Trial Outcomes & Findings for Safety & Immunogenicity of 1 Dose of GSK134612 in Children 12-14 Months and 3-5 Years Old (NCT NCT00196976)

NCT ID: NCT00196976

Last Updated: 2018-06-08

Results Overview

A responder to serum bactericidal assay meningococcal serogroups A, C, W and Y, using rabbit complement (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY) was defined as follows: -for initially seronegative subjects (antibody titers \< 1:8 for rSBA-Men), a subject achieving a post-vaccination rSBA-Men antibody titer of ≥ 1:32; - for initially seropositive subjects (antibody titers ≥ 1:8 for rSBA-Men), a subject having a ≥ 4-fold increase in rSBA-Men antibody titer from pre to post vaccination.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 461 participants
• Primary outcome timeframe: One month after the first vaccine dose (Month 1)
• Results posted on: 2018-06-08

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

Measure	GSK134612A Form1 (T), Primary Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form2 (T), Primary Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form3 (T), Primary Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form4 (T), Primary Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	Control (T), Primary Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form1 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form2 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form3 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form4 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	Control (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).	GSK134612A Form1 (T), Booster Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).	Control (T), Booster Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer's Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).	GSK134612A Form1 (C), Booster Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination.	Control (C), Booster Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer's Meningitec™ conjugate vaccine, did not receive any booster vaccination.
Primary Study STARTED	39	41	41	40	40	54	50	52	52	52	0	0	0	0
Primary Study COMPLETED	38	40	37	39	37	52	50	49	52	51	0	0	0	0
Primary Study NOT COMPLETED	1	1	4	1	3	2	0	3	0	1	0	0	0	0
Booster Study STARTED	0	0	0	0	0	0	0	0	0	0	33	32	45	43
Booster Study COMPLETED	0	0	0	0	0	0	0	0	0	0	31	30	45	43
Booster Study NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	2	2	0	0

Reasons for withdrawal

Measure	GSK134612A Form1 (T), Primary Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form2 (T), Primary Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form3 (T), Primary Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form4 (T), Primary Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	Control (T), Primary Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form1 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form2 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form3 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form4 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	Control (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).	GSK134612A Form1 (T), Booster Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).	Control (T), Booster Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer's Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).	GSK134612A Form1 (C), Booster Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination.	Control (C), Booster Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer's Meningitec™ conjugate vaccine, did not receive any booster vaccination.
Primary Study Migrated from study area	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Primary Study Protocol Violation	0	1	1	0	0	0	0	0	0	0	0	0	0	0
Primary Study Withdrawal by Subject	1	0	1	1	2	1	0	0	0	1	0	0	0	0
Primary Study Lost to Follow-up	0	0	0	0	1	1	0	2	0	0	0	0	0	0
Primary Study Other	0	0	2	0	0	0	0	0	0	0	0	0	0	0
Booster Study Withdrawal by Subject	0	0	0	0	0	0	0	0	0	0	1	0	0	0
Booster Study Lost to Follow-up	0	0	0	0	0	0	0	0	0	0	1	2	0	0

Baseline Characteristics

Safety & Immunogenicity of 1 Dose of GSK134612 in Children 12-14 Months and 3-5 Years Old

Baseline characteristics by cohort

Measure	GSK134612A Form1 (T), Primary Group n=39 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form2 (T), Primary Group n=41 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form3 (T), Primary Group n=41 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form4 (T), Primary Group n=40 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	Control (T), Primary Group n=40 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form1 (C), Primary Group n=54 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form2 (C), Primary Group n=50 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form3 (C), Primary Group n=52 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form4 (C), Primary Group n=52 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	Control (C), Primary Group n=52 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).	GSK134612A Form1 (T), Booster Group n=33 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).	Control (T), Booster Group n=32 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer's Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).	GSK134612A Form1 (C), Booster Group n=45 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination.	Control (C), Booster Group n=43 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer's Meningitec™ conjugate vaccine, did not receive any booster vaccination.	Total n=614 Participants Total of all reporting groups
Age, Continuous	NA Months STANDARD_DEVIATION NA • n=5 Participants	NA Months STANDARD_DEVIATION NA • n=7 Participants	NA Months STANDARD_DEVIATION NA • n=5 Participants	NA Months STANDARD_DEVIATION NA • n=4 Participants	NA Months STANDARD_DEVIATION NA • n=21 Participants	NA Months STANDARD_DEVIATION NA • n=8 Participants	NA Months STANDARD_DEVIATION NA • n=8 Participants	NA Months STANDARD_DEVIATION NA • n=24 Participants	NA Months STANDARD_DEVIATION NA • n=42 Participants	NA Months STANDARD_DEVIATION NA • n=42 Participants	24.9 Months STANDARD_DEVIATION 1.24 • n=42 Participants	24.9 Months STANDARD_DEVIATION 1.27 • n=42 Participants	60.8 Months STANDARD_DEVIATION 7.23 • n=36 Participants	60.0 Months STANDARD_DEVIATION 7.36 • n=36 Participants	45.32 Months STANDARD_DEVIATION 18.47 • n=24 Participants
Sex: Female, Male Female	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants	NA Participants n=4 Participants	NA Participants n=21 Participants	NA Participants n=8 Participants	NA Participants n=8 Participants	NA Participants n=24 Participants	NA Participants n=42 Participants	NA Participants n=42 Participants	11 Participants n=42 Participants	15 Participants n=42 Participants	16 Participants n=36 Participants	23 Participants n=36 Participants	NA Participants n=24 Participants
Sex: Female, Male Male	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants	NA Participants n=4 Participants	NA Participants n=21 Participants	NA Participants n=8 Participants	NA Participants n=8 Participants	NA Participants n=24 Participants	NA Participants n=42 Participants	NA Participants n=42 Participants	22 Participants n=42 Participants	17 Participants n=42 Participants	29 Participants n=36 Participants	20 Participants n=36 Participants	NA Participants n=24 Participants
Race/Ethnicity, Customized White/ Caucasian	38 Participants n=5 Participants	40 Participants n=7 Participants	40 Participants n=5 Participants	38 Participants n=4 Participants	39 Participants n=21 Participants	53 Participants n=8 Participants	50 Participants n=8 Participants	50 Participants n=24 Participants	50 Participants n=42 Participants	51 Participants n=42 Participants	NA Participants n=42 Participants	NA Participants n=42 Participants	NA Participants n=36 Participants	NA Participants n=36 Participants	NA Participants n=24 Participants
Race/Ethnicity, Customized Arabic/ north african	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	2 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	NA Participants n=42 Participants	NA Participants n=42 Participants	NA Participants n=36 Participants	NA Participants n=36 Participants	NA Participants n=24 Participants
Race/Ethnicity, Customized East/ south east asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	NA Participants n=42 Participants	NA Participants n=42 Participants	NA Participants n=36 Participants	NA Participants n=36 Participants	NA Participants n=24 Participants
Race/Ethnicity, Customized Black	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	NA Participants n=42 Participants	NA Participants n=42 Participants	NA Participants n=36 Participants	NA Participants n=36 Participants	NA Participants n=24 Participants
Race/Ethnicity, Customized White/Caucasian	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants	NA Participants n=4 Participants	NA Participants n=21 Participants	NA Participants n=8 Participants	NA Participants n=8 Participants	NA Participants n=24 Participants	NA Participants n=42 Participants	NA Participants n=42 Participants	32 Participants n=42 Participants	31 Participants n=42 Participants	44 Participants n=36 Participants	43 Participants n=36 Participants	NA Participants n=24 Participants
Race/Ethnicity, Customized Arabic/north African	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants	NA Participants n=4 Participants	NA Participants n=21 Participants	NA Participants n=8 Participants	NA Participants n=8 Participants	NA Participants n=24 Participants	NA Participants n=42 Participants	NA Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=36 Participants	0 Participants n=36 Participants	NA Participants n=24 Participants

PRIMARY outcome

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

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

A responder to serum bactericidal assay meningococcal serogroups A, C, W and Y, using rabbit complement (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY) was defined as follows: -for initially seronegative subjects (antibody titers < 1:8 for rSBA-Men), a subject achieving a post-vaccination rSBA-Men antibody titer of ≥ 1:32; - for initially seropositive subjects (antibody titers ≥ 1:8 for rSBA-Men), a subject having a ≥ 4-fold increase in rSBA-Men antibody titer from pre to post vaccination.

Outcome measures

Measure	GSK134612A Form1 (T), Primary Group n=36 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form2 (T), Primary Group n=36 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form3 (T), Primary Group n=29 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form4 (T), Primary Group n=35 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	Control (T), Primary Group n=33 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form1 (C), Primary Group n=50 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form2 (C), Primary Group n=48 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form3 (C), Primary Group n=46 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form4 (C), Primary Group n=50 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	Control (C), Primary Group n=43 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
Number of Subjects With an Immune Response to Different Meningococcal Serogroups rSBA-MenA	30 Participants	32 Participants	26 Participants	27 Participants	6 Participants	41 Participants	38 Participants	41 Participants	42 Participants	36 Participants
Number of Subjects With an Immune Response to Different Meningococcal Serogroups rSBA-MenC	30 Participants	32 Participants	26 Participants	33 Participants	30 Participants	45 Participants	44 Participants	44 Participants	46 Participants	34 Participants
Number of Subjects With an Immune Response to Different Meningococcal Serogroups rSBA-MenW-135	34 Participants	36 Participants	27 Participants	35 Participants	3 Participants	46 Participants	44 Participants	46 Participants	48 Participants	36 Participants
Number of Subjects With an Immune Response to Different Meningococcal Serogroups rSBA-MenY	33 Participants	34 Participants	26 Participants	34 Participants	3 Participants	46 Participants	47 Participants	45 Participants	47 Participants	34 Participants

SECONDARY outcome

Timeframe: Prior to (Month 0) and one month after (Month 1) the first vaccine dose

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

A seroprotected subject against meningococcal serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY assessed, was defined as having antibody titers greater than or equal to (≥) 1:8.

Outcome measures

Measure	GSK134612A Form1 (T), Primary Group n=36 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form2 (T), Primary Group n=38 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form3 (T), Primary Group n=30 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form4 (T), Primary Group n=35 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	Control (T), Primary Group n=35 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form1 (C), Primary Group n=51 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form2 (C), Primary Group n=48 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form3 (C), Primary Group n=48 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form4 (C), Primary Group n=50 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	Control (C), Primary Group n=44 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
Number of Seroprotected Subjects Against Different Meningococcal Serogroups rSBA-MenA, Month 0	23 Participants	22 Participants	19 Participants	21 Participants	20 Participants	41 Participants	42 Participants	40 Participants	47 Participants	39 Participants
Number of Seroprotected Subjects Against Different Meningococcal Serogroups rSBA-MenA, Month 1	36 Participants	38 Participants	30 Participants	34 Participants	23 Participants	50 Participants	47 Participants	48 Participants	50 Participants	43 Participants
Number of Seroprotected Subjects Against Different Meningococcal Serogroups rSBA-MenC, Month 0	5 Participants	2 Participants	2 Participants	5 Participants	3 Participants	16 Participants	8 Participants	17 Participants	12 Participants	14 Participants
Number of Seroprotected Subjects Against Different Meningococcal Serogroups rSBA-MenC, Month 1	36 Participants	38 Participants	28 Participants	35 Participants	34 Participants	50 Participants	47 Participants	47 Participants	49 Participants	43 Participants
Number of Seroprotected Subjects Against Different Meningococcal Serogroups rSBA-MenW-135, Month 0	17 Participants	19 Participants	12 Participants	13 Participants	15 Participants	34 Participants	24 Participants	25 Participants	36 Participants	27 Participants
Number of Seroprotected Subjects Against Different Meningococcal Serogroups rSBA-MenW-135, Month 1	35 Participants	38 Participants	30 Participants	35 Participants	15 Participants	50 Participants	48 Participants	48 Participants	50 Participants	44 Participants
Number of Seroprotected Subjects Against Different Meningococcal Serogroups rSBA-MenY, Month 0	23 Participants	17 Participants	16 Participants	19 Participants	22 Participants	37 Participants	42 Participants	39 Participants	42 Participants	36 Participants
Number of Seroprotected Subjects Against Different Meningococcal Serogroups rSBA-MenY, Month 1	35 Participants	38 Participants	29 Participants	35 Participants	25 Participants	51 Participants	48 Participants	48 Participants	50 Participants	44 Participants

SECONDARY outcome

Timeframe: Prior to (Month 0) and one month after (Month 1) after the first vaccine dose

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

A seropositive subject for meningococcal serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Y assessed, was defined as having antibody titers greater than or equal to (≥) 1:128.

Outcome measures

Measure	GSK134612A Form1 (T), Primary Group n=36 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form2 (T), Primary Group n=38 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form3 (T), Primary Group n=30 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form4 (T), Primary Group n=35 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	Control (T), Primary Group n=35 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form1 (C), Primary Group n=51 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form2 (C), Primary Group n=48 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form3 (C), Primary Group n=48 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form4 (C), Primary Group n=50 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	Control (C), Primary Group n=44 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
Number of Seropositive Subjects for Different Anti-meningococcal Serogroups rSBA-MenA, Month 0	19 Participants	19 Participants	13 Participants	19 Participants	17 Participants	41 Participants	39 Participants	40 Participants	46 Participants	37 Participants
Number of Seropositive Subjects for Different Anti-meningococcal Serogroups rSBA-MenA, Month 1	36 Participants	38 Participants	29 Participants	34 Participants	20 Participants	49 Participants	47 Participants	48 Participants	50 Participants	43 Participants
Number of Seropositive Subjects for Different Anti-meningococcal Serogroups rSBA-MenC, Month 0	3 Participants	0 Participants	0 Participants	3 Participants	1 Participants	9 Participants	4 Participants	5 Participants	7 Participants	5 Participants
Number of Seropositive Subjects for Different Anti-meningococcal Serogroups rSBA-MenC, Month 1	35 Participants	34 Participants	26 Participants	31 Participants	27 Participants	49 Participants	46 Participants	45 Participants	48 Participants	39 Participants
Number of Seropositive Subjects for Different Anti-meningococcal Serogroups rSBA-MenW-135, Month 0	8 Participants	9 Participants	4 Participants	4 Participants	8 Participants	19 Participants	11 Participants	9 Participants	15 Participants	12 Participants
Number of Seropositive Subjects for Different Anti-meningococcal Serogroups rSBA-MenW-135, Month 1	35 Participants	38 Participants	29 Participants	35 Participants	9 Participants	50 Participants	48 Participants	48 Participants	49 Participants	42 Participants
Number of Seropositive Subjects for Different Anti-meningococcal Serogroups rSBA-MenY, Month 0	17 Participants	11 Participants	9 Participants	12 Participants	17 Participants	29 Participants	37 Participants	32 Participants	33 Participants	30 Participants
Number of Seropositive Subjects for Different Anti-meningococcal Serogroups rSBA-MenY, Month 1	35 Participants	37 Participants	29 Participants	34 Participants	18 Participants	51 Participants	48 Participants	48 Participants	50 Participants	43 Participants

SECONDARY outcome

Timeframe: Prior to (Month 0) and one month after (Month 1) the first vaccine dose

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

Antibody titers against meningococcal serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and MenY) have been assessed, using rabbit complement and expressed as geometric mean titers (GMTs).

Outcome measures

Measure	GSK134612A Form1 (T), Primary Group n=36 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form2 (T), Primary Group n=38 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form3 (T), Primary Group n=30 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form4 (T), Primary Group n=35 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	Control (T), Primary Group n=35 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form1 (C), Primary Group n=51 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form2 (C), Primary Group n=48 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form3 (C), Primary Group n=48 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form4 (C), Primary Group n=50 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	Control (C), Primary Group n=44 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
Antibody Titers Against Different Meningococcal Serogroups rSBA-MenA, Month 0	84.2 Titers Interval 39.3 to 180.1	77.3 Titers Interval 32.9 to 181.6	68.4 Titers Interval 30.1 to 155.3	76 Titers Interval 33.8 to 170.8	69.1 Titers Interval 28.1 to 169.9	359.7 Titers Interval 212.0 to 610.4	367.2 Titers Interval 222.1 to 607.0	375.9 Titers Interval 227.4 to 621.2	465.2 Titers Interval 307.2 to 704.4	427.4 Titers Interval 280.3 to 651.7
Antibody Titers Against Different Meningococcal Serogroups rSBA-MenA, Month 1	6648 Titers Interval 4787.3 to 9231.9	5406.8 Titers Interval 3961.5 to 7379.4	6225.2 Titers Interval 3510.2 to 11040.2	3928.6 Titers Interval 2851.5 to 5412.4	125.9 Titers Interval 53.1 to 298.3	7469.5 Titers Interval 5468.8 to 10202.1	7569.7 Titers Interval 6044.0 to 9480.6	13668.3 Titers Interval 11274.3 to 16570.6	4878 Titers Interval 4002.5 to 5944.9	4556.8 Titers Interval 3598.0 to 5771.1
Antibody Titers Against Different Meningococcal Serogroups rSBA-MenC, Month 0	6.9 Titers Interval 4.1 to 11.5	4.5 Titers Interval 3.8 to 5.2	4.6 Titers Interval 3.8 to 5.7	6.6 Titers Interval 4.2 to 10.2	5.3 Titers Interval 3.8 to 7.3	12.5 Titers Interval 7.6 to 20.5	7.4 Titers Interval 4.7 to 11.6	11.8 Titers Interval 7.5 to 18.5	8.9 Titers Interval 5.7 to 14.1	11.9 Titers Interval 7.0 to 20.2
Antibody Titers Against Different Meningococcal Serogroups rSBA-MenC, Month 1	656.4 Titers Interval 483.0 to 892.0	495.7 Titers Interval 334.6 to 734.4	477.2 Titers Interval 245.1 to 929.4	464.3 Titers Interval 324.4 to 664.5	404.5 Titers Interval 222.5 to 735.4	967.6 Titers Interval 672.0 to 1393.3	1115 Titers Interval 746.4 to 1665.7	1738.8 Titers Interval 1159.7 to 2607.0	1197.6 Titers Interval 765.0 to 1874.7	378.3 Titers Interval 257.2 to 556.5
Antibody Titers Against Different Meningococcal Serogroups rSBA-MenW-135, Month 0	19.8 Titers Interval 10.7 to 36.9	21.1 Titers Interval 11.5 to 38.6	14.5 Titers Interval 7.7 to 27.3	12.1 Titers Interval 7.1 to 20.6	18 Titers Interval 9.7 to 33.6	45.8 Titers Interval 27.9 to 75.2	22.3 Titers Interval 12.7 to 39.0	23.7 Titers Interval 14.2 to 39.7	44.6 Titers Interval 28.1 to 71.0	31.5 Titers Interval 18.0 to 55.0
Antibody Titers Against Different Meningococcal Serogroups rSBA-MenW-135, Month 1	2781.4 Titers Interval 1647.0 to 4697.2	3447.5 Titers Interval 2484.8 to 4783.3	2545 Titers Interval 1522.2 to 4254.9	3260.8 Titers Interval 2342.1 to 4539.8	21.7 Titers Interval 10.5 to 44.9	4317.4 Titers Interval 3114.8 to 5984.3	3856.5 Titers Interval 3153.4 to 4716.4	5262.1 Titers Interval 4417.8 to 6267.7	4556.1 Titers Interval 3576.6 to 5803.7	912.7 Titers Interval 659.1 to 1264.1
Antibody Titers Against Different Meningococcal Serogroups rSBA-MenY, Month 0	57.7 Titers Interval 27.5 to 121.3	24.4 Titers Interval 12.0 to 49.7	32.4 Titers Interval 14.3 to 73.0	32.9 Titers Interval 15.9 to 68.3	52.8 Titers Interval 25.5 to 109.5	98.7 Titers Interval 54.9 to 177.5	181.9 Titers Interval 112.1 to 295.3	146.8 Titers Interval 86.2 to 250.1	140.6 Titers Interval 82.8 to 238.9	123.6 Titers Interval 73.3 to 208.6
Antibody Titers Against Different Meningococcal Serogroups rSBA-MenY, Month 1	2599.9 Titers Interval 1531.8 to 4412.7	2150.9 Titers Interval 1486.2 to 3112.9	1920.9 Titers Interval 1014.2 to 3638.2	3544.7 Titers Interval 2480.2 to 5065.9	75.6 Titers Interval 38.1 to 150.1	5249.1 Titers Interval 4107.9 to 6707.4	5150.5 Titers Interval 4149.8 to 6392.6	5896.3 Titers Interval 4686.4 to 7418.5	7548.4 Titers Interval 6116.1 to 9316.2	1527.3 Titers Interval 1110.8 to 2099.9

SECONDARY outcome

Timeframe: Prior to (Month 0) and one month after (Month 1) the first vaccine dose

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

A seropositive subject for meningococcal polysaccharide A (PSA), C (PSC), W-135 (PSW-135) and Y (PSY) assessed, was defined as having antibody (anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY) concentrations greater than or equal to (≥) the cut-off value of 0.3 micrograms per milliliter (μg/mL). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA).

Outcome measures

Measure	GSK134612A Form1 (T), Primary Group n=36 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form2 (T), Primary Group n=38 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form3 (T), Primary Group n=31 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form4 (T), Primary Group n=35 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	Control (T), Primary Group n=34 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form1 (C), Primary Group n=51 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form2 (C), Primary Group n=47 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form3 (C), Primary Group n=48 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form4 (C), Primary Group n=50 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	Control (C), Primary Group n=44 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides Anti-PSA, Month 0	1 Participants	2 Participants	0 Participants	1 Participants	0 Participants	10 Participants	4 Participants	6 Participants	9 Participants	10 Participants
Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides Anti-PSA, Month 1	35 Participants	36 Participants	30 Participants	34 Participants	2 Participants	48 Participants	45 Participants	48 Participants	48 Participants	44 Participants
Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides Anti-PSC, Month 0	1 Participants	1 Participants	0 Participants	1 Participants	1 Participants	3 Participants	4 Participants	1 Participants	1 Participants	2 Participants
Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides Anti-PSC, Month 1	33 Participants	38 Participants	30 Participants	35 Participants	34 Participants	49 Participants	45 Participants	48 Participants	48 Participants	44 Participants
Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides Anti-PSW-135, Month 0	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants	4 Participants	2 Participants	0 Participants	1 Participants
Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides Anti-PSW-135, Month 1	34 Participants	36 Participants	30 Participants	35 Participants	0 Participants	48 Participants	45 Participants	48 Participants	48 Participants	44 Participants
Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides Anti-PSY, Month 0	2 Participants	0 Participants	2 Participants	1 Participants	1 Participants	2 Participants	4 Participants	2 Participants	1 Participants	1 Participants
Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides Anti-PSY, Month 1	34 Participants	37 Participants	30 Participants	34 Participants	2 Participants	49 Participants	45 Participants	46 Participants	48 Participants	44 Participants

SECONDARY outcome

Timeframe: Prior to (Month 0) and one month after (Month 1) the first vaccine dose

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

A seroprotected subject for meningococcal polysaccharide A (PSA), C (PSC), W-135 (PSW-135) and Y (PSY) assessed, was defined as having antibody (anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY) concentrations greater than or equal to (≥) the value of 2.0 micrograms per milliliter (μg/mL). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA).

Outcome measures

Measure	GSK134612A Form1 (T), Primary Group n=36 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form2 (T), Primary Group n=38 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form3 (T), Primary Group n=31 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form4 (T), Primary Group n=35 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	Control (T), Primary Group n=34 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form1 (C), Primary Group n=51 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form2 (C), Primary Group n=47 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form3 (C), Primary Group n=48 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form4 (C), Primary Group n=50 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	Control (C), Primary Group n=44 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides Anti-PSA, Month 0	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	2 Participants	5 Participants
Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides Anti-PSA, Month 1	35 Participants	35 Participants	30 Participants	25 Participants	0 Participants	48 Participants	44 Participants	47 Participants	34 Participants	40 Participants
Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides Anti-PSC, Month 0	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	2 Participants	0 Participants	0 Participants	2 Participants
Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides Anti-PSC, Month 1	33 Participants	37 Participants	29 Participants	34 Participants	33 Participants	44 Participants	45 Participants	45 Participants	47 Participants	44 Participants
Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides Anti-PSW-135, Month 0	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides Anti-PSW-135, Month 1	33 Participants	27 Participants	23 Participants	32 Participants	0 Participants	41 Participants	31 Participants	41 Participants	39 Participants	39 Participants
Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides Anti-PSY, Month 0	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides Anti-PSY, Month 1	34 Participants	34 Participants	27 Participants	33 Participants	0 Participants	46 Participants	40 Participants	39 Participants	47 Participants	42 Participants

SECONDARY outcome

Timeframe: Prior to (Month 0) and one month after (Month 1) the first vaccine dose

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

The meningococcal polysaccharides assessed included polysaccharide A (anti-PSA), polysaccharide B (anti-PSB), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).

Outcome measures

Measure	GSK134612A Form1 (T), Primary Group n=36 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form2 (T), Primary Group n=38 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form3 (T), Primary Group n=31 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form4 (T), Primary Group n=35 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	Control (T), Primary Group n=34 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form1 (C), Primary Group n=51 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form2 (C), Primary Group n=47 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form3 (C), Primary Group n=48 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form4 (C), Primary Group n=50 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	Control (C), Primary Group n=44 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
Antibody Concentrations Against Different Meningococcal Polysaccharides Anti-PSC, Month 1	10.67 μg/mL Interval 7.47 to 15.23	11.23 μg/mL Interval 8.75 to 14.4	12.91 μg/mL Interval 8.83 to 18.88	10.74 μg/mL Interval 8.43 to 13.68	11.99 μg/mL Interval 9.26 to 15.53	6.33 μg/mL Interval 4.81 to 8.34	7.76 μg/mL Interval 5.76 to 10.44	7.71 μg/mL Interval 6.05 to 9.83	7.78 μg/mL Interval 5.83 to 10.38	14.44 μg/mL Interval 11.32 to 18.42
Antibody Concentrations Against Different Meningococcal Polysaccharides Anti-PSW-135, Month 0	0.15 μg/mL Interval 0.15 to 0.16	0.15 μg/mL Interval 0.15 to 0.15	0.16 μg/mL Interval 0.14 to 0.17	0.15 μg/mL Interval 0.15 to 0.16	0.15 μg/mL Interval 0.15 to 0.15	0.15 μg/mL Interval 0.15 to 0.16	0.17 μg/mL Interval 0.15 to 0.2	0.16 μg/mL Interval 0.15 to 0.17	0.15 μg/mL Interval 0.15 to 0.15	0.16 μg/mL Interval 0.14 to 0.17
Antibody Concentrations Against Different Meningococcal Polysaccharides Anti-PSW-135, Month 1	7.52 μg/mL Interval 4.97 to 11.36	3.12 μg/mL Interval 2.3 to 4.22	3.62 μg/mL Interval 2.31 to 5.68	7.09 μg/mL Interval 5.19 to 9.7	0.15 μg/mL Interval 0.15 to 0.15	4.76 μg/mL Interval 3.4 to 6.66	3.2 μg/mL Interval 2.33 to 4.39	3.85 μg/mL Interval 2.85 to 5.21	4.99 μg/mL Interval 3.7 to 6.73	7.93 μg/mL Interval 5.39 to 11.66
Antibody Concentrations Against Different Meningococcal Polysaccharides Anti-PSY, Month 0	0.16 μg/mL Interval 0.14 to 0.18	0.15 μg/mL Interval 0.15 to 0.15	0.16 μg/mL Interval 0.15 to 0.17	0.16 μg/mL Interval 0.14 to 0.2	0.15 μg/mL Interval 0.15 to 0.16	0.16 μg/mL Interval 0.14 to 0.18	0.19 μg/mL Interval 0.15 to 0.24	0.16 μg/mL Interval 0.15 to 0.17	0.15 μg/mL Interval 0.15 to 0.16	0.15 μg/mL Interval 0.15 to 0.16
Antibody Concentrations Against Different Meningococcal Polysaccharides Anti-PSY, Month 1	10.86 μg/mL Interval 7.41 to 15.92	6.71 μg/mL Interval 5.12 to 8.8	6.01 μg/mL Interval 4.0 to 9.03	13.38 μg/mL Interval 9.48 to 18.89	0.16 μg/mL Interval 0.15 to 0.17	9.41 μg/mL Interval 6.66 to 13.31	6.59 μg/mL Interval 4.7 to 9.25	5.75 μg/mL Interval 4.23 to 7.81	11.7 μg/mL Interval 8.39 to 16.32	18.96 μg/mL Interval 13.68 to 26.29
Antibody Concentrations Against Different Meningococcal Polysaccharides Anti-PSA, Month 0	0.16 μg/mL Interval 0.14 to 0.18	0.16 μg/mL Interval 0.14 to 0.19	0.15 μg/mL Interval 0.15 to 0.15	0.16 μg/mL Interval 0.14 to 0.17	0.15 μg/mL Interval 0.15 to 0.15	0.2 μg/mL Interval 0.17 to 0.25	0.17 μg/mL Interval 0.15 to 0.2	0.17 μg/mL Interval 0.15 to 0.19	0.21 μg/mL Interval 0.17 to 0.26	0.25 μg/mL Interval 0.18 to 0.35
Antibody Concentrations Against Different Meningococcal Polysaccharides Anti-PSA, Month 1	30.65 μg/mL Interval 19.83 to 47.38	22.09 μg/mL Interval 16.35 to 29.84	34.68 μg/mL Interval 21.7 to 55.42	4.03 μg/mL Interval 2.72 to 5.98	0.17 μg/mL Interval 0.14 to 0.2	20.01 μg/mL Interval 14.53 to 27.56	12.62 μg/mL Interval 8.74 to 18.22	24.69 μg/mL Interval 19.14 to 31.85	3.63 μg/mL Interval 2.62 to 5.04	13.79 μg/mL Interval 9.04 to 21.02
Antibody Concentrations Against Different Meningococcal Polysaccharides Anti-PSC, Month 0	0.16 μg/mL Interval 0.14 to 0.17	0.16 μg/mL Interval 0.14 to 0.17	0.15 μg/mL Interval 0.15 to 0.15	0.15 μg/mL Interval 0.15 to 0.16	0.16 μg/mL Interval 0.14 to 0.17	0.18 μg/mL Interval 0.15 to 0.22	0.18 μg/mL Interval 0.15 to 0.23	0.16 μg/mL Interval 0.14 to 0.17	0.15 μg/mL Interval 0.15 to 0.16	0.18 μg/mL Interval 0.14 to 0.22

SECONDARY outcome

Timeframe: Prior to (Month 0) and one month after (Month 1) the first vaccine dose

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

A seropositive subject for anti-tetanus was defined as having antibody concentrations greater than or equal to (≥) the cut-off value of 0.1 international units per milliliter (IU/mL). Antibody titers were determined by enzyme-linked immunosorbent assay (ELISA).

Outcome measures

Measure	GSK134612A Form1 (T), Primary Group n=36 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form2 (T), Primary Group n=37 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form3 (T), Primary Group n=30 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form4 (T), Primary Group n=35 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	Control (T), Primary Group n=35 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form1 (C), Primary Group n=51 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form2 (C), Primary Group n=48 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form3 (C), Primary Group n=48 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form4 (C), Primary Group n=50 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	Control (C), Primary Group n=44 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
Number of Seropositive Subjects for Anti-tetanus (Anti-T) Anti-T, Month 0	34 Participants	36 Participants	30 Participants	32 Participants	33 Participants	49 Participants	47 Participants	46 Participants	48 Participants	43 Participants
Number of Seropositive Subjects for Anti-tetanus (Anti-T) Anti-T, Month 1	36 Participants	37 Participants	30 Participants	35 Participants	34 Participants	48 Participants	47 Participants	48 Participants	50 Participants	43 Participants

SECONDARY outcome

Timeframe: Prior to (Month 0) and one month after (Month 1) the first vaccine dose

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) method, presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).

Outcome measures

Measure	GSK134612A Form1 (T), Primary Group n=36 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form2 (T), Primary Group n=37 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form3 (T), Primary Group n=30 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form4 (T), Primary Group n=35 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	Control (T), Primary Group n=35 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form1 (C), Primary Group n=51 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form2 (C), Primary Group n=48 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form3 (C), Primary Group n=48 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form4 (C), Primary Group n=50 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	Control (C), Primary Group n=44 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
Antibody Concentrations Against Tetanus (Anti-T) Anti-T, Month 1	7.559 IU/mL Interval 5.04 to 11.335	5.353 IU/mL Interval 3.832 to 7.477	8.094 IU/mL Interval 4.855 to 13.492	7.675 IU/mL Interval 4.783 to 12.315	0.696 IU/mL Interval 0.52 to 0.932	17.284 IU/mL Interval 11.812 to 25.292	15.823 IU/mL Interval 11.728 to 21.348	19.369 IU/mL Interval 13.226 to 28.363	15.957 IU/mL Interval 11.767 to 21.639	1.231 IU/mL Interval 0.833 to 1.82
Antibody Concentrations Against Tetanus (Anti-T) Anti-T, Month 0	1.007 IU/mL Interval 0.671 to 1.51	1.159 IU/mL Interval 0.814 to 1.65	1.203 IU/mL Interval 0.871 to 1.662	1.293 IU/mL Interval 0.826 to 2.023	0.792 IU/mL Interval 0.578 to 1.084	1.426 IU/mL Interval 0.94 to 2.164	1.312 IU/mL Interval 0.935 to 1.841	1.232 IU/mL Interval 0.849 to 1.788	1.18 IU/mL Interval 0.823 to 1.694	1.083 IU/mL Interval 0.742 to 1.58

SECONDARY outcome

Timeframe: During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who had filled in the symptom sheets.

The toddlers subgroup received 2 primary vaccine doses, as follows: first dose of a meningococcal vaccine and second dose of a diphtheria, tetanus and acellular pertusis-containing vaccine. Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.

Outcome measures

Measure	GSK134612A Form1 (T), Primary Group n=38 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form2 (T), Primary Group n=41 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form3 (T), Primary Group n=39 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form4 (T), Primary Group n=40 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	Control (T), Primary Group n=39 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form1 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form2 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form3 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form4 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	Control (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
Number of Toddlers With Any Solicited Local Symptoms Pain, Dose 2	3 Participants	10 Participants	6 Participants	7 Participants	6 Participants	—	—	—	—	—
Number of Toddlers With Any Solicited Local Symptoms Pain, Dose 1	4 Participants	8 Participants	3 Participants	6 Participants	4 Participants	—	—	—	—	—
Number of Toddlers With Any Solicited Local Symptoms Redness, Dose 1	9 Participants	12 Participants	10 Participants	9 Participants	11 Participants	—	—	—	—	—
Number of Toddlers With Any Solicited Local Symptoms Swelling, Dose 1	1 Participants	6 Participants	7 Participants	6 Participants	4 Participants	—	—	—	—	—
Number of Toddlers With Any Solicited Local Symptoms Redness, Dose 2	7 Participants	13 Participants	9 Participants	8 Participants	7 Participants	—	—	—	—	—
Number of Toddlers With Any Solicited Local Symptoms Swelling, Dose 2	3 Participants	7 Participants	9 Participants	7 Participants	3 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had filled in the symptom sheets.

The children subgroup received one dose of the meningococcal vaccine. Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.

Outcome measures

Measure	GSK134612A Form1 (T), Primary Group n=52 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form2 (T), Primary Group n=50 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form3 (T), Primary Group n=50 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form4 (T), Primary Group n=52 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	Control (T), Primary Group n=51 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form1 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form2 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form3 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form4 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	Control (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
Number of Children With Any Solicited Local Symptoms Redness	9 Participants	11 Participants	10 Participants	9 Participants	7 Participants	—	—	—	—	—
Number of Children With Any Solicited Local Symptoms Pain	10 Participants	11 Participants	9 Participants	11 Participants	13 Participants	—	—	—	—	—
Number of Children With Any Solicited Local Symptoms Swelling	7 Participants	9 Participants	8 Participants	10 Participants	4 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had filled in the symptom sheets.

The toddlers subgroup received 2 primary vaccine doses, as follows: first dose of a meningococcal vaccine and second dose of a diphtheria, tetanus and acellular pertusis-containing vaccine. Assessed solicited general symptoms included drowsiness, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = incidence of a particular symptom regardless of intensity or relationship to vaccination.

Outcome measures

Measure	GSK134612A Form1 (T), Primary Group n=38 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form2 (T), Primary Group n=41 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form3 (T), Primary Group n=39 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form4 (T), Primary Group n=40 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	Control (T), Primary Group n=39 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form1 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form2 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form3 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form4 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	Control (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
Number of Toddlers With Any Solicited General Symptoms Fever (Axillary), Dose 2	4 Participants	5 Participants	5 Participants	5 Participants	8 Participants	—	—	—	—	—
Number of Toddlers With Any Solicited General Symptoms Irritability, Dose 2	6 Participants	7 Participants	3 Participants	9 Participants	5 Participants	—	—	—	—	—
Number of Toddlers With Any Solicited General Symptoms Irritability, Dose 1	4 Participants	9 Participants	6 Participants	5 Participants	5 Participants	—	—	—	—	—
Number of Toddlers With Any Solicited General Symptoms Fever (Axillary), Dose 1	5 Participants	8 Participants	8 Participants	3 Participants	5 Participants	—	—	—	—	—
Number of Toddlers With Any Solicited General Symptoms Drowsiness, Dose 1	1 Participants	5 Participants	4 Participants	4 Participants	5 Participants	—	—	—	—	—
Number of Toddlers With Any Solicited General Symptoms Loss of appetite, Dose 1	1 Participants	6 Participants	5 Participants	3 Participants	6 Participants	—	—	—	—	—
Number of Toddlers With Any Solicited General Symptoms Drowsiness, Dose 2	2 Participants	2 Participants	3 Participants	7 Participants	3 Participants	—	—	—	—	—
Number of Toddlers With Any Solicited General Symptoms Loss of appetite, Dose 2	4 Participants	3 Participants	2 Participants	6 Participants	2 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had filled in the symptom sheets.

The children subgroup received one primary meningococcal vaccine dose. Assessed solicited general symptoms included drowsiness, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = incidence of a particular symptom regardless of intensity or relationship to vaccination.

Outcome measures

Measure	GSK134612A Form1 (T), Primary Group n=52 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form2 (T), Primary Group n=50 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form3 (T), Primary Group n=50 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form4 (T), Primary Group n=52 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	Control (T), Primary Group n=51 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form1 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form2 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form3 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form4 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	Control (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
Number of Children With Any Solicited General Symptoms Loss of appetite	2 Participants	3 Participants	2 Participants	6 Participants	3 Participants	—	—	—	—	—
Number of Children With Any Solicited General Symptoms Drowsiness	4 Participants	2 Participants	0 Participants	5 Participants	4 Participants	—	—	—	—	—
Number of Children With Any Solicited General Symptoms Fever (Axillary)	4 Participants	4 Participants	3 Participants	3 Participants	3 Participants	—	—	—	—	—
Number of Children With Any Solicited General Symptoms Irritability	2 Participants	4 Participants	2 Participants	4 Participants	7 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: At one month (M1) and 12 months (M12) post-primary vaccination

Population: The analysis was performed on the According-to-Protocol (ATP) Cohort for antibody persistence, which included subjects primed with the selected GSK134612A formulation or the control vaccine in both age strata, for whom assay results were available for antibodies against at least one study vaccine antigen component for the Month 12 blood sampling.

A seroprotected subject against meningococcal serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY assessed, was defined as having antibody titers greater than or equal to (≥) 1:8.

Outcome measures

Measure	GSK134612A Form1 (T), Primary Group n=31 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form2 (T), Primary Group n=30 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form3 (T), Primary Group n=44 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form4 (T), Primary Group n=37 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	Control (T), Primary Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form1 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form2 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form3 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form4 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	Control (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
Number of Seroprotected Subjects Against Different Meningococcal Serogroups rSBA-MenA, Month 1	31 Participants	18 Participants	43 Participants	36 Participants	—	—	—	—	—	—
Number of Seroprotected Subjects Against Different Meningococcal Serogroups rSBA-MenC, Month 1	31 Participants	29 Participants	43 Participants	36 Participants	—	—	—	—	—	—
Number of Seroprotected Subjects Against Different Meningococcal Serogroups rSBA-MenA, Month 12	23 Participants	20 Participants	39 Participants	33 Participants	—	—	—	—	—	—
Number of Seroprotected Subjects Against Different Meningococcal Serogroups rSBA-MenC, Month 12	29 Participants	25 Participants	40 Participants	22 Participants	—	—	—	—	—	—
Number of Seroprotected Subjects Against Different Meningococcal Serogroups rSBA-MenW-135, Month 12	30 Participants	11 Participants	41 Participants	31 Participants	—	—	—	—	—	—
Number of Seroprotected Subjects Against Different Meningococcal Serogroups rSBA-MenY, Month 12	31 Participants	23 Participants	41 Participants	36 Participants	—	—	—	—	—	—
Number of Seroprotected Subjects Against Different Meningococcal Serogroups rSBA-MenW-135, Month 1	30 Participants	11 Participants	43 Participants	37 Participants	—	—	—	—	—	—
Number of Seroprotected Subjects Against Different Meningococcal Serogroups rSBA-MenY, Month 1	30 Participants	20 Participants	44 Participants	37 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At one month (M1) and 12 months (M12) post-primary vaccination

Population: The analysis was performed on the According-to-Protocol (ATP) Cohort for antibody persistence, which included subjects primed with the selected GSK134612A formulation or the control vaccine in both age strata, for whom assay results were available for antibodies against at least one study vaccine antigen component for the Month 12 blood sampling.

A seropositive subject for meningococcal serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Y assessed, was defined as having antibody titers greater than or equal to (≥) 1:128.

Outcome measures

Measure	GSK134612A Form1 (T), Primary Group n=31 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form2 (T), Primary Group n=30 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form3 (T), Primary Group n=44 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form4 (T), Primary Group n=37 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	Control (T), Primary Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form1 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form2 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form3 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form4 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	Control (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
Number of Seropositive Subjects for Different Anti-meningococcal Serogroups rSBA-MenA, Month 1	31 Participants	14 Participants	42 Participants	36 Participants	—	—	—	—	—	—
Number of Seropositive Subjects for Different Anti-meningococcal Serogroups rSBA-MenC, Month 1	31 Participants	23 Participants	42 Participants	34 Participants	—	—	—	—	—	—
Number of Seropositive Subjects for Different Anti-meningococcal Serogroups rSBA-MenW-135, Month 1	30 Participants	6 Participants	43 Participants	35 Participants	—	—	—	—	—	—
Number of Seropositive Subjects for Different Anti-meningococcal Serogroups rSBA-MenY, Month 1	30 Participants	13 Participants	44 Participants	36 Participants	—	—	—	—	—	—
Number of Seropositive Subjects for Different Anti-meningococcal Serogroups rSBA-MenA, Month 12	23 Participants	19 Participants	39 Participants	32 Participants	—	—	—	—	—	—
Number of Seropositive Subjects for Different Anti-meningococcal Serogroups rSBA-MenC, Month 12	13 Participants	15 Participants	27 Participants	10 Participants	—	—	—	—	—	—
Number of Seropositive Subjects for Different Anti-meningococcal Serogroups rSBA-MenW-135, Month 12	27 Participants	6 Participants	41 Participants	27 Participants	—	—	—	—	—	—
Number of Seropositive Subjects for Different Anti-meningococcal Serogroups rSBA-MenY, Month 12	30 Participants	17 Participants	40 Participants	32 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At one month (M1) and 12 months (M12) post-primary vaccination

Population: The analysis was performed on the According-to-Protocol (ATP) Cohort for antibody persistence, which included subjects primed with the selected GSK134612A formulation or the control vaccine in both age strata, for whom assay results were available for antibodies against at least one study vaccine antigen component for the Month 12 blood sampling.

Antibody titers against meningococcal serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and MenY) have been assessed, using rabbit complement and expressed as geometric mean titers (GMTs).

Outcome measures

Measure	GSK134612A Form1 (T), Primary Group n=31 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form2 (T), Primary Group n=30 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form3 (T), Primary Group n=44 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form4 (T), Primary Group n=37 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	Control (T), Primary Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form1 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form2 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form3 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form4 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	Control (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
Antibody Titers Against Different Meningococcal Serogroups rSBA-MenA, Month 1	6577.8 Titers Interval 4606.7 to 9392.4	84.9 Titers Interval 32.4 to 222.8	6565.3 Titers Interval 4616.3 to 9337.2	4649.5 Titers Interval 3572.8 to 6050.8	—	—	—	—	—	—
Antibody Titers Against Different Meningococcal Serogroups rSBA-MenC, Month 1	660.4 Titers Interval 484.4 to 900.3	440.2 Titers Interval 227.1 to 853.1	893.6 Titers Interval 600.3 to 1330.3	416.2 Titers Interval 270.5 to 640.5	—	—	—	—	—	—
Antibody Titers Against Different Meningococcal Serogroups rSBA-MenY, Month 1	2483.9 Titers Interval 1363.8 to 4524.1	57.7 Titers Interval 27.1 to 123.2	4808.5 Titers Interval 3653.0 to 6329.6	1641.1 Titers Interval 1131.2 to 2380.9	—	—	—	—	—	—
Antibody Titers Against Different Meningococcal Serogroups rSBA-MenA, Month 12	2369.1 Titers Interval 1642.0 to 3418.2	179.3 Titers Interval 76.1 to 422.9	2356.7 Titers Interval 1786.7 to 3108.4	1134.3 Titers Interval 767.8 to 1675.5	—	—	—	—	—	—
Antibody Titers Against Different Meningococcal Serogroups rSBA-MenC, Month 12	110.2 Titers Interval 60.6 to 200.7	122 Titers Interval 59.0 to 252.2	172.5 Titers Interval 117.7 to 252.9	41.7 Titers Interval 22.0 to 79.2	—	—	—	—	—	—
Antibody Titers Against Different Meningococcal Serogroups rSBA-MenW-135, Month 12	541.8 Titers Interval 305.5 to 961.0	18.9 Titers Interval 8.4 to 42.9	1322.2 Titers Interval 978.3 to 1786.8	181.7 Titers Interval 104.6 to 315.8	—	—	—	—	—	—
Antibody Titers Against Different Meningococcal Serogroups rSBA-MenY, Month 12	740.3 Titers Interval 493.4 to 1110.9	110.6 Titers Interval 51.6 to 237.1	1400.8 Titers Interval 1008.8 to 1945.1	347.2 Titers Interval 228.2 to 528.5	—	—	—	—	—	—
Antibody Titers Against Different Meningococcal Serogroups rSBA-MenW-135, Month 1	2523.5 Titers Interval 1433.1 to 4443.7	17.2 Titers Interval 7.9 to 37.8	3893.6 Titers Interval 2671.2 to 5675.6	1004.4 Titers Interval 690.4 to 1461.2	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At one month (M1) and 12 months (M12) post-primary vaccination

Population: The analysis was performed on the According-to-Protocol (ATP) Cohort for antibody persistence, which included subjects primed with the selected GSK134612A formulation or the control vaccine in both age strata, for whom assay results were available for antibodies against at least one study vaccine antigen component for the Month 12 blood sampling.

A seropositive subject for meningococcal polysaccharide A (PSA), C (PSC), W-135 (PSW-135) and Y (PSY) assessed, was defined as having antibody (anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY) concentrations greater than or equal to (≥) the cut-off value of 0.3 micrograms per milliliter (μg/mL). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA).

Outcome measures

Measure	GSK134612A Form1 (T), Primary Group n=31 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form2 (T), Primary Group n=30 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form3 (T), Primary Group n=43 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form4 (T), Primary Group n=37 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	Control (T), Primary Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form1 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form2 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form3 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form4 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	Control (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides Anti-PSA, Month 1	30 Participants	1 Participants	41 Participants	37 Participants	—	—	—	—	—	—
Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides Anti-PSC, Month 1	28 Participants	30 Participants	42 Participants	37 Participants	—	—	—	—	—	—
Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides Anti-PSW-135, Month 1	29 Participants	0 Participants	41 Participants	37 Participants	—	—	—	—	—	—
Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides Anti-PSY, Month 1	29 Participants	2 Participants	42 Participants	37 Participants	—	—	—	—	—	—
Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides Anti-PSA, Month 12	22 Participants	2 Participants	34 Participants	34 Participants	—	—	—	—	—	—
Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides Anti-PSC, Month 12	13 Participants	18 Participants	18 Participants	36 Participants	—	—	—	—	—	—
Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides Anti-PSW-135, Month 12	25 Participants	3 Participants	34 Participants	32 Participants	—	—	—	—	—	—
Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides Anti-PSY, Month 12	26 Participants	3 Participants	34 Participants	35 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At one month (M1) and 12 months (M12) post primary vaccination

Population: The analysis was performed on the According-to-Protocol (ATP) Cohort for antibody persistence, which included subjects primed with the selected GSK134612A formulation or the control vaccine in both age strata, for whom assay results were available for antibodies against at least one study vaccine antigen component for the Month 12 blood sampling.

A seroprotected subject for meningococcal polysaccharide A (PSA), C (PSC), W-135 (PSW-135) and Y (PSY) assessed, was defined as having antibody (anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY) concentrations greater than or equal to (≥) the value of 2.0 micrograms per milliliter (μg/mL). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA).

Outcome measures

Measure	GSK134612A Form1 (T), Primary Group n=31 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form2 (T), Primary Group n=30 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form3 (T), Primary Group n=43 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form4 (T), Primary Group n=37 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	Control (T), Primary Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form1 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form2 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form3 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form4 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	Control (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides Anti-PSA, Month 1	30 Participants	0 Participants	41 Participants	33 Participants	—	—	—	—	—	—
Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides Anti-PSW-135, Month 1	28 Participants	0 Participants	34 Participants	32 Participants	—	—	—	—	—	—
Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides Anti-PSY, Month 1	29 Participants	0 Participants	39 Participants	35 Participants	—	—	—	—	—	—
Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides Anti-PSA, Month 12	10 Participants	0 Participants	12 Participants	22 Participants	—	—	—	—	—	—
Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides Anti-PSY, Month 12	15 Participants	1 Participants	19 Participants	30 Participants	—	—	—	—	—	—
Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides Anti-PSC, Month 1	28 Participants	29 Participants	37 Participants	37 Participants	—	—	—	—	—	—
Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides Anti-PSC, Month 12	2 Participants	4 Participants	0 Participants	24 Participants	—	—	—	—	—	—
Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides Anti-PSW-135, Month 12	6 Participants	2 Participants	10 Participants	23 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At one month (M1) and 12 months (M12) post-primary vaccination

Population: The analysis was performed on the According-to-Protocol (ATP) Cohort for antibody persistence, which included subjects primed with the selected GSK134612A formulation or the control vaccine in both age strata, for whom assay results were available for antibodies against at least one study vaccine antigen component for the Month 12 blood sampling.

The meningococcal polysaccharides assessed included polysaccharide A (anti-PSA), polysaccharide B (anti-PSB), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).

Outcome measures

Measure	GSK134612A Form1 (T), Primary Group n=31 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form2 (T), Primary Group n=30 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form3 (T), Primary Group n=43 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form4 (T), Primary Group n=37 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	Control (T), Primary Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form1 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form2 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form3 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form4 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	Control (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
Antibody Concentrations Against Different Meningococcal Polysaccharides Anti-PSA, Month 1	32.72 µg/mL Interval 20.12 to 53.22	0.17 µg/mL Interval 0.14 to 0.2	18.29 µg/mL Interval 12.86 to 26.01	13 µg/mL Interval 8.19 to 20.63	—	—	—	—	—	—
Antibody Concentrations Against Different Meningococcal Polysaccharides Anti-PSC, Month 1	11.25 µg/mL Interval 7.48 to 16.93	12.43 µg/mL Interval 9.28 to 16.65	5.64 µg/mL Interval 4.21 to 7.57	14.5 µg/mL Interval 11.01 to 19.1	—	—	—	—	—	—
Antibody Concentrations Against Different Meningococcal Polysaccharides Anti-PSW-135, Month 1	6.65 µg/mL Interval 4.29 to 10.3	0.15 µg/mL Interval 0.15 to 0.15	4.23 µg/mL Interval 2.94 to 6.09	8.17 µg/mL Interval 5.19 to 12.86	—	—	—	—	—	—
Antibody Concentrations Against Different Meningococcal Polysaccharides Anti-PSA, Month 12	1.25 µg/mL Interval 0.68 to 2.3	0.17 µg/mL Interval 0.14 to 0.21	1.32 µg/mL Interval 0.9 to 1.95	4.43 µg/mL Interval 2.55 to 7.7	—	—	—	—	—	—
Antibody Concentrations Against Different Meningococcal Polysaccharides Anti-PSW-135, Month 12	1.36 µg/mL Interval 1.06 to 1.74	0.21 µg/mL Interval 0.14 to 0.32	1.11 µg/mL Interval 0.79 to 1.57	3.16 µg/mL Interval 1.87 to 5.34	—	—	—	—	—	—
Antibody Concentrations Against Different Meningococcal Polysaccharides Anti-PSY, Month 1	10.37 µg/mL Interval 6.74 to 15.94	0.16 µg/mL Interval 0.15 to 0.17	8.07 µg/mL Interval 5.79 to 11.24	18.12 µg/mL Interval 12.41 to 26.46	—	—	—	—	—	—
Antibody Concentrations Against Different Meningococcal Polysaccharides Anti-PSC, Month 12	0.39 µg/mL Interval 0.23 to 0.66	0.54 µg/mL Interval 0.34 to 0.86	0.28 µg/mL Interval 0.22 to 0.36	2.9 µg/mL Interval 1.94 to 4.35	—	—	—	—	—	—
Antibody Concentrations Against Different Meningococcal Polysaccharides Anti-PSY, Month 12	2.36 µg/mL Interval 1.75 to 3.18	0.21 µg/mL Interval 0.14 to 0.33	1.84 µg/mL Interval 1.2 to 2.82	6.9 µg/mL Interval 4.51 to 10.54	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination

Population: The analysis was performed on the According-to-Protocol (ATP) Cohort for immune memory, which included subjects in the Toddlers subgroup from the ATP cohort for persistence, for whom assay results were available for antibodies against at least one study vaccine antigen component for the post-booster dose blood sampling.

A seropositive subject for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY was defined as a vaccinated subject with antibody titers greater than or equal to (≥) 1:128, while for a seroprotected subject, titers were ≥1:8.

Outcome measures

Measure	GSK134612A Form1 (T), Primary Group n=27 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form2 (T), Primary Group n=24 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form3 (T), Primary Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form4 (T), Primary Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	Control (T), Primary Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form1 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form2 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form3 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form4 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	Control (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups rSBA-MenA ≥ 1:8, PRE	20 Participants	17 Participants	—	—	—	—	—	—	—	—
Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups rSBA-MenC ≥ 1:8, PRE	25 Participants	20 Participants	—	—	—	—	—	—	—	—
Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups rSBA-MenW-135 ≥ 1:8, PRE	26 Participants	9 Participants	—	—	—	—	—	—	—	—
Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups rSBA-MenW-135 ≥ 1:128, PRE	23 Participants	4 Participants	—	—	—	—	—	—	—	—
Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups rSBA-MenY ≥ 1:128, PRE	26 Participants	14 Participants	—	—	—	—	—	—	—	—
Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups rSBA-MenY ≥ 1:8, Month 13	25 Participants	22 Participants	—	—	—	—	—	—	—	—
Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups rSBA-MenA ≥ 1:128, Month 13	6 Participants	19 Participants	—	—	—	—	—	—	—	—
Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups rSBA-MenY ≥ 1:128, Month 13	25 Participants	20 Participants	—	—	—	—	—	—	—	—
Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups rSBA-MenY ≥ 1:8, PRE	27 Participants	18 Participants	—	—	—	—	—	—	—	—
Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups rSBA-MenA ≥ 1:128, PRE	20 Participants	16 Participants	—	—	—	—	—	—	—	—
Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups rSBA-MenC ≥ 1:128, PRE	10 Participants	12 Participants	—	—	—	—	—	—	—	—
Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups rSBA-MenA ≥ 1:8, Month 13	6 Participants	19 Participants	—	—	—	—	—	—	—	—
Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups rSBA-MenC ≥ 1:8, Month 13	25 Participants	24 Participants	—	—	—	—	—	—	—	—
Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups rSBA-MenW-135 ≥ 1:8, Month 13	25 Participants	21 Participants	—	—	—	—	—	—	—	—
Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups rSBA-MenC ≥ 1:128, Month 13	24 Participants	24 Participants	—	—	—	—	—	—	—	—
Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups rSBA-MenW-135 ≥ 1:128, Month 13	25 Participants	18 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination

Population: The analysis was performed on the According-to-Protocol (ATP) Cohort for immune memory, which included subjects in the Toddlers subgroup from the ATP cohort for persistence, for whom assay results were available for antibodies against at least one study vaccine antigen component for the post-booster dose blood sampling.

Antibody titers against meningococcal serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and MenY) have been assessed, using rabbit complement and expressed as geometric mean titers (GMTs).

Outcome measures

Measure	GSK134612A Form1 (T), Primary Group n=27 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form2 (T), Primary Group n=24 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form3 (T), Primary Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form4 (T), Primary Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	Control (T), Primary Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form1 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form2 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form3 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form4 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	Control (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
Antibody Titers Against Different Meningococcal Serogroups rSBA-MenY, Month 13	3337.7 Titers Interval 2013.7 to 5532.1	323.8 Titers Interval 153.6 to 682.7	—	—	—	—	—	—	—	—
Antibody Titers Against Different Meningococcal Serogroups rSBA-MenA, Month 13	3695.2 Titers Interval 1535.2 to 8894.7	984.6 Titers Interval 479.7 to 2021.2	—	—	—	—	—	—	—	—
Antibody Titers Against Different Meningococcal Serogroups rSBA-MenA, PRE	2163.4 Titers Interval 1436.6 to 3257.9	175.7 Titers Interval 70.5 to 437.8	—	—	—	—	—	—	—	—
Antibody Titers Against Different Meningococcal Serogroups rSBA-MenC, PRE	82.5 Titers Interval 50.3 to 135.4	102.5 Titers Interval 47.7 to 220.3	—	—	—	—	—	—	—	—
Antibody Titers Against Different Meningococcal Serogroups rSBA-MenW-135, PRE	436 Titers Interval 243.7 to 780.2	15.5 Titers Interval 7.0 to 34.3	—	—	—	—	—	—	—	—
Antibody Titers Against Different Meningococcal Serogroups rSBA-MenY, PRE	634.5 Titers Interval 420.0 to 958.3	93.6 Titers Interval 38.4 to 228.1	—	—	—	—	—	—	—	—
Antibody Titers Against Different Meningococcal Serogroups rSBA-MenC, Month 13	7067.4 Titers Interval 4070.7 to 12270.3	9209.3 Titers Interval 5153.4 to 16457.5	—	—	—	—	—	—	—	—
Antibody Titers Against Different Meningococcal Serogroups rSBA-MenW-135, Month 13	5642.4 Titers Interval 3360.0 to 9475.4	255.6 Titers Interval 110.1 to 593.6	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination

Population: The analysis was performed on the According-to-Protocol (ATP) Cohort for immune memory, which included subjects in the Toddlers subgroup from the ATP cohort for persistence, for whom assay results were available for antibodies against at least one study vaccine antigen component for the post-booster dose blood sampling.

A seropositive subject for anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY was defined as a vaccinated subject with antibody concentrations greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL), while for a seroprotected subject, antibody concentrations were ≥ 2.0 μg/mL.

Outcome measures

Measure	GSK134612A Form1 (T), Primary Group n=26 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form2 (T), Primary Group n=23 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form3 (T), Primary Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form4 (T), Primary Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	Control (T), Primary Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form1 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form2 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form3 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form4 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	Control (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides Anti-PSA ≥ 0.3 μg/mL, PRE	19 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides Anti-PSC ≥ 0.3 μg/mL, PRE	11 Participants	15 Participants	—	—	—	—	—	—	—	—
Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides Anti-PSY ≥ 0.3 μg/mL, PRE	24 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides Anti-PSA ≥ 2.0 μg/mL, PRE	7 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides Anti-PSC ≥ 2.0 μg/mL, PRE	1 Participants	3 Participants	—	—	—	—	—	—	—	—
Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides Anti-PSW-135 ≥ 2.0 μg/mL, PRE	5 Participants	1 Participants	—	—	—	—	—	—	—	—
Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides Anti-PSW-135 ≥ 0.3 μg/mL, PRE	23 Participants	2 Participants	—	—	—	—	—	—	—	—
Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides Anti-PSY ≥ 2.0 μg/mL, PRE	14 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides Anti-PSA ≥ 0.3 μg/mL, Month 13	26 Participants	19 Participants	—	—	—	—	—	—	—	—
Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides Anti-PSC ≥ 0.3 μg/mL, Month 13	25 Participants	22 Participants	—	—	—	—	—	—	—	—
Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides Anti-PSW-135 ≥ 0.3 μg/mL, Month 13	25 Participants	18 Participants	—	—	—	—	—	—	—	—
Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides Anti-PSY ≥ 0.3 μg/mL, Month 13	25 Participants	20 Participants	—	—	—	—	—	—	—	—
Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides Anti-PSA ≥ 2.0 μg/mL, Month 13	25 Participants	13 Participants	—	—	—	—	—	—	—	—
Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides Anti-PSC ≥ 2.0 μg/mL, Month 13	25 Participants	22 Participants	—	—	—	—	—	—	—	—
Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides Anti-PSW-135 ≥ 2.0 μg/mL, Month 13	24 Participants	9 Participants	—	—	—	—	—	—	—	—
Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides Anti-PSY ≥ 2.0 μg/mL, Month 13	24 Participants	12 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination

Population: The analysis was performed on the According-to-Protocol (ATP) Cohort for immune memory, which included subjects in the Toddlers subgroup from the ATP cohort for persistence, for whom assay results were available for antibodies against at least one study vaccine antigen component for the post-booster dose blood sampling.

The meningococcal polysaccharides assessed included polysaccharide A (anti-PSA), polysaccharide B (anti-PSB), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).

Outcome measures

Measure	GSK134612A Form1 (T), Primary Group n=26 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form2 (T), Primary Group n=23 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form3 (T), Primary Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form4 (T), Primary Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	Control (T), Primary Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form1 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form2 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form3 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form4 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	Control (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
Antibody Concentrations Against Different Meningococcal Polysaccharides Anti-PSY, Month 13	79.03 μg/mL Interval 52.06 to 119.97	4.19 μg/mL Interval 2.0 to 8.78	—	—	—	—	—	—	—	—
Antibody Concentrations Against Different Meningococcal Polysaccharides Anti-PSA, PRE	0.98 μg/mL Interval 0.56 to 1.69	0.16 μg/mL Interval 0.14 to 0.18	—	—	—	—	—	—	—	—
Antibody Concentrations Against Different Meningococcal Polysaccharides Anti-PSC, PRE	1.33 μg/mL Interval 1.02 to 1.72	0.19 μg/mL Interval 0.13 to 0.27	—	—	—	—	—	—	—	—
Antibody Concentrations Against Different Meningococcal Polysaccharides Anti-PSW-135, PRE	25.67 μg/mL Interval 17.39 to 37.91	3.1 μg/mL Interval 1.34 to 7.2	—	—	—	—	—	—	—	—
Antibody Concentrations Against Different Meningococcal Polysaccharides Anti-PSY, PRE	56.94 μg/mL Interval 35.87 to 90.38	1.34 μg/mL Interval 0.63 to 2.88	—	—	—	—	—	—	—	—
Antibody Concentrations Against Different Meningococcal Polysaccharides Anti-PSA, Month 13	0.32 μg/mL Interval 0.22 to 0.48	0.5 μg/mL Interval 0.31 to 0.8	—	—	—	—	—	—	—	—
Antibody Concentrations Against Different Meningococcal Polysaccharides Anti-PSC, Month 13	2.34 μg/mL Interval 1.69 to 3.24	0.19 μg/mL Interval 0.13 to 0.26	—	—	—	—	—	—	—	—
Antibody Concentrations Against Different Meningococcal Polysaccharides Anti-PSW-135, Month 13	11.63 μg/mL Interval 7.73 to 17.5	15.23 μg/mL Interval 10.66 to 21.77	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: During the 8-day (Days 0-7) post-vaccination period following booster dose

Population: The analysis was performed on the Booster Total Vaccinated Cohort, which included all subjects who received the booster dose of Mencevax™ ACWY vaccine and had the symptom sheets filled in.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.

Outcome measures

Measure	GSK134612A Form1 (T), Primary Group n=31 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form2 (T), Primary Group n=30 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form3 (T), Primary Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form4 (T), Primary Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	Control (T), Primary Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form1 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form2 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form3 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form4 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	Control (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
Number of Subjects With Any Solicited Local Symptoms Any Pain	1 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any Solicited Local Symptoms Any Redness	3 Participants	3 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any Solicited Local Symptoms Any Swelling	1 Participants	1 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: During the 8-day (Days 0-7) post-vaccination period following booster dose

Population: The analysis was performed on the Booster Total Vaccinated Cohort, which included all subjects who received the booster dose of Mencevax™ ACWY vaccine and had the symptom sheets filled in.

Assessed solicited general symptoms were drowsiness, fever [defined as rectal temperature equal to or above 38.0 degrees Celsius (°C)], irritability and loss of appetite. Any = incidence of a particular symptom regardless of intensity or relationship to vaccination.

Outcome measures

Measure	GSK134612A Form1 (T), Primary Group n=31 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form2 (T), Primary Group n=30 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form3 (T), Primary Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form4 (T), Primary Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	Control (T), Primary Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form1 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form2 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form3 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form4 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	Control (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
Number of Subjects With Any Solicited General Symptoms Any Irritability	4 Participants	5 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any Solicited General Symptoms Any Drowsiness	3 Participants	5 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any Solicited General Symptoms Any Fever (Rectally)	5 Participants	3 Participants	—	—	—	—	—	—	—	—
Number of Subjects With Any Solicited General Symptoms Any Loss of appetite	2 Participants	2 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Within 31 days (Days 0-30) after the primary meningococcal vaccination

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.

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	GSK134612A Form1 (T), Primary Group n=39 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form2 (T), Primary Group n=41 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form3 (T), Primary Group n=41 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form4 (T), Primary Group n=40 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	Control (T), Primary Group n=40 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form1 (C), Primary Group n=54 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form2 (C), Primary Group n=50 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form3 (C), Primary Group n=52 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form4 (C), Primary Group n=52 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	Control (C), Primary Group n=52 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
Number of Subjects With Any Unsolicited Adverse Events (AEs) After the Primary Vaccination	11 Participants	16 Participants	5 Participants	8 Participants	14 Participants	6 Participants	12 Participants	7 Participants	5 Participants	6 Participants

SECONDARY outcome

Timeframe: Within 31 days (Days 0-30) post-vaccination with diphteria, tetanus and acellular pertusis-containing vaccine, during the primary vaccination

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.

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	GSK134612A Form1 (T), Primary Group n=38 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form2 (T), Primary Group n=40 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form3 (T), Primary Group n=37 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form4 (T), Primary Group n=40 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	Control (T), Primary Group n=39 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form1 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form2 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form3 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form4 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	Control (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
Number of Subjects With Any Unsolicited AEs During the Primary Vaccination	5 Participants	8 Participants	5 Participants	5 Participants	7 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Within 31 days (Days 0-30) after the booster vaccination

Population: The analysis was performed on the Booster Total Vaccinated Cohort, which included all subjects who received the booster dose of Mencevax™ ACWY vaccine.

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	GSK134612A Form1 (T), Primary Group n=33 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form2 (T), Primary Group n=32 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form3 (T), Primary Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form4 (T), Primary Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	Control (T), Primary Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form1 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form2 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form3 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form4 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	Control (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
Number of Subjects With Any Unsolicited AEs	3 Participants	5 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: During the primary vaccination study (from Month 0 up to Month 2)

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.

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	GSK134612A Form1 (T), Primary Group n=39 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form2 (T), Primary Group n=41 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form3 (T), Primary Group n=41 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form4 (T), Primary Group n=40 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	Control (T), Primary Group n=40 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form1 (C), Primary Group n=54 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form2 (C), Primary Group n=50 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form3 (C), Primary Group n=52 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form4 (C), Primary Group n=52 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	Control (C), Primary Group n=52 Participants Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
Number of Subjects With Serious Adverse Events (SAEs)	1 Participants	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Since the last study contact in the primary study up to the end of the booster study (from Month 2 up to Month 13)

Population: The analysis was performed on the Booster Total Vaccinated Cohort, which included all subjects who received the booster dose of Mencevax™ ACWY vaccine.

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	GSK134612A Form1 (T), Primary Group n=33 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form2 (T), Primary Group n=32 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form3 (T), Primary Group n=45 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form4 (T), Primary Group n=43 Participants Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	Control (T), Primary Group Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form1 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form2 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form3 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form4 (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	Control (C), Primary Group Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
Number of Subjects With SAEs	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—

Adverse Events

GSK134612A Form1 (T), Primary Group

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

GSK134612A Form2 (T), Primary Group

Serious events: 1 serious events

Other events: 27 other events

Deaths: 0 deaths

GSK134612A Form3 (T), Primary Group

Serious events: 1 serious events

Other events: 23 other events

Deaths: 0 deaths

GSK134612A Form4 (T), Primary Group

Serious events: 1 serious events

Other events: 24 other events

Deaths: 0 deaths

Control (T), Primary Group

Serious events: 1 serious events

Other events: 25 other events

Deaths: 0 deaths

GSK134612A Form1 (C), Primary Group

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

GSK134612A Form2 (C), Primary Group

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

GSK134612A Form3 (C), Primary Group

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

GSK134612A Form4 (C), Primary Group

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Control (C), Primary Group

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

GSK134612A Form1 (T), Booster Group

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Control (T), Booster Group

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

GSK134612A Form1 (C), Booster Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control (C), Booster Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	GSK134612A Form1 (T), Primary Group n=39 participants at risk Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form2 (T), Primary Group n=41 participants at risk Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form3 (T), Primary Group n=41 participants at risk Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form4 (T), Primary Group n=40 participants at risk Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	Control (T), Primary Group n=40 participants at risk Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form1 (C), Primary Group n=54 participants at risk Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form2 (C), Primary Group n=50 participants at risk Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form3 (C), Primary Group n=52 participants at risk Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form4 (C), Primary Group n=52 participants at risk Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	Control (C), Primary Group n=52 participants at risk Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).	GSK134612A Form1 (T), Booster Group n=33 participants at risk Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).	Control (T), Booster Group n=32 participants at risk Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer's Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).	GSK134612A Form1 (C), Booster Group n=45 participants at risk Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination.	Control (C), Booster Group n=43 participants at risk Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer's Meningitec™ conjugate vaccine, did not receive any booster vaccination.
Skin and subcutaneous tissue disorders Maculo-papular rash (toddlers subgroup)	0.00% 0/39 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/41 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/41 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/40 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	2.5% 1/40 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/54 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/50 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/33 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/32 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/45 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/43 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
Infections and infestations Laryngitis (toddlers subgroup)	0.00% 0/39 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/41 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	2.4% 1/41 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	2.5% 1/40 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/40 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/54 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/50 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/33 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/32 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/45 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/43 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
Infections and infestations Bronchiolitis (toddlers subgroup)	2.6% 1/39 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/41 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/41 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/40 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/40 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/54 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/50 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/33 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/32 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/45 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/43 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
Infections and infestations Acute bronchitis (toddlers subgroup)	0.00% 0/39 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	2.4% 1/41 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/41 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/40 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/40 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/54 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/50 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/33 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/32 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/45 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/43 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.

Other adverse events

Measure	GSK134612A Form1 (T), Primary Group n=39 participants at risk Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form2 (T), Primary Group n=41 participants at risk Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form3 (T), Primary Group n=41 participants at risk Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form4 (T), Primary Group n=40 participants at risk Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	Control (T), Primary Group n=40 participants at risk Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.	GSK134612A Form1 (C), Primary Group n=54 participants at risk Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form2 (C), Primary Group n=50 participants at risk Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form3 (C), Primary Group n=52 participants at risk Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	GSK134612A Form4 (C), Primary Group n=52 participants at risk Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).	Control (C), Primary Group n=52 participants at risk Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).	GSK134612A Form1 (T), Booster Group n=33 participants at risk Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).	Control (T), Booster Group n=32 participants at risk Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer's Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).	GSK134612A Form1 (C), Booster Group n=45 participants at risk Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination.	Control (C), Booster Group n=43 participants at risk Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer's Meningitec™ conjugate vaccine, did not receive any booster vaccination.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/39 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	7.3% 3/41 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/41 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/40 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	2.5% 1/40 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	1.9% 1/54 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/50 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	1.9% 1/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
General disorders Pyrexia	2.6% 1/39 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/41 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/41 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/40 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	5.0% 2/40 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	1.9% 1/54 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/50 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
Gastrointestinal disorders Diarrhea	0.00% 0/39 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/41 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/41 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	5.0% 2/40 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/40 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/54 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	2.0% 1/50 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	1.9% 1/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	3.0% 1/33 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/32 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
Skin and subcutaneous tissue disorders Rash	0.00% 0/39 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	7.3% 3/41 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/41 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/40 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/40 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/54 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/50 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
Infections and infestations Rhinitis	7.7% 3/39 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	4.9% 2/41 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/41 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	2.5% 1/40 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	7.5% 3/40 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/54 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/50 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	1.9% 1/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	1.9% 1/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
Infections and infestations Pharyngitis	2.6% 1/39 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/41 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/41 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/40 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	5.0% 2/40 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/54 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	2.0% 1/50 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	3.0% 1/33 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/32 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
Infections and infestations Gastroenteritis viral	5.1% 2/39 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/41 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/41 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/40 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/40 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/54 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	2.0% 1/50 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	1.9% 1/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
Infections and infestations Bronchitis	0.00% 0/39 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/41 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/41 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	2.5% 1/40 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	5.0% 2/40 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	1.9% 1/54 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	2.0% 1/50 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/33 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	6.2% 2/32 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
General disorders Pain (GSK134612A conjugate vaccine)	10.5% 4/38 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	19.5% 8/41 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	7.7% 3/39 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	15.0% 6/40 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	10.3% 4/39 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	19.2% 10/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	22.0% 11/50 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	18.0% 9/50 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	21.2% 11/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	25.5% 13/51 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	3.2% 1/31 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/30 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
General disorders Pain (Infanrix™-containing vaccine)	7.9% 3/38 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	25.6% 10/39 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	16.2% 6/37 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	17.9% 7/39 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	16.2% 6/37 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
General disorders Redness (GSK134612A conjugate vaccine)	23.7% 9/38 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	29.3% 12/41 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	25.6% 10/39 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	22.5% 9/40 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	28.2% 11/39 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	17.3% 9/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	22.0% 11/50 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	20.0% 10/50 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	17.3% 9/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	13.7% 7/51 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	9.7% 3/31 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	10.0% 3/30 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
General disorders Redness (Infanrix™-containing vaccine)	18.4% 7/38 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	33.3% 13/39 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	24.3% 9/37 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	20.5% 8/39 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	18.9% 7/37 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
General disorders Swelling (GSK134612A conjugate vaccine)	2.6% 1/38 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	14.6% 6/41 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	17.9% 7/39 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	15.0% 6/40 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	10.3% 4/39 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	13.5% 7/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	18.0% 9/50 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	16.0% 8/50 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	19.2% 10/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	7.8% 4/51 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	3.2% 1/31 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	3.3% 1/30 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
General disorders Swelling (Infanrix™-containing vaccine)	7.9% 3/38 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	17.9% 7/39 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	24.3% 9/37 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	17.9% 7/39 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	8.1% 3/37 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
General disorders Drowsiness (GSK134612A conjugate vaccine)	2.6% 1/38 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	12.2% 5/41 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	10.3% 4/39 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	10.0% 4/40 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	12.8% 5/39 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	7.7% 4/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	4.0% 2/50 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	0.00% 0/50 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	9.6% 5/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	7.8% 4/51 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	9.7% 3/31 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	16.7% 5/30 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
General disorders Drowsiness (Infanrix™-containing vaccine)	5.3% 2/38 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	5.1% 2/39 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	8.1% 3/37 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	17.9% 7/39 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	8.1% 3/37 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
General disorders Axillary/Rectally fever (GSK134612A conjugate vaccine)	13.2% 5/38 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	19.5% 8/41 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	20.5% 8/39 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	7.5% 3/40 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	12.8% 5/39 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	7.7% 4/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	8.0% 4/50 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	6.0% 3/50 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	5.8% 3/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	5.9% 3/51 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	16.1% 5/31 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	10.0% 3/30 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
General disorders Axillary fever (Infanrix™-containing vaccine)	10.5% 4/38 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	12.8% 5/39 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	13.5% 5/37 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	12.8% 5/39 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	21.6% 8/37 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
General disorders Irritability (GSK134612A conjugate vaccine)	10.5% 4/38 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	22.0% 9/41 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	15.4% 6/39 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	12.5% 5/40 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	12.8% 5/39 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	3.8% 2/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	8.0% 4/50 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	4.0% 2/50 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	7.7% 4/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	13.7% 7/51 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	12.9% 4/31 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	16.7% 5/30 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
General disorders Irritability (Infanrix™-containing vaccine)	15.8% 6/38 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	17.9% 7/39 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	8.1% 3/37 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	23.1% 9/39 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	13.5% 5/37 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
General disorders Loss of appetite (GSK134612A conjugate vaccine)	2.6% 1/38 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	14.6% 6/41 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	12.8% 5/39 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	7.5% 3/40 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	15.4% 6/39 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	3.8% 2/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	6.0% 3/50 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	4.0% 2/50 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	11.5% 6/52 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	5.9% 3/51 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	6.5% 2/31 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	6.7% 2/30 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
General disorders Loss of appetite (Infanrix™-containing vaccine)	10.5% 4/38 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	7.7% 3/39 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	5.4% 2/37 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	15.4% 6/39 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	5.4% 2/37 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.	— 0/0 • Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs: within 31 days (Days 0-30) after each vaccination. SAEs: from the beginning of the primary study up to the end of the booster study (from Month 0 up to Month 13). The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.

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