Safety & Immunogenicity Study of Meningococcal Vaccine GSK134612 Given With Priorix-Tetra™ to 12-23 Month-Old Children

Immunogenicity & Safety Study of GSK Biologicals' Meningococcal Vaccine GSK134612 When Co-Administered With GSK Biologicals' MMRV Vaccine (Priorix-Tetra™) in Healthy 12 to 23-Month-Old Children

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00474266

Enrollment

1000

Registered

2007-05-16

Start date

2007-06-05

Completion date

2008-03-26

Last updated

2019-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infections, Meningococcal

Keywords

MMRV vaccine, co-administration, immunogenicity, meningococcal vaccine, conjugate vaccine

Brief summary

The purpose of this study is to demonstrate, in 12-23 month old children, the non-inferiority of the meningococcal vaccine 134612 given with Priorix-Tetra. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed description

Open multicentre study with 4 treatment groups. Two groups will receive the 134612 vaccine with Priorix-Tetra either at the same or different visits followed by a second Priorix-Tetra vaccination at 84 days. Two control groups will receive Priorix-Tetra and Meningitec at different visits followed by a second Priorix-Tetra vaccination at 84 days. For all subjects, two blood samples will be taken: prior to and 42 days after the first vaccination. In a subset (30% of subjects in Groups A en C) from selected study centres: additional sample 42 days after second Priorix-Tetra dose.

Interventions

BIOLOGICALMeningococcal vaccine GSK134612 (Nimenrix)

Single dose intramuscular injection

BIOLOGICALPriorix-Tetra

2-dose subcutaneous injection

BIOLOGICALMeningitec

Single dose intramuscular injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Months to 23 Months

Healthy volunteers

Yes

Inclusion criteria

* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol. * A male or female between, and including, 12 and 23 months of age at the time of the vaccination. * Written informed consent obtained from the parent or guardian of the subject. * Free of obvious health problems as established by medical history and clinical examination before entering into the study. * Previously completed routine childhood vaccinations to the best of parents' or legal guardians' knowledge.

Exclusion criteria

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. * Planned administration/ administration of a vaccine not foreseen by the study protocol within one month before and 42 days after the first dose of vaccine(s). * Previous vaccination with meningococcal vaccine of serogroup A, C W and/or Y. * History of meningococcal disease. * Previous vaccination against measles, mumps, rubella, and/or varicella. * History of measles, mumps, rubella and/or varicella. * Known exposure to measles, mumps, rubella, varicella or zoster within 30 days prior to vaccination. * Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including neomycin. * Major congenital defects or serious chronic illness. * Acute disease at the time of enrolment. * Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.

Design outcomes

Primary

Measure	Time frame	Description
Number of Subjects With rSBA-MenC, rSBA-MenA, rSBA-MenW-135, rSBA-MenY Titers Greater Than or Equal to (≥) the Cut-off Values	42 days after the first vaccine dose (Day 42)	The cut-off values for the rSBA titers were ≥ 1:8. The analysis was performed only on subjects receiving meningitis vaccination (Nimenrix) at Day 0.
Number of Subjects With Anti-measles Antibody Concentrations ≥ the Cut-off Values	42 days after the first vaccine dose (Day 42)	The cut-off values for anti-measles antibody concentrations were ≥ 150 milli-international units per milliliter (mIU/mL).
Number of Subjects With Anti-mumps Antibody Concentrations ≥ the Cut-off Values	42 days after the first vaccine dose (Day 42)	The cut-off values for anti-mumps antibody concentrations were ≥ 231 units per milliliter (U/mL).
Number of Subjects With Anti-rubella Antibody Concentrations ≥ the Cut-off Values.	42 days after the first vaccine dose (Day 42)	The cut-off values for anti-rubella antibody concentrations were ≥ 4 international units per milliliter (IU/mL).
Number of Subjects With Anti-varicella Antibody Concentrations ≥ the Cut-off Values	42 days after the first vaccine dose (Day 42)	The cut-off values for anti-varicella antibody concentrations were ≥ 1:4.

Secondary

Measure	Time frame	Description
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers	Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)	Anti-hSBA antibody titers were expressed as geometric mean titers (GMTs) for Nimenrix + Priorix-Tetra group, Nimenrix group, Meningitec group and Pooled group (Nimenrix + Priorix-Tetra and Nimenrix groups), respectively. The analysis was performed only on subjects receiving meningitis vaccination (Nimenrix) at Day 0.
Anti-measles Antibody Concentrations	42 days after the first vaccine dose (Day 42)	Anti-measles antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL) in all groups.
Anti-mumps Antibody Concentrations	42 days after the first vaccine dose (Day 42)	Anti-mumps antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in units per milliliter (U/mL) in all groups.
Anti-rubella Antibody Concentrations	42 days after the first vaccine dose (Day 42)	Anti-rubella antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in international units per millilier (IU/mL) in all groups.
Anti-varicella Antibody Titers	42 days after the first vaccine dose (Day 42)	Anti-varicella antibody titers were given as geometric mean titers (GMTs) for all groups.
Number of Subjects Reporting Solicited Local Symptoms Specific for Priorix-Tetra Vaccination	During the 4-day (Days 0-3) after vaccination with first dose of Priorix-Tetra vaccine at Day 0	Solicited local symptoms assessed were pain, redness and swelling for the Nimenrix + Priorix-Tetra Group and Priorix-Tetra Group, respectively. The analysis was performed only on subjects receiving varicella vaccination (Priorix-Tetra) at Day 0.
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	Prior to vaccination (Day 0) and after the first vaccination dose (Day 42)	The cut-off values for the rSBA titers were ≥ 1:8 and ≥ 1:128 respectively. At pre-vaccination for all groups, half of the subjects were sera tested for rSBA-MenC while the other half was tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY. At Post vaccination I (Day 42), all subjects from Nimenrix + Priorix-Tetra and Nimenrix groups were sera tested for each rSBA. For Meningitec and Priorix-Tetra groups, all subjects were tested for rSBA-MenC while half of subjects were tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY.
Number of Subjects Reporting Solicited General Symptoms	During the 4-day (Days 0-3) follow-up period after first vaccination dose in all groups	Solicited general symptoms assessed were drowsiness, fever (measured rectally and temperature ≥ 38.0°C ), irritability and loss of appetite, Meningismus, Parotiditis and Rash.
Number of Subjects With Priorix-Tetra - Specific Solicited General Symptoms	During the 43-day (Days 0-42) after first vaccination dose	Solicited general symptoms assessed were fever (measured rectally and temperature ≥ 38.0°C ), Meningismus, Parotiditis and Rash.
Number of Subjects Reporting Specific Adverse Events (AEs)	From Day 0 up to Month 6 after first vaccine dose	Specific AEs include: rash, New Onset of Chronic Illness(es) (NOCI), and/or conditions prompting emergency room (ER) visits or non-routine physician office visits.
Number of Subjects Reporting Unsolicited Symptoms	During the 43-day (Days 0-42) post Dose 1 vaccination period	Unsolicited symptom covers any symptom 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.
Number of Subjects Reporting Serious Adverse Events (SAEs)	From Day 0 up to Month 6 after vaccination	SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization, result in disability/ incapacity or are a congenital anomaly/ birth defect in the offspring of a study subject.
Number of Subjects Reporting Solicited Local Symptoms After Nimenrix or Meningitec Vaccination at Day 0	During the 4-day (Days 0-3) after vaccination with Nimenrix or Meningitec at Day 0	Solicited local symptoms assessed were pain, redness and swelling for the Nimenrix + Priorix-Tetra Group, Nimenrix Group and Meningitec Group, respectively. The analysis was performed only on subjects receiving meningitis vaccination (Priorix-Tetra) at Day 0.
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers	Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)	Antibody titers were expressed as geometric mean titers (GMTs). At pre-vaccination for all groups, half of the subjects were sera tested for rSBA-MenC while the other half were tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY. At Post vaccination I (Day 42), all subjects from Nimenrix + Priorix-Tetra and Nimenrix groups were sera tested for each rSBA. For Meningitec and Priorix-Tetra groups, all subjects were tested for rSBA-MenC while half of subjects were tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY.
Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Prior to the first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)	Anti-PS antibody concentrations were given as geometric mean concentrations (GMCs) and expressed as microgram per milliliter (μg/mL). At pre-vaccination (Day 0) and Post-vaccination I (Day 42), a quarter of the subjects were tested for anti-PSC and another quarter for anti-PSA, anti-PSW-135 and anti-PSY.
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)	The cut-off values for anti-PS antibody concentrations were ≥ 0.3 μg/mL and ≥ 2.0 μg/mL respectively. At pre-vaccination (Day 0) and Post-vaccination I (Day 42), a quarter of the subjects were tested for anti-PSC and another quarter for anti-PSA, anti-PSW-135 and anti-PSY.
Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)	The cut-off values for hSBA antibody titers were ≥ 1:4 and ≥ 1:8 for Nimenrix + Priorix-Tetra group, Nimenrix group, Meningitec group and Pooled group (Nimenrix + Priorix-Tetra and Nimenrix groups), respectively. The analysis was performed only on subjects receiving meningitis vaccination (Nimenrix) at Day 0.

Countries

Finland

Participant flow

Pre-assignment details

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

Participants by arm

Arm	Count
Nimenrix + Priorix-Tetra Group Subjects received 1 dose of Nimenrix™ vaccine and 1 dose of Priorix-Tetra™ vaccine on Day 0 and a second dose of Priorix-Tetra™ vaccine on Day 84.	375
Nimenrix Group Subjects received 1 dose of Nimenrix™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	374
Priorix-Tetra Group Subjects received 1 dose of Priorix-Tetra™ vaccine on Day 0, 1 dose of Meningitec™ vaccine on Day 42 and a second dose of Priorix-Tetra™ vaccine on Day 84.	126
Meningitec Group Subjects received 1 dose of Meningitec™ vaccine on Day 0 followed by 2 doses of Priorix-Tetra™ vaccine, respectively 42 and 84 days later.	125
Total	1,000

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
Overall Study	Withdrawal by Subject	7	20	4	7

Baseline characteristics

Characteristic	Nimenrix + Priorix-Tetra Group	Nimenrix Group	Priorix-Tetra Group	Meningitec Group	Total
Age, Continuous	14.7 Months STANDARD_DEVIATION 1.5	14.6 Months STANDARD_DEVIATION 1.49	14.6 Months STANDARD_DEVIATION 1.41	14.4 Months STANDARD_DEVIATION 1.47	14.61 Months STANDARD_DEVIATION 1.48
Race/Ethnicity, Customized Other	4 Participants	2 Participants	2 Participants	2 Participants	10 Participants
Race/Ethnicity, Customized White - Arabic / North African heritage	2 Participants	0 Participants	1 Participants	0 Participants	3 Participants
Race/Ethnicity, Customized White-Caucasian/ European heritage, n (%)	369 Participants	372 Participants	123 Participants	123 Participants	987 Participants
Sex/Gender, Customized Female	180 Participants	174 Participants	68 Participants	60 Participants	482 Participants
Sex/Gender, Customized Male	195 Participants	200 Participants	58 Participants	65 Participants	518 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	0 / 375	0 / 125	0 / 374	0 / 126
other Total, other adverse events	340 / 375	103 / 125	313 / 374	108 / 126
serious Total, serious adverse events	13 / 375	2 / 125	10 / 374	3 / 126

Outcome results

Primary

Number of Subjects With Anti-measles Antibody Concentrations ≥ the Cut-off Values

The cut-off values for anti-measles antibody concentrations were ≥ 150 milli-international units per milliliter (mIU/mL).

Time frame: 42 days after the first vaccine dose (Day 42)

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Nimenrix + Priorix-Tetra Group	Number of Subjects With Anti-measles Antibody Concentrations ≥ the Cut-off Values	361 Participants
Nimenrix Group	Number of Subjects With Anti-measles Antibody Concentrations ≥ the Cut-off Values	0 Participants
Meningitec Group	Number of Subjects With Anti-measles Antibody Concentrations ≥ the Cut-off Values	118 Participants
Meningitec Group	Number of Subjects With Anti-measles Antibody Concentrations ≥ the Cut-off Values	0 Participants

95% CI: [-1.06, 3.17]

Primary

Number of Subjects With Anti-mumps Antibody Concentrations ≥ the Cut-off Values

The cut-off values for anti-mumps antibody concentrations were ≥ 231 units per milliliter (U/mL).

Time frame: 42 days after the first vaccine dose (Day 42)

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Nimenrix + Priorix-Tetra Group	Number of Subjects With Anti-mumps Antibody Concentrations ≥ the Cut-off Values	306 Participants
Nimenrix Group	Number of Subjects With Anti-mumps Antibody Concentrations ≥ the Cut-off Values	0 Participants
Meningitec Group	Number of Subjects With Anti-mumps Antibody Concentrations ≥ the Cut-off Values	97 Participants
Meningitec Group	Number of Subjects With Anti-mumps Antibody Concentrations ≥ the Cut-off Values	0 Participants

95% CI: [-2.82, 12.46]

Primary

Number of Subjects With Anti-rubella Antibody Concentrations ≥ the Cut-off Values.

The cut-off values for anti-rubella antibody concentrations were ≥ 4 international units per milliliter (IU/mL).

Time frame: 42 days after the first vaccine dose (Day 42)

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Nimenrix + Priorix-Tetra Group	Number of Subjects With Anti-rubella Antibody Concentrations ≥ the Cut-off Values.	361 Participants
Nimenrix Group	Number of Subjects With Anti-rubella Antibody Concentrations ≥ the Cut-off Values.	1 Participants
Meningitec Group	Number of Subjects With Anti-rubella Antibody Concentrations ≥ the Cut-off Values.	118 Participants
Meningitec Group	Number of Subjects With Anti-rubella Antibody Concentrations ≥ the Cut-off Values.	1 Participants

95% CI: [-1.06, 3.18]

Primary

Number of Subjects With Anti-varicella Antibody Concentrations ≥ the Cut-off Values

The cut-off values for anti-varicella antibody concentrations were ≥ 1:4.

Time frame: 42 days after the first vaccine dose (Day 42)

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Nimenrix + Priorix-Tetra Group	Number of Subjects With Anti-varicella Antibody Concentrations ≥ the Cut-off Values	326 Participants
Nimenrix Group	Number of Subjects With Anti-varicella Antibody Concentrations ≥ the Cut-off Values	6 Participants
Meningitec Group	Number of Subjects With Anti-varicella Antibody Concentrations ≥ the Cut-off Values	105 Participants
Meningitec Group	Number of Subjects With Anti-varicella Antibody Concentrations ≥ the Cut-off Values	2 Participants

95% CI: [-0.28, 9.5]

Primary

Number of Subjects With rSBA-MenC, rSBA-MenA, rSBA-MenW-135, rSBA-MenY Titers Greater Than or Equal to (≥) the Cut-off Values

The cut-off values for the rSBA titers were ≥ 1:8. The analysis was performed only on subjects receiving meningitis vaccination (Nimenrix) at Day 0.

Time frame: 42 days after the first vaccine dose (Day 42)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Nimenrix + Priorix-Tetra Group	Number of Subjects With rSBA-MenC, rSBA-MenA, rSBA-MenW-135, rSBA-MenY Titers Greater Than or Equal to (≥) the Cut-off Values	rSBA-MenY, D42	359 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects With rSBA-MenC, rSBA-MenA, rSBA-MenW-135, rSBA-MenY Titers Greater Than or Equal to (≥) the Cut-off Values	rSBA-MenC, D42	357 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects With rSBA-MenC, rSBA-MenA, rSBA-MenW-135, rSBA-MenY Titers Greater Than or Equal to (≥) the Cut-off Values	rSBA-MenA, D42	360 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects With rSBA-MenC, rSBA-MenA, rSBA-MenW-135, rSBA-MenY Titers Greater Than or Equal to (≥) the Cut-off Values	rSBA-MenW-135, D42	360 Participants
Nimenrix Group	Number of Subjects With rSBA-MenC, rSBA-MenA, rSBA-MenW-135, rSBA-MenY Titers Greater Than or Equal to (≥) the Cut-off Values	rSBA-MenC, D42	353 Participants
Nimenrix Group	Number of Subjects With rSBA-MenC, rSBA-MenA, rSBA-MenW-135, rSBA-MenY Titers Greater Than or Equal to (≥) the Cut-off Values	rSBA-MenA, D42	353 Participants
Nimenrix Group	Number of Subjects With rSBA-MenC, rSBA-MenA, rSBA-MenW-135, rSBA-MenY Titers Greater Than or Equal to (≥) the Cut-off Values	rSBA-MenW-135, D42	354 Participants
Nimenrix Group	Number of Subjects With rSBA-MenC, rSBA-MenA, rSBA-MenW-135, rSBA-MenY Titers Greater Than or Equal to (≥) the Cut-off Values	rSBA-MenY, D42	354 Participants
Meningitec Group	Number of Subjects With rSBA-MenC, rSBA-MenA, rSBA-MenW-135, rSBA-MenY Titers Greater Than or Equal to (≥) the Cut-off Values	rSBA-MenW-135, D42	29 Participants
Meningitec Group	Number of Subjects With rSBA-MenC, rSBA-MenA, rSBA-MenW-135, rSBA-MenY Titers Greater Than or Equal to (≥) the Cut-off Values	rSBA-MenA, D42	23 Participants
Meningitec Group	Number of Subjects With rSBA-MenC, rSBA-MenA, rSBA-MenW-135, rSBA-MenY Titers Greater Than or Equal to (≥) the Cut-off Values	rSBA-MenY, D42	32 Participants
Meningitec Group	Number of Subjects With rSBA-MenC, rSBA-MenA, rSBA-MenW-135, rSBA-MenY Titers Greater Than or Equal to (≥) the Cut-off Values	rSBA-MenC, D42	118 Participants

95% CI: [0.29, 6.78]

95% CI: [-0.78, 1.58]

95% CI: [-0.79, 1.58]

95% CI: [-1.06, 1.07]

Secondary

Anti-measles Antibody Concentrations

Anti-measles antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL) in all groups.

Time frame: 42 days after the first vaccine dose (Day 42)

Arm	Measure	Value (GEOMETRIC_MEAN)
Nimenrix + Priorix-Tetra Group	Anti-measles Antibody Concentrations	4273.4 mIU/mL
Nimenrix Group	Anti-measles Antibody Concentrations	75 mIU/mL
Meningitec Group	Anti-measles Antibody Concentrations	4457.3 mIU/mL
Meningitec Group	Anti-measles Antibody Concentrations	75 mIU/mL

Secondary

Anti-measles Antibody Concentrations

Anti-measles antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in mIU/mL in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only. The analysis was performed only on subjects receiving varicella vaccination (Priorix-Tetra) at Day 0.

Time frame: 42 days after the second Priorix-Tetra vaccine dose (Day 126)

Arm	Measure	Value (GEOMETRIC_MEAN)
Nimenrix + Priorix-Tetra Group	Anti-measles Antibody Concentrations	7113.8 mIU/mL
Nimenrix Group	Anti-measles Antibody Concentrations	8699.8 mIU/mL

Secondary

Anti-mumps Antibody Concentrations

Anti-mumps antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in units per milliliter (U/mL) in all groups.

Time frame: 42 days after the first vaccine dose (Day 42)

Arm	Measure	Value (GEOMETRIC_MEAN)
Nimenrix + Priorix-Tetra Group	Anti-mumps Antibody Concentrations	662.9 U/mL
Nimenrix Group	Anti-mumps Antibody Concentrations	115.5 U/mL
Meningitec Group	Anti-mumps Antibody Concentrations	710.1 U/mL
Meningitec Group	Anti-mumps Antibody Concentrations	115.5 U/mL

Secondary

Anti-mumps Antibody Concentrations

Anti-mumps antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in U/mL in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only. The analysis was performed only on subjects receiving varicella vaccination ( Priorix-Tetra) at Day 0.

Time frame: 42 days after the second Priorix-Tetra vaccine dose (Day 126)

Arm	Measure	Value (GEOMETRIC_MEAN)
Nimenrix + Priorix-Tetra Group	Anti-mumps Antibody Concentrations	3351.2 U/mL
Nimenrix Group	Anti-mumps Antibody Concentrations	3334.1 U/mL

Secondary

Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values

Anti-PS antibody concentrations were given as geometric mean concentrations (GMCs) and expressed as microgram per milliliter (μg/mL). At pre-vaccination (Day 0) and Post-vaccination I (Day 42), a quarter of the subjects were tested for anti-PSC and another quarter for anti-PSA, anti-PSW-135 and anti-PSY.

Time frame: Prior to the first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Nimenrix + Priorix-Tetra Group	Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSA, D42	28.74 μg/mL
Nimenrix + Priorix-Tetra Group	Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSC, D0	0.15 μg/mL
Nimenrix + Priorix-Tetra Group	Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSW-135, D42	6.5 μg/mL
Nimenrix + Priorix-Tetra Group	Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSY, D42	8.56 μg/mL
Nimenrix + Priorix-Tetra Group	Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSW-135, D0	0.16 μg/mL
Nimenrix + Priorix-Tetra Group	Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSC, D42	9.26 μg/mL
Nimenrix + Priorix-Tetra Group	Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSY, D0	0.15 μg/mL
Nimenrix + Priorix-Tetra Group	Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSA, D0	0.17 μg/mL
Nimenrix Group	Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSY, D0	0.16 μg/mL
Nimenrix Group	Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSW-135, D0	0.15 μg/mL
Nimenrix Group	Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSW-135, D42	4.5 μg/mL
Nimenrix Group	Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSA, D42	15.71 μg/mL
Nimenrix Group	Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSA, D0	0.15 μg/mL
Nimenrix Group	Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSC, D0	0.15 μg/mL
Nimenrix Group	Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSY, D42	6.37 μg/mL
Nimenrix Group	Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSC, D42	7.44 μg/mL
Meningitec Group	Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSW-135, D42	0.16 μg/mL
Meningitec Group	Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSA, D42	0.16 μg/mL
Meningitec Group	Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSY, D42	0.16 μg/mL
Meningitec Group	Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSY, D0	0.15 μg/mL
Meningitec Group	Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSC, D0	0.15 μg/mL
Meningitec Group	Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSA, D0	0.16 μg/mL
Meningitec Group	Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSC, D42	0.15 μg/mL
Meningitec Group	Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSW-135, D0	0.16 μg/mL
Meningitec Group	Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSY, D42	0.15 μg/mL
Meningitec Group	Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSA, D0	0.16 μg/mL
Meningitec Group	Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSA, D42	0.15 μg/mL
Meningitec Group	Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSC, D0	0.15 μg/mL
Meningitec Group	Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSC, D42	4.89 μg/mL
Meningitec Group	Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSW-135, D0	0.15 μg/mL
Meningitec Group	Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSW-135, D42	0.15 μg/mL
Meningitec Group	Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSY, D0	0.15 μg/mL

Secondary

Anti-rubella Antibody Concentrations

Anti-rubella antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in IU/mL in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only. The analysis was performed only on subjects receiving varicella vaccination (Priorix-Tetra) at Day 0.

Time frame: 42 days after the second Priorix-Tetra vaccine dose (Day 126)

Arm	Measure	Value (GEOMETRIC_MEAN)
Nimenrix + Priorix-Tetra Group	Anti-rubella Antibody Concentrations	87.2 IU/mL
Nimenrix Group	Anti-rubella Antibody Concentrations	117 IU/mL

Secondary

Anti-rubella Antibody Concentrations

Anti-rubella antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in international units per millilier (IU/mL) in all groups.

Time frame: 42 days after the first vaccine dose (Day 42)

Arm	Measure	Value (GEOMETRIC_MEAN)
Nimenrix + Priorix-Tetra Group	Anti-rubella Antibody Concentrations	43.1 IU/mL
Nimenrix Group	Anti-rubella Antibody Concentrations	2 IU/mL
Meningitec Group	Anti-rubella Antibody Concentrations	53.2 IU/mL
Meningitec Group	Anti-rubella Antibody Concentrations	2 IU/mL

Secondary

Anti-varicella Antibody Titers

Anti-varicella antibody titers were given as geometric mean titers (GMTs) in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only. The analysis was performed only on subjects receiving varicella vaccination ( Priorix-Tetra) at Day 0.

Time frame: 42 days after the second Priorix-Tetra vaccine dose (Day 126)

Arm	Measure	Value (GEOMETRIC_MEAN)
Nimenrix + Priorix-Tetra Group	Anti-varicella Antibody Titers	4175.6 Titers
Nimenrix Group	Anti-varicella Antibody Titers	3360.1 Titers

Secondary

Anti-varicella Antibody Titers

Anti-varicella antibody titers were given as geometric mean titers (GMTs) for all groups.

Time frame: 42 days after the first vaccine dose (Day 42)

Arm	Measure	Value (GEOMETRIC_MEAN)
Nimenrix + Priorix-Tetra Group	Anti-varicella Antibody Titers	152.8 Titers
Nimenrix Group	Anti-varicella Antibody Titers	2.2 Titers
Meningitec Group	Anti-varicella Antibody Titers	128.8 Titers
Meningitec Group	Anti-varicella Antibody Titers	2.2 Titers

Secondary

hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers

Anti-hSBA antibody titers were expressed as geometric mean titers (GMTs) for Nimenrix + Priorix-Tetra group, Nimenrix group, Meningitec group and Pooled group (Nimenrix + Priorix-Tetra and Nimenrix groups), respectively. The analysis was performed only on subjects receiving meningitis vaccination (Nimenrix) at Day 0.

Time frame: Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Nimenrix + Priorix-Tetra Group	hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers	hSBA- MenA, D0	2.1 Titer
Nimenrix + Priorix-Tetra Group	hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers	hSBA-MenY, D42	38.7 Titer
Nimenrix + Priorix-Tetra Group	hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers	hSBA-MenW-135, D42	57.3 Titer
Nimenrix + Priorix-Tetra Group	hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers	hSBA-MenC, D42	209.1 Titer
Nimenrix + Priorix-Tetra Group	hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers	hSBA-MenC, D0	2 Titer
Nimenrix + Priorix-Tetra Group	hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers	hSBA-MenW-135, D0	2.1 Titer
Nimenrix + Priorix-Tetra Group	hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers	hSBA- MenA, D42	33.7 Titer
Nimenrix + Priorix-Tetra Group	hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers	hSBA-MenY, D0	2.1 Titer
Nimenrix Group	hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers	hSBA-MenW-135, D42	48.9 Titer
Nimenrix Group	hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers	hSBA- MenA, D0	2.1 Titer
Nimenrix Group	hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers	hSBA-MenY, D42	30.9 Titer
Nimenrix Group	hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers	hSBA- MenA, D42	19 Titer
Nimenrix Group	hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers	hSBA-MenW-135, D0	2.1 Titer
Nimenrix Group	hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers	hSBA-MenC, D0	2 Titer
Nimenrix Group	hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers	hSBA-MenY, D0	2.1 Titer
Nimenrix Group	hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers	hSBA-MenC, D42	196 Titer
Meningitec Group	hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers	hSBA- MenA, D0	2 Titer
Meningitec Group	hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers	hSBA-MenC, D0	2 Titer
Meningitec Group	hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers	hSBA-MenW-135, D0	2 Titer
Meningitec Group	hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers	hSBA-MenY, D42	2.1 Titer
Meningitec Group	hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers	hSBA- MenA, D42	2 Titer
Meningitec Group	hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers	hSBA-MenC, D42	40.3 Titer
Meningitec Group	hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers	hSBA-MenW-135, D42	2 Titer
Meningitec Group	hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers	hSBA-MenY, D0	2.1 Titer
Meningitec Group	hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers	hSBA- MenA, D42	25.4 Titer
Meningitec Group	hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers	hSBA-MenC, D42	202.5 Titer
Meningitec Group	hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers	hSBA-MenC, D0	2 Titer
Meningitec Group	hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers	hSBA- MenA, D0	2.1 Titer
Meningitec Group	hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers	hSBA-MenY, D42	34.6 Titer
Meningitec Group	hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers	hSBA-MenY, D0	2.1 Titer
Meningitec Group	hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers	hSBA-MenW-135, D42	52.9 Titer
Meningitec Group	hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers	hSBA-MenW-135, D0	2.1 Titer

Secondary

Number of Subjects Reporting Serious Adverse Events (SAEs)

SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization, result in disability/ incapacity or are a congenital anomaly/ birth defect in the offspring of a study subject.

Time frame: From Day 0 up to Month 6 after vaccination

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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Nimenrix + Priorix-Tetra Group	Number of Subjects Reporting Serious Adverse Events (SAEs)	13 Participants
Nimenrix Group	Number of Subjects Reporting Serious Adverse Events (SAEs)	10 Participants
Meningitec Group	Number of Subjects Reporting Serious Adverse Events (SAEs)	3 Participants
Meningitec Group	Number of Subjects Reporting Serious Adverse Events (SAEs)	2 Participants

Secondary

Number of Subjects Reporting Solicited General Symptoms

Solicited general symptoms assessed were drowsiness, fever (measured rectally and temperature ≥ 38.0°C ), irritability and loss of appetite, Meningismus, Parotiditis and Rash.

Time frame: During the 4-day (Days 0-3) follow-up period after first vaccination dose in all groups

Population: The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects with the symptom sheet filled-in.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Nimenrix + Priorix-Tetra Group	Number of Subjects Reporting Solicited General Symptoms	Drowsiness	122 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects Reporting Solicited General Symptoms	Parotiditis	0 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects Reporting Solicited General Symptoms	Fever≥38.0˚C	56 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects Reporting Solicited General Symptoms	Irritability	190 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects Reporting Solicited General Symptoms	Loss of appetite	107 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects Reporting Solicited General Symptoms	Meningismus	0 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects Reporting Solicited General Symptoms	Rash	22 Participants
Nimenrix Group	Number of Subjects Reporting Solicited General Symptoms	Parotiditis	0 Participants
Nimenrix Group	Number of Subjects Reporting Solicited General Symptoms	Drowsiness	103 Participants
Nimenrix Group	Number of Subjects Reporting Solicited General Symptoms	Fever≥38.0˚C	34 Participants
Nimenrix Group	Number of Subjects Reporting Solicited General Symptoms	Rash	23 Participants
Nimenrix Group	Number of Subjects Reporting Solicited General Symptoms	Loss of appetite	84 Participants
Nimenrix Group	Number of Subjects Reporting Solicited General Symptoms	Irritability	150 Participants
Nimenrix Group	Number of Subjects Reporting Solicited General Symptoms	Meningismus	0 Participants
Meningitec Group	Number of Subjects Reporting Solicited General Symptoms	Meningismus	0 Participants
Meningitec Group	Number of Subjects Reporting Solicited General Symptoms	Rash	10 Participants
Meningitec Group	Number of Subjects Reporting Solicited General Symptoms	Irritability	48 Participants
Meningitec Group	Number of Subjects Reporting Solicited General Symptoms	Parotiditis	0 Participants
Meningitec Group	Number of Subjects Reporting Solicited General Symptoms	Drowsiness	29 Participants
Meningitec Group	Number of Subjects Reporting Solicited General Symptoms	Fever≥38.0˚C	14 Participants
Meningitec Group	Number of Subjects Reporting Solicited General Symptoms	Loss of appetite	29 Participants
Meningitec Group	Number of Subjects Reporting Solicited General Symptoms	Parotiditis	0 Participants
Meningitec Group	Number of Subjects Reporting Solicited General Symptoms	Fever≥38.0˚C	16 Participants
Meningitec Group	Number of Subjects Reporting Solicited General Symptoms	Rash	6 Participants
Meningitec Group	Number of Subjects Reporting Solicited General Symptoms	Irritability	54 Participants
Meningitec Group	Number of Subjects Reporting Solicited General Symptoms	Loss of appetite	33 Participants
Meningitec Group	Number of Subjects Reporting Solicited General Symptoms	Meningismus	0 Participants
Meningitec Group	Number of Subjects Reporting Solicited General Symptoms	Drowsiness	40 Participants

Secondary

Number of Subjects Reporting Solicited Local Symptoms After Nimenrix or Meningitec Vaccination at Day 0

Solicited local symptoms assessed were pain, redness and swelling for the Nimenrix + Priorix-Tetra Group, Nimenrix Group and Meningitec Group, respectively. The analysis was performed only on subjects receiving meningitis vaccination (Priorix-Tetra) at Day 0.

Time frame: During the 4-day (Days 0-3) after vaccination with Nimenrix or Meningitec at Day 0

Population: The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects with the symptom sheet filled-in.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Nimenrix + Priorix-Tetra Group	Number of Subjects Reporting Solicited Local Symptoms After Nimenrix or Meningitec Vaccination at Day 0	Swelling	52 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects Reporting Solicited Local Symptoms After Nimenrix or Meningitec Vaccination at Day 0	Redness	133 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects Reporting Solicited Local Symptoms After Nimenrix or Meningitec Vaccination at Day 0	Pain	91 Participants
Nimenrix Group	Number of Subjects Reporting Solicited Local Symptoms After Nimenrix or Meningitec Vaccination at Day 0	Swelling	69 Participants
Nimenrix Group	Number of Subjects Reporting Solicited Local Symptoms After Nimenrix or Meningitec Vaccination at Day 0	Pain	107 Participants
Nimenrix Group	Number of Subjects Reporting Solicited Local Symptoms After Nimenrix or Meningitec Vaccination at Day 0	Redness	136 Participants
Meningitec Group	Number of Subjects Reporting Solicited Local Symptoms After Nimenrix or Meningitec Vaccination at Day 0	Redness	39 Participants
Meningitec Group	Number of Subjects Reporting Solicited Local Symptoms After Nimenrix or Meningitec Vaccination at Day 0	Pain	31 Participants
Meningitec Group	Number of Subjects Reporting Solicited Local Symptoms After Nimenrix or Meningitec Vaccination at Day 0	Swelling	10 Participants

Secondary

Number of Subjects Reporting Solicited Local Symptoms Specific for Priorix-Tetra Vaccination

Solicited local symptoms assessed were pain, redness and swelling for the Nimenrix + Priorix-Tetra Group and Priorix-Tetra Group, respectively. The analysis was performed only on subjects receiving varicella vaccination (Priorix-Tetra) at Day 0.

Time frame: During the 4-day (Days 0-3) after vaccination with first dose of Priorix-Tetra vaccine at Day 0

Population: The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects with the symptom sheet filled-in.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Nimenrix + Priorix-Tetra Group	Number of Subjects Reporting Solicited Local Symptoms Specific for Priorix-Tetra Vaccination	Pain	75 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects Reporting Solicited Local Symptoms Specific for Priorix-Tetra Vaccination	Redness	126 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects Reporting Solicited Local Symptoms Specific for Priorix-Tetra Vaccination	Swelling	28 Participants
Nimenrix Group	Number of Subjects Reporting Solicited Local Symptoms Specific for Priorix-Tetra Vaccination	Pain	22 Participants
Nimenrix Group	Number of Subjects Reporting Solicited Local Symptoms Specific for Priorix-Tetra Vaccination	Redness	48 Participants
Nimenrix Group	Number of Subjects Reporting Solicited Local Symptoms Specific for Priorix-Tetra Vaccination	Swelling	7 Participants

Secondary

Number of Subjects Reporting Specific Adverse Events (AEs)

Specific AEs include: rash, New Onset of Chronic Illness(es) (NOCI), and/or conditions prompting emergency room (ER) visits or non-routine physician office visits.

Time frame: From Day 0 up to Month 6 after first vaccine dose

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Nimenrix + Priorix-Tetra Group	Number of Subjects Reporting Specific Adverse Events (AEs)	Rash (es)	13 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects Reporting Specific Adverse Events (AEs)	ER visit (s)	28 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects Reporting Specific Adverse Events (AEs)	NOCI (s)	6 Participants
Nimenrix Group	Number of Subjects Reporting Specific Adverse Events (AEs)	ER visit (s)	29 Participants
Nimenrix Group	Number of Subjects Reporting Specific Adverse Events (AEs)	Rash (es)	10 Participants
Nimenrix Group	Number of Subjects Reporting Specific Adverse Events (AEs)	NOCI (s)	3 Participants
Meningitec Group	Number of Subjects Reporting Specific Adverse Events (AEs)	ER visit (s)	3 Participants
Meningitec Group	Number of Subjects Reporting Specific Adverse Events (AEs)	NOCI (s)	1 Participants
Meningitec Group	Number of Subjects Reporting Specific Adverse Events (AEs)	Rash (es)	2 Participants
Meningitec Group	Number of Subjects Reporting Specific Adverse Events (AEs)	Rash (es)	6 Participants
Meningitec Group	Number of Subjects Reporting Specific Adverse Events (AEs)	ER visit (s)	7 Participants
Meningitec Group	Number of Subjects Reporting Specific Adverse Events (AEs)	NOCI (s)	1 Participants

Secondary

Number of Subjects Reporting Unsolicited Symptoms

Unsolicited symptom covers any symptom 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.

Time frame: During the 43-day (Days 0-42) post Dose 1 vaccination period

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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Nimenrix + Priorix-Tetra Group	Number of Subjects Reporting Unsolicited Symptoms	243 Participants
Nimenrix Group	Number of Subjects Reporting Unsolicited Symptoms	225 Participants
Meningitec Group	Number of Subjects Reporting Unsolicited Symptoms	86 Participants
Meningitec Group	Number of Subjects Reporting Unsolicited Symptoms	68 Participants

Secondary

Number of Subjects Reporting Unsolicited Symptoms

Time frame: During the 43-day (Days 0-42) follow-up period after each vaccination

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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Nimenrix + Priorix-Tetra Group	Number of Subjects Reporting Unsolicited Symptoms	252 Participants
Nimenrix Group	Number of Subjects Reporting Unsolicited Symptoms	233 Participants
Meningitec Group	Number of Subjects Reporting Unsolicited Symptoms	90 Participants
Meningitec Group	Number of Subjects Reporting Unsolicited Symptoms	75 Participants

Secondary

Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values

The cut-off values for anti-PS antibody concentrations were ≥ 0.3 μg/mL and ≥ 2.0 μg/mL respectively. At pre-vaccination (Day 0) and Post-vaccination I (Day 42), a quarter of the subjects were tested for anti-PSC and another quarter for anti-PSA, anti-PSW-135 and anti-PSY.

Time frame: Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Nimenrix + Priorix-Tetra Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSC ≥ 0.3 μg/mL, D42	89 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSA ≥ 0.3 μg/mL, D0	6 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSW-135 ≥ 0.3 μg/mL, D42	90 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSY ≥ 2 μg/mL, D42	87 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSC ≥ 0.3 μg/mL, D0	0 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSA ≥ 2 μg/mL, D0	0 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSW-135 ≥ 2 μg/mL, D0	0 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSY ≥ 2 μg/mL, D0	0 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSC ≥ 2 μg/mL, D0	0 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSY ≥ 0.3 μg/mL, D42	90 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSW-135 ≥ 2 μg/mL, D42	82 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSA ≥ 2 μg/mL, D42	90 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSW-135 ≥ 0.3 μg/mL, D0	4 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSA ≥ 0.3 μg/mL, D42	90 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSY ≥ 0.3 μg/mL, D0	0 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSC ≥ 2 μg/mL, D42	85 Participants
Nimenrix Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSY ≥ 0.3 μg/mL, D0	4 Participants
Nimenrix Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSA ≥ 0.3 μg/mL, D0	1 Participants
Nimenrix Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSY ≥ 0.3 μg/mL, D42	89 Participants
Nimenrix Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSA ≥ 2 μg/mL, D42	88 Participants
Nimenrix Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSY ≥ 2 μg/mL, D0	0 Participants
Nimenrix Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSY ≥ 2 μg/mL, D42	79 Participants
Nimenrix Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSC ≥ 2 μg/mL, D42	85 Participants
Nimenrix Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSC ≥ 0.3 μg/mL, D0	0 Participants
Nimenrix Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSW-135 ≥ 0.3 μg/mL, D0	2 Participants
Nimenrix Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSA ≥ 2 μg/mL, D0	0 Participants
Nimenrix Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSW-135 ≥ 0.3 μg/mL, D42	89 Participants
Nimenrix Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSW-135 ≥ 2 μg/mL, D0	0 Participants
Nimenrix Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSA ≥ 0.3 μg/mL, D42	89 Participants
Nimenrix Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSW-135 ≥ 2 μg/mL, D42	80 Participants
Nimenrix Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSC ≥ 2 μg/mL, D0	0 Participants
Nimenrix Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSC ≥ 0.3 μg/mL, D42	87 Participants
Meningitec Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSW-135 ≥ 0.3 μg/mL, D0	1 Participants
Meningitec Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSC ≥ 0.3 μg/mL, D42	0 Participants
Meningitec Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSY ≥ 2 μg/mL, D42	0 Participants
Meningitec Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSC ≥ 2 μg/mL, D0	0 Participants
Meningitec Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSC ≥ 2 μg/mL, D42	0 Participants
Meningitec Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSW-135 ≥ 0.3 μg/mL, D42	1 Participants
Meningitec Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSW-135 ≥ 2 μg/mL, D0	0 Participants
Meningitec Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSW-135 ≥ 2 μg/mL, D42	0 Participants
Meningitec Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSY ≥ 0.3 μg/mL, D0	0 Participants
Meningitec Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSY ≥ 0.3 μg/mL, D42	1 Participants
Meningitec Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSY ≥ 2 μg/mL, D0	0 Participants
Meningitec Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSA ≥ 0.3 μg/mL, D0	1 Participants
Meningitec Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSA ≥ 0.3 μg/mL, D42	2 Participants
Meningitec Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSA ≥ 2 μg/mL, D0	0 Participants
Meningitec Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSA ≥ 2 μg/mL, D42	0 Participants
Meningitec Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSC ≥ 0.3 μg/mL, D0	0 Participants
Meningitec Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSW-135 ≥ 2 μg/mL, D42	0 Participants
Meningitec Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSW-135 ≥ 2 μg/mL, D0	0 Participants
Meningitec Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSC ≥ 0.3 μg/mL, D42	29 Participants
Meningitec Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSA ≥ 0.3 μg/mL, D42	1 Participants
Meningitec Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSW-135 ≥ 0.3 μg/mL, D42	0 Participants
Meningitec Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSW-135 ≥ 0.3 μg/mL, D0	0 Participants
Meningitec Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSY ≥ 2 μg/mL, D42	0 Participants
Meningitec Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSA ≥ 2 μg/mL, D0	0 Participants
Meningitec Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSC ≥ 2 μg/mL, D42	26 Participants
Meningitec Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSC ≥ 2 μg/mL, D0	0 Participants
Meningitec Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSC ≥ 0.3 μg/mL, D0	0 Participants
Meningitec Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSY ≥ 2 μg/mL, D0	0 Participants
Meningitec Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSY ≥ 0.3 μg/mL, D42	0 Participants
Meningitec Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSY ≥ 0.3 μg/mL, D0	0 Participants
Meningitec Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSA ≥ 2 μg/mL, D42	0 Participants
Meningitec Group	Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values	Anti-PSA ≥ 0.3 μg/mL, D0	1 Participants

Secondary

Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values

The cut-off values for hSBA antibody titers were ≥ 1:4 and ≥ 1:8 for Nimenrix + Priorix-Tetra group, Nimenrix group, Meningitec group and Pooled group (Nimenrix + Priorix-Tetra and Nimenrix groups), respectively. The analysis was performed only on subjects receiving meningitis vaccination (Nimenrix) at Day 0.

Time frame: Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Nimenrix + Priorix-Tetra Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenY ≥1:4, D0	4 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenC ≥1:4, D42	339 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenC ≥1:4, D0	1 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenA ≥1:8, D0	7 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenY ≥1:4, D42	273 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenA ≥1:8, D42	292 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenW-135 ≥1:8, D42	279 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenW-135 ≥1:8, D0	4 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenY ≥1:8, D0	4 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenA ≥1:4, D0	14 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenW-135 ≥1:4, D42	280 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenW-135 ≥1:4, D0	4 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenY ≥1:8, D42	271 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenC ≥1:8, D42	339 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenC ≥1:8, D0	1 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenA ≥1:4, D42	305 Participants
Nimenrix Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenW-135 ≥1:8, D42	294 Participants
Nimenrix Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenA ≥1:4, D0	8 Participants
Nimenrix Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenY ≥1:4, D0	5 Participants
Nimenrix Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenY ≥1:8, D0	5 Participants
Nimenrix Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenA ≥1:4, D42	273 Participants
Nimenrix Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenA ≥1:8, D0	7 Participants
Nimenrix Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenA ≥1:8, D42	261 Participants
Nimenrix Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenC ≥1:4, D0	3 Participants
Nimenrix Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenC ≥1:4, D42	339 Participants
Nimenrix Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenC ≥1:8, D0	3 Participants
Nimenrix Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenC ≥1:8, D42	336 Participants
Nimenrix Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenW-135 ≥1:4, D0	3 Participants
Nimenrix Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenW-135 ≥1:4, D42	295 Participants
Nimenrix Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenW-135 ≥1:8, D0	2 Participants
Nimenrix Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenY ≥1:4, D42	261 Participants
Nimenrix Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenY ≥1:8, D42	261 Participants
Meningitec Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenA ≥1:4, D42	1 Participants
Meningitec Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenC ≥1:4, D42	95 Participants
Meningitec Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenC ≥1:8, D0	1 Participants
Meningitec Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenA ≥1:4, D0	2 Participants
Meningitec Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenW-135 ≥1:8, D0	0 Participants
Meningitec Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenC ≥1:8, D42	95 Participants
Meningitec Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenY ≥1:8, D42	2 Participants
Meningitec Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenW-135 ≥1:4, D0	0 Participants
Meningitec Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenY ≥1:8, D0	1 Participants
Meningitec Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenY ≥1:4, D42	2 Participants
Meningitec Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenW-135 ≥1:4, D42	1 Participants
Meningitec Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenA ≥1:8, D0	1 Participants
Meningitec Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenY ≥1:4, D0	1 Participants
Meningitec Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenA ≥1:8, D42	1 Participants
Meningitec Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenC ≥1:4, D0	1 Participants
Meningitec Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenW-135 ≥1:8, D42	1 Participants
Meningitec Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenC ≥1:4, D0	4 Participants
Meningitec Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenA ≥1:8, D42	553 Participants
Meningitec Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenC ≥1:4, D42	677 Participants
Meningitec Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenA ≥1:4, D0	22 Participants
Meningitec Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenY ≥1:4, D0	9 Participants
Meningitec Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenW-135 ≥1:4, D42	575 Participants
Meningitec Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenC ≥1:8, D0	4 Participants
Meningitec Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenY ≥1:4, D42	534 Participants
Meningitec Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenY ≥1:8, D42	532 Participants
Meningitec Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenW-135 ≥1:8, D0	6 Participants
Meningitec Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenC ≥1:8, D42	675 Participants
Meningitec Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenY ≥1:8, D0	9 Participants
Meningitec Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenA ≥1:8, D0	14 Participants
Meningitec Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenA ≥1:4, D42	578 Participants
Meningitec Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenW-135 ≥1:4, D0	7 Participants
Meningitec Group	Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values	hSBA-MenW-135 ≥1:8, D42	573 Participants

Secondary

Number of Subjects With Priorix-Tetra - Specific Solicited General Symptoms

Solicited general symptoms assessed were fever (measured rectally and temperature ≥ 38.0°C ), Meningismus, Parotiditis and Rash.

Time frame: During the 43-day (Days 0-42) after first vaccination dose

Population: The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects with the symptom sheet filled-in.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Nimenrix + Priorix-Tetra Group	Number of Subjects With Priorix-Tetra - Specific Solicited General Symptoms	Fever ≥ 38.0˚C	295 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects With Priorix-Tetra - Specific Solicited General Symptoms	Meningismus	1 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects With Priorix-Tetra - Specific Solicited General Symptoms	Rash	119 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects With Priorix-Tetra - Specific Solicited General Symptoms	Parotiditis	0 Participants
Nimenrix Group	Number of Subjects With Priorix-Tetra - Specific Solicited General Symptoms	Fever ≥ 38.0˚C	164 Participants
Nimenrix Group	Number of Subjects With Priorix-Tetra - Specific Solicited General Symptoms	Parotiditis	0 Participants
Nimenrix Group	Number of Subjects With Priorix-Tetra - Specific Solicited General Symptoms	Meningismus	0 Participants
Nimenrix Group	Number of Subjects With Priorix-Tetra - Specific Solicited General Symptoms	Rash	66 Participants
Meningitec Group	Number of Subjects With Priorix-Tetra - Specific Solicited General Symptoms	Meningismus	0 Participants
Meningitec Group	Number of Subjects With Priorix-Tetra - Specific Solicited General Symptoms	Rash	36 Participants
Meningitec Group	Number of Subjects With Priorix-Tetra - Specific Solicited General Symptoms	Parotiditis	0 Participants
Meningitec Group	Number of Subjects With Priorix-Tetra - Specific Solicited General Symptoms	Fever ≥ 38.0˚C	99 Participants
Meningitec Group	Number of Subjects With Priorix-Tetra - Specific Solicited General Symptoms	Rash	24 Participants
Meningitec Group	Number of Subjects With Priorix-Tetra - Specific Solicited General Symptoms	Meningismus	1 Participants
Meningitec Group	Number of Subjects With Priorix-Tetra - Specific Solicited General Symptoms	Parotiditis	0 Participants
Meningitec Group	Number of Subjects With Priorix-Tetra - Specific Solicited General Symptoms	Fever ≥ 38.0˚C	56 Participants

Secondary

Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values

The cut-off values for the rSBA titers were ≥ 1:8 and ≥ 1:128 respectively. At pre-vaccination for all groups, half of the subjects were sera tested for rSBA-MenC while the other half was tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY. At Post vaccination I (Day 42), all subjects from Nimenrix + Priorix-Tetra and Nimenrix groups were sera tested for each rSBA. For Meningitec and Priorix-Tetra groups, all subjects were tested for rSBA-MenC while half of subjects were tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY.

Time frame: Prior to vaccination (Day 0) and after the first vaccination dose (Day 42)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Nimenrix + Priorix-Tetra Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenY ≥ 1:8, D0	103 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenW-135 ≥ 1:128, D0	30 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenW-135 ≥ 1:128, D42	360 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenY ≥ 1:128, D42	358 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenA ≥ 1:128, D42	359 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenC ≥ 1:8, D0	48 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenA ≥ 1:8, D0	57 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenY ≥ 1:128, D0	75 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenC ≥ 1:128, D0	19 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenC ≥ 1:128, D42	337 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenA ≥ 1:128, D0	32 Participants
Nimenrix + Priorix-Tetra Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenW-135 ≥ 1:8, D0	76 Participants
Nimenrix Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenC ≥ 1:128, D0	22 Participants
Nimenrix Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenW-135 ≥ 1:8, D0	81 Participants
Nimenrix Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenA ≥ 1:128, D0	50 Participants
Nimenrix Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenW-135 ≥ 1:128, D42	352 Participants
Nimenrix Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenC ≥ 1:8, D0	47 Participants
Nimenrix Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenW-135 ≥ 1:128, D0	28 Participants
Nimenrix Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenA ≥ 1:128, D42	353 Participants
Nimenrix Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenY ≥ 1:128, D42	353 Participants
Nimenrix Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenA ≥ 1:8, D0	77 Participants
Nimenrix Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenY ≥ 1:8, D0	112 Participants
Nimenrix Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenC ≥ 1:128, D42	339 Participants
Nimenrix Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenY ≥ 1:128, D0	79 Participants
Meningitec Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenW-135 ≥ 1:128, D0	14 Participants
Meningitec Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenA ≥ 1:128, D42	22 Participants
Meningitec Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenA ≥ 1:8, D0	24 Participants
Meningitec Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenA ≥ 1:128, D0	18 Participants
Meningitec Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenC ≥ 1:8, D0	16 Participants
Meningitec Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenC ≥ 1:128, D0	4 Participants
Meningitec Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenC ≥ 1:128, D42	13 Participants
Meningitec Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenW-135 ≥ 1:8, D0	29 Participants
Meningitec Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenW-135 ≥ 1:128, D42	16 Participants
Meningitec Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenY ≥ 1:8, D0	41 Participants
Meningitec Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenY ≥ 1:128, D0	30 Participants
Meningitec Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenY ≥ 1:128, D42	30 Participants
Meningitec Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenC ≥ 1:128, D42	85 Participants
Meningitec Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenC ≥ 1:128, D0	4 Participants
Meningitec Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenA ≥ 1:8, D0	18 Participants
Meningitec Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenY ≥ 1:8, D0	34 Participants
Meningitec Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenC ≥ 1:8, D0	13 Participants
Meningitec Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenA ≥ 1:128, D42	17 Participants
Meningitec Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenY ≥ 1:128, D42	21 Participants
Meningitec Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenY ≥ 1:128, D0	23 Participants
Meningitec Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenW-135 ≥ 1:128, D0	12 Participants
Meningitec Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenW-135 ≥ 1:8, D0	30 Participants
Meningitec Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenA ≥ 1:128, D0	10 Participants
Meningitec Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenW-135 ≥ 1:128, D42	15 Participants

Secondary

rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers

Antibody titers were expressed as geometric mean titers (GMTs). At pre-vaccination for all groups, half of the subjects were sera tested for rSBA-MenC while the other half were tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY. At Post vaccination I (Day 42), all subjects from Nimenrix + Priorix-Tetra and Nimenrix groups were sera tested for each rSBA. For Meningitec and Priorix-Tetra groups, all subjects were tested for rSBA-MenC while half of subjects were tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY.

Time frame: Prior to first vaccine dose (Day 0) and 42 days after the first vaccine dose (Day 42)

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Nimenrix + Priorix-Tetra Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers	rSBA-MenA, D0	14.6 Titer
Nimenrix + Priorix-Tetra Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers	rSBA-MenY, D0	41.4 Titer
Nimenrix + Priorix-Tetra Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers	rSBA-MenC, D0	9.2 Titer
Nimenrix + Priorix-Tetra Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers	rSBA-MenY, D42	2282.4 Titer
Nimenrix + Priorix-Tetra Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers	rSBA-MenW-135, D0	16.2 Titer
Nimenrix + Priorix-Tetra Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers	rSBA-MenA, D42	2085.9 Titer
Nimenrix + Priorix-Tetra Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers	rSBA-MenC, D42	519 Titer
Nimenrix + Priorix-Tetra Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers	rSBA-MenW-135, D42	2055.8 Titer
Nimenrix Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers	rSBA-MenC, D42	477.6 Titer
Nimenrix Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers	rSBA-MenW-135, D0	16.7 Titer
Nimenrix Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers	rSBA-MenY, D42	2729.4 Titer
Nimenrix Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers	rSBA-MenA, D42	2205 Titer
Nimenrix Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers	rSBA-MenC, D0	10 Titer
Nimenrix Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers	rSBA-MenA, D0	22.8 Titer
Nimenrix Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers	rSBA-MenW-135, D42	2681.7 Titer
Nimenrix Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers	rSBA-MenY, D0	50.1 Titer
Meningitec Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers	rSBA-MenC, D42	11.2 Titer
Meningitec Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers	rSBA-MenA, D0	24.4 Titer
Meningitec Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers	rSBA-MenA, D42	33.1 Titer
Meningitec Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers	rSBA-MenC, D0	8.5 Titer
Meningitec Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers	rSBA-MenW-135, D0	21.9 Titer
Meningitec Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers	rSBA-MenW-135, D42	25.6 Titer
Meningitec Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers	rSBA-MenY, D0	71 Titer
Meningitec Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers	rSBA-MenY, D42	70 Titer
Meningitec Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers	rSBA-MenA, D0	14.3 Titer
Meningitec Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers	rSBA-MenW-135, D42	25.1 Titer
Meningitec Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers	rSBA-MenA, D42	24.3 Titer
Meningitec Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers	rSBA-MenY, D42	31.4 Titer
Meningitec Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers	rSBA-MenY, D0	31.7 Titer
Meningitec Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers	rSBA-MenW-135, D0	20.8 Titer
Meningitec Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers	rSBA-MenC, D42	212.3 Titer
Meningitec Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers	rSBA-MenC, D0	7.6 Titer

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026

Safety & Immunogenicity Study of Meningococcal Vaccine GSK134612 Given With Priorix-Tetra™ to 12-23 Month-Old Children

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Number of Subjects With Anti-measles Antibody Concentrations ≥ the Cut-off Values

Number of Subjects With Anti-mumps Antibody Concentrations ≥ the Cut-off Values

Number of Subjects With Anti-rubella Antibody Concentrations ≥ the Cut-off Values.

Number of Subjects With Anti-varicella Antibody Concentrations ≥ the Cut-off Values

Number of Subjects With rSBA-MenC, rSBA-MenA, rSBA-MenW-135, rSBA-MenY Titers Greater Than or Equal to (≥) the Cut-off Values

Anti-measles Antibody Concentrations

Anti-measles Antibody Concentrations

Anti-mumps Antibody Concentrations

Anti-mumps Antibody Concentrations

Anti-PSA (Anti-polysaccharide A), Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values

Anti-rubella Antibody Concentrations

Anti-rubella Antibody Concentrations

Anti-varicella Antibody Titers

Anti-varicella Antibody Titers

hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers

Number of Subjects Reporting Serious Adverse Events (SAEs)

Number of Subjects Reporting Solicited General Symptoms

Number of Subjects Reporting Solicited Local Symptoms After Nimenrix or Meningitec Vaccination at Day 0

Number of Subjects Reporting Solicited Local Symptoms Specific for Priorix-Tetra Vaccination

Number of Subjects Reporting Specific Adverse Events (AEs)

Number of Subjects Reporting Unsolicited Symptoms

Number of Subjects Reporting Unsolicited Symptoms

Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibodies Concentrations ≥ the Cut-off Values

Number of Subjects With hSBA-MenA (Meningococcal Polysaccharide A Serum Bactericidal Antibodies Using Human Complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ the Cut-off Values

Number of Subjects With Priorix-Tetra - Specific Solicited General Symptoms

Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values

rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers