Co-Administration of Meningococcal Vaccine GSK134612 With Infanrix Hexa™ Versus Individual Administration of Each Vaccine

Co-Administration of GSK Biologicals' Meningococcal Vaccine GSK134612 With Infanrix Hexa™, Compared to Individual Administration of Each Vaccine, in Healthy 12- Through 23-Month-Old Children

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00508261

Enrollment

793

Registered

2007-07-27

Start date

2007-08-01

Completion date

2008-10-27

Last updated

2019-01-24

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

Conditions

Infections, Meningococcal

Keywords

Meningococcal vaccine, Immunogenicity, Routine infancy vaccination, Safety

Brief summary

The purpose of this study is to demonstrate, in 12-23 months old subjects, the non-inferiority of meningococcal vaccine GSK134612 co-administered with Infanrix hexa™, compared to each vaccine administered individually and to licensed meningococcal vaccine Meningitec™. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed description

Multicentre study with 4 parallel groups. One group will receive GSK134612 co-administered with Infanrix hexa™, two groups will receive sequential administration of GSK134612 and Infanrix hexa™ and the final group will receive Meningitec™. For subjects in Groups B and C, three blood samples will be taken: prior to first vaccination and 1 month after each vaccination. For subjects in Groups A and D, two blood samples will be taken: prior to and 1 month after vaccination.

Interventions

BIOLOGICALMeningococcal vaccine GSK134612

Single dose intramuscular injection

BIOLOGICALInfanrix™ hexa

Single dose intramuscular 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 first 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. * Documented three-dose primary vaccination with DTPa, hepatitis B, inactivated polio and Haemophilus influenzae type b conjugate vaccines, completed at least 180 days before administration of the first study vaccination.

Exclusion criteria

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines 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 first vaccine dose. * Planned administration/ administration of any vaccine not foreseen by the study protocol, including measles, mumps, rubella, varicella and pneumococcal vaccines, within 30 days before the first dose of vaccine(s) and 30 days after the last dose of vaccine(s). * Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W and/or Y. * Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C, W and/or Y. * Previous booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis or Haemophilus influenzae type b. * History of meningococcal disease. * 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 reactions or allergic disease likely to be exacerbated by any component of the vaccine(s). * 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. Additional criteria for subjects receiving Infanrix hexa™ * Hypersensitivity reaction due to previous vaccination with Infanrix hexa™. * Encephalopathy defined as an acute, severe central nervous system disorder occurring within 7 days following vaccination and generally consisting of major alterations in consciousness, unresponsiveness, generalised or focal seizures that persist more than a few hours, with failure to recover within 24 hours.

Design outcomes

Primary

Measure	Time frame	Description
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off.	1 month after vaccination with Nimenrix vaccine (Month 1)	The cut-off for the assay was greater than or equal to (≥) 1:8. The analysis was based only on subjects receiving Nimenrix vaccination at Day 0.
Anti-PT, Anti-FHA and Anti-PRN Concentrations	1 month after the first vaccination (Month 1)	The analysis was based only on subjects receiving Infanrix-hexa vaccination. The results were calculated as geometric mean expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Number of Subjects With Anti-HBs Concentrations ≥ the Cut-off	1 month after vaccination with Nimenrix vaccine (Month 1)	The cut-off for the assay was greater than or equal to (≥) 10 milli-interantional units per milliliter (mIU/mL).
Number of Subjects With Anti-PRP Concentrations ≥ the Cut-off	1 month after vaccination with Nimenrix vaccine (Month 1)	The cut-off for the assay was ≥ 1μg/mL.

Secondary

Measure	Time frame	Description
Number of Seroprotected Subjects for Anti-tetanus Toxoid (Anti-TT)	At month 0, month 1 and month 2	The cut-off for the assay was ≥ 0.1
Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations	At month 0, month 1 and month 2	The results for the assay were tabulated as geometric mean expressed in internationl units per milliliter (IU/mL).
Number of Subjects Seroprotected for Anti-diphtheria (Anti-D) ≥ the Cut-off	At month 0, month 1 and month 2	The cut-off for the assay was ≥ 0.1
Anti-diphtheria (Anti-D) Antibody Concentrations	At month 0, month 1 and month 2	The results for the assay were tabulated as geometric mean expressed in internationl units per milliliter (IU/mL).
Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off	At month 0, month 1 and month 2	The cut-off for the assay was ≥ 1:8.
Anti-polio Type 1, 2 & 3 Titers	At month 0, 1 and 2	The results for the assay were tabulated as geometric mean expressed in titers.
Numbers of Seroprotected Subjects for Anti-PRP ≥ the Cut-off	At month 0, month 1 and month 2	The cut-off for the assay was ≥ 1.0
Anti-PRP Antibody Concentrations	At month 0, month 1 and month 2	The results for the assay were tabulated as geometric mean expressed in microgram per milliliter (μg/mL).
Number of Seroprotected Subjects for Anti-HBs ≥ the Cut-offs	At month 0, month 1 and month 2	The cut-offs for the assay were ≥ 10 mIU/mL and ≥ 100 mIU/mL respectively .
Anti-HBs Antibody Concentrations	At month 0, month 1 and month 2	The results for the assay were tabulated as geometric mean expressed in milli-international units per milliliter (mIU/mL).
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	At month 0, month 1 and month 2	The cut-off values for the assay were ≥ 1:8 and ≥ 1:128
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations	At month 0, month 1 and month 2	The results were tabulated as geometric mean expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination	During the 4-day (Days 0-3) follow-up period after Nimenrix or Meningitec vaccination	Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any local symptom irrespective of intensity grade. Grade 3 Pain was defined as crying when limb was moved/ spontaneously painful.
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-combined Diphtheria Vaccination	During the 4-day (Days 0-3) follow-up period after Infanrix-hexa vaccination	The analysis was based only on subjects receiving combined-diphtheria vaccination.
Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose	During the 4-day (Days 0-3) post-vaccination dose 1 (D1) and second dose (D2)	Solicited general symptoms assessed were drowsiness, fever, irritability and loss of appetite. Any was defined as occurrence of any general symptom irrespective of intensity grade and relationship. Subjects in the Nimenrix + Infanrix-hexa Group did not receive a second dose of vaccination.
Number of Subjects Reporting Any Rash	Day 0 - Month 7	Any was defined as occurrence of at least one symptom experienced.
Number of Subjects Reporting Any New Onset of Chronic Illnesses (NOCIs)	Day 0 - Month 7	Any was defined as occurrence of at least one symptom experienced.
Number of Subjects Reporting Any Conditions Prompting Emergency Room Visits (ER)	Day 0 - Month 7	Any was defined as occurrence of at least one symptom experienced.
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the First Dose	Occurring within Day 0-30 following vaccination	An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the Second Dose	Occurring within Day 0-30 following vaccination	An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. The analysis was based only on subjects receiving a second dose of vaccination.
Number of Subjects Reporting Any Serious Adverse Events (SAEs)	From dose 1 (Month 0) up to study end (Month 7)	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.
Number of Subjects With a Vaccine Response to PT, FHA and PRN Antigens	1 month after vaccination (Month 1)	Vaccine response to these antigens is defined as appearance of antibodies in subjects who were seronegative (antibody concentration \< 5 EL.U/mL) at pre-vaccination or as at least a 2-fold increase in post-over pre-vaccination antibody concentrations in subjects seropositive at pre-vaccination. The analysis was based only on subjects receiving experimental vaccination.
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers	At month 0, month 1 and month 2	The results were tabulated as geometric mean expressed in titers.
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	At month 0, month 1 and month 2	The cut-off for the assay were ≥ 0.3 microgram per milliliter (μg/mL) and ≥ 2.0 μg/mL, respectively.
Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations	At month 0, month 1 and month 2	The results for the assay were tabulated as geometric mean expressed in microgram per milliliter (μg/mL).

Countries

Austria, Germany, Greece

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 + Infanrix-hexa Group Subjects received concomitant administration of 1 dose of Nimenrix™ and Infanrix-hexa™ vaccines at Day 0.	222
Nimenrix Group Subjects received a single dose of Nimenrix™ vaccine at Day 0, followed one month later by 1 dose of Infanrix-hexa™ vaccine.	220
Infanrix-Hexa Group Subjects received a single dose of Infanrix-Hexa™ vaccine at Day 0, followed one month later by 1 dose of Nimenrix™ vaccine.	224
Meningitec Group Subjects received 1 dose of Meningitec™ vaccine at Day 0 and were permitted to receive the routinely recommended Infanrix-hexa booster once the active safety follow-up of this study was completed.	127
Total	793

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
Overall Study	Lost to Follow-up	0	1	1	1
Overall Study	Migrated/ moved from study area	0	1	0	0
Overall Study	Other	0	1	1	0
Overall Study	Serious Adverse Event	0	1	0	0
Overall Study	Withdrawal by Subject	3	4	4	0

Baseline characteristics

Characteristic	Nimenrix + Infanrix-hexa Group	Nimenrix Group	Infanrix-Hexa Group	Meningitec Group	Total
Age, Continuous	14.6 Months STANDARD_DEVIATION 3.01	15 Months STANDARD_DEVIATION 3.33	14.9 Months STANDARD_DEVIATION 3.17	14.6 Months STANDARD_DEVIATION 2.99	14.8 Months STANDARD_DEVIATION 3.14
Race/Ethnicity, Customized African heritage / African American	3 Participants	4 Participants	1 Participants	2 Participants	10 Participants
Race/Ethnicity, Customized American Indian or Alaskan native	2 Participants	1 Participants	0 Participants	1 Participants	4 Participants
Race/Ethnicity, Customized Asian - Central/ South Asian heritage	1 Participants	2 Participants	1 Participants	0 Participants	4 Participants
Race/Ethnicity, Customized Asian - East Asian heritage	2 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Race/Ethnicity, Customized Asian - South east Asian heritage	2 Participants	0 Participants	4 Participants	2 Participants	8 Participants
Race/Ethnicity, Customized Other	4 Participants	1 Participants	2 Participants	0 Participants	7 Participants
Race/Ethnicity, Customized White - Arabic / North African heritage	4 Participants	7 Participants	4 Participants	2 Participants	17 Participants
Race/Ethnicity, Customized White - Caucasian/ European heritage, n (%)	204 Participants	205 Participants	212 Participants	120 Participants	741 Participants
Sex/Gender, Customized Female	109 Participants	106 Participants	119 Participants	61 Participants	395 Participants
Sex/Gender, Customized Male	113 Participants	114 Participants	105 Participants	66 Participants	398 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 / 222	0 / 220	1 / 224	0 / 127
other Total, other adverse events	166 / 222	183 / 220	185 / 224	75 / 127
serious Total, serious adverse events	10 / 222	8 / 220	11 / 224	6 / 127

Outcome results

Primary

Anti-PT, Anti-FHA and Anti-PRN Concentrations

The analysis was based only on subjects receiving Infanrix-hexa vaccination. The results were calculated as geometric mean expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

Time frame: 1 month after the first vaccination (Month 1)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.The analysis for the primary outcome was based only on subjects receiving Infanrix-hexa vaccination at month 1.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Nimenrix + Infanrix-hexa Group	Anti-PT, Anti-FHA and Anti-PRN Concentrations	Anti-PT, M1	86 EL.U/mL
Nimenrix + Infanrix-hexa Group	Anti-PT, Anti-FHA and Anti-PRN Concentrations	Anti-FHA, M1	542 EL.U/mL
Nimenrix + Infanrix-hexa Group	Anti-PT, Anti-FHA and Anti-PRN Concentrations	Anti-PRN, M1	470 EL.U/mL
Nimenrix Group	Anti-PT, Anti-FHA and Anti-PRN Concentrations	Anti-PT, M1	85 EL.U/mL
Nimenrix Group	Anti-PT, Anti-FHA and Anti-PRN Concentrations	Anti-FHA, M1	544 EL.U/mL
Nimenrix Group	Anti-PT, Anti-FHA and Anti-PRN Concentrations	Anti-PRN, M1	450 EL.U/mL

Comparison: Demonstration of non-inferiority of combined Infanrix-hexa vaccine co-administered with Nimenrix vaccine to Infanrix-hexa vaccine given alone in terms of geometric mean concentrations (GMCs) of antibodies to pertussis toxoid (PT), at month 1.95% CI: [0.83, 1.12]

Comparison: Demonstration of non-inferiority of combined Infanrix-hexa vaccine co-administered with Nimenrix vaccine to Infanrix-hexa vaccine given alone in terms of geometric mean concentrations (GMCs) of antibodies to filamentous haemagglutinin (FHA), at month 1.95% CI: [0.85, 1.13]

Primary

Number of Subjects With Anti-HBs Concentrations ≥ the Cut-off

The cut-off for the assay was greater than or equal to (≥) 10 milli-interantional units per milliliter (mIU/mL).

Time frame: 1 month after vaccination with Nimenrix vaccine (Month 1)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. The analysis for the primary outcome measure was based only on subjects receiving Infanrix-hexa vaccination at Month 1.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Nimenrix + Infanrix-hexa Group	Number of Subjects With Anti-HBs Concentrations ≥ the Cut-off	180 Participants
Nimenrix Group	Number of Subjects With Anti-HBs Concentrations ≥ the Cut-off	166 Participants

95% CI: [-1.47, 4.6]

Primary

Number of Subjects With Anti-PRP Concentrations ≥ the Cut-off

The cut-off for the assay was ≥ 1μg/mL.

Time frame: 1 month after vaccination with Nimenrix vaccine (Month 1)

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Nimenrix + Infanrix-hexa Group	Number of Subjects With Anti-PRP Concentrations ≥ the Cut-off	183 Participants
Nimenrix Group	Number of Subjects With Anti-PRP Concentrations ≥ the Cut-off	170 Participants

95% CI: [-1.45, 4.5]

Primary

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

The cut-off for the assay was greater than or equal to (≥) 1:8. The analysis was based only on subjects receiving Nimenrix vaccination at Day 0.

Time frame: 1 month after vaccination with Nimenrix vaccine (Month 1)

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Nimenrix + Infanrix-hexa Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off.	rSBA-MenA, M1	193 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off.	rSBA-MenC, M1	191 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off.	rSBA-MenW-135, M1	193 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off.	rSBA-MenY, M1	192 Participants
Nimenrix Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off.	rSBA-MenY, M1	180 Participants
Nimenrix Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off.	rSBA-MenA, M1	180 Participants
Nimenrix Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off.	rSBA-MenW-135, M1	183 Participants
Nimenrix Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off.	rSBA-MenC, M1	178 Participants

Comparison: Demonstration of the non-inferiority of Nimenrix vaccine co-administered with combined Infanrix-hexa vaccine given alone in terms of bactericidal antibodies to Neisseria meningitidis serogroup A, at month 1.95% CI: [-0.33, 4.71]

Comparison: Demonstration of the non-inferiority of the Nimenrix vaccine co-administered with combined Infanrix-hexa vaccine given alone in terms of bactericidal antibodies to Neisseria meningitidis serogroup C, at month 1.95% CI: [0.73, 6.24]

Secondary

Anti-diphtheria (Anti-D) Antibody Concentrations

The results for the assay were tabulated as geometric mean expressed in internationl units per milliliter (IU/mL).

Time frame: At month 0, month 1 and month 2

Population: ATP cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. Subjects in Nimenrix + Infanrix-hexa Group and Meningitec Group only had 2 blood samples taken: prior to (M0) and 1 month after vaccination (M1).

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Nimenrix + Infanrix-hexa Group	Anti-diphtheria (Anti-D) Antibody Concentrations	anti-D [M 0]	0.477 IU/mL
Nimenrix + Infanrix-hexa Group	Anti-diphtheria (Anti-D) Antibody Concentrations	anti-D [M 1]	7.636 IU/mL
Nimenrix Group	Anti-diphtheria (Anti-D) Antibody Concentrations	anti-D [M 1]	0.404 IU/mL
Nimenrix Group	Anti-diphtheria (Anti-D) Antibody Concentrations	anti-D [M 0]	0.476 IU/mL
Nimenrix Group	Anti-diphtheria (Anti-D) Antibody Concentrations	anti-D [M 2]	8.561 IU/mL
Infanrix-Hexa Group	Anti-diphtheria (Anti-D) Antibody Concentrations	anti-D [M 0]	0.437 IU/mL
Infanrix-Hexa Group	Anti-diphtheria (Anti-D) Antibody Concentrations	anti-D [M 1]	7.292 IU/mL
Infanrix-Hexa Group	Anti-diphtheria (Anti-D) Antibody Concentrations	anti-D [M 2]	5.21 IU/mL
Meningitec Group	Anti-diphtheria (Anti-D) Antibody Concentrations	anti-D [M 1]	5.201 IU/mL
Meningitec Group	Anti-diphtheria (Anti-D) Antibody Concentrations	anti-D [M 0]	0.452 IU/mL

Secondary

Anti-HBs Antibody Concentrations

The results for the assay were tabulated as geometric mean expressed in milli-international units per milliliter (mIU/mL).

Time frame: At month 0, month 1 and month 2

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Nimenrix + Infanrix-hexa Group	Anti-HBs Antibody Concentrations	anti-HBS [M 0]	111.6 mIU/mL
Nimenrix + Infanrix-hexa Group	Anti-HBs Antibody Concentrations	anti-HBS [M 1]	2048.4 mIU/mL
Nimenrix Group	Anti-HBs Antibody Concentrations	anti-HBS [M 1]	95 mIU/mL
Nimenrix Group	Anti-HBs Antibody Concentrations	anti-HBS [M 0]	92.8 mIU/mL
Nimenrix Group	Anti-HBs Antibody Concentrations	anti-HBS [M 2]	2392.3 mIU/mL
Infanrix-Hexa Group	Anti-HBs Antibody Concentrations	anti-HBS [M 0]	101.2 mIU/mL
Infanrix-Hexa Group	Anti-HBs Antibody Concentrations	anti-HBS [M 1]	1711.6 mIU/mL
Infanrix-Hexa Group	Anti-HBs Antibody Concentrations	anti-HBS [M 2]	1241 mIU/mL
Meningitec Group	Anti-HBs Antibody Concentrations	anti-HBS [M 1]	101.6 mIU/mL
Meningitec Group	Anti-HBs Antibody Concentrations	anti-HBS [M 0]	85.6 mIU/mL

Secondary

Anti-polio Type 1, 2 & 3 Titers

The results for the assay were tabulated as geometric mean expressed in titers.

Time frame: At month 0, 1 and 2

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Nimenrix + Infanrix-hexa Group	Anti-polio Type 1, 2 & 3 Titers	anti-p1 [M 0]	84.2 Titers
Nimenrix + Infanrix-hexa Group	Anti-polio Type 1, 2 & 3 Titers	anti-p2 [M 1]	1372 Titers
Nimenrix + Infanrix-hexa Group	Anti-polio Type 1, 2 & 3 Titers	anti-p3 [M 0]	104.4 Titers
Nimenrix + Infanrix-hexa Group	Anti-polio Type 1, 2 & 3 Titers	anti-p2 [M 0]	76.8 Titers
Nimenrix + Infanrix-hexa Group	Anti-polio Type 1, 2 & 3 Titers	anti-p1 [M 1]	984.4 Titers
Nimenrix + Infanrix-hexa Group	Anti-polio Type 1, 2 & 3 Titers	anti-p3 [M 1]	2295.6 Titers
Nimenrix Group	Anti-polio Type 1, 2 & 3 Titers	anti-p2 [M 1]	70.3 Titers
Nimenrix Group	Anti-polio Type 1, 2 & 3 Titers	anti-p1 [M 0]	72.5 Titers
Nimenrix Group	Anti-polio Type 1, 2 & 3 Titers	anti-p1 [M 1]	74.2 Titers
Nimenrix Group	Anti-polio Type 1, 2 & 3 Titers	anti-p1 [M 2]	1288.2 Titers
Nimenrix Group	Anti-polio Type 1, 2 & 3 Titers	anti-p2 [M 0]	66.3 Titers
Nimenrix Group	Anti-polio Type 1, 2 & 3 Titers	anti-p2 [M 2]	1650.5 Titers
Nimenrix Group	Anti-polio Type 1, 2 & 3 Titers	anti-p3 [M 0]	99.8 Titers
Nimenrix Group	Anti-polio Type 1, 2 & 3 Titers	anti-p3 [M 1]	96.6 Titers
Nimenrix Group	Anti-polio Type 1, 2 & 3 Titers	anti-p3 [M 2]	2478 Titers
Infanrix-Hexa Group	Anti-polio Type 1, 2 & 3 Titers	anti-p1 [M 1]	1308.5 Titers
Infanrix-Hexa Group	Anti-polio Type 1, 2 & 3 Titers	anti-p2 [M 1]	1540.4 Titers
Infanrix-Hexa Group	Anti-polio Type 1, 2 & 3 Titers	anti-p2 [M 2]	1174.5 Titers
Infanrix-Hexa Group	Anti-polio Type 1, 2 & 3 Titers	anti-p3 [M 0]	113.2 Titers
Infanrix-Hexa Group	Anti-polio Type 1, 2 & 3 Titers	anti-p1 [M 0]	83.6 Titers
Infanrix-Hexa Group	Anti-polio Type 1, 2 & 3 Titers	anti-p1 [M 2]	1108.4 Titers
Infanrix-Hexa Group	Anti-polio Type 1, 2 & 3 Titers	anti-p3 [M 2]	1655.1 Titers
Infanrix-Hexa Group	Anti-polio Type 1, 2 & 3 Titers	anti-p2 [M 0]	65.6 Titers
Infanrix-Hexa Group	Anti-polio Type 1, 2 & 3 Titers	anti-p3 [M 1]	2034.3 Titers
Meningitec Group	Anti-polio Type 1, 2 & 3 Titers	anti-p2 [M 1]	49.8 Titers
Meningitec Group	Anti-polio Type 1, 2 & 3 Titers	anti-p3 [M 0]	102.9 Titers
Meningitec Group	Anti-polio Type 1, 2 & 3 Titers	anti-p2 [M 0]	49.3 Titers
Meningitec Group	Anti-polio Type 1, 2 & 3 Titers	anti-p1 [M 0]	71.7 Titers
Meningitec Group	Anti-polio Type 1, 2 & 3 Titers	anti-p3 [M 1]	85.3 Titers
Meningitec Group	Anti-polio Type 1, 2 & 3 Titers	anti-p1 [M 1]	66.3 Titers

Secondary

Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations

The results for the assay were tabulated as geometric mean expressed in microgram per milliliter (μg/mL).

Time frame: At month 0, month 1 and month 2

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Nimenrix + Infanrix-hexa Group	Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations	Anti-PSA [M 0]	0.17 μg/mL
Nimenrix + Infanrix-hexa Group	Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations	Anti-PSA [M 1]	31.01 μg/mL
Nimenrix + Infanrix-hexa Group	Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations	Anti-PSC [M 0]	0.16 μg/mL
Nimenrix + Infanrix-hexa Group	Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations	Anti-PSC [M 1]	13.74 μg/mL
Nimenrix + Infanrix-hexa Group	Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations	Anti-PSW-135 [M 0]	0.16 μg/mL
Nimenrix + Infanrix-hexa Group	Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations	Anti-PSW-135 [M 1]	6.43 μg/mL
Nimenrix + Infanrix-hexa Group	Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations	Anti-PSY [M 0]	0.15 μg/mL
Nimenrix + Infanrix-hexa Group	Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations	Anti-PSY [M 1]	6.52 μg/mL
Nimenrix Group	Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations	Anti-PSA [M 0]	0.15 μg/mL
Nimenrix Group	Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations	Anti-PSW-135 [M 0]	0.15 μg/mL
Nimenrix Group	Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations	Anti-PSA [M 2]	16.93 μg/mL
Nimenrix Group	Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations	Anti-PSC [M 0]	0.16 μg/mL
Nimenrix Group	Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations	Anti-PSY [M 1]	9.42 μg/mL
Nimenrix Group	Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations	Anti-PSW-135 [M 1]	4.15 μg/mL
Nimenrix Group	Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations	Anti-PSC [M 1]	23.52 μg/mL
Nimenrix Group	Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations	Anti-PSC [M 2]	9.73 μg/mL
Nimenrix Group	Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations	Anti-PSW-135 [M 2]	3.99 μg/mL
Nimenrix Group	Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations	Anti-PSA [M 1]	33.15 μg/mL
Nimenrix Group	Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations	Anti-PSY [M 2]	7.86 μg/mL
Nimenrix Group	Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations	Anti-PSY [M 0]	0.15 μg/mL
Infanrix-Hexa Group	Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations	Anti-PSY [M 1]	0.17 μg/mL
Infanrix-Hexa Group	Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations	Anti-PSA [M 0]	0.16 μg/mL
Infanrix-Hexa Group	Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations	Anti-PSA [M 1]	0.17 μg/mL
Infanrix-Hexa Group	Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations	Anti-PSC [M 1]	0.16 μg/mL
Infanrix-Hexa Group	Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations	Anti-PSY [M 2]	4.76 μg/mL
Infanrix-Hexa Group	Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations	Anti-PSC [M 2]	5.84 μg/mL
Infanrix-Hexa Group	Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations	Anti-PSY [M 0]	0.15 μg/mL
Infanrix-Hexa Group	Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations	Anti-PSW-135 [M 0]	0.17 μg/mL
Infanrix-Hexa Group	Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations	Anti-PSC [M 0]	0.16 μg/mL
Infanrix-Hexa Group	Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations	Anti-PSW-135 [M 1]	0.18 μg/mL
Infanrix-Hexa Group	Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations	Anti-PSA [M 2]	12.28 μg/mL
Infanrix-Hexa Group	Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations	Anti-PSW-135 [M 2]	3.4 μg/mL
Meningitec Group	Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations	Anti-PSA [M 1]	0.16 μg/mL
Meningitec Group	Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations	Anti-PSC [M 0]	0.15 μg/mL
Meningitec Group	Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations	Anti-PSC [M 1]	7.99 μg/mL
Meningitec Group	Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations	Anti-PSW-135 [M 0]	0.15 μg/mL
Meningitec Group	Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations	Anti-PSY [M 1]	0.15 μg/mL
Meningitec Group	Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations	Anti-PSW-135 [M 1]	0.15 μg/mL
Meningitec Group	Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations	Anti-PSA [M 0]	0.16 μg/mL
Meningitec Group	Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations	Anti-PSY [M 0]	0.15 μg/mL

Secondary

Anti-PRP Antibody Concentrations

The results for the assay were tabulated as geometric mean expressed in microgram per milliliter (μg/mL).

Time frame: At month 0, month 1 and month 2

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Nimenrix + Infanrix-hexa Group	Anti-PRP Antibody Concentrations	anti-PRP [M 0]	0.806 μg/mL
Nimenrix + Infanrix-hexa Group	Anti-PRP Antibody Concentrations	anti-PRP [M 1]	25.556 μg/mL
Nimenrix Group	Anti-PRP Antibody Concentrations	anti-PRP [M 1]	0.711 μg/mL
Nimenrix Group	Anti-PRP Antibody Concentrations	anti-PRP [M 0]	0.665 μg/mL
Nimenrix Group	Anti-PRP Antibody Concentrations	anti-PRP [M 2]	12.239 μg/mL
Infanrix-Hexa Group	Anti-PRP Antibody Concentrations	anti-PRP [M 0]	0.766 μg/mL
Infanrix-Hexa Group	Anti-PRP Antibody Concentrations	anti-PRP [M 1]	31.165 μg/mL
Infanrix-Hexa Group	Anti-PRP Antibody Concentrations	anti-PRP [M 2]	21.023 μg/mL
Meningitec Group	Anti-PRP Antibody Concentrations	anti-PRP [M 1]	0.55 μg/mL
Meningitec Group	Anti-PRP Antibody Concentrations	anti-PRP [M 0]	0.585 μg/mL

Secondary

Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations

The results were tabulated as geometric mean expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

Time frame: At month 0, month 1 and month 2

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Nimenrix + Infanrix-hexa Group	Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations	Anti-PT [M 0]	11 EL.U/mL
Nimenrix + Infanrix-hexa Group	Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations	Anti-FHA [M 1]	542 EL.U/mL
Nimenrix + Infanrix-hexa Group	Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations	Anti-PRN [M 0]	26 EL.U/mL
Nimenrix + Infanrix-hexa Group	Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations	Anti-FHA [M 0]	51 EL.U/mL
Nimenrix + Infanrix-hexa Group	Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations	Anti-PT [M 1]	86 EL.U/mL
Nimenrix + Infanrix-hexa Group	Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations	Anti-PRN [M 1]	470 EL.U/mL
Nimenrix Group	Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations	Anti-FHA [M 1]	48 EL.U/mL
Nimenrix Group	Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations	Anti-PT [M 0]	10 EL.U/mL
Nimenrix Group	Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations	Anti-PT [M 1]	8 EL.U/mL
Nimenrix Group	Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations	Anti-PT [M 2]	91 EL.U/mL
Nimenrix Group	Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations	Anti-FHA [M 0]	55 EL.U/mL
Nimenrix Group	Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations	Anti-FHA [M 2]	664 EL.U/mL
Nimenrix Group	Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations	Anti-PRN [M 0]	26 EL.U/mL
Nimenrix Group	Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations	Anti-PRN [M 1]	23 EL.U/mL
Nimenrix Group	Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations	Anti-PRN [M 2]	583 EL.U/mL
Infanrix-Hexa Group	Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations	Anti-PT [M 1]	85 EL.U/mL
Infanrix-Hexa Group	Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations	Anti-FHA [M 1]	544 EL.U/mL
Infanrix-Hexa Group	Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations	Anti-FHA [M 2]	413 EL.U/mL
Infanrix-Hexa Group	Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations	Anti-PRN [M 0]	21 EL.U/mL
Infanrix-Hexa Group	Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations	Anti-PT [M 0]	10 EL.U/mL
Infanrix-Hexa Group	Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations	Anti-PT [M 2]	63 EL.U/mL
Infanrix-Hexa Group	Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations	Anti-PRN [M 2]	336 EL.U/mL
Infanrix-Hexa Group	Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations	Anti-FHA [M 0]	49 EL.U/mL
Infanrix-Hexa Group	Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations	Anti-PRN [M 1]	450 EL.U/mL
Meningitec Group	Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations	Anti-FHA [M 1]	55 EL.U/mL
Meningitec Group	Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations	Anti-PRN [M 0]	23 EL.U/mL
Meningitec Group	Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations	Anti-FHA [M 0]	55 EL.U/mL
Meningitec Group	Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations	Anti-PT [M 0]	11 EL.U/mL
Meningitec Group	Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations	Anti-PRN [M 1]	21 EL.U/mL
Meningitec Group	Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations	Anti-PT [M 1]	9 EL.U/mL

Secondary

Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations

The results for the assay were tabulated as geometric mean expressed in internationl units per milliliter (IU/mL).

Time frame: At month 0, month 1 and month 2

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Nimenrix + Infanrix-hexa Group	Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations	anti-TT [M 0]	0.481 IU/mL
Nimenrix + Infanrix-hexa Group	Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations	anti-TT [M 1]	10.47 IU/mL
Nimenrix Group	Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations	anti-TT [M 1]	7.941 IU/mL
Nimenrix Group	Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations	anti-TT [M 0]	0.39 IU/mL
Nimenrix Group	Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations	anti-TT [M 2]	13.966 IU/mL
Infanrix-Hexa Group	Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations	anti-TT [M 0]	0.416 IU/mL
Infanrix-Hexa Group	Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations	anti-TT [M 1]	6.189 IU/mL
Infanrix-Hexa Group	Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations	anti-TT [M 2]	8.236 IU/mL
Meningitec Group	Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations	anti-TT [M 1]	0.374 IU/mL
Meningitec Group	Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations	anti-TT [M 0]	0.393 IU/mL

Secondary

Number of Seroprotected Subjects for Anti-HBs ≥ the Cut-offs

The cut-offs for the assay were ≥ 10 mIU/mL and ≥ 100 mIU/mL respectively .

Time frame: At month 0, month 1 and month 2

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Nimenrix + Infanrix-hexa Group	Number of Seroprotected Subjects for Anti-HBs ≥ the Cut-offs	anti-HBS [M 0] ≥10	173 Participants
Nimenrix + Infanrix-hexa Group	Number of Seroprotected Subjects for Anti-HBs ≥ the Cut-offs	anti-HBS [M 1] ≥10	180 Participants
Nimenrix + Infanrix-hexa Group	Number of Seroprotected Subjects for Anti-HBs ≥ the Cut-offs	anti-HBS [M 0] ≥100	92 Participants
Nimenrix + Infanrix-hexa Group	Number of Seroprotected Subjects for Anti-HBs ≥ the Cut-offs	anti-HBS [M 1] ≥100	169 Participants
Nimenrix Group	Number of Seroprotected Subjects for Anti-HBs ≥ the Cut-offs	anti-HBS [M 1] ≥100	85 Participants
Nimenrix Group	Number of Seroprotected Subjects for Anti-HBs ≥ the Cut-offs	anti-HBS [M 0] ≥10	158 Participants
Nimenrix Group	Number of Seroprotected Subjects for Anti-HBs ≥ the Cut-offs	anti-HBS [M 1] ≥10	160 Participants
Nimenrix Group	Number of Seroprotected Subjects for Anti-HBs ≥ the Cut-offs	anti-HBS [M 2] ≥10	172 Participants
Nimenrix Group	Number of Seroprotected Subjects for Anti-HBs ≥ the Cut-offs	anti-HBS [M 2] ≥100	168 Participants
Nimenrix Group	Number of Seroprotected Subjects for Anti-HBs ≥ the Cut-offs	anti-HBS [M 0] ≥100	80 Participants
Infanrix-Hexa Group	Number of Seroprotected Subjects for Anti-HBs ≥ the Cut-offs	anti-HBS [M 2] ≥100	158 Participants
Infanrix-Hexa Group	Number of Seroprotected Subjects for Anti-HBs ≥ the Cut-offs	anti-HBS [M 1] ≥100	155 Participants
Infanrix-Hexa Group	Number of Seroprotected Subjects for Anti-HBs ≥ the Cut-offs	anti-HBS [M 0] ≥10	155 Participants
Infanrix-Hexa Group	Number of Seroprotected Subjects for Anti-HBs ≥ the Cut-offs	anti-HBS [M 0] ≥100	75 Participants
Infanrix-Hexa Group	Number of Seroprotected Subjects for Anti-HBs ≥ the Cut-offs	anti-HBS [M 1] ≥10	166 Participants
Infanrix-Hexa Group	Number of Seroprotected Subjects for Anti-HBs ≥ the Cut-offs	anti-HBS [M 2] ≥10	167 Participants
Meningitec Group	Number of Seroprotected Subjects for Anti-HBs ≥ the Cut-offs	anti-HBS [M 0] ≥10	95 Participants
Meningitec Group	Number of Seroprotected Subjects for Anti-HBs ≥ the Cut-offs	anti-HBS [M 1] ≥10	100 Participants
Meningitec Group	Number of Seroprotected Subjects for Anti-HBs ≥ the Cut-offs	anti-HBS [M 0] ≥100	46 Participants
Meningitec Group	Number of Seroprotected Subjects for Anti-HBs ≥ the Cut-offs	anti-HBS [M 1] ≥100	46 Participants

Secondary

Number of Seroprotected Subjects for Anti-tetanus Toxoid (Anti-TT)

The cut-off for the assay was ≥ 0.1

Time frame: At month 0, month 1 and month 2

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Nimenrix + Infanrix-hexa Group	Number of Seroprotected Subjects for Anti-tetanus Toxoid (Anti-TT)	anti-TT [M 0], ≥0.1	177 Participants
Nimenrix + Infanrix-hexa Group	Number of Seroprotected Subjects for Anti-tetanus Toxoid (Anti-TT)	anti-TT [M 1], ≥0.1	184 Participants
Nimenrix Group	Number of Seroprotected Subjects for Anti-tetanus Toxoid (Anti-TT)	anti-TT [M 1], ≥0.1	177 Participants
Nimenrix Group	Number of Seroprotected Subjects for Anti-tetanus Toxoid (Anti-TT)	anti-TT [M 0], ≥0.1	161 Participants
Nimenrix Group	Number of Seroprotected Subjects for Anti-tetanus Toxoid (Anti-TT)	anti-TT [M 2], ≥0.1	177 Participants
Infanrix-Hexa Group	Number of Seroprotected Subjects for Anti-tetanus Toxoid (Anti-TT)	anti-TT [M 0], ≥0.1	155 Participants
Infanrix-Hexa Group	Number of Seroprotected Subjects for Anti-tetanus Toxoid (Anti-TT)	anti-TT [M 1], ≥0.1	173 Participants
Infanrix-Hexa Group	Number of Seroprotected Subjects for Anti-tetanus Toxoid (Anti-TT)	anti-TT [M 2], ≥0.1	176 Participants
Meningitec Group	Number of Seroprotected Subjects for Anti-tetanus Toxoid (Anti-TT)	anti-TT [M 1], ≥0.1	99 Participants
Meningitec Group	Number of Seroprotected Subjects for Anti-tetanus Toxoid (Anti-TT)	anti-TT [M 0], ≥0.1	99 Participants

Secondary

Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-combined Diphtheria Vaccination

The analysis was based only on subjects receiving combined-diphtheria vaccination.

Time frame: During the 4-day (Days 0-3) follow-up period after Infanrix-hexa vaccination

Population: The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects with the symptom sheet filled-in after the Infanrix-hexa vaccination. Subjects in the Meningitec Group did not receive any Infanrix-hexa and hence are not included in this analysis.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Nimenrix + Infanrix-hexa Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-combined Diphtheria Vaccination	Any Pain	60 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-combined Diphtheria Vaccination	Grade 3 Pain	6 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-combined Diphtheria Vaccination	Any Redness	70 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-combined Diphtheria Vaccination	Grade 3 Redness	11 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-combined Diphtheria Vaccination	Any Swelling	48 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-combined Diphtheria Vaccination	Grade 3 Swelling	12 Participants
Nimenrix Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-combined Diphtheria Vaccination	Grade 3 Swelling	14 Participants
Nimenrix Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-combined Diphtheria Vaccination	Any Pain	65 Participants
Nimenrix Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-combined Diphtheria Vaccination	Grade 3 Redness	14 Participants
Nimenrix Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-combined Diphtheria Vaccination	Any Swelling	53 Participants
Nimenrix Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-combined Diphtheria Vaccination	Grade 3 Pain	5 Participants
Nimenrix Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-combined Diphtheria Vaccination	Any Redness	77 Participants
Infanrix-Hexa Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-combined Diphtheria Vaccination	Grade 3 Pain	10 Participants
Infanrix-Hexa Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-combined Diphtheria Vaccination	Any Redness	99 Participants
Infanrix-Hexa Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-combined Diphtheria Vaccination	Grade 3 Swelling	22 Participants
Infanrix-Hexa Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-combined Diphtheria Vaccination	Grade 3 Redness	27 Participants
Infanrix-Hexa Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-combined Diphtheria Vaccination	Any Pain	64 Participants
Infanrix-Hexa Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-combined Diphtheria Vaccination	Any Swelling	74 Participants

Secondary

Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination

Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any local symptom irrespective of intensity grade. Grade 3 Pain was defined as crying when limb was moved/ spontaneously painful.

Time frame: During the 4-day (Days 0-3) follow-up period after Nimenrix or Meningitec vaccination

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Nimenrix + Infanrix-hexa Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination	Any Pain	49 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination	Grade 3 Pain	3 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination	Any Redness	70 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination	Grade 3 Redness	3 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination	Any Swelling	42 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination	Grade 3 Swelling	2 Participants
Nimenrix Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination	Grade 3 Swelling	3 Participants
Nimenrix Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination	Grade 3 Redness	8 Participants
Nimenrix Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination	Any Pain	30 Participants
Nimenrix Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination	Any Redness	74 Participants
Nimenrix Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination	Grade 3 Pain	0 Participants
Nimenrix Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination	Any Swelling	36 Participants
Infanrix-Hexa Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination	Grade 3 Pain	1 Participants
Infanrix-Hexa Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination	Any Redness	56 Participants
Infanrix-Hexa Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination	Grade 3 Redness	8 Participants
Infanrix-Hexa Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination	Grade 3 Swelling	7 Participants
Infanrix-Hexa Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination	Any Swelling	36 Participants
Infanrix-Hexa Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination	Any Pain	35 Participants
Meningitec Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination	Any Swelling	23 Participants
Meningitec Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination	Grade 3 Swelling	0 Participants
Meningitec Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination	Grade 3 Pain	1 Participants
Meningitec Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination	Grade 3 Redness	2 Participants
Meningitec Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination	Any Pain	16 Participants
Meningitec Group	Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination	Any Redness	36 Participants

Secondary

Number of Subjects Reporting Any Conditions Prompting Emergency Room Visits (ER)

Any was defined as occurrence of at least one symptom experienced.

Time frame: Day 0 - Month 7

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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Nimenrix + Infanrix-hexa Group	Number of Subjects Reporting Any Conditions Prompting Emergency Room Visits (ER)	5 Participants
Nimenrix Group	Number of Subjects Reporting Any Conditions Prompting Emergency Room Visits (ER)	3 Participants
Infanrix-Hexa Group	Number of Subjects Reporting Any Conditions Prompting Emergency Room Visits (ER)	14 Participants
Meningitec Group	Number of Subjects Reporting Any Conditions Prompting Emergency Room Visits (ER)	6 Participants

Secondary

Number of Subjects Reporting Any New Onset of Chronic Illnesses (NOCIs)

Any was defined as occurrence of at least one symptom experienced.

Time frame: Day 0 - Month 7

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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Nimenrix + Infanrix-hexa Group	Number of Subjects Reporting Any New Onset of Chronic Illnesses (NOCIs)	1 Participants
Nimenrix Group	Number of Subjects Reporting Any New Onset of Chronic Illnesses (NOCIs)	2 Participants
Infanrix-Hexa Group	Number of Subjects Reporting Any New Onset of Chronic Illnesses (NOCIs)	6 Participants
Meningitec Group	Number of Subjects Reporting Any New Onset of Chronic Illnesses (NOCIs)	1 Participants

Secondary

Number of Subjects Reporting Any Rash

Any was defined as occurrence of at least one symptom experienced.

Time frame: Day 0 - Month 7

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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Nimenrix + Infanrix-hexa Group	Number of Subjects Reporting Any Rash	13 Participants
Nimenrix Group	Number of Subjects Reporting Any Rash	25 Participants
Infanrix-Hexa Group	Number of Subjects Reporting Any Rash	22 Participants
Meningitec Group	Number of Subjects Reporting Any Rash	12 Participants

Secondary

Number of Subjects Reporting Any Serious Adverse Events (SAEs)

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

Time frame: From dose 1 (Month 0) up to study end (Month 7)

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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Nimenrix + Infanrix-hexa Group	Number of Subjects Reporting Any Serious Adverse Events (SAEs)	10 Participants
Nimenrix Group	Number of Subjects Reporting Any Serious Adverse Events (SAEs)	8 Participants
Infanrix-Hexa Group	Number of Subjects Reporting Any Serious Adverse Events (SAEs)	11 Participants
Meningitec Group	Number of Subjects Reporting Any Serious Adverse Events (SAEs)	6 Participants

Secondary

Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose

Solicited general symptoms assessed were drowsiness, fever, irritability and loss of appetite. Any was defined as occurrence of any general symptom irrespective of intensity grade and relationship. Subjects in the Nimenrix + Infanrix-hexa Group did not receive a second dose of vaccination.

Time frame: During the 4-day (Days 0-3) post-vaccination dose 1 (D1) and second dose (D2)

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 + Infanrix-hexa Group	Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose	Drowsiness, D1	85 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose	Fever, D1	80 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose	Irritability, D1	83 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose	Loss of appetite, D1	51 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose	Drowsiness, D2	0 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose	Fever, D2	0 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose	Irritability, D2	0 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose	Loss of appetite, D2	0 Participants
Nimenrix Group	Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose	Fever, D2	60 Participants
Nimenrix Group	Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose	Drowsiness, D2	63 Participants
Nimenrix Group	Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose	Fever, D1	41 Participants
Nimenrix Group	Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose	Loss of appetite, D2	54 Participants
Nimenrix Group	Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose	Irritability, D2	75 Participants
Nimenrix Group	Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose	Loss of appetite, D1	46 Participants
Nimenrix Group	Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose	Irritability, D1	63 Participants
Nimenrix Group	Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose	Drowsiness, D1	56 Participants
Infanrix-Hexa Group	Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose	Irritability, D2	50 Participants
Infanrix-Hexa Group	Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose	Irritability, D1	75 Participants
Infanrix-Hexa Group	Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose	Loss of appetite, D1	51 Participants
Infanrix-Hexa Group	Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose	Drowsiness, D2	56 Participants
Infanrix-Hexa Group	Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose	Fever, D2	37 Participants
Infanrix-Hexa Group	Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose	Loss of appetite, D2	38 Participants
Infanrix-Hexa Group	Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose	Drowsiness, D1	80 Participants
Infanrix-Hexa Group	Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose	Fever, D1	71 Participants
Meningitec Group	Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose	Irritability, D1	25 Participants
Meningitec Group	Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose	Loss of appetite, D1	15 Participants
Meningitec Group	Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose	Fever, D1	15 Participants
Meningitec Group	Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose	Drowsiness, D1	29 Participants
Meningitec Group	Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose	Drowsiness, D2	0 Participants
Meningitec Group	Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose	Loss of appetite, D2	0 Participants
Meningitec Group	Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose	Irritability, D2	0 Participants
Meningitec Group	Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose	Fever, D2	0 Participants

Secondary

Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the First Dose

An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.

Time frame: Occurring within Day 0-30 following vaccination

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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Nimenrix + Infanrix-hexa Group	Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the First Dose	71 Participants
Nimenrix Group	Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the First Dose	81 Participants
Infanrix-Hexa Group	Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the First Dose	83 Participants
Meningitec Group	Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the First Dose	42 Participants

Secondary

Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the Second Dose

Time frame: Occurring within Day 0-30 following vaccination

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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Nimenrix + Infanrix-hexa Group	Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the Second Dose	87 Participants
Nimenrix Group	Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the Second Dose	79 Participants

Secondary

Number of Subjects Seroprotected for Anti-diphtheria (Anti-D) ≥ the Cut-off

The cut-off for the assay was ≥ 0.1

Time frame: At month 0, month 1 and month 2

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Nimenrix + Infanrix-hexa Group	Number of Subjects Seroprotected for Anti-diphtheria (Anti-D) ≥ the Cut-off	anti-D [M 0], ≥0.1	169 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects Seroprotected for Anti-diphtheria (Anti-D) ≥ the Cut-off	anti-D [M 1], ≥0.1	184 Participants
Nimenrix Group	Number of Subjects Seroprotected for Anti-diphtheria (Anti-D) ≥ the Cut-off	anti-D [M 1], ≥0.1	156 Participants
Nimenrix Group	Number of Subjects Seroprotected for Anti-diphtheria (Anti-D) ≥ the Cut-off	anti-D [M 0], ≥0.1	157 Participants
Nimenrix Group	Number of Subjects Seroprotected for Anti-diphtheria (Anti-D) ≥ the Cut-off	anti-D [M 2], ≥0.1	176 Participants
Infanrix-Hexa Group	Number of Subjects Seroprotected for Anti-diphtheria (Anti-D) ≥ the Cut-off	anti-D [M 0], ≥0.1	154 Participants
Infanrix-Hexa Group	Number of Subjects Seroprotected for Anti-diphtheria (Anti-D) ≥ the Cut-off	anti-D [M 1], ≥0.1	173 Participants
Infanrix-Hexa Group	Number of Subjects Seroprotected for Anti-diphtheria (Anti-D) ≥ the Cut-off	anti-D [M 2], ≥0.1	176 Participants
Meningitec Group	Number of Subjects Seroprotected for Anti-diphtheria (Anti-D) ≥ the Cut-off	anti-D [M 1], ≥0.1	109 Participants
Meningitec Group	Number of Subjects Seroprotected for Anti-diphtheria (Anti-D) ≥ the Cut-off	anti-D [M 0], ≥0.1	94 Participants

Secondary

Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off

The cut-off for the assay was ≥ 1:8.

Time frame: At month 0, month 1 and month 2

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Nimenrix + Infanrix-hexa Group	Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off	anti-p1 [M 0]	158 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off	anti-p2 [M 1]	166 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off	anti-p3 [M 0]	155 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off	anti-p2 [M 0]	153 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off	anti-p1 [M 1]	166 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off	anti-p3 [M 1]	167 Participants
Nimenrix Group	Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off	anti-p2 [M 1]	147 Participants
Nimenrix Group	Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off	anti-p1 [M 0]	143 Participants
Nimenrix Group	Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off	anti-p1 [M 1]	149 Participants
Nimenrix Group	Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off	anti-p1 [M 2]	159 Participants
Nimenrix Group	Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off	anti-p2 [M 0]	141 Participants
Nimenrix Group	Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off	anti-p2 [M 2]	159 Participants
Nimenrix Group	Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off	anti-p3 [M 0]	148 Participants
Nimenrix Group	Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off	anti-p3 [M 1]	150 Participants
Nimenrix Group	Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off	anti-p3 [M 2]	159 Participants
Infanrix-Hexa Group	Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off	anti-p1 [M 1]	163 Participants
Infanrix-Hexa Group	Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off	anti-p2 [M 1]	161 Participants
Infanrix-Hexa Group	Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off	anti-p2 [M 2]	161 Participants
Infanrix-Hexa Group	Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off	anti-p3 [M 0]	143 Participants
Infanrix-Hexa Group	Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off	anti-p1 [M 0]	142 Participants
Infanrix-Hexa Group	Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off	anti-p1 [M 2]	161 Participants
Infanrix-Hexa Group	Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off	anti-p3 [M 2]	159 Participants
Infanrix-Hexa Group	Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off	anti-p2 [M 0]	145 Participants
Infanrix-Hexa Group	Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off	anti-p3 [M 1]	160 Participants
Meningitec Group	Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off	anti-p2 [M 1]	80 Participants
Meningitec Group	Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off	anti-p3 [M 0]	88 Participants
Meningitec Group	Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off	anti-p2 [M 0]	80 Participants
Meningitec Group	Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off	anti-p1 [M 0]	90 Participants
Meningitec Group	Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off	anti-p3 [M 1]	87 Participants
Meningitec Group	Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off	anti-p1 [M 1]	89 Participants

Secondary

Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off

The cut-off for the assay were ≥ 0.3 microgram per milliliter (μg/mL) and ≥ 2.0 μg/mL, respectively.

Time frame: At month 0, month 1 and month 2

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Nimenrix + Infanrix-hexa Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSA [Month 0], ≥0.3	4 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSA [Month 1], ≥0.3	46 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSA [Month 0], ≥2.0	0 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSA [Month 1], ≥2.0	46 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSA [Month 2], ≥2.0	0 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSC [Month 0], ≥0.3	1 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSC [Month 1], ≥0.3	51 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSC [Month 0], ≥2.0	1 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSC [Month 1], ≥2.0	50 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSW-135 [Month 0], ≥0.3	1 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSW-135 [Month 1], ≥0.3	44 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSW-135 [Month 2], ≥0.3	0 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSW-135 [Month 0], ≥2.0	0 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSW-135 [Month 1], ≥2.0	40 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSY [Month 0], ≥0.3	1 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSY [Month 1], ≥0.3	45 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSY [Month 0], ≥2.0	0 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSY [Month 1], ≥2.0	40 Participants
Nimenrix Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSY [Month 0], ≥2.0	0 Participants
Nimenrix Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSW-135 [Month 0], ≥0.3	1 Participants
Nimenrix Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSC [Month 1], ≥0.3	41 Participants
Nimenrix Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSY [Month 0], ≥0.3	1 Participants
Nimenrix Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSA [Month 1], ≥2.0	44 Participants
Nimenrix Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSW-135 [Month 1], ≥0.3	43 Participants
Nimenrix Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSA [Month 2], ≥0.3	44 Participants
Nimenrix Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSW-135 [Month 2], ≥2.0	36 Participants
Nimenrix Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSW-135 [Month 1], ≥2.0	39 Participants
Nimenrix Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSW-135 [Month 2], ≥0.3	43 Participants
Nimenrix Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSC [Month 2], ≥0.3	41 Participants
Nimenrix Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSY [Month 1], ≥2.0	42 Participants
Nimenrix Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSY [Month 1], ≥0.3	43 Participants
Nimenrix Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSW-135 [Month 0], ≥2.0	0 Participants
Nimenrix Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSC [Month 0], ≥0.3	1 Participants
Nimenrix Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSC [Month 0], ≥2.0	0 Participants
Nimenrix Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSA [Month 2], ≥2.0	43 Participants
Nimenrix Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSA [Month 1], ≥0.3	45 Participants
Nimenrix Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSY [Month 2], ≥2.0	40 Participants
Nimenrix Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSC [Month 1], ≥2.0	41 Participants
Nimenrix Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSA [Month 0], ≥2.0	0 Participants
Nimenrix Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSA [Month 0], ≥0.3	1 Participants
Nimenrix Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSC [Month 2], ≥2.0	41 Participants
Nimenrix Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSY [Month 2], ≥0.3	44 Participants
Infanrix-Hexa Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSA [Month 2], ≥0.3	42 Participants
Infanrix-Hexa Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSA [Month 2], ≥2.0	40 Participants
Infanrix-Hexa Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSC [Month 0], ≥0.3	2 Participants
Infanrix-Hexa Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSC [Month 1], ≥0.3	2 Participants
Infanrix-Hexa Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSC [Month 2], ≥0.3	47 Participants
Infanrix-Hexa Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSY [Month 2], ≥0.3	41 Participants
Infanrix-Hexa Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSC [Month 0], ≥2.0	0 Participants
Infanrix-Hexa Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSC [Month 1], ≥2.0	0 Participants
Infanrix-Hexa Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSC [Month 2], ≥2.0	43 Participants
Infanrix-Hexa Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSW-135 [Month 0], ≥0.3	2 Participants
Infanrix-Hexa Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSY [Month 0], ≥2.0	0 Participants
Infanrix-Hexa Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSW-135 [Month 1], ≥0.3	2 Participants
Infanrix-Hexa Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSW-135 [Month 2], ≥0.3	41 Participants
Infanrix-Hexa Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSY [Month 2], ≥2.0	34 Participants
Infanrix-Hexa Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSW-135 [Month 0], ≥2.0	1 Participants
Infanrix-Hexa Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSW-135 [Month 1], ≥2.0	2 Participants
Infanrix-Hexa Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSW-135 [Month 2], ≥2.0	29 Participants
Infanrix-Hexa Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSY [Month 1], ≥2.0	1 Participants
Infanrix-Hexa Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSY [Month 0], ≥0.3	0 Participants
Infanrix-Hexa Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSA [Month 0], ≥0.3	1 Participants
Infanrix-Hexa Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSA [Month 1], ≥0.3	1 Participants
Infanrix-Hexa Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSY [Month 1], ≥0.3	1 Participants
Infanrix-Hexa Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSA [Month 0], ≥2.0	0 Participants
Infanrix-Hexa Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSA [Month 1], ≥2.0	1 Participants
Meningitec Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSA [Month 1], ≥2.0	0 Participants
Meningitec Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSC [Month 1], ≥2.0	26 Participants
Meningitec Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSA [Month 0], ≥2.0	0 Participants
Meningitec Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSA [Month 0], ≥0.3	1 Participants
Meningitec Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSY [Month 0], ≥0.3	0 Participants
Meningitec Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSC [Month 0], ≥2.0	0 Participants
Meningitec Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSY [Month 1], ≥0.3	0 Participants
Meningitec Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSA [Month 1], ≥0.3	1 Participants
Meningitec Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSC [Month 1], ≥0.3	28 Participants
Meningitec Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSW-135 [Month 0], ≥2.0	0 Participants
Meningitec Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSW-135 [Month 2], ≥0.3	0 Participants
Meningitec Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSY [Month 0], ≥2.0	0 Participants
Meningitec Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSA [Month 2], ≥2.0	0 Participants
Meningitec Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSW-135 [Month 1], ≥2.0	0 Participants
Meningitec Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSW-135 [Month 1], ≥0.3	0 Participants
Meningitec Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSY [Month 1], ≥2.0	0 Participants
Meningitec Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSC [Month 0], ≥0.3	0 Participants
Meningitec Group	Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off	Anti-PSW-135 [Month 0], ≥0.3	0 Participants

Secondary

Number of Subjects With a Vaccine Response to PT, FHA and PRN Antigens

Vaccine response to these antigens is defined as appearance of antibodies in subjects who were seronegative (antibody concentration \< 5 EL.U/mL) at pre-vaccination or as at least a 2-fold increase in post-over pre-vaccination antibody concentrations in subjects seropositive at pre-vaccination. The analysis was based only on subjects receiving experimental vaccination.

Time frame: 1 month after vaccination (Month 1)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Nimenrix + Infanrix-hexa Group	Number of Subjects With a Vaccine Response to PT, FHA and PRN Antigens	Anti-FHA	184 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects With a Vaccine Response to PT, FHA and PRN Antigens	Anti-PT	180 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects With a Vaccine Response to PT, FHA and PRN Antigens	Anti-PRN	186 Participants
Nimenrix Group	Number of Subjects With a Vaccine Response to PT, FHA and PRN Antigens	Anti-FHA	159 Participants
Nimenrix Group	Number of Subjects With a Vaccine Response to PT, FHA and PRN Antigens	Anti-PT	169 Participants
Nimenrix Group	Number of Subjects With a Vaccine Response to PT, FHA and PRN Antigens	Anti-PRN	173 Participants
Infanrix-Hexa Group	Number of Subjects With a Vaccine Response to PT, FHA and PRN Antigens	Anti-PT	163 Participants
Infanrix-Hexa Group	Number of Subjects With a Vaccine Response to PT, FHA and PRN Antigens	Anti-PRN	172 Participants
Infanrix-Hexa Group	Number of Subjects With a Vaccine Response to PT, FHA and PRN Antigens	Anti-FHA	158 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 assay were ≥ 1:8 and ≥ 1:128

Time frame: At month 0, month 1 and month 2

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Nimenrix + Infanrix-hexa Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenC [M 0], ≥1:8	20 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenA [M 1], ≥1:8	193 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenA [M 0], ≥1:128	18 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenA [M 1], ≥1:128	193 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenA [M 0], ≥1:8	30 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenC [M 1], ≥1:8	191 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenC [M 0], ≥1:128	5 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenC [M 1], ≥1:128	189 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenW-135 [M 0], ≥1:8	43 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenW-135 [M 1], ≥1:8	193 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenW-135 [M 0], ≥1:128	17 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenW-135 [M 1] ≥1:128	193 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenY [M 0], ≥1:8	57 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenY [M 1], ≥1:8	192 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenY [M 0], ≥1:128	38 Participants
Nimenrix + Infanrix-hexa Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenY [M 1], ≥1:128	192 Participants
Nimenrix Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenC [M 1], ≥1:8	178 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 [M 0], ≥1:8	42 Participants
Nimenrix Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenY [M 2], ≥1:8	91 Participants
Nimenrix Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenA [M 0], ≥1:8	32 Participants
Nimenrix Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenY [M 0], ≥1:8	53 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 [M 1], ≥1:8	183 Participants
Nimenrix Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenA [M 2], ≥1:8	90 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 [M 2], ≥1:128	90 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 [M 2], ≥1:8	91 Participants
Nimenrix Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenC [M 2], ≥1:8	91 Participants
Nimenrix Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenC [M 0], ≥1:8	25 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 [M 0], ≥1:128	11 Participants
Nimenrix Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenY [M 2], ≥1:128	91 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 [M 1] ≥1:128	180 Participants
Nimenrix Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenY [M 1], ≥1:128	178 Participants
Nimenrix Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenC [M 0], ≥1:128	8 Participants
Nimenrix Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenA [M 2], ≥1:128	90 Participants
Nimenrix Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenA [M 1], ≥1:8	180 Participants
Nimenrix Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenY [M 0], ≥1:128	37 Participants
Nimenrix Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenC [M 1], ≥1:128	172 Participants
Nimenrix Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenA [M 0], ≥1:128	21 Participants
Nimenrix Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenY [M 1], ≥1:8	180 Participants
Nimenrix Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenC [M 2], ≥1:128	85 Participants
Nimenrix Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenA [M 1], ≥1:128	179 Participants
Infanrix-Hexa Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenC [M 0], ≥1:128	5 Participants
Infanrix-Hexa Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenA [M 2], ≥1:128	178 Participants
Infanrix-Hexa Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenC [M 0], ≥1:8	13 Participants
Infanrix-Hexa Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenY [M 2], ≥1:8	178 Participants
Infanrix-Hexa Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenC [M 1], ≥1:8	34 Participants
Infanrix-Hexa Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenC [M 2], ≥1:8	178 Participants
Infanrix-Hexa Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenA [M 1], ≥1:128	57 Participants
Infanrix-Hexa Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenC [M 1], ≥1:128	14 Participants
Infanrix-Hexa Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenC [M 2], ≥1:128	157 Participants
Infanrix-Hexa Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenY [M 0], ≥1:128	34 Participants
Infanrix-Hexa Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenW-135 [M 0], ≥1:8	46 Participants
Infanrix-Hexa Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenW-135 [M 1], ≥1:8	86 Participants
Infanrix-Hexa Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenW-135 [M 2], ≥1:8	179 Participants
Infanrix-Hexa Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenY [M 2], ≥1:128	178 Participants
Infanrix-Hexa Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenW-135 [M 0], ≥1:128	23 Participants
Infanrix-Hexa Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenW-135 [M 1] ≥1:128	49 Participants
Infanrix-Hexa Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenW-135 [M 2], ≥1:128	178 Participants
Infanrix-Hexa Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenY [M 1], ≥1:128	79 Participants
Infanrix-Hexa Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenY [M 0], ≥1:8	53 Participants
Infanrix-Hexa Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenA [M 0], ≥1:8	34 Participants
Infanrix-Hexa Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenA [M 1], ≥1:8	71 Participants
Infanrix-Hexa Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenA [M 2], ≥1:8	178 Participants
Infanrix-Hexa Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenY [M 1], ≥1:8	103 Participants
Infanrix-Hexa Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenA [M 0], ≥1:128	24 Participants
Meningitec Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenY [M 1], ≥1:128	38 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 [M 0], ≥1:8	22 Participants
Meningitec Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenC [M 0], ≥1:8	11 Participants
Meningitec Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenA [M 0], ≥1:8	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 [M 1], ≥1:128	102 Participants
Meningitec Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenC [M 0], ≥1:128	3 Participants
Meningitec Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenA [M 1], ≥1:128	30 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 [M 0], ≥1:128	10 Participants
Meningitec Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenA [M 1], ≥1:8	43 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 [M 1] ≥1:128	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 [M 1], ≥1:8	41 Participants
Meningitec Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenC [M 1], ≥1:8	112 Participants
Meningitec Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenA [M 0], ≥1:128	11 Participants
Meningitec Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenY [M 0], ≥1:128	20 Participants
Meningitec Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenY [M 1], ≥1:8	71 Participants
Meningitec Group	Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values	rSBA-MenY [M 0], ≥1:8	30 Participants

Secondary

Numbers of Seroprotected Subjects for Anti-PRP ≥ the Cut-off

The cut-off for the assay was ≥ 1.0

Time frame: At month 0, month 1 and month 2

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Nimenrix + Infanrix-hexa Group	Numbers of Seroprotected Subjects for Anti-PRP ≥ the Cut-off	anti-PRP [M 0] ≥1.0	73 Participants
Nimenrix + Infanrix-hexa Group	Numbers of Seroprotected Subjects for Anti-PRP ≥ the Cut-off	anti-PRP [M 1] ≥1.0	183 Participants
Nimenrix Group	Numbers of Seroprotected Subjects for Anti-PRP ≥ the Cut-off	anti-PRP [M 1] ≥1.0	70 Participants
Nimenrix Group	Numbers of Seroprotected Subjects for Anti-PRP ≥ the Cut-off	anti-PRP [M 0] ≥1.0	64 Participants
Nimenrix Group	Numbers of Seroprotected Subjects for Anti-PRP ≥ the Cut-off	anti-PRP [M 2] ≥1.0	172 Participants
Infanrix-Hexa Group	Numbers of Seroprotected Subjects for Anti-PRP ≥ the Cut-off	anti-PRP [M 0] ≥1.0	65 Participants
Infanrix-Hexa Group	Numbers of Seroprotected Subjects for Anti-PRP ≥ the Cut-off	anti-PRP [M 1] ≥1.0	170 Participants
Infanrix-Hexa Group	Numbers of Seroprotected Subjects for Anti-PRP ≥ the Cut-off	anti-PRP [M 2] ≥1.0	170 Participants
Meningitec Group	Numbers of Seroprotected Subjects for Anti-PRP ≥ the Cut-off	anti-PRP [M 1] ≥1.0	34 Participants
Meningitec Group	Numbers of Seroprotected Subjects for Anti-PRP ≥ the Cut-off	anti-PRP [M 0] ≥1.0	34 Participants

Secondary

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

The results were tabulated as geometric mean expressed in titers.

Time frame: At month 0, month 1 and month 2

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Nimenrix + Infanrix-hexa Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers	rSBA-MenW-135 [M 0]	19 Titers
Nimenrix + Infanrix-hexa Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers	rSBA-MenY [M 1]	3461.8 Titers
Nimenrix + Infanrix-hexa Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers	rSBA-MenC [M 1]	879.7 Titers
Nimenrix + Infanrix-hexa Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers	rSBA-MenC [M 0]	7.4 Titers
Nimenrix + Infanrix-hexa Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers	rSBA-MenY [M 0]	36.8 Titers
Nimenrix + Infanrix-hexa Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers	rSBA-MenA [M 1]	3152.9 Titers
Nimenrix + Infanrix-hexa Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers	rSBA-MenA [M 0]	15 Titers
Nimenrix + Infanrix-hexa Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers	rSBA-MenW-135 [M 1]	4147 Titers
Nimenrix Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers	rSBA-MenC [M 0]	9.1 Titers
Nimenrix Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers	rSBA-MenA [M 0]	19 Titers
Nimenrix Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers	rSBA-MenA [M 1]	3169.9 Titers
Nimenrix Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers	rSBA-MenA [M 2]	2881.9 Titers
Nimenrix Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers	rSBA-MenC [M 1]	828.7 Titers
Nimenrix Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers	rSBA-MenC [M 2]	519.6 Titers
Nimenrix Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers	rSBA-MenW-135 [M 0]	19.2 Titers
Nimenrix Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers	rSBA-MenW-135 [M 1]	4022.3 Titers
Nimenrix Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers	rSBA-MenW-135 [M 2]	3630.1 Titers
Nimenrix Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers	rSBA-MenY [M 0]	45.4 Titers
Nimenrix Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers	rSBA-MenY [M 1]	3167.7 Titers
Nimenrix Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers	rSBA-MenY [M 2]	3010.4 Titers
Infanrix-Hexa Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers	rSBA-MenC [M 0]	6.1 Titers
Infanrix-Hexa Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers	rSBA-MenY [M 2]	2446.9 Titers
Infanrix-Hexa Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers	rSBA-MenA [M 2]	1938.3 Titers
Infanrix-Hexa Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers	rSBA-MenY [M 0]	41.2 Titers
Infanrix-Hexa Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers	rSBA-MenC [M 1]	7.5 Titers
Infanrix-Hexa Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers	rSBA-MenW-135 [M 1]	25.2 Titers
Infanrix-Hexa Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers	rSBA-MenW-135 [M 0]	24.8 Titers
Infanrix-Hexa Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers	rSBA-MenC [M 2]	386 Titers
Infanrix-Hexa Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers	rSBA-MenY [M 1]	45.9 Titers
Infanrix-Hexa Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers	rSBA-MenW-135 [M 2]	2466.4 Titers
Infanrix-Hexa Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers	rSBA-MenA [M 0]	24 Titers
Infanrix-Hexa Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers	rSBA-MenA [M 1]	24.2 Titers
Meningitec Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers	rSBA-MenA [M 0]	15.9 Titers
Meningitec Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers	rSBA-MenW-135 [M 0]	15.6 Titers
Meningitec Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers	rSBA-MenW-135 [M 1]	14.2 Titers
Meningitec Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers	rSBA-MenA [M 1]	21.5 Titers
Meningitec Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers	rSBA-MenY [M 1]	47.2 Titers
Meningitec Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers	rSBA-MenC [M 0]	7.6 Titers
Meningitec Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers	rSBA-MenC [M 1]	691.4 Titers
Meningitec Group	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers	rSBA-MenY [M 0]	32 Titers

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Co-Administration of Meningococcal Vaccine GSK134612 With Infanrix Hexa™ Versus Individual Administration of Each Vaccine

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

Anti-PT, Anti-FHA and Anti-PRN Concentrations

Number of Subjects With Anti-HBs Concentrations ≥ the Cut-off

Number of Subjects With Anti-PRP Concentrations ≥ the Cut-off

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

Anti-diphtheria (Anti-D) Antibody Concentrations

Anti-HBs Antibody Concentrations

Anti-polio Type 1, 2 & 3 Titers

Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations

Anti-PRP Antibody Concentrations

Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations

Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations

Number of Seroprotected Subjects for Anti-HBs ≥ the Cut-offs

Number of Seroprotected Subjects for Anti-tetanus Toxoid (Anti-TT)

Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-combined Diphtheria Vaccination

Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination

Number of Subjects Reporting Any Conditions Prompting Emergency Room Visits (ER)

Number of Subjects Reporting Any New Onset of Chronic Illnesses (NOCIs)

Number of Subjects Reporting Any Rash

Number of Subjects Reporting Any Serious Adverse Events (SAEs)

Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose

Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the First Dose

Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the Second Dose

Number of Subjects Seroprotected for Anti-diphtheria (Anti-D) ≥ the Cut-off

Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off

Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off

Number of Subjects With a Vaccine Response to PT, FHA and PRN Antigens

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

Numbers of Seroprotected Subjects for Anti-PRP ≥ the Cut-off

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