67
Persistence Phase (Month 56-68) NOT COMPLETED	0	0
Booster Phase (Month 68-69) STARTED	179	62
Booster Phase (Month 68-69) COMPLETED	174	60
Booster Phase (Month 68-69) NOT COMPLETED	5	2

Reasons for withdrawal

Measure	Nimenrix Group Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.	Menjugate Group Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
Booster Phase (Month 68-69) Lost to Follow-up	5	1
Booster Phase (Month 68-69) Withdrawal by Subject	0	1

Baseline Characteristics

Persistence and Booster Study of GSK Biologicals' Meningococcal Vaccine (GSK134612) in Healthy Children

Baseline characteristics by cohort

Measure	Nimenrix Group n=199 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.	Menjugate Group n=72 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.	Total n=271 Participants Total of all reporting groups
Age, Continuous	8.4 Years STANDARD_DEVIATION 2.58 • n=5 Participants	8.1 Years STANDARD_DEVIATION 2.42 • n=7 Participants	8.32 Years STANDARD_DEVIATION 2.54 • n=5 Participants
Sex: Female, Male Female	103 Participants n=5 Participants	34 Participants n=7 Participants	137 Participants n=5 Participants
Sex: Female, Male Male	96 Participants n=5 Participants	38 Participants n=7 Participants	134 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · African heritage / African American	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · American Indian or Alaskan native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian - Central/South Asian heritage	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian - East Asian heritage	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian - Japanese heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian - South East Asian heritage	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · Native Hawaiian or other pacific islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · White - Arabic / North African heritage	12 Participants n=5 Participants	6 Participants n=7 Participants	18 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · White - Caucasian/European Heritage	169 Participants n=5 Participants	61 Participants n=7 Participants	230 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · Other	8 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Month 32, post-primary vaccination

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Month 32, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 32.

The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory.

Outcome measures

Measure	Nimenrix Group n=193 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.	Menjugate Group n=69 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With Serum Bactericidal Assay, Using Baby Rabbit Complement, Against Neisseria Meningitides Serogroup A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Was Greater Than or Equal to (≥) 1:8, at Month 32. rSBA-MenA	167 Participants	15 Participants
Number of Subjects With Serum Bactericidal Assay, Using Baby Rabbit Complement, Against Neisseria Meningitides Serogroup A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Was Greater Than or Equal to (≥) 1:8, at Month 32. rSBA-MenC	124 Participants	53 Participants
Number of Subjects With Serum Bactericidal Assay, Using Baby Rabbit Complement, Against Neisseria Meningitides Serogroup A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Was Greater Than or Equal to (≥) 1:8, at Month 32. rSBA-MenW-135	149 Participants	5 Participants
Number of Subjects With Serum Bactericidal Assay, Using Baby Rabbit Complement, Against Neisseria Meningitides Serogroup A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Was Greater Than or Equal to (≥) 1:8, at Month 32. rSBA-MenY	157 Participants	10 Participants

PRIMARY outcome

Timeframe: At Month 44, post-primary vaccination

Population: The analysis was performed on the ATP cohort for persistence at Month 44, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 44.

The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory.

Outcome measures

Measure	Nimenrix Group n=189 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.	Menjugate Group n=66 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 44. rSBA-MenA	162 Participants	17 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 44. rSBA-MenC	70 Participants	30 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 44. rSBA-MenW-135	129 Participants	7 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 44. rSBA-MenY	118 Participants	4 Participants

PRIMARY outcome

Timeframe: At Month 56, post-primary vaccination

Population: The analysis was performed on the ATP cohort for persistence at Month 56, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 56.

The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory.

Outcome measures

Measure	Nimenrix Group n=186 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.	Menjugate Group n=65 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 56. rSBA-MenA	161 Participants	19 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 56. rSBA-MenC	110 Participants	42 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 56. rSBA-MenW-135	145 Participants	17 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 56. rSBA-MenY	149 Participants	14 Participants

PRIMARY outcome

Timeframe: At Month 68, post-primary vaccination

Population: The analysis was performed on the ATP cohort for persistence at Month 68, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 68.

The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory.

Outcome measures

Measure	Nimenrix Group n=178 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.	Menjugate Group n=61 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 68. rSBA-MenA	154 Participants	18 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 68. rSBA-MenC	71 Participants	38 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 68. rSBA-MenW-135	94 Participants	9 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:8, at Month 68. rSBA-MenY	127 Participants	8 Participants

SECONDARY outcome

Timeframe: At Month 32, post-primary vaccination

Population: The analysis was performed on the ATP cohort for persistence at Month 32, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 32.

The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:128. These analyses have been performed by the Health Protection Agency (HPA) laboratory.

Outcome measures

Measure	Nimenrix Group n=193 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.	Menjugate Group n=69 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 32. rSBA-MenA	140 Participants	9 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 32. rSBA-MenC	69 Participants	35 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 32. rSBA-MenW-135	136 Participants	5 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 32. rSBA-MenY	145 Participants	8 Participants

SECONDARY outcome

Timeframe: At Month 44, post-primary vaccination

Population: The analysis was performed on the ATP cohort for persistence at Month 44, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 44.

The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:128. These analyses have been performed by the Health Protection Agency (HPA) laboratory.

Outcome measures

Measure	Nimenrix Group n=189 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.	Menjugate Group n=66 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 44. rSBA-MenA	151 Participants	16 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 44. rSBA-MenC	38 Participants	23 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 44. rSBA-MenW-135	120 Participants	5 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 44. rSBA-MenY	107 Participants	3 Participants

SECONDARY outcome

Timeframe: At Month 56, post-primary vaccination

Population: The analysis was performed on the ATP cohort for persistence at Month 56, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 56.

The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:128. These analyses have been performed by the Health Protection Agency (HPA) laboratory.

Outcome measures

Measure	Nimenrix Group n=186 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.	Menjugate Group n=65 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 56. rSBA-MenA	107 Participants	10 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 56. rSBA-MenC	65 Participants	32 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 56. rSBA-MenW-135	123 Participants	10 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 56. rSBA-MenY	139 Participants	10 Participants

SECONDARY outcome

Timeframe: At Month 68, post-primary vaccination

Population: The analysis was performed on the ATP cohort for persistence at Month 68, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 68.

The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:128. These analyses have been performed by the Health Protection Agency (HPA) laboratory.

Outcome measures

Measure	Nimenrix Group n=178 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.	Menjugate Group n=61 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 68. rSBA-MenA	107 Participants	12 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 68. rSBA-MenC	38 Participants	25 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 68. rSBA-MenW-135	84 Participants	8 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128, at Month 68. rSBA-MenY	118 Participants	6 Participants

SECONDARY outcome

Timeframe: At Month 32, post-primary vaccination

Population: The analysis was performed on the ATP cohort for persistence at Month 32, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 32.

Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed by the Health Protection Agency (HPA) laboratory.

Outcome measures

Measure	Nimenrix Group n=193 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.	Menjugate Group n=69 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 32. rSBA-MenA	196.3 Titers Interval 144.1 to 267.2	8 Titers Interval 5.5 to 11.7
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 32. rSBA-MenC	34.8 Titers Interval 26.0 to 46.4	86.5 Titers Interval 47.3 to 158.1
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 32. rSBA-MenW-135	213.9 Titers Interval 149.3 to 306.6	5.6 Titers Interval 4.2 to 7.6
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 32. rSBA-MenY	227.4 Titers Interval 164.8 to 313.7	7.2 Titers Interval 5.0 to 10.4

SECONDARY outcome

Timeframe: At Month 44, post-primary vaccination

Population: The analysis was performed on the ATP cohort for persistence at Month 44, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 44.

Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed by the Health Protection Agency (HPA) laboratory.

Outcome measures

Measure	Nimenrix Group n=189 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.	Menjugate Group n=66 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 44. rSBA-MenA	307.5 Titers Interval 223.7 to 422.8	13.5 Titers Interval 8.0 to 23.0
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 44. rSBA-MenC	14.5 Titers Interval 10.9 to 19.2	31 Titers Interval 16.6 to 58.0
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 44. rSBA-MenW-135	103.5 Titers Interval 72.5 to 147.6	5.9 Titers Interval 4.3 to 8.1
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 44. rSBA-MenY	78.9 Titers Interval 54.6 to 114.0	4.9 Titers Interval 3.9 to 6.2

SECONDARY outcome

Timeframe: At Month 56, post-primary vaccination

Population: The analysis was performed on the ATP cohort for persistence at Month 56, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 56.

Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed by the Health Protection Agency (HPA) laboratory.

Outcome measures

Measure	Nimenrix Group n=186 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.	Menjugate Group n=65 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 56. rSBA-MenC	30.5 Titers Interval 22.6 to 41.1	69.0 Titers Interval 36.9 to 128.9
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 56. rSBA-MenA	120.1 Titers Interval 87.0 to 165.9	9.8 Titers Interval 6.4 to 15.0
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 56. rSBA-MenW-135	158.3 Titers Interval 112.4 to 222.9	10.3 Titers Interval 6.4 to 16.6
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 56. rSBA-MenY	233.2 Titers Interval 166.0 to 327.6	9.0 Titers Interval 6.0 to 13.6

SECONDARY outcome

Timeframe: At Month 68, post-primary vaccination

Population: The analysis was performed on the ATP cohort for persistence at Month 68, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 68.

Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed by the Health Protection Agency (HPA) laboratory.

Outcome measures

Measure	Nimenrix Group n=178 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.	Menjugate Group n=61 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 68. rSBA-MenY	139.4 Titers Interval 96.0 to 202.5	6.8 Titers Interval 4.6 to 10.2
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 68. rSBA-MenA	129.5 Titers Interval 93.5 to 179.3	11.1 Titers Interval 7.0 to 17.7
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 68. rSBA-MenC	14.2 Titers Interval 10.8 to 18.7	44.5 Titers Interval 23.7 to 83.6
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY, at Month 68. rSBA-MenW-135	59.2 Titers Interval 39.3 to 89.2	7.8 Titers Interval 5.0 to 12.1

SECONDARY outcome

Timeframe: At Month 32, post-primary vaccination

Population: The analysis was performed on the ATP cohort for persistence at Month 32, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 32.

The pre-defined cut-off values of the assay for the hSBA titers were greater than or equal to (≥) 1:4 and ≥ 1:8. These analyses have been performed on 50% of the subjects in each group, by the Health Protection Agency (HPA) laboratory.

Outcome measures

Measure	Nimenrix Group n=91 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.	Menjugate Group n=34 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With Serum Bactericidal Assay, Using Human Complement, Against N. Meningitides Serogroup A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 32. hSBA-MenA, ≥ 1:4	24 Participants	5 Participants
Number of Subjects With Serum Bactericidal Assay, Using Human Complement, Against N. Meningitides Serogroup A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 32. hSBA-MenC, ≥ 1:4	86 Participants	30 Participants
Number of Subjects With Serum Bactericidal Assay, Using Human Complement, Against N. Meningitides Serogroup A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 32. hSBA-MenW-135, ≥ 1:4	73 Participants	4 Participants
Number of Subjects With Serum Bactericidal Assay, Using Human Complement, Against N. Meningitides Serogroup A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 32. hSBA-MenY, ≥ 1:4	74 Participants	13 Participants
Number of Subjects With Serum Bactericidal Assay, Using Human Complement, Against N. Meningitides Serogroup A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 32. hSBA-MenA, ≥ 1:8	23 Participants	5 Participants
Number of Subjects With Serum Bactericidal Assay, Using Human Complement, Against N. Meningitides Serogroup A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 32. hSBA-MenC, ≥ 1:8	86 Participants	30 Participants
Number of Subjects With Serum Bactericidal Assay, Using Human Complement, Against N. Meningitides Serogroup A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 32. hSBA-MenW-135, ≥ 1:8	73 Participants	4 Participants
Number of Subjects With Serum Bactericidal Assay, Using Human Complement, Against N. Meningitides Serogroup A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 32. hSBA-MenY, ≥ 1:8	74 Participants	13 Participants

SECONDARY outcome

Timeframe: At Month 44, post-primary vaccination

Population: The analysis was performed on the ATP cohort for persistence at Month 44, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 44.

The pre-defined cut-off values of the assay for the hSBA titers were greater than or equal to (≥) 1:4 and ≥ 1:8. These analyses have been performed on 50% of the subjects in each group, by the Health Protection Agency (HPA) laboratory.

Outcome measures

Measure	Nimenrix Group n=89 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.	Menjugate Group n=31 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 44. hSBA-MenA, ≥ 1:4	26 Participants	5 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 44. hSBA-MenC, ≥ 1:4	63 Participants	20 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 44. hSBA-MenW-135, ≥ 1:4	70 Participants	8 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 44. hSBA-MenY, ≥ 1:4	63 Participants	12 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 44. hSBA-MenA, ≥ 1:8	23 Participants	5 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 44. hSBA-MenC, ≥ 1:8	63 Participants	20 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 44. hSBA-MenW-135, ≥ 1:8	70 Participants	8 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 44. hSBA-MenY, ≥ 1:8	63 Participants	12 Participants

SECONDARY outcome

Timeframe: At Month 56, post-primary vaccination

Population: The analysis was performed on the ATP cohort for persistence at Month 56, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 56.

The pre-defined cut-off values of the assay for the hSBA titers were greater than or equal to (≥) 1:4 and ≥ 1:8. These analyses have been performed on 50% of the subjects in each group, by the Health Protection Agency (HPA) laboratory.

Outcome measures

Measure	Nimenrix Group n=89 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.	Menjugate Group n=33 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 56. hSBA-MenA, ≥ 1:4	53 Participants	19 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 56. hSBA-MenC, ≥ 1:4	66 Participants	21 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 56. hSBA-MenW-135, ≥ 1:4	69 Participants	13 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 56. hSBA-MenY, ≥ 1:4	79 Participants	22 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 56. hSBA-MenA, ≥ 1:8	53 Participants	19 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 56. hSBA-MenC, ≥ 1:8	64 Participants	21 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 56. hSBA-MenW-135, ≥ 1:8	69 Participants	13 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 56. hSBA-MenY, ≥ 1:8	79 Participants	22 Participants

SECONDARY outcome

Timeframe: At Month 68, post-primary vaccination

Population: The analysis was performed on the ATP cohort for persistence at Month 68, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 68.

The pre-defined cut-off values of the assay for the hSBA titers were greater than or equal to (≥) 1:4 and ≥ 1:8. These analyses have been performed in all subjects, by the Health Protection Agency (HPA) laboratory.

Outcome measures

Measure	Nimenrix Group n=172 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.	Menjugate Group n=59 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 68. hSBA-MenA, ≥ 1:4	70 Participants	23 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 68. hSBA-MenC, ≥ 1:4	134 Participants	43 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 68. hSBA-MenW-135, ≥ 1:4	125 Participants	19 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 68. hSBA-MenY, ≥ 1:4	116 Participants	24 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 68. hSBA-MenA, ≥ 1:8	69 Participants	21 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 68. hSBA-MenC, ≥ 1:8	130 Participants	43 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 68. hSBA-MenW-135, ≥ 1:8	125 Participants	19 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and ≥ 1:8, at Month 68. hSBA-MenY, ≥ 1:8	116 Participants	24 Participants

SECONDARY outcome

Timeframe: At Month 32, post-primary vaccination

Population: The analysis was performed on the ATP cohort for persistence at Month 32, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 32.

Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed on 50% of the subjects in each group, by the Health Protection Agency (HPA) laboratory.

Outcome measures

Measure	Nimenrix Group n=91 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.	Menjugate Group n=34 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 32. hSBA-MenA	4.6 Titers Interval 3.3 to 6.3	2.7 Titers Interval 2.1 to 3.4
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 32. hSBA-MenC	75.9 Titers Interval 53.4 to 107.9	82.2 Titers Interval 34.6 to 195.8
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 32. hSBA-MenW-135	69.9 Titers Interval 48.2 to 101.5	3.8 Titers Interval 2.0 to 7.1
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 32. hSBA-MenY	79.2 Titers Interval 52.5 to 119.3	15.1 Titers Interval 6.3 to 36.5

SECONDARY outcome

Timeframe: At Month 44, post-primary vaccination

Population: The analysis was performed on the ATP cohort for persistence at Month 44, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 44.

Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed on 50% of the subjects in each group, by the Health Protection Agency (HPA) laboratory.

Outcome measures

Measure	Nimenrix Group n=89 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.	Menjugate Group n=31 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 44. hSBA-MenA	4.8 Titers Interval 3.4 to 6.7	2.8 Titers Interval 2.1 to 3.7
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 44. hSBA-MenC	36.4 Titers Interval 23.1 to 57.2	38.8 Titers Interval 13.3 to 113.2
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 44. hSBA-MenW-135	64.3 Titers Interval 42.7 to 96.8	5.2 Titers Interval 2.8 to 9.5
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 44. hSBA-MenY	126.7 Titers Interval 78.0 to 205.7	16.8 Titers Interval 16.8 to 44.9

SECONDARY outcome

Timeframe: At Month 56, post-primary vaccination

Population: The analysis was performed on the ATP cohort for persistence at Month 56, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 56.

Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed on 50% of the subjects in each group, by the Health Protection Agency (HPA) laboratory.

Outcome measures

Measure	Nimenrix Group n=89 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.	Menjugate Group n=33 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 56. hSBA-MenA	10.6 Titers Interval 7.6 to 14.9	7.6 Titers Interval 5.0 to 11.8
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 56. hSBA-MenC	20.6 Titers Interval 13.8 to 30.8	31.2 Titers Interval 11.5 to 85.0
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 56. hSBA-MenW-135	59.3 Titers Interval 40.2 to 87.6	9.2 Titers Interval 4.7 to 18.2
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 56. hSBA-MenY	117.9 Titers Interval 80.8 to 171.9	35.7 Titers Interval 16.8 to 75.9

SECONDARY outcome

Timeframe: At Month 68, post-primary vaccination

Population: The analysis was performed on the ATP cohort for persistence at Month 68, which included all evaluable subjects primed during the primary 111414 study (NCT00674583) according to their treatment group, for whom assay results were available for at least one tested antigen at Month 68.

Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed by the Health Protection Agency (HPA) laboratory.

Outcome measures

Measure	Nimenrix Group n=172 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.	Menjugate Group n=59 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 68. hSBA-MenA	6.9 Titers Interval 5.4 to 8.9	4.5 Titers Interval 3.3 to 6.0
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 68. hSBA-MenC	28.4 Titers Interval 21.2 to 37.9	34.3 Titers Interval 19.0 to 61.0
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 68. hSBA-MenW-135	56.7 Titers Interval 41.5 to 77.3	8.1 Titers Interval 4.7 to 13.8
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY, at Month 68. hSBA-MenY	56.3 Titers Interval 39.5 to 80.3	13.3 Titers Interval 7.0 to 25.1

SECONDARY outcome

Timeframe: At Month 69, one month post-booster vaccination

Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects from the Booster ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the booster vaccination.

The pre-defined cut-off values of the assay for the rSBA titers were greater than or equal to (≥) 1:128 and ≥ 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory.

Outcome measures

Measure	Nimenrix Group n=165 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.	Menjugate Group n=55 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128 and 1:8. rSBA-MenA, ≥ 1:128	165 Participants	55 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128 and 1:8. rSBA-MenC, ≥ 1:128	165 Participants	55 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128 and 1:8. rSBA-MenY, ≥ 1:128	165 Participants	55 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128 and 1:8. rSBA-MenW-135, ≥ 1:128	165 Participants	55 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128 and 1:8. rSBA-MenA, ≥ 1:8	165 Participants	55 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128 and 1:8. rSBA-MenC, ≥ 1:8	165 Participants	55 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128 and 1:8. rSBA-MenW-135, ≥ 1:8	165 Participants	55 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ 1:128 and 1:8. rSBA-MenY, ≥ 1:8	165 Participants	55 Participants

SECONDARY outcome

Timeframe: At Month 69, one month post-booster vaccination

Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects from the Booster ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the booster vaccination.

Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed by the Health Protection Agency (HPA) laboratory.

Outcome measures

Measure	Nimenrix Group n=165 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.	Menjugate Group n=55 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY rSBA-MenA	5613.0 Titers Interval 4946.3 to 6369.4	3521.1 Titers Interval 2912.5 to 4256.9
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY rSBA-MenC	5314.6 Titers Interval 4596.2 to 6145.4	7042.2 Titers Interval 5317.4 to 9326.5
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY rSBA-MenW-135	14750.6 Titers Interval 12779.6 to 17025.6	10540.4 Titers Interval 8455.2 to 13139.8
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY rSBA-MenY	7954.6 Titers Interval 7167.8 to 8827.8	5829.2 Titers Interval 4725.6 to 7190.6

SECONDARY outcome

Timeframe: At Month 69, one month post-booster vaccination

Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects from the Booster ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the booster vaccination.

The pre-defined cut-off values of the assay for the hSBA titers were greater than or equal to (≥) 1:4 and ≥ 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory.

Outcome measures

Measure	Nimenrix Group n=163 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.	Menjugate Group n=54 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and 1:8. hSBA-MenA, ≥ 1:4	163 Participants	46 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and 1:8. hSBA-MenC, ≥ 1:4	161 Participants	54 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and 1:8. hSBA-MenW-135, ≥ 1:4	156 Participants	50 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and 1:8. hSBA-MenY, ≥ 1:4	160 Participants	52 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and 1:8. hSBA-MenA, ≥ 1:8	163 Participants	46 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and 1:8. hSBA-MenC, ≥ 1:8	161 Participants	54 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and 1:8. hSBA-MenW-135, ≥ 1:8	156 Participants	50 Participants
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ 1:4 and 1:8. hSBA-MenY, ≥ 1:8	160 Participants	52 Participants

SECONDARY outcome

Timeframe: At Month 69, one month post-booster vaccination

Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects from the Booster ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the booster vaccination.

Antibody titers were presented as geometric mean titers (GMTs). These analyses were performed by the Health Protection Agency (HPA) laboratory.

Outcome measures

Measure	Nimenrix Group n=163 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.	Menjugate Group n=54 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY hSBA-MenA	1376.5 Titers Interval 1138.2 to 1664.6	101.2 Titers Interval 59.3 to 172.8
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY hSBA-MenC	11986.8 Titers Interval 10085.2 to 14247.0	13692.2 Titers Interval 10094.2 to 18572.8
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY hSBA-MenW-135	14582.1 Titers Interval 12448.5 to 17081.5	235.7 Titers Interval 152.0 to 365.5
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY hSBA-MenY	12835.9 Titers Interval 11074.4 to 14877.5	527.3 Titers Interval 356.5 to 779.9

SECONDARY outcome

Timeframe: At Month 69, one month post-booster vaccination

Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects from the Booster ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the booster vaccination.

Vaccine response to rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY 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

Measure	Nimenrix Group n=165 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.	Menjugate Group n=55 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With a Vaccine Response to rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies rSBA-MenA	147 Participants	54 Participants
Number of Subjects With a Vaccine Response to rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies rSBA-MenC	161 Participants	48 Participants
Number of Subjects With a Vaccine Response to rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies rSBA-MenW-135	157 Participants	54 Participants
Number of Subjects With a Vaccine Response to rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies rSBA-MenY	156 Participants	54 Participants

SECONDARY outcome

Timeframe: At Month 69, one month post-booster vaccination

Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects from the Booster ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the booster vaccination.

Vaccine response to hSBA-MenA, hSBA-MenC, rSBA-MenW-135 and hSBA-MenY was defined as hSBA antibody titers ≥ 1:8, for initially seronegative subjects (i.e. pre-vaccination hSBA 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 hSBA antibody titers ≥1:4).

Outcome measures

Measure	Nimenrix Group n=159 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.	Menjugate Group n=52 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With a Vaccine Response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies hSBA-MenA	156 Participants	43 Participants
Number of Subjects With a Vaccine Response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies hSBA-MenC	153 Participants	46 Participants
Number of Subjects With a Vaccine Response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies hSBA-MenW-135	136 Participants	34 Participants
Number of Subjects With a Vaccine Response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies hSBA-MenY	142 Participants	35 Participants

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) period following the booster vaccination

Population: The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in the primary 111414 study (NCT00674583) with the booster vaccine administration documented, who filled in their symptom sheets.

Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 50 millimeters (mm). "Any" was defined as incidence of the specified symptom regardless of intensity.

Outcome measures

Measure	Nimenrix Group n=171 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.	Menjugate Group n=60 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain	113 Participants	35 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain	7 Participants	4 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness	62 Participants	25 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness	8 Participants	4 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling	52 Participants	19 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling	4 Participants	3 Participants

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) period following the booster vaccination

Population: The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in the primary 111414 study (NCT00674583) with the booster vaccine administration documented, who had their symptom sheets filled in.

Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache and temperature (axillary temperature higher than [≥] 37.5 degrees Celsius [°C]). Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Fatigue = Fatigue that prevented normal activity. Grade 3 Gastrointestinal symptoms = Gastrointestinal symptoms that prevented normal everyday activities. Grade 3 Headache = Headache that prevented normal acitivity. Grade 3 Fever = Rectal temperature higher than (>) 39.5°C.

Outcome measures

Measure	Nimenrix Group n=169 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.	Menjugate Group n=58 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With Any, Grade 3 and Solicited General Symptoms Any Gastrointestinal symptoms	19 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Solicited General Symptoms Grade 3 Gastrointestinal symptoms	2 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Solicited General Symptoms Related Gastrointestinal symptoms	10 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Solicited General Symptoms Any Headache	43 Participants	10 Participants
Number of Subjects With Any, Grade 3 and Solicited General Symptoms Grade 3 Headache	7 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Solicited General Symptoms Related Headache	27 Participants	8 Participants
Number of Subjects With Any, Grade 3 and Solicited General Symptoms Any Temperature	11 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Solicited General Symptoms Grade 3 Temperature	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Solicited General Symptoms Related Temperature	9 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Solicited General Symptoms Any Fatigue	38 Participants	12 Participants
Number of Subjects With Any, Grade 3 and Solicited General Symptoms Grade 3 Fatigue	3 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Solicited General Symptoms Related Fatigue	28 Participants	10 Participants

SECONDARY outcome

Timeframe: During the 31-day (Days 0-30) period following the booster vaccination

Population: The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in the primary 111414 study (NCT00674583) with the booster vaccine administration documented.

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

Outcome measures

Measure	Nimenrix Group n=179 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.	Menjugate Group n=62 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With Any Unsolicited Adverse Events (AEs)	26 Participants	8 Participants

SECONDARY outcome

Timeframe: During the 31-day (Days 0-30) period following the booster vaccination

Population: The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in the primary 111414 study (NCT00674583) with the booster 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

Measure	Nimenrix Group n=179 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.	Menjugate Group n=62 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With Serious Adverse Events (SAEs)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During the 31-day (Days 0-30) period following the booster vaccination

Population: The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in the primary 111414 study (NCT00674583) with the booster vaccine administration documented.

New onset of chronic illnesses (NOCIs) included: autoimmune disorders, asthma, type I diabetes and allergies.

Outcome measures

Measure	Nimenrix Group n=179 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.	Menjugate Group n=62 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With Any New Onset of Chronic Illnesses (NOCIs)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Month 32, 44, 56 and 68

Population: The analysis was performed on the Total Vaccinated cohort at Months 32, 44, 56 annd 68, which included all vaccinated subjects in the primary 111414 study (NCT00674583) who came back for persistence visit at Months 32, 44, 56 and 68, respectively.

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

Outcome measures

Measure	Nimenrix Group n=199 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.	Menjugate Group n=72 Participants Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With Serious Adverse Events SAEs Up to Month 44	0 Participants	0 Participants
Number of Subjects With Serious Adverse Events SAEs Up to Month 32	0 Participants	0 Participants
Number of Subjects With Serious Adverse Events SAEs Up to Month 56	0 Participants	0 Participants
Number of Subjects With Serious Adverse Events SAEs Up to Month 68	0 Participants	0 Participants

Adverse Events

Nimenrix Group

Serious events: 0 serious events

Other events: 130 other events

Deaths: 0 deaths

Menjugate Group

Serious events: 0 serious events

Other events: 48 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Nimenrix Group n=179 participants at risk Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.	Menjugate Group n=62 participants at risk Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm.
Skin and subcutaneous tissue disorders Erythema	34.6% 62/179 • Number of events 62 • 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: during the entire study period (Month 32 up to Month 69).	40.3% 25/62 • Number of events 25 • 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: during the entire study period (Month 32 up to Month 69).
General disorders Fatigue	21.2% 38/179 • Number of events 38 • 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: during the entire study period (Month 32 up to Month 69).	19.4% 12/62 • Number of events 12 • 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: during the entire study period (Month 32 up to Month 69).
Gastrointestinal disorders Gastrointestinal disorder	10.6% 19/179 • 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: during the entire study period (Month 32 up to Month 69).	11.3% 7/62 • Number of events 7 • 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: during the entire study period (Month 32 up to Month 69).
Nervous system disorders Headache	24.0% 43/179 • Number of events 49 • 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: during the entire study period (Month 32 up to Month 69).	16.1% 10/62 • Number of events 10 • 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: during the entire study period (Month 32 up to Month 69).
General disorders Pain	63.1% 113/179 • Number of events 113 • 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: during the entire study period (Month 32 up to Month 69).	56.5% 35/62 • Number of events 35 • 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: during the entire study period (Month 32 up to Month 69).
General disorders Pyrexia	9.5% 17/179 • Number of events 17 • 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: during the entire study period (Month 32 up to Month 69).	12.9% 8/62 • Number of events 8 • 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: during the entire study period (Month 32 up to Month 69).
General disorders Swelling	29.1% 52/179 • Number of events 52 • 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: during the entire study period (Month 32 up to Month 69).	30.6% 19/62 • 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: during the entire study period (Month 32 up to Month 69).

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: GSKClinicalSupportHD@gsk.com

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