Dose Ranging Study of Combined Haemophilus Influenzae Type B-Meningococcal Serogroups CY (Hib-MenCY-TT) Vaccine

A Phase II, Open (Partially Double-blind), Randomised, Controlled, Multicentre, Primary Vaccination Study to Evaluate the Immunogenicity (Including Immune Memory), Reactogenicity and Safety of Three Different Formulations of the GSK Biologicals' Combined Haemophilus Influenzae Type B-meningococcal Serogroups CY Conjugate Vaccine Given Concomitantly With Infanrix® Penta and Prevenar®, Versus ActHIB® and Meningitec® Given Concomitantly With Infanrix® Penta and Versus ActHIB® Given Concomitantly With Infanrix® Penta and Prevenar® in Infants According to a 2-4-6 Month Schedule.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00127855

Enrollment

409

Registered

2005-08-09

Start date

2003-03-01

Completion date

2004-02-12

Last updated

2018-08-27

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

Conditions

Haemophilus Influenzae Type b, Neisseria Meningitidis

Keywords

Invasive bacterial disease caused by Hib, Neisseria meningitidis serogroups C & Y

Brief summary

This study evaluated the safety and immunogenicity of 3 formulations of Hib-MenCY-TT vaccine compared to 2 control groups receiving licensed meningococcal serogroup C conjugate vaccine and/or licensed Hib conjugate vaccine administered at 2, 4, and 6 months of age. Antibody persistence and immune responses to polysaccharide vaccine boosters were additionally assessed at 11 to 14 months of age.

Interventions

BIOLOGICALHib-MenCY-TT vaccine (MenHibrix)

Three doses were administered intramuscularly (IM) in left thigh at Months 0,2 and 4 respectively

BIOLOGICALMeningitec®

Three doses were administered IM in right lower thigh at Months 0,2 and 4.

BIOLOGICALActHIB®

Three doses were administered IM in left thigh at Months 0,2 and 4.

BIOLOGICALInfanrix® Penta

Three doses were administered IM in right upper thigh at Months 0,2 and 4 respectively.

BIOLOGICALPrevenar®

Three doses were administered IM in right lower thigh at Months 0,2 and 4 respectively.

BIOLOGICALMencevax® ACWY

One fifth of one dose was administered IM in deltoid region of right arm at Month 10 as booster.

BIOLOGICALPRP (Polyribosyl Ribitol Phosphate)

One dose was administered IM in deltoid region of left arm at Month 10 as booster.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

6 Weeks to 12 Weeks

Healthy volunteers

Yes

Inclusion criteria

* A male or female between, and including, 6 and 12 weeks (42-90 days) 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. * Vaccinated against hepatitis B at birth. * Born after a gestation period of 36 - 42 weeks.

Exclusion criteria

* Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs since birth * Any chronic drug therapy to be continued during the study period. * Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the first dose of vaccine(s). * Previous vaccination against diphtheria, tetanus, pertussis, polio, N. meningitidis of serogroups C and Y, Haemophilus influenzae type b or Streptococcus pneumoniae. * History of or known exposure to diphtheria, tetanus, pertussis, polio, or invasive diseases due to N. meningitidis of serogroups C and Y, Haemophilus influenzae type b or Streptococcus pneumoniae. * Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. * A family history of congenital or hereditary immunodeficiency. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. * Major congenital defects or serious chronic illness. * History of any neurologic disorders or seizures. * Acute disease at the time of enrolment. * Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

Design outcomes

Primary

Measure	Time frame	Description
Number of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 1 Milligram Per Milliliter	One month after primary vaccination (Month 5)	The cut-off concentration assessed was 1 milligram per milliliter (mg/mL).
Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8	One month after primary vaccination (Month 5)	The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.
Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers Greater Than or Equal to 1:8	One month after primary vaccination (Month 5)	The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.

Secondary

Measure	Time frame	Description
Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)	Titers were presented as geometric mean titers (GMTs) expressed as the reciprocal of the dilution resulting in 50 percent inhibition.
Number of Subjects With Anti-polysaccharide C (PSC) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)	The cut-off concentration assessed was 30 micrograms per milliliter (µg/mL).
Anti-polysaccharide C (PSC) Antibody Concentration	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)	Titers are presented as Geometric Mean Titers (GMTs) expressed as micrograms per milliliter (µg/mL).
Number of Subjects With Anti-polysaccharide Y (PSY) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)	The cut-off concentration assessed was 30 micrograms per milliliter (µg/mL).
Anti-polysaccharide Y (PSY) Antibody Concentration	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)	Titers are presented as Geometric Mean Titers (GMTs) expressed as micrograms per milliliter (µg/mL).
Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)	The cut-off concentrations assessed were 0.15 micrograms per milliliter (µg/mL) and 1 µg/mL.
Anti-PRP Antibody Concentration	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)	Concentrations are presented as GMCs and expressed as µg/mL.
Number of Subjects Seroprotected for Anti-diphtheria Antibodies	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)	Seroprotection is defined as anti-diphtheria toxoid antibody concentration greater than or equal to 0.1 International Units per Milliliter (IU/mL).
Anti-diphtheria Antibody Concentrations	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)	Concentrations are presented as GMCs and expressed as International Units per Milliliter (IU/mL).
Number of Subjects Seroprotected for Anti-tetanus Antibodies	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)	Seroprotection is defined as anti-tetanus toxoid antibody concentration greater than or equal to 0.1 International Units per Milliliter (IU/mL).
Anti-tetanus Antibody Concentrations	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)	Concentrations are presented as GMCs and expressed as International Units per Milliliter (IU/mL).
Number of Subjects Seroseropositive for Anti-filamentus Haemagglutinin (FHA) Antibodies	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)	Seropositivity is defined as anti-FHA antibody concentration greater than or equal to 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).
Anti- FHA Antibody Concentrations	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)	Concentrations are presented as GMCs and expressed as Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).
Number of Subjects Seroseropositive for Anti-pertactin (PRN) Antibodies	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)	Seropositivity is defined as anti-PRN antibody concentration greater than or equal to 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).
Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8	Prior to vaccination (Day 0), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)	The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.
Number of Subjects Seroseropositive for Anti-pertussis Toxoid (PT) Antibodies	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)	Seropositivity is defined as anti-PT antibody concentration greater than or equal to 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).
Anti- PT Antibody Concentrations	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)	Concentrations are presented as GMCs and expressed as Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).
Number of Subjects Seroprotected for Anti-hepatitis B (HBs) Antibodies	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)	Seroprotection is defined as anti-HBs antibody concentration greater than or equal to 10 Milli-International Units per Milliliter (mIU/mL).
Anti- HBs Antibody Concentrations	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)	Concentrations are presented as GMCs and expressed as Milli-International Units per Milliliter (mIU/mL).
Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)	Seroprotection is defined as anti-polio antibody titer greater than or equal to 1:8 dilution.
Anti-poliovirus Types 1, 2 and 3 Antibody Titers	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)	Titers are presented as GMTs and expressed in terms of the 50 % inhibitory dilution.
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)	Pneumococcal antibodies assessed included anti-4, anti-6B, anti-9V, anti-14, anti-18C, anti-19F and anti-23F antibodies. The cut-off values assessed were 0.05 and 0.2 micrograms per milliliter (µg/mL).
Anti-pneumococcal Antibody Concentrations	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)	Pneumococcal antibodies assessed included anti-4, anti-6B, anti-9V, anti-14, anti-18C, anti-19F and anti-23F antibodies. Concentrations are presented as GMCs and expressed as micrograms per milliliter (µg/mL).
Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course	During the 8-Day (Day 0-7) follow-up period after any vaccine dose during the primary vaccination course	Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include drowsiness, irritability, loss of appetite and fever (rectal temperature greater than or equal to 38 degrees Celcius).
Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose	During the 8-Day (Day 0-7) follow-up period after the polysaccharide challenge dose	Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include drowsiness, irritability, loss of appetite and fever (rectal temperature greater than or equal to 38 degrees Celcius).
Number of Subjects Reporting Unsolicited Adverse Events During the Primary Vaccination Course	During the 31-Day (Day 0-30) follow-up period after any vaccine dose during the primary vaccination course	Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Number of Subjects Reporting Unsolicited Adverse Events After Administration of the Polysaccharide Challenge Dose	During the 31-Day (Day 0-30) follow-up period after administration of the polysaccharide challenge dose	Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Number of Subjects Reporting Serious Adverse Events During the Primary Vaccination Course	Up to one month after the 3-dose primary vaccination course (Month 5)	Serious adverse events cover all medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Number of Subjects Reporting Serious Adverse Events After Administration of the Polysaccharide Challenge Dose	Up to one month following administration of the polysaccharide challenge dose (Month 11)	Serious adverse events cover all medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Anti-PRN Antibody Concentrations	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)	Concentrations are presented as GMCs and expressed as Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).
Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers	Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)	Titers were presented as geometric mean titers (GMTs) expressed as the reciprocal of the dilution resulting in 50 percent inhibition.
Number of Subjects With rSBA-MenY Titers Greater Than or Equal to 1:8	Prior to vaccination (Day 0), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)	The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.

Countries

Australia

Participant flow

Pre-assignment details

Of the 409 subjects enrolled, two subjects were determined to be ineligible for enrolment and were actually never vaccinated. Not all subjects that started the primary vaccination course returned for the polysaccharide challenge dose administration.

Participants by arm

Arm	Count
MenHibrix Formulation 1 Group Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	82
MenHibrix Formulation 2 Group Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	82
MenHibrix Formulation 3 Group Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	80
Menjugate Group Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	81
ActHIB Group Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	82
Total	407

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG004
Primary Vaccination Course	Adverse Event	0	0	1	0
Primary Vaccination Course	Lost to Follow-up	1	1	1	2
Primary Vaccination Course	Other	0	0	0	1
Primary Vaccination Course	Withdrawal by Subject	1	0	0	1

Baseline characteristics

Characteristic	MenHibrix Formulation 1 Group	MenHibrix Formulation 2 Group	MenHibrix Formulation 3 Group	Menjugate Group	ActHIB Group	Total
Age, Continuous	8.1 Weeks STANDARD_DEVIATION 1.39	8.3 Weeks STANDARD_DEVIATION 1.46	8.2 Weeks STANDARD_DEVIATION 1.65	8.0 Weeks STANDARD_DEVIATION 1.65	8.1 Weeks STANDARD_DEVIATION 1.43	8.1 Weeks STANDARD_DEVIATION 1.5
Sex: Female, Male Female	38 Participants	45 Participants	41 Participants	43 Participants	37 Participants	204 Participants
Sex: Female, Male Male	44 Participants	37 Participants	39 Participants	38 Participants	45 Participants	203 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —	— / —
other Total, other adverse events	81 / 82	81 / 82	77 / 80	81 / 81	82 / 82
serious Total, serious adverse events	5 / 82	5 / 82	2 / 80	4 / 81	6 / 82

Outcome results

Primary

Number of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 1 Milligram Per Milliliter

The cut-off concentration assessed was 1 milligram per milliliter (mg/mL).

Time frame: One month after primary vaccination (Month 5)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample during the primary vaccination course.

Arm	Measure	Value (NUMBER)
MenHibrix Formulation 1 Group	Number of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 1 Milligram Per Milliliter	72 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 1 Milligram Per Milliliter	75 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 1 Milligram Per Milliliter	65 Subjects
Menjugate Group	Number of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 1 Milligram Per Milliliter	66 Subjects
ActHIB Group	Number of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 1 Milligram Per Milliliter	70 Subjects

Primary

Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8

The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.

Time frame: One month after primary vaccination (Month 5)

Arm	Measure	Value (NUMBER)
MenHibrix Formulation 1 Group	Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8	69 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8	76 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8	72 Subjects
Menjugate Group	Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8	74 Subjects
ActHIB Group	Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8	1 Subjects

Primary

Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers Greater Than or Equal to 1:8

The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.

Time frame: One month after primary vaccination (Month 5)

Arm	Measure	Value (NUMBER)
MenHibrix Formulation 1 Group	Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers Greater Than or Equal to 1:8	66 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers Greater Than or Equal to 1:8	68 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers Greater Than or Equal to 1:8	68 Subjects
Menjugate Group	Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers Greater Than or Equal to 1:8	10 Subjects
ActHIB Group	Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers Greater Than or Equal to 1:8	12 Subjects

Secondary

Anti-diphtheria Antibody Concentrations

Concentrations are presented as GMCs and expressed as International Units per Milliliter (IU/mL).

Time frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
MenHibrix Formulation 1 Group	Anti-diphtheria Antibody Concentrations	Day 0 (N= 68; 70; 65; 69; 74)	0.090 International Units per Milliliter
MenHibrix Formulation 1 Group	Anti-diphtheria Antibody Concentrations	Month 10 (N= 78; 78; 75; 80; 75)	0.513 International Units per Milliliter
MenHibrix Formulation 1 Group	Anti-diphtheria Antibody Concentrations	Month 5 (N= 74; 76; 74; 77; 76)	1.721 International Units per Milliliter
MenHibrix Formulation 2 Group	Anti-diphtheria Antibody Concentrations	Month 5 (N= 74; 76; 74; 77; 76)	1.797 International Units per Milliliter
MenHibrix Formulation 2 Group	Anti-diphtheria Antibody Concentrations	Day 0 (N= 68; 70; 65; 69; 74)	0.098 International Units per Milliliter
MenHibrix Formulation 2 Group	Anti-diphtheria Antibody Concentrations	Month 10 (N= 78; 78; 75; 80; 75)	0.505 International Units per Milliliter
MenHibrix Formulation 3 Group	Anti-diphtheria Antibody Concentrations	Month 5 (N= 74; 76; 74; 77; 76)	2.000 International Units per Milliliter
MenHibrix Formulation 3 Group	Anti-diphtheria Antibody Concentrations	Day 0 (N= 68; 70; 65; 69; 74)	0.101 International Units per Milliliter
MenHibrix Formulation 3 Group	Anti-diphtheria Antibody Concentrations	Month 10 (N= 78; 78; 75; 80; 75)	0.519 International Units per Milliliter
Menjugate Group	Anti-diphtheria Antibody Concentrations	Day 0 (N= 68; 70; 65; 69; 74)	0.090 International Units per Milliliter
Menjugate Group	Anti-diphtheria Antibody Concentrations	Month 10 (N= 78; 78; 75; 80; 75)	0.405 International Units per Milliliter
Menjugate Group	Anti-diphtheria Antibody Concentrations	Month 5 (N= 74; 76; 74; 77; 76)	1.845 International Units per Milliliter
ActHIB Group	Anti-diphtheria Antibody Concentrations	Month 5 (N= 74; 76; 74; 77; 76)	1.970 International Units per Milliliter
ActHIB Group	Anti-diphtheria Antibody Concentrations	Day 0 (N= 68; 70; 65; 69; 74)	0.093 International Units per Milliliter
ActHIB Group	Anti-diphtheria Antibody Concentrations	Month 10 (N= 78; 78; 75; 80; 75)	0.543 International Units per Milliliter

Secondary

Anti- FHA Antibody Concentrations

Concentrations are presented as GMCs and expressed as Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).

Time frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
MenHibrix Formulation 1 Group	Anti- FHA Antibody Concentrations	Day 0 (N= 64; 69; 65; 67; 70)	5.1 ELISA Units per Milliliter (EL.U/mL)
MenHibrix Formulation 1 Group	Anti- FHA Antibody Concentrations	Month 10 (N= 78; 78; 75; 79; 75)	49.4 ELISA Units per Milliliter (EL.U/mL)
MenHibrix Formulation 1 Group	Anti- FHA Antibody Concentrations	Month 5 (N= 74; 76; 74; 77; 76)	137.2 ELISA Units per Milliliter (EL.U/mL)
MenHibrix Formulation 2 Group	Anti- FHA Antibody Concentrations	Month 5 (N= 74; 76; 74; 77; 76)	141.5 ELISA Units per Milliliter (EL.U/mL)
MenHibrix Formulation 2 Group	Anti- FHA Antibody Concentrations	Day 0 (N= 64; 69; 65; 67; 70)	4.6 ELISA Units per Milliliter (EL.U/mL)
MenHibrix Formulation 2 Group	Anti- FHA Antibody Concentrations	Month 10 (N= 78; 78; 75; 79; 75)	50.9 ELISA Units per Milliliter (EL.U/mL)
MenHibrix Formulation 3 Group	Anti- FHA Antibody Concentrations	Month 5 (N= 74; 76; 74; 77; 76)	136.2 ELISA Units per Milliliter (EL.U/mL)
MenHibrix Formulation 3 Group	Anti- FHA Antibody Concentrations	Day 0 (N= 64; 69; 65; 67; 70)	5.8 ELISA Units per Milliliter (EL.U/mL)
MenHibrix Formulation 3 Group	Anti- FHA Antibody Concentrations	Month 10 (N= 78; 78; 75; 79; 75)	44.3 ELISA Units per Milliliter (EL.U/mL)
Menjugate Group	Anti- FHA Antibody Concentrations	Day 0 (N= 64; 69; 65; 67; 70)	7.4 ELISA Units per Milliliter (EL.U/mL)
Menjugate Group	Anti- FHA Antibody Concentrations	Month 10 (N= 78; 78; 75; 79; 75)	39.9 ELISA Units per Milliliter (EL.U/mL)
Menjugate Group	Anti- FHA Antibody Concentrations	Month 5 (N= 74; 76; 74; 77; 76)	132.1 ELISA Units per Milliliter (EL.U/mL)
ActHIB Group	Anti- FHA Antibody Concentrations	Month 5 (N= 74; 76; 74; 77; 76)	146.7 ELISA Units per Milliliter (EL.U/mL)
ActHIB Group	Anti- FHA Antibody Concentrations	Day 0 (N= 64; 69; 65; 67; 70)	4.8 ELISA Units per Milliliter (EL.U/mL)
ActHIB Group	Anti- FHA Antibody Concentrations	Month 10 (N= 78; 78; 75; 79; 75)	50.2 ELISA Units per Milliliter (EL.U/mL)

Secondary

Anti- HBs Antibody Concentrations

Concentrations are presented as GMCs and expressed as Milli-International Units per Milliliter (mIU/mL).

Time frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
MenHibrix Formulation 1 Group	Anti- HBs Antibody Concentrations	Day 0 (N= 57; 55; 56; 52; 57)	13.7 Milli-International Units per Milliliter
MenHibrix Formulation 1 Group	Anti- HBs Antibody Concentrations	Month 10 (N= 74; 70; 70; 75; 69)	452.3 Milli-International Units per Milliliter
MenHibrix Formulation 1 Group	Anti- HBs Antibody Concentrations	Month 5 (N= 72; 74; 74; 76; 75)	1769.2 Milli-International Units per Milliliter
MenHibrix Formulation 2 Group	Anti- HBs Antibody Concentrations	Month 5 (N= 72; 74; 74; 76; 75)	1840.7 Milli-International Units per Milliliter
MenHibrix Formulation 2 Group	Anti- HBs Antibody Concentrations	Day 0 (N= 57; 55; 56; 52; 57)	12.2 Milli-International Units per Milliliter
MenHibrix Formulation 2 Group	Anti- HBs Antibody Concentrations	Month 10 (N= 74; 70; 70; 75; 69)	490.5 Milli-International Units per Milliliter
MenHibrix Formulation 3 Group	Anti- HBs Antibody Concentrations	Month 5 (N= 72; 74; 74; 76; 75)	1652.6 Milli-International Units per Milliliter
MenHibrix Formulation 3 Group	Anti- HBs Antibody Concentrations	Day 0 (N= 57; 55; 56; 52; 57)	10.0 Milli-International Units per Milliliter
MenHibrix Formulation 3 Group	Anti- HBs Antibody Concentrations	Month 10 (N= 74; 70; 70; 75; 69)	452.9 Milli-International Units per Milliliter
Menjugate Group	Anti- HBs Antibody Concentrations	Day 0 (N= 57; 55; 56; 52; 57)	10.1 Milli-International Units per Milliliter
Menjugate Group	Anti- HBs Antibody Concentrations	Month 10 (N= 74; 70; 70; 75; 69)	390.5 Milli-International Units per Milliliter
Menjugate Group	Anti- HBs Antibody Concentrations	Month 5 (N= 72; 74; 74; 76; 75)	1752.2 Milli-International Units per Milliliter
ActHIB Group	Anti- HBs Antibody Concentrations	Month 5 (N= 72; 74; 74; 76; 75)	1609.7 Milli-International Units per Milliliter
ActHIB Group	Anti- HBs Antibody Concentrations	Day 0 (N= 57; 55; 56; 52; 57)	18.8 Milli-International Units per Milliliter
ActHIB Group	Anti- HBs Antibody Concentrations	Month 10 (N= 74; 70; 70; 75; 69)	534.9 Milli-International Units per Milliliter

Secondary

Anti-pneumococcal Antibody Concentrations

Pneumococcal antibodies assessed included anti-4, anti-6B, anti-9V, anti-14, anti-18C, anti-19F and anti-23F antibodies. Concentrations are presented as GMCs and expressed as micrograms per milliliter (µg/mL).

Time frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
MenHibrix Formulation 1 Group	Anti-pneumococcal Antibody Concentrations	Anti-6B Month 10 (N= 69; 63; 62; 71; 62)	0.307 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 1 Group	Anti-pneumococcal Antibody Concentrations	Anti-18C Day 0 (N= 40; 40; 37; 47; 47)	0.073 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 1 Group	Anti-pneumococcal Antibody Concentrations	Anti-6B Day 0 (N= 44; 41; 39; 49; 49)	0.055 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 1 Group	Anti-pneumococcal Antibody Concentrations	Anti-4 Day 0 (N= 44; 43; 39; 51; 46)	0.036 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 1 Group	Anti-pneumococcal Antibody Concentrations	Anti-14 Month 10 (N= 68; 67; 64; 69; 61)	2.362 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 1 Group	Anti-pneumococcal Antibody Concentrations	Anti-19F Month 5 (N= 65; 67; 66; 56; 65)	2.303 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 1 Group	Anti-pneumococcal Antibody Concentrations	Anti-23F Month 5 (N= 66; 68; 70; 59; 66)	2.581 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 1 Group	Anti-pneumococcal Antibody Concentrations	Anti-23F Month 10 (N= 73; 69; 63; 75; 65)	0.783 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 1 Group	Anti-pneumococcal Antibody Concentrations	Anti-19F Day 0 (N= 42; 42; 36; 50; 45)	0.124 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 1 Group	Anti-pneumococcal Antibody Concentrations	Anti-9V Day 0 (N= 46; 42; 40; 52; 48)	0.058 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 1 Group	Anti-pneumococcal Antibody Concentrations	Anti-23F Day 0 (N= 41; 43; 38; 48; 48)	0.053 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 1 Group	Anti-pneumococcal Antibody Concentrations	Anti-6B Month 5 (N= 68; 70; 69; 63; 65)	1.060 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 1 Group	Anti-pneumococcal Antibody Concentrations	Anti-14 Month 5 (N= 65; 65; 68; 49; 65)	4.095 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 1 Group	Anti-pneumococcal Antibody Concentrations	Anti-18C Month 10 (N= 48; 52; 51; 53; 46)	0.775 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 1 Group	Anti-pneumococcal Antibody Concentrations	Anti-9V Month 5 (N= 68; 71; 71; 62; 67)	3.102 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 1 Group	Anti-pneumococcal Antibody Concentrations	Anti-4 Month 5 (N= 69; 70; 69; 58; 66)	2.101 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 1 Group	Anti-pneumococcal Antibody Concentrations	Anti-14 Day 0 (N= 31; 33; 31; 41; 43)	0.367 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 1 Group	Anti-pneumococcal Antibody Concentrations	Anti-19F Month 10 (N= 73; 71; 65; 77; 63)	0.413 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 1 Group	Anti-pneumococcal Antibody Concentrations	Anti-18C Month 5 (N= 67; 71; 72; 65; 67)	3.518 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 1 Group	Anti-pneumococcal Antibody Concentrations	Anti-9V Month 10 (N= 60; 60; 56; 63; 56)	0.818 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 1 Group	Anti-pneumococcal Antibody Concentrations	Anti-4 Month 10 (N= 70; 68; 66; 69; 64)	0.495 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 2 Group	Anti-pneumococcal Antibody Concentrations	Anti-9V Month 10 (N= 60; 60; 56; 63; 56)	0.721 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 2 Group	Anti-pneumococcal Antibody Concentrations	Anti-18C Day 0 (N= 40; 40; 37; 47; 47)	0.063 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 2 Group	Anti-pneumococcal Antibody Concentrations	Anti-14 Day 0 (N= 31; 33; 31; 41; 43)	0.227 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 2 Group	Anti-pneumococcal Antibody Concentrations	Anti-23F Day 0 (N= 41; 43; 38; 48; 48)	0.045 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 2 Group	Anti-pneumococcal Antibody Concentrations	Anti-14 Month 10 (N= 68; 67; 64; 69; 61)	2.767 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 2 Group	Anti-pneumococcal Antibody Concentrations	Anti-14 Month 5 (N= 65; 65; 68; 49; 65)	5.592 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 2 Group	Anti-pneumococcal Antibody Concentrations	Anti-6B Month 10 (N= 69; 63; 62; 71; 62)	0.307 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 2 Group	Anti-pneumococcal Antibody Concentrations	Anti-4 Day 0 (N= 44; 43; 39; 51; 46)	0.035 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 2 Group	Anti-pneumococcal Antibody Concentrations	Anti-19F Month 10 (N= 73; 71; 65; 77; 63)	0.335 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 2 Group	Anti-pneumococcal Antibody Concentrations	Anti-4 Month 5 (N= 69; 70; 69; 58; 66)	2.049 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 2 Group	Anti-pneumococcal Antibody Concentrations	Anti-4 Month 10 (N= 70; 68; 66; 69; 64)	0.528 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 2 Group	Anti-pneumococcal Antibody Concentrations	Anti-19F Month 5 (N= 65; 67; 66; 56; 65)	1.846 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 2 Group	Anti-pneumococcal Antibody Concentrations	Anti-6B Day 0 (N= 44; 41; 39; 49; 49)	0.080 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 2 Group	Anti-pneumococcal Antibody Concentrations	Anti-23F Month 5 (N= 66; 68; 70; 59; 66)	2.112 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 2 Group	Anti-pneumococcal Antibody Concentrations	Anti-19F Day 0 (N= 42; 42; 36; 50; 45)	0.126 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 2 Group	Anti-pneumococcal Antibody Concentrations	Anti-9V Day 0 (N= 46; 42; 40; 52; 48)	0.065 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 2 Group	Anti-pneumococcal Antibody Concentrations	Anti-18C Month 10 (N= 48; 52; 51; 53; 46)	0.742 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 2 Group	Anti-pneumococcal Antibody Concentrations	Anti-9V Month 5 (N= 68; 71; 71; 62; 67)	2.363 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 2 Group	Anti-pneumococcal Antibody Concentrations	Anti-6B Month 5 (N= 68; 70; 69; 63; 65)	1.079 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 2 Group	Anti-pneumococcal Antibody Concentrations	Anti-18C Month 5 (N= 67; 71; 72; 65; 67)	2.969 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 2 Group	Anti-pneumococcal Antibody Concentrations	Anti-23F Month 10 (N= 73; 69; 63; 75; 65)	0.642 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 3 Group	Anti-pneumococcal Antibody Concentrations	Anti-4 Month 5 (N= 69; 70; 69; 58; 66)	2.023 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 3 Group	Anti-pneumococcal Antibody Concentrations	Anti-4 Month 10 (N= 70; 68; 66; 69; 64)	0.508 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 3 Group	Anti-pneumococcal Antibody Concentrations	Anti-6B Month 5 (N= 68; 70; 69; 63; 65)	0.834 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 3 Group	Anti-pneumococcal Antibody Concentrations	Anti-4 Day 0 (N= 44; 43; 39; 51; 46)	0.040 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 3 Group	Anti-pneumococcal Antibody Concentrations	Anti-6B Day 0 (N= 44; 41; 39; 49; 49)	0.067 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 3 Group	Anti-pneumococcal Antibody Concentrations	Anti-6B Month 10 (N= 69; 63; 62; 71; 62)	0.292 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 3 Group	Anti-pneumococcal Antibody Concentrations	Anti-9V Day 0 (N= 46; 42; 40; 52; 48)	0.079 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 3 Group	Anti-pneumococcal Antibody Concentrations	Anti-9V Month 5 (N= 68; 71; 71; 62; 67)	2.823 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 3 Group	Anti-pneumococcal Antibody Concentrations	Anti-9V Month 10 (N= 60; 60; 56; 63; 56)	0.933 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 3 Group	Anti-pneumococcal Antibody Concentrations	Anti-14 Day 0 (N= 31; 33; 31; 41; 43)	0.258 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 3 Group	Anti-pneumococcal Antibody Concentrations	Anti-14 Month 5 (N= 65; 65; 68; 49; 65)	4.309 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 3 Group	Anti-pneumococcal Antibody Concentrations	Anti-14 Month 10 (N= 68; 67; 64; 69; 61)	2.549 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 3 Group	Anti-pneumococcal Antibody Concentrations	Anti-18C Day 0 (N= 40; 40; 37; 47; 47)	0.075 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 3 Group	Anti-pneumococcal Antibody Concentrations	Anti-18C Month 5 (N= 67; 71; 72; 65; 67)	2.936 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 3 Group	Anti-pneumococcal Antibody Concentrations	Anti-18C Month 10 (N= 48; 52; 51; 53; 46)	0.708 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 3 Group	Anti-pneumococcal Antibody Concentrations	Anti-19F Day 0 (N= 42; 42; 36; 50; 45)	0.129 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 3 Group	Anti-pneumococcal Antibody Concentrations	Anti-19F Month 5 (N= 65; 67; 66; 56; 65)	2.061 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 3 Group	Anti-pneumococcal Antibody Concentrations	Anti-19F Month 10 (N= 73; 71; 65; 77; 63)	0.397 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 3 Group	Anti-pneumococcal Antibody Concentrations	Anti-23F Day 0 (N= 41; 43; 38; 48; 48)	0.062 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 3 Group	Anti-pneumococcal Antibody Concentrations	Anti-23F Month 5 (N= 66; 68; 70; 59; 66)	2.098 Micrograms per milliliter (µg/mL)
MenHibrix Formulation 3 Group	Anti-pneumococcal Antibody Concentrations	Anti-23F Month 10 (N= 73; 69; 63; 75; 65)	0.644 Micrograms per milliliter (µg/mL)
Menjugate Group	Anti-pneumococcal Antibody Concentrations	Anti-18C Month 5 (N= 67; 71; 72; 65; 67)	0.029 Micrograms per milliliter (µg/mL)
Menjugate Group	Anti-pneumococcal Antibody Concentrations	Anti-9V Month 5 (N= 68; 71; 71; 62; 67)	0.028 Micrograms per milliliter (µg/mL)
Menjugate Group	Anti-pneumococcal Antibody Concentrations	Anti-6B Month 10 (N= 69; 63; 62; 71; 62)	0.026 Micrograms per milliliter (µg/mL)
Menjugate Group	Anti-pneumococcal Antibody Concentrations	Anti-4 Month 5 (N= 69; 70; 69; 58; 66)	0.027 Micrograms per milliliter (µg/mL)
Menjugate Group	Anti-pneumococcal Antibody Concentrations	Anti-19F Month 10 (N= 73; 71; 65; 77; 63)	0.042 Micrograms per milliliter (µg/mL)
Menjugate Group	Anti-pneumococcal Antibody Concentrations	Anti-23F Month 10 (N= 73; 69; 63; 75; 65)	0.025 Micrograms per milliliter (µg/mL)
Menjugate Group	Anti-pneumococcal Antibody Concentrations	Anti-4 Day 0 (N= 44; 43; 39; 51; 46)	0.034 Micrograms per milliliter (µg/mL)
Menjugate Group	Anti-pneumococcal Antibody Concentrations	Anti-6B Month 5 (N= 68; 70; 69; 63; 65)	0.027 Micrograms per milliliter (µg/mL)
Menjugate Group	Anti-pneumococcal Antibody Concentrations	Anti-19F Day 0 (N= 42; 42; 36; 50; 45)	0.135 Micrograms per milliliter (µg/mL)
Menjugate Group	Anti-pneumococcal Antibody Concentrations	Anti-23F Day 0 (N= 41; 43; 38; 48; 48)	0.060 Micrograms per milliliter (µg/mL)
Menjugate Group	Anti-pneumococcal Antibody Concentrations	Anti-9V Day 0 (N= 46; 42; 40; 52; 48)	0.059 Micrograms per milliliter (µg/mL)
Menjugate Group	Anti-pneumococcal Antibody Concentrations	Anti-14 Month 5 (N= 65; 65; 68; 49; 65)	0.062 Micrograms per milliliter (µg/mL)
Menjugate Group	Anti-pneumococcal Antibody Concentrations	Anti-23F Month 5 (N= 66; 68; 70; 59; 66)	0.027 Micrograms per milliliter (µg/mL)
Menjugate Group	Anti-pneumococcal Antibody Concentrations	Anti-18C Month 10 (N= 48; 52; 51; 53; 46)	0.025 Micrograms per milliliter (µg/mL)
Menjugate Group	Anti-pneumococcal Antibody Concentrations	Anti-14 Day 0 (N= 31; 33; 31; 41; 43)	0.394 Micrograms per milliliter (µg/mL)
Menjugate Group	Anti-pneumococcal Antibody Concentrations	Anti-18C Day 0 (N= 40; 40; 37; 47; 47)	0.063 Micrograms per milliliter (µg/mL)
Menjugate Group	Anti-pneumococcal Antibody Concentrations	Anti-14 Month 10 (N= 68; 67; 64; 69; 61)	0.039 Micrograms per milliliter (µg/mL)
Menjugate Group	Anti-pneumococcal Antibody Concentrations	Anti-4 Month 10 (N= 70; 68; 66; 69; 64)	0.026 Micrograms per milliliter (µg/mL)
Menjugate Group	Anti-pneumococcal Antibody Concentrations	Anti-19F Month 5 (N= 65; 67; 66; 56; 65)	0.030 Micrograms per milliliter (µg/mL)
Menjugate Group	Anti-pneumococcal Antibody Concentrations	Anti-9V Month 10 (N= 60; 60; 56; 63; 56)	0.030 Micrograms per milliliter (µg/mL)
Menjugate Group	Anti-pneumococcal Antibody Concentrations	Anti-6B Day 0 (N= 44; 41; 39; 49; 49)	0.070 Micrograms per milliliter (µg/mL)
ActHIB Group	Anti-pneumococcal Antibody Concentrations	Anti-6B Day 0 (N= 44; 41; 39; 49; 49)	0.067 Micrograms per milliliter (µg/mL)
ActHIB Group	Anti-pneumococcal Antibody Concentrations	Anti-18C Day 0 (N= 40; 40; 37; 47; 47)	0.078 Micrograms per milliliter (µg/mL)
ActHIB Group	Anti-pneumococcal Antibody Concentrations	Anti-9V Month 5 (N= 68; 71; 71; 62; 67)	2.651 Micrograms per milliliter (µg/mL)
ActHIB Group	Anti-pneumococcal Antibody Concentrations	Anti-18C Month 5 (N= 67; 71; 72; 65; 67)	3.326 Micrograms per milliliter (µg/mL)
ActHIB Group	Anti-pneumococcal Antibody Concentrations	Anti-9V Day 0 (N= 46; 42; 40; 52; 48)	0.055 Micrograms per milliliter (µg/mL)
ActHIB Group	Anti-pneumococcal Antibody Concentrations	Anti-18C Month 10 (N= 48; 52; 51; 53; 46)	0.668 Micrograms per milliliter (µg/mL)
ActHIB Group	Anti-pneumococcal Antibody Concentrations	Anti-6B Month 10 (N= 69; 63; 62; 71; 62)	0.308 Micrograms per milliliter (µg/mL)
ActHIB Group	Anti-pneumococcal Antibody Concentrations	Anti-23F Month 5 (N= 66; 68; 70; 59; 66)	1.988 Micrograms per milliliter (µg/mL)
ActHIB Group	Anti-pneumococcal Antibody Concentrations	Anti-19F Day 0 (N= 42; 42; 36; 50; 45)	0.115 Micrograms per milliliter (µg/mL)
ActHIB Group	Anti-pneumococcal Antibody Concentrations	Anti-6B Month 5 (N= 68; 70; 69; 63; 65)	0.879 Micrograms per milliliter (µg/mL)
ActHIB Group	Anti-pneumococcal Antibody Concentrations	Anti-4 Month 10 (N= 70; 68; 66; 69; 64)	0.450 Micrograms per milliliter (µg/mL)
ActHIB Group	Anti-pneumococcal Antibody Concentrations	Anti-19F Month 5 (N= 65; 67; 66; 56; 65)	1.881 Micrograms per milliliter (µg/mL)
ActHIB Group	Anti-pneumococcal Antibody Concentrations	Anti-4 Month 5 (N= 69; 70; 69; 58; 66)	2.062 Micrograms per milliliter (µg/mL)
ActHIB Group	Anti-pneumococcal Antibody Concentrations	Anti-4 Day 0 (N= 44; 43; 39; 51; 46)	0.036 Micrograms per milliliter (µg/mL)
ActHIB Group	Anti-pneumococcal Antibody Concentrations	Anti-19F Month 10 (N= 73; 71; 65; 77; 63)	0.339 Micrograms per milliliter (µg/mL)
ActHIB Group	Anti-pneumococcal Antibody Concentrations	Anti-23F Month 10 (N= 73; 69; 63; 75; 65)	0.578 Micrograms per milliliter (µg/mL)
ActHIB Group	Anti-pneumococcal Antibody Concentrations	Anti-23F Day 0 (N= 41; 43; 38; 48; 48)	0.065 Micrograms per milliliter (µg/mL)
ActHIB Group	Anti-pneumococcal Antibody Concentrations	Anti-14 Month 5 (N= 65; 65; 68; 49; 65)	4.372 Micrograms per milliliter (µg/mL)
ActHIB Group	Anti-pneumococcal Antibody Concentrations	Anti-14 Day 0 (N= 31; 33; 31; 41; 43)	0.388 Micrograms per milliliter (µg/mL)
ActHIB Group	Anti-pneumococcal Antibody Concentrations	Anti-14 Month 10 (N= 68; 67; 64; 69; 61)	2.379 Micrograms per milliliter (µg/mL)
ActHIB Group	Anti-pneumococcal Antibody Concentrations	Anti-9V Month 10 (N= 60; 60; 56; 63; 56)	0.881 Micrograms per milliliter (µg/mL)

Secondary

Anti-poliovirus Types 1, 2 and 3 Antibody Titers

Titers are presented as GMTs and expressed in terms of the 50 % inhibitory dilution.

Time frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
MenHibrix Formulation 1 Group	Anti-poliovirus Types 1, 2 and 3 Antibody Titers	Polio-3 Month 10 (N= 71; 70; 69; 76; 67)	348.4 Titer
MenHibrix Formulation 1 Group	Anti-poliovirus Types 1, 2 and 3 Antibody Titers	Polio-2 Month 5 (N= 59; 66; 64; 66; 64)	533.8 Titer
MenHibrix Formulation 1 Group	Anti-poliovirus Types 1, 2 and 3 Antibody Titers	Polio-1 Month 5 (N= 62; 68; 66; 66; 65)	669.6 Titer
MenHibrix Formulation 1 Group	Anti-poliovirus Types 1, 2 and 3 Antibody Titers	Polio-2 Month 10 (N= 71; 70; 69; 75; 67)	139.8 Titer
MenHibrix Formulation 1 Group	Anti-poliovirus Types 1, 2 and 3 Antibody Titers	Polio-3 Month 5 (N= 62; 68; 66; 66; 65)	1266.3 Titer
MenHibrix Formulation 1 Group	Anti-poliovirus Types 1, 2 and 3 Antibody Titers	Polio-1 Month 10 (N= 71; 69; 70; 76; 66)	175.8 Titer
MenHibrix Formulation 1 Group	Anti-poliovirus Types 1, 2 and 3 Antibody Titers	Polio-3 Day 0 (N= 56; 59; 50; 56; 52)	6.4 Titer
MenHibrix Formulation 1 Group	Anti-poliovirus Types 1, 2 and 3 Antibody Titers	Polio-2 Day 0 (N= 56; 59; 50; 55; 52)	14.9 Titer
MenHibrix Formulation 1 Group	Anti-poliovirus Types 1, 2 and 3 Antibody Titers	Polio-1 Day 0 (N= 56; 58; 50; 56; 52)	36.7 Titer
MenHibrix Formulation 2 Group	Anti-poliovirus Types 1, 2 and 3 Antibody Titers	Polio-3 Day 0 (N= 56; 59; 50; 56; 52)	6.6 Titer
MenHibrix Formulation 2 Group	Anti-poliovirus Types 1, 2 and 3 Antibody Titers	Polio-2 Month 10 (N= 71; 70; 69; 75; 67)	94.1 Titer
MenHibrix Formulation 2 Group	Anti-poliovirus Types 1, 2 and 3 Antibody Titers	Polio-2 Day 0 (N= 56; 59; 50; 55; 52)	13.8 Titer
MenHibrix Formulation 2 Group	Anti-poliovirus Types 1, 2 and 3 Antibody Titers	Polio-2 Month 5 (N= 59; 66; 64; 66; 64)	369.8 Titer
MenHibrix Formulation 2 Group	Anti-poliovirus Types 1, 2 and 3 Antibody Titers	Polio-1 Month 10 (N= 71; 69; 70; 76; 66)	120.6 Titer
MenHibrix Formulation 2 Group	Anti-poliovirus Types 1, 2 and 3 Antibody Titers	Polio-3 Month 10 (N= 71; 70; 69; 76; 67)	263.8 Titer
MenHibrix Formulation 2 Group	Anti-poliovirus Types 1, 2 and 3 Antibody Titers	Polio-1 Month 5 (N= 62; 68; 66; 66; 65)	476.8 Titer
MenHibrix Formulation 2 Group	Anti-poliovirus Types 1, 2 and 3 Antibody Titers	Polio-1 Day 0 (N= 56; 58; 50; 56; 52)	33.3 Titer
MenHibrix Formulation 2 Group	Anti-poliovirus Types 1, 2 and 3 Antibody Titers	Polio-3 Month 5 (N= 62; 68; 66; 66; 65)	1034.8 Titer
MenHibrix Formulation 3 Group	Anti-poliovirus Types 1, 2 and 3 Antibody Titers	Polio-2 Month 10 (N= 71; 70; 69; 75; 67)	110.1 Titer
MenHibrix Formulation 3 Group	Anti-poliovirus Types 1, 2 and 3 Antibody Titers	Polio-1 Day 0 (N= 56; 58; 50; 56; 52)	32.9 Titer
MenHibrix Formulation 3 Group	Anti-poliovirus Types 1, 2 and 3 Antibody Titers	Polio-1 Month 5 (N= 62; 68; 66; 66; 65)	574.7 Titer
MenHibrix Formulation 3 Group	Anti-poliovirus Types 1, 2 and 3 Antibody Titers	Polio-1 Month 10 (N= 71; 69; 70; 76; 66)	162.4 Titer
MenHibrix Formulation 3 Group	Anti-poliovirus Types 1, 2 and 3 Antibody Titers	Polio-2 Day 0 (N= 56; 59; 50; 55; 52)	15.9 Titer
MenHibrix Formulation 3 Group	Anti-poliovirus Types 1, 2 and 3 Antibody Titers	Polio-2 Month 5 (N= 59; 66; 64; 66; 64)	408.0 Titer
MenHibrix Formulation 3 Group	Anti-poliovirus Types 1, 2 and 3 Antibody Titers	Polio-3 Day 0 (N= 56; 59; 50; 56; 52)	7.9 Titer
MenHibrix Formulation 3 Group	Anti-poliovirus Types 1, 2 and 3 Antibody Titers	Polio-3 Month 5 (N= 62; 68; 66; 66; 65)	1062.2 Titer
MenHibrix Formulation 3 Group	Anti-poliovirus Types 1, 2 and 3 Antibody Titers	Polio-3 Month 10 (N= 71; 70; 69; 76; 67)	250.9 Titer
Menjugate Group	Anti-poliovirus Types 1, 2 and 3 Antibody Titers	Polio-2 Day 0 (N= 56; 59; 50; 55; 52)	17.2 Titer
Menjugate Group	Anti-poliovirus Types 1, 2 and 3 Antibody Titers	Polio-2 Month 10 (N= 71; 70; 69; 75; 67)	89.6 Titer
Menjugate Group	Anti-poliovirus Types 1, 2 and 3 Antibody Titers	Polio-1 Month 10 (N= 71; 69; 70; 76; 66)	116.4 Titer
Menjugate Group	Anti-poliovirus Types 1, 2 and 3 Antibody Titers	Polio-3 Day 0 (N= 56; 59; 50; 56; 52)	7.7 Titer
Menjugate Group	Anti-poliovirus Types 1, 2 and 3 Antibody Titers	Polio-1 Month 5 (N= 62; 68; 66; 66; 65)	454.0 Titer
Menjugate Group	Anti-poliovirus Types 1, 2 and 3 Antibody Titers	Polio-3 Month 10 (N= 71; 70; 69; 76; 67)	264.0 Titer
Menjugate Group	Anti-poliovirus Types 1, 2 and 3 Antibody Titers	Polio-3 Month 5 (N= 62; 68; 66; 66; 65)	1084.9 Titer
Menjugate Group	Anti-poliovirus Types 1, 2 and 3 Antibody Titers	Polio-1 Day 0 (N= 56; 58; 50; 56; 52)	52.3 Titer
Menjugate Group	Anti-poliovirus Types 1, 2 and 3 Antibody Titers	Polio-2 Month 5 (N= 59; 66; 64; 66; 64)	348.9 Titer
ActHIB Group	Anti-poliovirus Types 1, 2 and 3 Antibody Titers	Polio-1 Day 0 (N= 56; 58; 50; 56; 52)	36.6 Titer
ActHIB Group	Anti-poliovirus Types 1, 2 and 3 Antibody Titers	Polio-2 Day 0 (N= 56; 59; 50; 55; 52)	17.1 Titer
ActHIB Group	Anti-poliovirus Types 1, 2 and 3 Antibody Titers	Polio-2 Month 10 (N= 71; 70; 69; 75; 67)	88.3 Titer
ActHIB Group	Anti-poliovirus Types 1, 2 and 3 Antibody Titers	Polio-1 Month 10 (N= 71; 69; 70; 76; 66)	166.4 Titer
ActHIB Group	Anti-poliovirus Types 1, 2 and 3 Antibody Titers	Polio-2 Month 5 (N= 59; 66; 64; 66; 64)	368.0 Titer
ActHIB Group	Anti-poliovirus Types 1, 2 and 3 Antibody Titers	Polio-3 Month 10 (N= 71; 70; 69; 76; 67)	203.9 Titer
ActHIB Group	Anti-poliovirus Types 1, 2 and 3 Antibody Titers	Polio-3 Month 5 (N= 62; 68; 66; 66; 65)	945.5 Titer
ActHIB Group	Anti-poliovirus Types 1, 2 and 3 Antibody Titers	Polio-3 Day 0 (N= 56; 59; 50; 56; 52)	8.0 Titer
ActHIB Group	Anti-poliovirus Types 1, 2 and 3 Antibody Titers	Polio-1 Month 5 (N= 62; 68; 66; 66; 65)	517.6 Titer

Secondary

Anti-polysaccharide C (PSC) Antibody Concentration

Titers are presented as Geometric Mean Titers (GMTs) expressed as micrograms per milliliter (µg/mL).

Time frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
MenHibrix Formulation 1 Group	Anti-polysaccharide C (PSC) Antibody Concentration	Day 0 (N= 54; 54; 49; 56; 56)	0.17 microgram per milliliter (µg/mL)
MenHibrix Formulation 1 Group	Anti-polysaccharide C (PSC) Antibody Concentration	Month 5 (N= 63; 65; 61; 62; 63)	12.02 microgram per milliliter (µg/mL)
MenHibrix Formulation 1 Group	Anti-polysaccharide C (PSC) Antibody Concentration	Month 10 (N= 63; 68; 61; 74; 67)	3.11 microgram per milliliter (µg/mL)
MenHibrix Formulation 1 Group	Anti-polysaccharide C (PSC) Antibody Concentration	Month 11 (N= 71; 70; 71; 76; 71)	11.47 microgram per milliliter (µg/mL)
MenHibrix Formulation 2 Group	Anti-polysaccharide C (PSC) Antibody Concentration	Day 0 (N= 54; 54; 49; 56; 56)	0.17 microgram per milliliter (µg/mL)
MenHibrix Formulation 2 Group	Anti-polysaccharide C (PSC) Antibody Concentration	Month 11 (N= 71; 70; 71; 76; 71)	7.94 microgram per milliliter (µg/mL)
MenHibrix Formulation 2 Group	Anti-polysaccharide C (PSC) Antibody Concentration	Month 5 (N= 63; 65; 61; 62; 63)	12.09 microgram per milliliter (µg/mL)
MenHibrix Formulation 2 Group	Anti-polysaccharide C (PSC) Antibody Concentration	Month 10 (N= 63; 68; 61; 74; 67)	3.10 microgram per milliliter (µg/mL)
MenHibrix Formulation 3 Group	Anti-polysaccharide C (PSC) Antibody Concentration	Month 11 (N= 71; 70; 71; 76; 71)	10.96 microgram per milliliter (µg/mL)
MenHibrix Formulation 3 Group	Anti-polysaccharide C (PSC) Antibody Concentration	Month 5 (N= 63; 65; 61; 62; 63)	9.95 microgram per milliliter (µg/mL)
MenHibrix Formulation 3 Group	Anti-polysaccharide C (PSC) Antibody Concentration	Month 10 (N= 63; 68; 61; 74; 67)	2.74 microgram per milliliter (µg/mL)
MenHibrix Formulation 3 Group	Anti-polysaccharide C (PSC) Antibody Concentration	Day 0 (N= 54; 54; 49; 56; 56)	0.17 microgram per milliliter (µg/mL)
Menjugate Group	Anti-polysaccharide C (PSC) Antibody Concentration	Day 0 (N= 54; 54; 49; 56; 56)	0.17 microgram per milliliter (µg/mL)
Menjugate Group	Anti-polysaccharide C (PSC) Antibody Concentration	Month 5 (N= 63; 65; 61; 62; 63)	15.36 microgram per milliliter (µg/mL)
Menjugate Group	Anti-polysaccharide C (PSC) Antibody Concentration	Month 11 (N= 71; 70; 71; 76; 71)	7.56 microgram per milliliter (µg/mL)
Menjugate Group	Anti-polysaccharide C (PSC) Antibody Concentration	Month 10 (N= 63; 68; 61; 74; 67)	2.87 microgram per milliliter (µg/mL)
ActHIB Group	Anti-polysaccharide C (PSC) Antibody Concentration	Month 11 (N= 71; 70; 71; 76; 71)	1.49 microgram per milliliter (µg/mL)
ActHIB Group	Anti-polysaccharide C (PSC) Antibody Concentration	Month 10 (N= 63; 68; 61; 74; 67)	0.15 microgram per milliliter (µg/mL)
ActHIB Group	Anti-polysaccharide C (PSC) Antibody Concentration	Month 5 (N= 63; 65; 61; 62; 63)	0.15 microgram per milliliter (µg/mL)
ActHIB Group	Anti-polysaccharide C (PSC) Antibody Concentration	Day 0 (N= 54; 54; 49; 56; 56)	0.17 microgram per milliliter (µg/mL)

Secondary

Anti-polysaccharide Y (PSY) Antibody Concentration

Titers are presented as Geometric Mean Titers (GMTs) expressed as micrograms per milliliter (µg/mL).

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
MenHibrix Formulation 1 Group	Anti-polysaccharide Y (PSY) Antibody Concentration	Month 5 (N= 67; 70; 72; 66; 69)	19.22 Microgram per milliliter (µg/mL)
MenHibrix Formulation 1 Group	Anti-polysaccharide Y (PSY) Antibody Concentration	Month 10 (N= 70; 69; 71; 76; 67)	5.26 Microgram per milliliter (µg/mL)
MenHibrix Formulation 1 Group	Anti-polysaccharide Y (PSY) Antibody Concentration	Month 11 (N= 69; 71; 71; 77; 71)	47.95 Microgram per milliliter (µg/mL)
MenHibrix Formulation 1 Group	Anti-polysaccharide Y (PSY) Antibody Concentration	Day 0 (N= 51; 51; 47; 56; 54)	0.17 Microgram per milliliter (µg/mL)
MenHibrix Formulation 2 Group	Anti-polysaccharide Y (PSY) Antibody Concentration	Month 11 (N= 69; 71; 71; 77; 71)	37.15 Microgram per milliliter (µg/mL)
MenHibrix Formulation 2 Group	Anti-polysaccharide Y (PSY) Antibody Concentration	Month 5 (N= 67; 70; 72; 66; 69)	19.09 Microgram per milliliter (µg/mL)
MenHibrix Formulation 2 Group	Anti-polysaccharide Y (PSY) Antibody Concentration	Day 0 (N= 51; 51; 47; 56; 54)	0.18 Microgram per milliliter (µg/mL)
MenHibrix Formulation 2 Group	Anti-polysaccharide Y (PSY) Antibody Concentration	Month 10 (N= 70; 69; 71; 76; 67)	5.20 Microgram per milliliter (µg/mL)
MenHibrix Formulation 3 Group	Anti-polysaccharide Y (PSY) Antibody Concentration	Month 5 (N= 67; 70; 72; 66; 69)	15.83 Microgram per milliliter (µg/mL)
MenHibrix Formulation 3 Group	Anti-polysaccharide Y (PSY) Antibody Concentration	Day 0 (N= 51; 51; 47; 56; 54)	0.17 Microgram per milliliter (µg/mL)
MenHibrix Formulation 3 Group	Anti-polysaccharide Y (PSY) Antibody Concentration	Month 11 (N= 69; 71; 71; 77; 71)	51.12 Microgram per milliliter (µg/mL)
MenHibrix Formulation 3 Group	Anti-polysaccharide Y (PSY) Antibody Concentration	Month 10 (N= 70; 69; 71; 76; 67)	4.10 Microgram per milliliter (µg/mL)
Menjugate Group	Anti-polysaccharide Y (PSY) Antibody Concentration	Month 5 (N= 67; 70; 72; 66; 69)	0.16 Microgram per milliliter (µg/mL)
Menjugate Group	Anti-polysaccharide Y (PSY) Antibody Concentration	Day 0 (N= 51; 51; 47; 56; 54)	0.20 Microgram per milliliter (µg/mL)
Menjugate Group	Anti-polysaccharide Y (PSY) Antibody Concentration	Month 11 (N= 69; 71; 71; 77; 71)	1.37 Microgram per milliliter (µg/mL)
Menjugate Group	Anti-polysaccharide Y (PSY) Antibody Concentration	Month 10 (N= 70; 69; 71; 76; 67)	0.15 Microgram per milliliter (µg/mL)
ActHIB Group	Anti-polysaccharide Y (PSY) Antibody Concentration	Month 11 (N= 69; 71; 71; 77; 71)	1.33 Microgram per milliliter (µg/mL)
ActHIB Group	Anti-polysaccharide Y (PSY) Antibody Concentration	Day 0 (N= 51; 51; 47; 56; 54)	0.19 Microgram per milliliter (µg/mL)
ActHIB Group	Anti-polysaccharide Y (PSY) Antibody Concentration	Month 10 (N= 70; 69; 71; 76; 67)	0.15 Microgram per milliliter (µg/mL)
ActHIB Group	Anti-polysaccharide Y (PSY) Antibody Concentration	Month 5 (N= 67; 70; 72; 66; 69)	0.15 Microgram per milliliter (µg/mL)

Secondary

Anti-PRN Antibody Concentrations

Concentrations are presented as GMCs and expressed as Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).

Time frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
MenHibrix Formulation 1 Group	Anti-PRN Antibody Concentrations	Day 0 (N= 67; 63; 67; 68; 71)	3.9 ELISA Units per Milliliter (EL.U/mL)
MenHibrix Formulation 1 Group	Anti-PRN Antibody Concentrations	Month 10 (N= 78; 78; 75; 80; 75)	36.2 ELISA Units per Milliliter (EL.U/mL)
MenHibrix Formulation 1 Group	Anti-PRN Antibody Concentrations	Month 5 (N= 74; 76; 74; 77; 76)	128.3 ELISA Units per Milliliter (EL.U/mL)
MenHibrix Formulation 2 Group	Anti-PRN Antibody Concentrations	Month 5 (N= 74; 76; 74; 77; 76)	120.7 ELISA Units per Milliliter (EL.U/mL)
MenHibrix Formulation 2 Group	Anti-PRN Antibody Concentrations	Day 0 (N= 67; 63; 67; 68; 71)	4.7 ELISA Units per Milliliter (EL.U/mL)
MenHibrix Formulation 2 Group	Anti-PRN Antibody Concentrations	Month 10 (N= 78; 78; 75; 80; 75)	31.8 ELISA Units per Milliliter (EL.U/mL)
MenHibrix Formulation 3 Group	Anti-PRN Antibody Concentrations	Month 5 (N= 74; 76; 74; 77; 76)	106.2 ELISA Units per Milliliter (EL.U/mL)
MenHibrix Formulation 3 Group	Anti-PRN Antibody Concentrations	Day 0 (N= 67; 63; 67; 68; 71)	4.6 ELISA Units per Milliliter (EL.U/mL)
MenHibrix Formulation 3 Group	Anti-PRN Antibody Concentrations	Month 10 (N= 78; 78; 75; 80; 75)	27.3 ELISA Units per Milliliter (EL.U/mL)
Menjugate Group	Anti-PRN Antibody Concentrations	Day 0 (N= 67; 63; 67; 68; 71)	5.3 ELISA Units per Milliliter (EL.U/mL)
Menjugate Group	Anti-PRN Antibody Concentrations	Month 10 (N= 78; 78; 75; 80; 75)	27.2 ELISA Units per Milliliter (EL.U/mL)
Menjugate Group	Anti-PRN Antibody Concentrations	Month 5 (N= 74; 76; 74; 77; 76)	112.9 ELISA Units per Milliliter (EL.U/mL)
ActHIB Group	Anti-PRN Antibody Concentrations	Month 5 (N= 74; 76; 74; 77; 76)	137.8 ELISA Units per Milliliter (EL.U/mL)
ActHIB Group	Anti-PRN Antibody Concentrations	Day 0 (N= 67; 63; 67; 68; 71)	4.4 ELISA Units per Milliliter (EL.U/mL)
ActHIB Group	Anti-PRN Antibody Concentrations	Month 10 (N= 78; 78; 75; 80; 75)	35.8 ELISA Units per Milliliter (EL.U/mL)

Secondary

Anti-PRP Antibody Concentration

Concentrations are presented as GMCs and expressed as µg/mL.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
MenHibrix Formulation 1 Group	Anti-PRP Antibody Concentration	Month 10 (N= 70; 72; 73; 76; 70)	1.386 Microgram per milliliter (µg/mL)
MenHibrix Formulation 1 Group	Anti-PRP Antibody Concentration	Month 5 (N= 74; 76; 70; 74; 74)	6.441 Microgram per milliliter (µg/mL)
MenHibrix Formulation 1 Group	Anti-PRP Antibody Concentration	Day 0 (N= 68; 70; 67; 67; 73)	0.152 Microgram per milliliter (µg/mL)
MenHibrix Formulation 1 Group	Anti-PRP Antibody Concentration	Month 11 (N= 68; 73; 71; 79; 72)	8.653 Microgram per milliliter (µg/mL)
MenHibrix Formulation 2 Group	Anti-PRP Antibody Concentration	Day 0 (N= 68; 70; 67; 67; 73)	0.224 Microgram per milliliter (µg/mL)
MenHibrix Formulation 2 Group	Anti-PRP Antibody Concentration	Month 11 (N= 68; 73; 71; 79; 72)	6.750 Microgram per milliliter (µg/mL)
MenHibrix Formulation 2 Group	Anti-PRP Antibody Concentration	Month 5 (N= 74; 76; 70; 74; 74)	7.324 Microgram per milliliter (µg/mL)
MenHibrix Formulation 2 Group	Anti-PRP Antibody Concentration	Month 10 (N= 70; 72; 73; 76; 70)	1.383 Microgram per milliliter (µg/mL)
MenHibrix Formulation 3 Group	Anti-PRP Antibody Concentration	Month 10 (N= 70; 72; 73; 76; 70)	1.148 Microgram per milliliter (µg/mL)
MenHibrix Formulation 3 Group	Anti-PRP Antibody Concentration	Month 11 (N= 68; 73; 71; 79; 72)	5.112 Microgram per milliliter (µg/mL)
MenHibrix Formulation 3 Group	Anti-PRP Antibody Concentration	Day 0 (N= 68; 70; 67; 67; 73)	0.214 Microgram per milliliter (µg/mL)
MenHibrix Formulation 3 Group	Anti-PRP Antibody Concentration	Month 5 (N= 74; 76; 70; 74; 74)	5.577 Microgram per milliliter (µg/mL)
Menjugate Group	Anti-PRP Antibody Concentration	Month 10 (N= 70; 72; 73; 76; 70)	0.949 Microgram per milliliter (µg/mL)
Menjugate Group	Anti-PRP Antibody Concentration	Day 0 (N= 68; 70; 67; 67; 73)	0.172 Microgram per milliliter (µg/mL)
Menjugate Group	Anti-PRP Antibody Concentration	Month 5 (N= 74; 76; 70; 74; 74)	4.465 Microgram per milliliter (µg/mL)
Menjugate Group	Anti-PRP Antibody Concentration	Month 11 (N= 68; 73; 71; 79; 72)	2.512 Microgram per milliliter (µg/mL)
ActHIB Group	Anti-PRP Antibody Concentration	Day 0 (N= 68; 70; 67; 67; 73)	0.201 Microgram per milliliter (µg/mL)
ActHIB Group	Anti-PRP Antibody Concentration	Month 10 (N= 70; 72; 73; 76; 70)	1.141 Microgram per milliliter (µg/mL)
ActHIB Group	Anti-PRP Antibody Concentration	Month 11 (N= 68; 73; 71; 79; 72)	3.283 Microgram per milliliter (µg/mL)
ActHIB Group	Anti-PRP Antibody Concentration	Month 5 (N= 74; 76; 70; 74; 74)	5.714 Microgram per milliliter (µg/mL)

Secondary

Anti- PT Antibody Concentrations

Concentrations are presented as GMCs and expressed as Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).

Time frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
MenHibrix Formulation 1 Group	Anti- PT Antibody Concentrations	Day 0 (N= 65; 66; 65; 63; 74)	2.7 ELISA Units per Milliliter (EL.U/mL)
MenHibrix Formulation 1 Group	Anti- PT Antibody Concentrations	Month 10 (N= 77; 76; 73; 78; 75)	11.6 ELISA Units per Milliliter (EL.U/mL)
MenHibrix Formulation 1 Group	Anti- PT Antibody Concentrations	Month 5 (N= 74; 76; 74; 77; 76)	55.1 ELISA Units per Milliliter (EL.U/mL)
MenHibrix Formulation 2 Group	Anti- PT Antibody Concentrations	Month 5 (N= 74; 76; 74; 77; 76)	55.2 ELISA Units per Milliliter (EL.U/mL)
MenHibrix Formulation 2 Group	Anti- PT Antibody Concentrations	Day 0 (N= 65; 66; 65; 63; 74)	2.7 ELISA Units per Milliliter (EL.U/mL)
MenHibrix Formulation 2 Group	Anti- PT Antibody Concentrations	Month 10 (N= 77; 76; 73; 78; 75)	11.6 ELISA Units per Milliliter (EL.U/mL)
MenHibrix Formulation 3 Group	Anti- PT Antibody Concentrations	Month 5 (N= 74; 76; 74; 77; 76)	53.7 ELISA Units per Milliliter (EL.U/mL)
MenHibrix Formulation 3 Group	Anti- PT Antibody Concentrations	Day 0 (N= 65; 66; 65; 63; 74)	2.8 ELISA Units per Milliliter (EL.U/mL)
MenHibrix Formulation 3 Group	Anti- PT Antibody Concentrations	Month 10 (N= 77; 76; 73; 78; 75)	9.9 ELISA Units per Milliliter (EL.U/mL)
Menjugate Group	Anti- PT Antibody Concentrations	Day 0 (N= 65; 66; 65; 63; 74)	3.1 ELISA Units per Milliliter (EL.U/mL)
Menjugate Group	Anti- PT Antibody Concentrations	Month 10 (N= 77; 76; 73; 78; 75)	8.2 ELISA Units per Milliliter (EL.U/mL)
Menjugate Group	Anti- PT Antibody Concentrations	Month 5 (N= 74; 76; 74; 77; 76)	49.7 ELISA Units per Milliliter (EL.U/mL)
ActHIB Group	Anti- PT Antibody Concentrations	Month 5 (N= 74; 76; 74; 77; 76)	54.8 ELISA Units per Milliliter (EL.U/mL)
ActHIB Group	Anti- PT Antibody Concentrations	Day 0 (N= 65; 66; 65; 63; 74)	2.7 ELISA Units per Milliliter (EL.U/mL)
ActHIB Group	Anti- PT Antibody Concentrations	Month 10 (N= 77; 76; 73; 78; 75)	9.8 ELISA Units per Milliliter (EL.U/mL)

Secondary

Anti-tetanus Antibody Concentrations

Concentrations are presented as GMCs and expressed as International Units per Milliliter (IU/mL).

Time frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
MenHibrix Formulation 1 Group	Anti-tetanus Antibody Concentrations	Day 0 (N= 62; 64; 60; 60; 68)	0.460 International Units per Milliliter
MenHibrix Formulation 1 Group	Anti-tetanus Antibody Concentrations	Month 10 (N= 78; 78; 75; 80; 75)	1.114 International Units per Milliliter
MenHibrix Formulation 1 Group	Anti-tetanus Antibody Concentrations	Month 5 (N= 74; 76; 74; 77; 76)	3.301 International Units per Milliliter
MenHibrix Formulation 2 Group	Anti-tetanus Antibody Concentrations	Month 5 (N= 74; 76; 74; 77; 76)	3.816 International Units per Milliliter
MenHibrix Formulation 2 Group	Anti-tetanus Antibody Concentrations	Day 0 (N= 62; 64; 60; 60; 68)	0.470 International Units per Milliliter
MenHibrix Formulation 2 Group	Anti-tetanus Antibody Concentrations	Month 10 (N= 78; 78; 75; 80; 75)	1.307 International Units per Milliliter
MenHibrix Formulation 3 Group	Anti-tetanus Antibody Concentrations	Month 5 (N= 74; 76; 74; 77; 76)	3.366 International Units per Milliliter
MenHibrix Formulation 3 Group	Anti-tetanus Antibody Concentrations	Day 0 (N= 62; 64; 60; 60; 68)	0.501 International Units per Milliliter
MenHibrix Formulation 3 Group	Anti-tetanus Antibody Concentrations	Month 10 (N= 78; 78; 75; 80; 75)	1.062 International Units per Milliliter
Menjugate Group	Anti-tetanus Antibody Concentrations	Day 0 (N= 62; 64; 60; 60; 68)	0.562 International Units per Milliliter
Menjugate Group	Anti-tetanus Antibody Concentrations	Month 10 (N= 78; 78; 75; 80; 75)	0.603 International Units per Milliliter
Menjugate Group	Anti-tetanus Antibody Concentrations	Month 5 (N= 74; 76; 74; 77; 76)	1.877 International Units per Milliliter
ActHIB Group	Anti-tetanus Antibody Concentrations	Month 5 (N= 74; 76; 74; 77; 76)	2.033 International Units per Milliliter
ActHIB Group	Anti-tetanus Antibody Concentrations	Day 0 (N= 62; 64; 60; 60; 68)	0.533 International Units per Milliliter
ActHIB Group	Anti-tetanus Antibody Concentrations	Month 10 (N= 78; 78; 75; 80; 75)	0.756 International Units per Milliliter

Secondary

Number of Subjects Reporting Serious Adverse Events After Administration of the Polysaccharide Challenge Dose

Serious adverse events cover all medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.

Time frame: Up to one month following administration of the polysaccharide challenge dose (Month 11)

Population: The analysis was performed on the Booster Total Vaccinated Cohort.

Arm	Measure	Value (NUMBER)
MenHibrix Formulation 1 Group	Number of Subjects Reporting Serious Adverse Events After Administration of the Polysaccharide Challenge Dose	0 Subjects
MenHibrix Formulation 2 Group	Number of Subjects Reporting Serious Adverse Events After Administration of the Polysaccharide Challenge Dose	0 Subjects
MenHibrix Formulation 3 Group	Number of Subjects Reporting Serious Adverse Events After Administration of the Polysaccharide Challenge Dose	0 Subjects
Menjugate Group	Number of Subjects Reporting Serious Adverse Events After Administration of the Polysaccharide Challenge Dose	0 Subjects
ActHIB Group	Number of Subjects Reporting Serious Adverse Events After Administration of the Polysaccharide Challenge Dose	2 Subjects

Secondary

Number of Subjects Reporting Serious Adverse Events During the Primary Vaccination Course

Time frame: Up to one month after the 3-dose primary vaccination course (Month 5)

Population: The analysis was performed on the Total Vaccinated Cohort.

Arm	Measure	Value (NUMBER)
MenHibrix Formulation 1 Group	Number of Subjects Reporting Serious Adverse Events During the Primary Vaccination Course	5 Subjects
MenHibrix Formulation 2 Group	Number of Subjects Reporting Serious Adverse Events During the Primary Vaccination Course	5 Subjects
MenHibrix Formulation 3 Group	Number of Subjects Reporting Serious Adverse Events During the Primary Vaccination Course	2 Subjects
Menjugate Group	Number of Subjects Reporting Serious Adverse Events During the Primary Vaccination Course	4 Subjects
ActHIB Group	Number of Subjects Reporting Serious Adverse Events During the Primary Vaccination Course	6 Subjects

Secondary

Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose

Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include drowsiness, irritability, loss of appetite and fever (rectal temperature greater than or equal to 38 degrees Celcius).

Time frame: During the 8-Day (Day 0-7) follow-up period after the polysaccharide challenge dose

Population: The analysis was performed on the Booster Total Vaccinated Cohort, on subjects having completed the symptom sheet.

Arm	Measure	Group	Value (NUMBER)
MenHibrix Formulation 1 Group	Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose	Pain	19 Subjects
MenHibrix Formulation 1 Group	Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose	Fever	29 Subjects
MenHibrix Formulation 1 Group	Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose	Loss of appetite	26 Subjects
MenHibrix Formulation 1 Group	Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose	Swelling	15 Subjects
MenHibrix Formulation 1 Group	Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose	Redness	39 Subjects
MenHibrix Formulation 1 Group	Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose	Drowsiness	26 Subjects
MenHibrix Formulation 1 Group	Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose	Irritability	48 Subjects
MenHibrix Formulation 2 Group	Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose	Irritability	48 Subjects
MenHibrix Formulation 2 Group	Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose	Drowsiness	25 Subjects
MenHibrix Formulation 2 Group	Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose	Redness	27 Subjects
MenHibrix Formulation 2 Group	Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose	Pain	15 Subjects
MenHibrix Formulation 2 Group	Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose	Loss of appetite	27 Subjects
MenHibrix Formulation 2 Group	Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose	Swelling	15 Subjects
MenHibrix Formulation 2 Group	Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose	Fever	20 Subjects
MenHibrix Formulation 3 Group	Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose	Drowsiness	17 Subjects
MenHibrix Formulation 3 Group	Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose	Pain	18 Subjects
MenHibrix Formulation 3 Group	Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose	Redness	27 Subjects
MenHibrix Formulation 3 Group	Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose	Swelling	13 Subjects
MenHibrix Formulation 3 Group	Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose	Irritability	45 Subjects
MenHibrix Formulation 3 Group	Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose	Loss of appetite	25 Subjects
MenHibrix Formulation 3 Group	Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose	Fever	27 Subjects
Menjugate Group	Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose	Swelling	15 Subjects
Menjugate Group	Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose	Irritability	46 Subjects
Menjugate Group	Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose	Redness	44 Subjects
Menjugate Group	Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose	Fever	36 Subjects
Menjugate Group	Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose	Loss of appetite	24 Subjects
Menjugate Group	Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose	Pain	17 Subjects
Menjugate Group	Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose	Drowsiness	26 Subjects
ActHIB Group	Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose	Swelling	12 Subjects
ActHIB Group	Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose	Fever	34 Subjects
ActHIB Group	Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose	Loss of appetite	23 Subjects
ActHIB Group	Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose	Irritability	49 Subjects
ActHIB Group	Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose	Redness	29 Subjects
ActHIB Group	Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose	Pain	16 Subjects
ActHIB Group	Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose	Drowsiness	18 Subjects

Secondary

Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course

Time frame: During the 8-Day (Day 0-7) follow-up period after any vaccine dose during the primary vaccination course

Population: The analysis was performed on the Total Vaccinated Cohort, on subjects having completed the symptom sheet.

Arm	Measure	Group	Value (NUMBER)
MenHibrix Formulation 1 Group	Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course	Pain	54 Subjects
MenHibrix Formulation 1 Group	Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course	Drowsiness	65 Subjects
MenHibrix Formulation 1 Group	Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course	Fever	65 Subjects
MenHibrix Formulation 1 Group	Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course	Loss of appetite	57 Subjects
MenHibrix Formulation 1 Group	Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course	Swelling	53 Subjects
MenHibrix Formulation 1 Group	Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course	Redness	67 Subjects
MenHibrix Formulation 1 Group	Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course	Irritability	76 Subjects
MenHibrix Formulation 2 Group	Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course	Irritability	79 Subjects
MenHibrix Formulation 2 Group	Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course	Drowsiness	72 Subjects
MenHibrix Formulation 2 Group	Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course	Fever	64 Subjects
MenHibrix Formulation 2 Group	Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course	Redness	67 Subjects
MenHibrix Formulation 2 Group	Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course	Pain	50 Subjects
MenHibrix Formulation 2 Group	Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course	Loss of appetite	56 Subjects
MenHibrix Formulation 2 Group	Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course	Swelling	64 Subjects
MenHibrix Formulation 3 Group	Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course	Swelling	56 Subjects
MenHibrix Formulation 3 Group	Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course	Pain	53 Subjects
MenHibrix Formulation 3 Group	Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course	Redness	64 Subjects
MenHibrix Formulation 3 Group	Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course	Drowsiness	58 Subjects
MenHibrix Formulation 3 Group	Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course	Irritability	76 Subjects
MenHibrix Formulation 3 Group	Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course	Loss of appetite	49 Subjects
MenHibrix Formulation 3 Group	Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course	Fever	64 Subjects
Menjugate Group	Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course	Swelling	60 Subjects
Menjugate Group	Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course	Irritability	80 Subjects
Menjugate Group	Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course	Redness	75 Subjects
Menjugate Group	Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course	Fever	64 Subjects
Menjugate Group	Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course	Loss of appetite	47 Subjects
Menjugate Group	Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course	Pain	66 Subjects
Menjugate Group	Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course	Drowsiness	70 Subjects
ActHIB Group	Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course	Swelling	58 Subjects
ActHIB Group	Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course	Fever	70 Subjects
ActHIB Group	Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course	Loss of appetite	58 Subjects
ActHIB Group	Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course	Irritability	80 Subjects
ActHIB Group	Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course	Redness	69 Subjects
ActHIB Group	Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course	Pain	60 Subjects
ActHIB Group	Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course	Drowsiness	67 Subjects

Secondary

Number of Subjects Reporting Unsolicited Adverse Events After Administration of the Polysaccharide Challenge Dose

Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

Time frame: During the 31-Day (Day 0-30) follow-up period after administration of the polysaccharide challenge dose

Population: The analysis was performed on the Booster Total Vaccinated Cohort.

Arm	Measure	Value (NUMBER)
MenHibrix Formulation 1 Group	Number of Subjects Reporting Unsolicited Adverse Events After Administration of the Polysaccharide Challenge Dose	39 Subjects
MenHibrix Formulation 2 Group	Number of Subjects Reporting Unsolicited Adverse Events After Administration of the Polysaccharide Challenge Dose	46 Subjects
MenHibrix Formulation 3 Group	Number of Subjects Reporting Unsolicited Adverse Events After Administration of the Polysaccharide Challenge Dose	47 Subjects
Menjugate Group	Number of Subjects Reporting Unsolicited Adverse Events After Administration of the Polysaccharide Challenge Dose	50 Subjects
ActHIB Group	Number of Subjects Reporting Unsolicited Adverse Events After Administration of the Polysaccharide Challenge Dose	52 Subjects

Secondary

Number of Subjects Reporting Unsolicited Adverse Events During the Primary Vaccination Course

Time frame: During the 31-Day (Day 0-30) follow-up period after any vaccine dose during the primary vaccination course

Population: The analysis was performed on the Total Vaccinated Cohort.

Arm	Measure	Value (NUMBER)
MenHibrix Formulation 1 Group	Number of Subjects Reporting Unsolicited Adverse Events During the Primary Vaccination Course	64 Subjects
MenHibrix Formulation 2 Group	Number of Subjects Reporting Unsolicited Adverse Events During the Primary Vaccination Course	68 Subjects
MenHibrix Formulation 3 Group	Number of Subjects Reporting Unsolicited Adverse Events During the Primary Vaccination Course	56 Subjects
Menjugate Group	Number of Subjects Reporting Unsolicited Adverse Events During the Primary Vaccination Course	58 Subjects
ActHIB Group	Number of Subjects Reporting Unsolicited Adverse Events During the Primary Vaccination Course	68 Subjects

Secondary

Number of Subjects Seroprotected for Anti-diphtheria Antibodies

Seroprotection is defined as anti-diphtheria toxoid antibody concentration greater than or equal to 0.1 International Units per Milliliter (IU/mL).

Time frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

Arm	Measure	Group	Value (NUMBER)
MenHibrix Formulation 1 Group	Number of Subjects Seroprotected for Anti-diphtheria Antibodies	Day 0 (N= 68; 70; 65; 69; 74)	26 Subjects
MenHibrix Formulation 1 Group	Number of Subjects Seroprotected for Anti-diphtheria Antibodies	Month 10 (N= 78; 78; 75; 80; 75)	76 Subjects
MenHibrix Formulation 1 Group	Number of Subjects Seroprotected for Anti-diphtheria Antibodies	Month 5 (N= 74; 76; 74; 77; 76)	74 Subjects
MenHibrix Formulation 2 Group	Number of Subjects Seroprotected for Anti-diphtheria Antibodies	Month 5 (N= 74; 76; 74; 77; 76)	76 Subjects
MenHibrix Formulation 2 Group	Number of Subjects Seroprotected for Anti-diphtheria Antibodies	Day 0 (N= 68; 70; 65; 69; 74)	28 Subjects
MenHibrix Formulation 2 Group	Number of Subjects Seroprotected for Anti-diphtheria Antibodies	Month 10 (N= 78; 78; 75; 80; 75)	75 Subjects
MenHibrix Formulation 3 Group	Number of Subjects Seroprotected for Anti-diphtheria Antibodies	Month 5 (N= 74; 76; 74; 77; 76)	74 Subjects
MenHibrix Formulation 3 Group	Number of Subjects Seroprotected for Anti-diphtheria Antibodies	Day 0 (N= 68; 70; 65; 69; 74)	28 Subjects
MenHibrix Formulation 3 Group	Number of Subjects Seroprotected for Anti-diphtheria Antibodies	Month 10 (N= 78; 78; 75; 80; 75)	72 Subjects
Menjugate Group	Number of Subjects Seroprotected for Anti-diphtheria Antibodies	Day 0 (N= 68; 70; 65; 69; 74)	26 Subjects
Menjugate Group	Number of Subjects Seroprotected for Anti-diphtheria Antibodies	Month 10 (N= 78; 78; 75; 80; 75)	74 Subjects
Menjugate Group	Number of Subjects Seroprotected for Anti-diphtheria Antibodies	Month 5 (N= 74; 76; 74; 77; 76)	77 Subjects
ActHIB Group	Number of Subjects Seroprotected for Anti-diphtheria Antibodies	Month 5 (N= 74; 76; 74; 77; 76)	76 Subjects
ActHIB Group	Number of Subjects Seroprotected for Anti-diphtheria Antibodies	Day 0 (N= 68; 70; 65; 69; 74)	29 Subjects
ActHIB Group	Number of Subjects Seroprotected for Anti-diphtheria Antibodies	Month 10 (N= 78; 78; 75; 80; 75)	75 Subjects

Secondary

Number of Subjects Seroprotected for Anti-hepatitis B (HBs) Antibodies

Seroprotection is defined as anti-HBs antibody concentration greater than or equal to 10 Milli-International Units per Milliliter (mIU/mL).

Time frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

Arm	Measure	Group	Value (NUMBER)
MenHibrix Formulation 1 Group	Number of Subjects Seroprotected for Anti-hepatitis B (HBs) Antibodies	Month 5 (N= 72; 74; 74; 76; 75)	71 Subjects
MenHibrix Formulation 1 Group	Number of Subjects Seroprotected for Anti-hepatitis B (HBs) Antibodies	Day 0 (N= 57; 55; 56; 52; 57)	15 Subjects
MenHibrix Formulation 1 Group	Number of Subjects Seroprotected for Anti-hepatitis B (HBs) Antibodies	Month 10 (N= 74; 70; 70; 75; 69)	72 Subjects
MenHibrix Formulation 2 Group	Number of Subjects Seroprotected for Anti-hepatitis B (HBs) Antibodies	Day 0 (N= 57; 55; 56; 52; 57)	16 Subjects
MenHibrix Formulation 2 Group	Number of Subjects Seroprotected for Anti-hepatitis B (HBs) Antibodies	Month 10 (N= 74; 70; 70; 75; 69)	68 Subjects
MenHibrix Formulation 2 Group	Number of Subjects Seroprotected for Anti-hepatitis B (HBs) Antibodies	Month 5 (N= 72; 74; 74; 76; 75)	74 Subjects
MenHibrix Formulation 3 Group	Number of Subjects Seroprotected for Anti-hepatitis B (HBs) Antibodies	Day 0 (N= 57; 55; 56; 52; 57)	12 Subjects
MenHibrix Formulation 3 Group	Number of Subjects Seroprotected for Anti-hepatitis B (HBs) Antibodies	Month 5 (N= 72; 74; 74; 76; 75)	74 Subjects
MenHibrix Formulation 3 Group	Number of Subjects Seroprotected for Anti-hepatitis B (HBs) Antibodies	Month 10 (N= 74; 70; 70; 75; 69)	68 Subjects
Menjugate Group	Number of Subjects Seroprotected for Anti-hepatitis B (HBs) Antibodies	Month 10 (N= 74; 70; 70; 75; 69)	72 Subjects
Menjugate Group	Number of Subjects Seroprotected for Anti-hepatitis B (HBs) Antibodies	Day 0 (N= 57; 55; 56; 52; 57)	14 Subjects
Menjugate Group	Number of Subjects Seroprotected for Anti-hepatitis B (HBs) Antibodies	Month 5 (N= 72; 74; 74; 76; 75)	76 Subjects
ActHIB Group	Number of Subjects Seroprotected for Anti-hepatitis B (HBs) Antibodies	Month 5 (N= 72; 74; 74; 76; 75)	74 Subjects
ActHIB Group	Number of Subjects Seroprotected for Anti-hepatitis B (HBs) Antibodies	Day 0 (N= 57; 55; 56; 52; 57)	22 Subjects
ActHIB Group	Number of Subjects Seroprotected for Anti-hepatitis B (HBs) Antibodies	Month 10 (N= 74; 70; 70; 75; 69)	68 Subjects

Secondary

Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies

Seroprotection is defined as anti-polio antibody titer greater than or equal to 1:8 dilution.

Time frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

Arm	Measure	Group	Value (NUMBER)
MenHibrix Formulation 1 Group	Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies	Polio-1 Month 10 (N= 71; 69; 70; 76; 66)	70 Subjects
MenHibrix Formulation 1 Group	Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies	Polio-2 Month 5 (N= 59; 66; 64; 66; 64)	59 Subjects
MenHibrix Formulation 1 Group	Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies	Polio-2 Day 0 (N= 56; 59; 50; 55; 52)	42 Subjects
MenHibrix Formulation 1 Group	Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies	Polio-3 Month 5 (N= 62; 68; 66; 66; 65)	62 Subjects
MenHibrix Formulation 1 Group	Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies	Polio-3 Day 0 (N= 56; 59; 50; 56; 52)	20 Subjects
MenHibrix Formulation 1 Group	Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies	Polio-1 Day 0 (N= 56; 58; 50; 56; 52)	45 Subjects
MenHibrix Formulation 1 Group	Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies	Polio-3 Month 10 (N= 71; 70; 69; 76; 67)	71 Subjects
MenHibrix Formulation 1 Group	Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies	Polio-2 Month 10 (N= 71; 70; 69; 75; 67)	70 Subjects
MenHibrix Formulation 1 Group	Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies	Polio-1 Month 5 (N= 62; 68; 66; 66; 65)	62 Subjects
MenHibrix Formulation 2 Group	Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies	Polio-2 Month 5 (N= 59; 66; 64; 66; 64)	66 Subjects
MenHibrix Formulation 2 Group	Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies	Polio-1 Day 0 (N= 56; 58; 50; 56; 52)	50 Subjects
MenHibrix Formulation 2 Group	Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies	Polio-1 Month 5 (N= 62; 68; 66; 66; 65)	68 Subjects
MenHibrix Formulation 2 Group	Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies	Polio-2 Day 0 (N= 56; 59; 50; 55; 52)	40 Subjects
MenHibrix Formulation 2 Group	Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies	Polio-2 Month 10 (N= 71; 70; 69; 75; 67)	66 Subjects
MenHibrix Formulation 2 Group	Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies	Polio-3 Month 10 (N= 71; 70; 69; 76; 67)	69 Subjects
MenHibrix Formulation 2 Group	Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies	Polio-3 Month 5 (N= 62; 68; 66; 66; 65)	68 Subjects
MenHibrix Formulation 2 Group	Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies	Polio-3 Day 0 (N= 56; 59; 50; 56; 52)	20 Subjects
MenHibrix Formulation 2 Group	Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies	Polio-1 Month 10 (N= 71; 69; 70; 76; 66)	65 Subjects
MenHibrix Formulation 3 Group	Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies	Polio-2 Month 10 (N= 71; 70; 69; 75; 67)	65 Subjects
MenHibrix Formulation 3 Group	Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies	Polio-1 Month 5 (N= 62; 68; 66; 66; 65)	66 Subjects
MenHibrix Formulation 3 Group	Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies	Polio-1 Day 0 (N= 56; 58; 50; 56; 52)	44 Subjects
MenHibrix Formulation 3 Group	Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies	Polio-1 Month 10 (N= 71; 69; 70; 76; 66)	69 Subjects
MenHibrix Formulation 3 Group	Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies	Polio-2 Day 0 (N= 56; 59; 50; 55; 52)	36 Subjects
MenHibrix Formulation 3 Group	Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies	Polio-2 Month 5 (N= 59; 66; 64; 66; 64)	64 Subjects
MenHibrix Formulation 3 Group	Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies	Polio-3 Day 0 (N= 56; 59; 50; 56; 52)	24 Subjects
MenHibrix Formulation 3 Group	Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies	Polio-3 Month 5 (N= 62; 68; 66; 66; 65)	65 Subjects
MenHibrix Formulation 3 Group	Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies	Polio-3 Month 10 (N= 71; 70; 69; 76; 67)	67 Subjects
Menjugate Group	Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies	Polio-1 Month 10 (N= 71; 69; 70; 76; 66)	76 Subjects
Menjugate Group	Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies	Polio-2 Month 5 (N= 59; 66; 64; 66; 64)	66 Subjects
Menjugate Group	Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies	Polio-1 Day 0 (N= 56; 58; 50; 56; 52)	49 Subjects
Menjugate Group	Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies	Polio-3 Day 0 (N= 56; 59; 50; 56; 52)	22 Subjects
Menjugate Group	Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies	Polio-2 Month 10 (N= 71; 70; 69; 75; 67)	71 Subjects
Menjugate Group	Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies	Polio-3 Month 10 (N= 71; 70; 69; 76; 67)	75 Subjects
Menjugate Group	Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies	Polio-3 Month 5 (N= 62; 68; 66; 66; 65)	65 Subjects
Menjugate Group	Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies	Polio-2 Day 0 (N= 56; 59; 50; 55; 52)	44 Subjects
Menjugate Group	Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies	Polio-1 Month 5 (N= 62; 68; 66; 66; 65)	66 Subjects
ActHIB Group	Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies	Polio-1 Month 5 (N= 62; 68; 66; 66; 65)	65 Subjects
ActHIB Group	Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies	Polio-1 Month 10 (N= 71; 69; 70; 76; 66)	65 Subjects
ActHIB Group	Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies	Polio-2 Month 5 (N= 59; 66; 64; 66; 64)	63 Subjects
ActHIB Group	Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies	Polio-1 Day 0 (N= 56; 58; 50; 56; 52)	45 Subjects
ActHIB Group	Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies	Polio-2 Day 0 (N= 56; 59; 50; 55; 52)	43 Subjects
ActHIB Group	Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies	Polio-3 Month 10 (N= 71; 70; 69; 76; 67)	65 Subjects
ActHIB Group	Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies	Polio-3 Month 5 (N= 62; 68; 66; 66; 65)	65 Subjects
ActHIB Group	Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies	Polio-3 Day 0 (N= 56; 59; 50; 56; 52)	21 Subjects
ActHIB Group	Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies	Polio-2 Month 10 (N= 71; 70; 69; 75; 67)	64 Subjects

Secondary

Number of Subjects Seroprotected for Anti-tetanus Antibodies

Seroprotection is defined as anti-tetanus toxoid antibody concentration greater than or equal to 0.1 International Units per Milliliter (IU/mL).

Time frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

Arm	Measure	Group	Value (NUMBER)
MenHibrix Formulation 1 Group	Number of Subjects Seroprotected for Anti-tetanus Antibodies	Month 5 (N= 74; 76; 74; 77; 76)	74 Subjects
MenHibrix Formulation 1 Group	Number of Subjects Seroprotected for Anti-tetanus Antibodies	Month 10 (N= 78; 78; 75; 80; 75)	78 Subjects
MenHibrix Formulation 1 Group	Number of Subjects Seroprotected for Anti-tetanus Antibodies	Day 0 (N= 62; 64; 60; 60; 68)	54 Subjects
MenHibrix Formulation 2 Group	Number of Subjects Seroprotected for Anti-tetanus Antibodies	Day 0 (N= 62; 64; 60; 60; 68)	58 Subjects
MenHibrix Formulation 2 Group	Number of Subjects Seroprotected for Anti-tetanus Antibodies	Month 10 (N= 78; 78; 75; 80; 75)	78 Subjects
MenHibrix Formulation 2 Group	Number of Subjects Seroprotected for Anti-tetanus Antibodies	Month 5 (N= 74; 76; 74; 77; 76)	76 Subjects
MenHibrix Formulation 3 Group	Number of Subjects Seroprotected for Anti-tetanus Antibodies	Month 5 (N= 74; 76; 74; 77; 76)	74 Subjects
MenHibrix Formulation 3 Group	Number of Subjects Seroprotected for Anti-tetanus Antibodies	Day 0 (N= 62; 64; 60; 60; 68)	57 Subjects
MenHibrix Formulation 3 Group	Number of Subjects Seroprotected for Anti-tetanus Antibodies	Month 10 (N= 78; 78; 75; 80; 75)	74 Subjects
Menjugate Group	Number of Subjects Seroprotected for Anti-tetanus Antibodies	Month 5 (N= 74; 76; 74; 77; 76)	77 Subjects
Menjugate Group	Number of Subjects Seroprotected for Anti-tetanus Antibodies	Month 10 (N= 78; 78; 75; 80; 75)	78 Subjects
Menjugate Group	Number of Subjects Seroprotected for Anti-tetanus Antibodies	Day 0 (N= 62; 64; 60; 60; 68)	57 Subjects
ActHIB Group	Number of Subjects Seroprotected for Anti-tetanus Antibodies	Day 0 (N= 62; 64; 60; 60; 68)	62 Subjects
ActHIB Group	Number of Subjects Seroprotected for Anti-tetanus Antibodies	Month 5 (N= 74; 76; 74; 77; 76)	76 Subjects
ActHIB Group	Number of Subjects Seroprotected for Anti-tetanus Antibodies	Month 10 (N= 78; 78; 75; 80; 75)	75 Subjects

Secondary

Number of Subjects Seroseropositive for Anti-filamentus Haemagglutinin (FHA) Antibodies

Seropositivity is defined as anti-FHA antibody concentration greater than or equal to 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).

Time frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

Arm	Measure	Group	Value (NUMBER)
MenHibrix Formulation 1 Group	Number of Subjects Seroseropositive for Anti-filamentus Haemagglutinin (FHA) Antibodies	Day 0 (N= 64; 69; 65; 67; 70)	34 Subjects
MenHibrix Formulation 1 Group	Number of Subjects Seroseropositive for Anti-filamentus Haemagglutinin (FHA) Antibodies	Month 10 (N= 78; 78; 75; 79; 75)	77 Subjects
MenHibrix Formulation 1 Group	Number of Subjects Seroseropositive for Anti-filamentus Haemagglutinin (FHA) Antibodies	Month 5 (N= 74; 76; 74; 77; 76)	74 Subjects
MenHibrix Formulation 2 Group	Number of Subjects Seroseropositive for Anti-filamentus Haemagglutinin (FHA) Antibodies	Month 5 (N= 74; 76; 74; 77; 76)	76 Subjects
MenHibrix Formulation 2 Group	Number of Subjects Seroseropositive for Anti-filamentus Haemagglutinin (FHA) Antibodies	Day 0 (N= 64; 69; 65; 67; 70)	28 Subjects
MenHibrix Formulation 2 Group	Number of Subjects Seroseropositive for Anti-filamentus Haemagglutinin (FHA) Antibodies	Month 10 (N= 78; 78; 75; 79; 75)	77 Subjects
MenHibrix Formulation 3 Group	Number of Subjects Seroseropositive for Anti-filamentus Haemagglutinin (FHA) Antibodies	Month 5 (N= 74; 76; 74; 77; 76)	74 Subjects
MenHibrix Formulation 3 Group	Number of Subjects Seroseropositive for Anti-filamentus Haemagglutinin (FHA) Antibodies	Day 0 (N= 64; 69; 65; 67; 70)	38 Subjects
MenHibrix Formulation 3 Group	Number of Subjects Seroseropositive for Anti-filamentus Haemagglutinin (FHA) Antibodies	Month 10 (N= 78; 78; 75; 79; 75)	72 Subjects
Menjugate Group	Number of Subjects Seroseropositive for Anti-filamentus Haemagglutinin (FHA) Antibodies	Day 0 (N= 64; 69; 65; 67; 70)	44 Subjects
Menjugate Group	Number of Subjects Seroseropositive for Anti-filamentus Haemagglutinin (FHA) Antibodies	Month 10 (N= 78; 78; 75; 79; 75)	79 Subjects
Menjugate Group	Number of Subjects Seroseropositive for Anti-filamentus Haemagglutinin (FHA) Antibodies	Month 5 (N= 74; 76; 74; 77; 76)	77 Subjects
ActHIB Group	Number of Subjects Seroseropositive for Anti-filamentus Haemagglutinin (FHA) Antibodies	Month 5 (N= 74; 76; 74; 77; 76)	76 Subjects
ActHIB Group	Number of Subjects Seroseropositive for Anti-filamentus Haemagglutinin (FHA) Antibodies	Day 0 (N= 64; 69; 65; 67; 70)	31 Subjects
ActHIB Group	Number of Subjects Seroseropositive for Anti-filamentus Haemagglutinin (FHA) Antibodies	Month 10 (N= 78; 78; 75; 79; 75)	75 Subjects

Secondary

Number of Subjects Seroseropositive for Anti-pertactin (PRN) Antibodies

Seropositivity is defined as anti-PRN antibody concentration greater than or equal to 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).

Time frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

Arm	Measure	Group	Value (NUMBER)
MenHibrix Formulation 1 Group	Number of Subjects Seroseropositive for Anti-pertactin (PRN) Antibodies	Day 0 (N= 67; 63; 67; 68; 71)	20 Subjects
MenHibrix Formulation 1 Group	Number of Subjects Seroseropositive for Anti-pertactin (PRN) Antibodies	Month 10 (N= 78; 78; 75; 80; 75)	76 Subjects
MenHibrix Formulation 1 Group	Number of Subjects Seroseropositive for Anti-pertactin (PRN) Antibodies	Month 5 (N= 74; 76; 74; 77; 76)	74 Subjects
MenHibrix Formulation 2 Group	Number of Subjects Seroseropositive for Anti-pertactin (PRN) Antibodies	Month 5 (N= 74; 76; 74; 77; 76)	76 Subjects
MenHibrix Formulation 2 Group	Number of Subjects Seroseropositive for Anti-pertactin (PRN) Antibodies	Day 0 (N= 67; 63; 67; 68; 71)	26 Subjects
MenHibrix Formulation 2 Group	Number of Subjects Seroseropositive for Anti-pertactin (PRN) Antibodies	Month 10 (N= 78; 78; 75; 80; 75)	75 Subjects
MenHibrix Formulation 3 Group	Number of Subjects Seroseropositive for Anti-pertactin (PRN) Antibodies	Month 5 (N= 74; 76; 74; 77; 76)	74 Subjects
MenHibrix Formulation 3 Group	Number of Subjects Seroseropositive for Anti-pertactin (PRN) Antibodies	Day 0 (N= 67; 63; 67; 68; 71)	25 Subjects
MenHibrix Formulation 3 Group	Number of Subjects Seroseropositive for Anti-pertactin (PRN) Antibodies	Month 10 (N= 78; 78; 75; 80; 75)	71 Subjects
Menjugate Group	Number of Subjects Seroseropositive for Anti-pertactin (PRN) Antibodies	Day 0 (N= 67; 63; 67; 68; 71)	30 Subjects
Menjugate Group	Number of Subjects Seroseropositive for Anti-pertactin (PRN) Antibodies	Month 10 (N= 78; 78; 75; 80; 75)	73 Subjects
Menjugate Group	Number of Subjects Seroseropositive for Anti-pertactin (PRN) Antibodies	Month 5 (N= 74; 76; 74; 77; 76)	76 Subjects
ActHIB Group	Number of Subjects Seroseropositive for Anti-pertactin (PRN) Antibodies	Month 5 (N= 74; 76; 74; 77; 76)	76 Subjects
ActHIB Group	Number of Subjects Seroseropositive for Anti-pertactin (PRN) Antibodies	Day 0 (N= 67; 63; 67; 68; 71)	26 Subjects
ActHIB Group	Number of Subjects Seroseropositive for Anti-pertactin (PRN) Antibodies	Month 10 (N= 78; 78; 75; 80; 75)	74 Subjects

Secondary

Number of Subjects Seroseropositive for Anti-pertussis Toxoid (PT) Antibodies

Seropositivity is defined as anti-PT antibody concentration greater than or equal to 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).

Time frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

Arm	Measure	Group	Value (NUMBER)
MenHibrix Formulation 1 Group	Number of Subjects Seroseropositive for Anti-pertussis Toxoid (PT) Antibodies	Day 0 (N= 65; 66; 65; 63; 74)	5 Subjects
MenHibrix Formulation 1 Group	Number of Subjects Seroseropositive for Anti-pertussis Toxoid (PT) Antibodies	Month 10 (N= 77; 76; 73; 78; 75)	71 Subjects
MenHibrix Formulation 1 Group	Number of Subjects Seroseropositive for Anti-pertussis Toxoid (PT) Antibodies	Month 5 (N= 74; 76; 74; 77; 76)	74 Subjects
MenHibrix Formulation 2 Group	Number of Subjects Seroseropositive for Anti-pertussis Toxoid (PT) Antibodies	Month 5 (N= 74; 76; 74; 77; 76)	76 Subjects
MenHibrix Formulation 2 Group	Number of Subjects Seroseropositive for Anti-pertussis Toxoid (PT) Antibodies	Day 0 (N= 65; 66; 65; 63; 74)	6 Subjects
MenHibrix Formulation 2 Group	Number of Subjects Seroseropositive for Anti-pertussis Toxoid (PT) Antibodies	Month 10 (N= 77; 76; 73; 78; 75)	66 Subjects
MenHibrix Formulation 3 Group	Number of Subjects Seroseropositive for Anti-pertussis Toxoid (PT) Antibodies	Month 5 (N= 74; 76; 74; 77; 76)	74 Subjects
MenHibrix Formulation 3 Group	Number of Subjects Seroseropositive for Anti-pertussis Toxoid (PT) Antibodies	Day 0 (N= 65; 66; 65; 63; 74)	5 Subjects
MenHibrix Formulation 3 Group	Number of Subjects Seroseropositive for Anti-pertussis Toxoid (PT) Antibodies	Month 10 (N= 77; 76; 73; 78; 75)	62 Subjects
Menjugate Group	Number of Subjects Seroseropositive for Anti-pertussis Toxoid (PT) Antibodies	Day 0 (N= 65; 66; 65; 63; 74)	11 Subjects
Menjugate Group	Number of Subjects Seroseropositive for Anti-pertussis Toxoid (PT) Antibodies	Month 10 (N= 77; 76; 73; 78; 75)	61 Subjects
Menjugate Group	Number of Subjects Seroseropositive for Anti-pertussis Toxoid (PT) Antibodies	Month 5 (N= 74; 76; 74; 77; 76)	77 Subjects
ActHIB Group	Number of Subjects Seroseropositive for Anti-pertussis Toxoid (PT) Antibodies	Month 5 (N= 74; 76; 74; 77; 76)	76 Subjects
ActHIB Group	Number of Subjects Seroseropositive for Anti-pertussis Toxoid (PT) Antibodies	Day 0 (N= 65; 66; 65; 63; 74)	3 Subjects
ActHIB Group	Number of Subjects Seroseropositive for Anti-pertussis Toxoid (PT) Antibodies	Month 10 (N= 77; 76; 73; 78; 75)	63 Subjects

Secondary

Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values

Pneumococcal antibodies assessed included anti-4, anti-6B, anti-9V, anti-14, anti-18C, anti-19F and anti-23F antibodies. The cut-off values assessed were 0.05 and 0.2 micrograms per milliliter (µg/mL).

Time frame: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

Arm	Measure	Group	Value (NUMBER)
MenHibrix Formulation 1 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-23F ≥ 0.2 µg/mL Month 10 (N=73;69;63;75;65)	66 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-4 ≥ 0.05 µg/mL Day 0 (N=44;43;39;51;46)	10 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-23F ≥ 0.05 µg/mL Month 5 (N=66;68;70;59;66)	65 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-23F ≥ 0.2 µg/mL Month 5 (N=66;68;70;59;66)	64 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-14 ≥ 0.2 µg/mL Month 10 (N=68;67;64;69;61)	64 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-14 ≥ 0.2 µg/mL Month 5 (N=65;65;68;49;65)	64 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-4 ≥ 0.05 µg/mL Month 5 (N=69;70;69;58;66)	69 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-6B ≥ 0.2 µg/mL Month 10 (N=69;63;62;71;62)	45 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-14 ≥ 0.05 µg/mL Day 0 (N=31;33;31;41;43)	29 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-18C ≥ 0.05 µg/mL Month 10 (N=48;52;51;53;46)	47 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-14 ≥ 0.2 µg/mL Day 0 (N=31;33;31;41;43)	20 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-4 ≥ 0.05 µg/mL Month 10 (N=70;68;66;69;64)	70 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-19F ≥ 0.2 µg/mL Day 0 (N=42;42;36;50;45)	14 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-6B ≥ 0.05 µg/mL Day 0 (N=44;41;39;49;49)	18 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-18C ≥ 0.05 µg/mL Month 5 (N=67;71;72;65;67)	66 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-9V ≥ 0.2 µg/mL Day 0 (N=46;42;40;52;48)	9 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-9V ≥ 0.2 µg/mL Month 10 (N=60;60;56;63;56)	55 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-19F ≥ 0.2 µg/mL Month 10 (N=73;71;65;77;63)	54 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-19F ≥ 0.05 µg/mL Month 5 (N=65;67;66;56;65)	65 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-9V ≥ 0.2 µg/mL Month 5 (N=68;71;71;62;67)	68 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-6B ≥ 0.05 µg/mL Month 10 (N=69;63;62;71;62)	62 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-18C ≥ 0.05 µg/mL Day 0 (N=40;40;37;47;47)	20 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-14 ≥ 0.05 µg/mL Month 5 (N=65;65;68;49;65)	65 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-6B ≥ 0.05 µg/mL Month 5 (N=68;70;69;63;65)	65 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-6B ≥ 0.2 µg/mL Month 5 (N=68;70;69;63;65)	58 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-9V ≥ 0.05 µg/mL Day 0 (N=46;42;40;52;48)	19 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-18C ≥ 0.2 µg/mL Month 10 (N=48;52;51;53;46)	47 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-19F ≥ 0.05 µg/mL Day 0 (N=42;42;36;50;45))	28 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-4 ≥ 0.2 µg/mL Month 10 (N=70;68;66;69;64)	65 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-18C ≥ 0.2 µg/mL Month 5 (N=67;71;72;65;67)	66 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-9V ≥ 0.05 µg/mL Month 5 (N=68;71;71;62;67)	68 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-18C ≥ 0.2 µg/mL Day 0 (N=40;40;37;47;47)	10 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-23F ≥ 0.2 µg/mL Day 0 (N=41;43;38;48;48)	5 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-4 ≥ 0.2 µg/mL Month 5 (N=69;70;69;58;66)	69 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-6B ≥ 0.2 µg/mL Day 0 (N=44;41;39;49;49)	6 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-9V ≥ 0.05 µg/mL Month 10 (N=60;60;56;63;56)	60 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-23F ≥ 0.05 µg/mL Day 0 (N=41;43;38;48;48)	17 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-19F ≥ 0.05 µg/mL Month 10 (N=73;71;65;77;63)	73 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-4 ≥ 0.2 µg/mL Day 0 (N=44;43;39;51;46)	3 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-14 ≥ 0.05 µg/mL Month 10 (N=68;67;64;69;61)	67 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-19F ≥ 0.2 µg/mL Month 5 (N=65;67;66;56;65)	65 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-23F ≥ 0.05 µg/mL Month 10 (N=73;69;63;75;65)	71 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-9V ≥ 0.05 µg/mL Month 5 (N=68;71;71;62;67)	70 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-23F ≥ 0.05 µg/mL Month 10 (N=73;69;63;75;65)	67 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-23F ≥ 0.05 µg/mL Day 0 (N=41;43;38;48;48)	14 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-18C ≥ 0.05 µg/mL Day 0 (N=40;40;37;47;47)	19 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-4 ≥ 0.2 µg/mL Month 10 (N=70;68;66;69;64)	60 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-19F ≥ 0.05 µg/mL Month 10 (N=73;71;65;77;63)	68 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-18C ≥ 0.05 µg/mL Month 5 (N=67;71;72;65;67)	71 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-23F ≥ 0.2 µg/mL Month 10 (N=73;69;63;75;65)	56 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-19F ≥ 0.05 µg/mL Month 5 (N=65;67;66;56;65)	66 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-18C ≥ 0.05 µg/mL Month 10 (N=48;52;51;53;46)	52 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-19F ≥ 0.05 µg/mL Day 0 (N=42;42;36;50;45))	28 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-6B ≥ 0.2 µg/mL Day 0 (N=44;41;39;49;49)	11 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-6B ≥ 0.2 µg/mL Month 5 (N=68;70;69;63;65)	64 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-19F ≥ 0.2 µg/mL Day 0 (N=42;42;36;50;45)	18 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-6B ≥ 0.2 µg/mL Month 10 (N=69;63;62;71;62)	41 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-18C ≥ 0.2 µg/mL Month 10 (N=48;52;51;53;46)	50 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-9V ≥ 0.2 µg/mL Month 10 (N=60;60;56;63;56)	54 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-23F ≥ 0.2 µg/mL Month 5 (N=66;68;70;59;66)	64 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-14 ≥ 0.2 µg/mL Month 5 (N=65;65;68;49;65)	65 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-18C ≥ 0.2 µg/mL Month 5 (N=67;71;72;65;67)	70 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-18C ≥ 0.2 µg/mL Day 0 (N=40;40;37;47;47)	6 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-6B ≥ 0.05 µg/mL Month 5 (N=68;70;69;63;65)	69 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-14 ≥ 0.2 µg/mL Month 10 (N=68;67;64;69;61)	65 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-19F ≥ 0.2 µg/mL Month 5 (N=65;67;66;56;65)	66 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-4 ≥ 0.05 µg/mL Day 0 (N=44;43;39;51;46)	9 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-4 ≥ 0.05 µg/mL Month 5 (N=69;70;69;58;66)	70 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-14 ≥ 0.2 µg/mL Day 0 (N=31;33;31;41;43)	18 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-4 ≥ 0.05 µg/mL Month 10 (N=70;68;66;69;64)	68 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-6B ≥ 0.05 µg/mL Day 0 (N=44;41;39;49;49)	21 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-14 ≥ 0.05 µg/mL Day 0 (N=31;33;31;41;43)	25 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-23F ≥ 0.2 µg/mL Day 0 (N=41;43;38;48;48)	6 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-9V ≥ 0.2 µg/mL Month 5 (N=68;71;71;62;67)	69 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-6B ≥ 0.05 µg/mL Month 10 (N=69;63;62;71;62)	57 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-9V ≥ 0.2 µg/mL Day 0 (N=46;42;40;52;48)	6 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-9V ≥ 0.05 µg/mL Day 0 (N=46;42;40;52;48)	22 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-14 ≥ 0.05 µg/mL Month 5 (N=65;65;68;49;65)	65 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-4 ≥ 0.2 µg/mL Month 5 (N=69;70;69;58;66)	70 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-14 ≥ 0.05 µg/mL Month 10 (N=68;67;64;69;61)	67 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-4 ≥ 0.2 µg/mL Day 0 (N=44;43;39;51;46)	1 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-9V ≥ 0.05 µg/mL Month 10 (N=60;60;56;63;56)	58 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-19F ≥ 0.2 µg/mL Month 10 (N=73;71;65;77;63)	51 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-23F ≥ 0.05 µg/mL Month 5 (N=66;68;70;59;66)	66 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-4 ≥ 0.05 µg/mL Month 10 (N=70;68;66;69;64)	65 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-4 ≥ 0.2 µg/mL Month 10 (N=70;68;66;69;64)	61 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-6B ≥ 0.2 µg/mL Month 5 (N=68;70;69;63;65)	56 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-9V ≥ 0.2 µg/mL Month 10 (N=60;60;56;63;56)	55 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-14 ≥ 0.2 µg/mL Month 5 (N=65;65;68;49;65)	68 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-18C ≥ 0.2 µg/mL Day 0 (N=40;40;37;47;47)	8 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-4 ≥ 0.05 µg/mL Day 0 (N=44;43;39;51;46)	10 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-4 ≥ 0.05 µg/mL Month 5 (N=69;70;69;58;66)	69 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-6B ≥ 0.05 µg/mL Day 0 (N=44;41;39;49;49)	20 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-6B ≥ 0.05 µg/mL Month 5 (N=68;70;69;63;65)	61 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-6B ≥ 0.05 µg/mL Month 10 (N=69;63;62;71;62)	55 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-9V ≥ 0.05 µg/mL Day 0 (N=46;42;40;52;48)	23 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-9V ≥ 0.05 µg/mL Month 5 (N=68;71;71;62;67)	71 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-9V ≥ 0.05 µg/mL Month 10 (N=60;60;56;63;56)	56 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-14 ≥ 0.05 µg/mL Day 0 (N=31;33;31;41;43)	26 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-14 ≥ 0.05 µg/mL Month 5 (N=65;65;68;49;65)	68 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-14 ≥ 0.05 µg/mL Month 10 (N=68;67;64;69;61)	63 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-18C ≥ 0.05 µg/mL Day 0 (N=40;40;37;47;47)	21 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-18C ≥ 0.05 µg/mL Month 5 (N=67;71;72;65;67)	72 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-18C ≥ 0.05 µg/mL Month 10 (N=48;52;51;53;46)	51 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-19F ≥ 0.05 µg/mL Day 0 (N=42;42;36;50;45))	25 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-19F ≥ 0.05 µg/mL Month 5 (N=65;67;66;56;65)	66 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-19F ≥ 0.05 µg/mL Month 10 (N=73;71;65;77;63)	65 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-23F ≥ 0.05 µg/mL Day 0 (N=41;43;38;48;48)	15 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-23F ≥ 0.05 µg/mL Month 5 (N=66;68;70;59;66)	67 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-23F ≥ 0.05 µg/mL Month 10 (N=73;69;63;75;65)	59 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-4 ≥ 0.2 µg/mL Day 0 (N=44;43;39;51;46)	3 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-4 ≥ 0.2 µg/mL Month 5 (N=69;70;69;58;66)	69 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-6B ≥ 0.2 µg/mL Day 0 (N=44;41;39;49;49)	7 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-6B ≥ 0.2 µg/mL Month 10 (N=69;63;62;71;62)	49 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-9V ≥ 0.2 µg/mL Day 0 (N=46;42;40;52;48)	8 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-9V ≥ 0.2 µg/mL Month 5 (N=68;71;71;62;67)	71 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-14 ≥ 0.2 µg/mL Day 0 (N=31;33;31;41;43)	16 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-14 ≥ 0.2 µg/mL Month 10 (N=68;67;64;69;61)	63 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-18C ≥ 0.2 µg/mL Month 5 (N=67;71;72;65;67)	72 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-18C ≥ 0.2 µg/mL Month 10 (N=48;52;51;53;46)	50 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-19F ≥ 0.2 µg/mL Day 0 (N=42;42;36;50;45)	16 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-19F ≥ 0.2 µg/mL Month 5 (N=65;67;66;56;65)	66 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-19F ≥ 0.2 µg/mL Month 10 (N=73;71;65;77;63)	55 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-23F ≥ 0.2 µg/mL Day 0 (N=41;43;38;48;48)	7 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-23F ≥ 0.2 µg/mL Month 5 (N=66;68;70;59;66)	67 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-23F ≥ 0.2 µg/mL Month 10 (N=73;69;63;75;65)	53 Subjects
Menjugate Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-4 ≥ 0.05 µg/mL Month 10 (N=70;68;66;69;64)	1 Subjects
Menjugate Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-19F ≥ 0.2 µg/mL Month 10 (N=73;71;65;77;63)	8 Subjects
Menjugate Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-23F ≥ 0.05 µg/mL Month 10 (N=73;69;63;75;65)	0 Subjects
Menjugate Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-9V ≥ 0.05 µg/mL Month 10 (N=60;60;56;63;56)	5 Subjects
Menjugate Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-4 ≥ 0.2 µg/mL Day 0 (N=44;43;39;51;46)	1 Subjects
Menjugate Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-9V ≥ 0.05 µg/mL Month 5 (N=68;71;71;62;67)	3 Subjects
Menjugate Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-14 ≥ 0.05 µg/mL Month 5 (N=65;65;68;49;65)	24 Subjects
Menjugate Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-4 ≥ 0.2 µg/mL Month 5 (N=69;70;69;58;66)	1 Subjects
Menjugate Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-9V ≥ 0.05 µg/mL Day 0 (N=46;42;40;52;48)	23 Subjects
Menjugate Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-6B ≥ 0.2 µg/mL Day 0 (N=44;41;39;49;49)	9 Subjects
Menjugate Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-6B ≥ 0.05 µg/mL Month 10 (N=69;63;62;71;62)	2 Subjects
Menjugate Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-23F ≥ 0.2 µg/mL Day 0 (N=41;43;38;48;48)	9 Subjects
Menjugate Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-9V ≥ 0.2 µg/mL Day 0 (N=46;42;40;52;48)	10 Subjects
Menjugate Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-6B ≥ 0.05 µg/mL Month 5 (N=68;70;69;63;65)	3 Subjects
Menjugate Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-9V ≥ 0.2 µg/mL Month 5 (N=68;71;71;62;67)	1 Subjects
Menjugate Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-6B ≥ 0.05 µg/mL Day 0 (N=44;41;39;49;49)	25 Subjects
Menjugate Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-9V ≥ 0.2 µg/mL Month 10 (N=60;60;56;63;56)	2 Subjects
Menjugate Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-4 ≥ 0.05 µg/mL Month 5 (N=69;70;69;58;66)	2 Subjects
Menjugate Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-14 ≥ 0.2 µg/mL Day 0 (N=31;33;31;41;43)	28 Subjects
Menjugate Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-4 ≥ 0.05 µg/mL Day 0 (N=44;43;39;51;46)	11 Subjects
Menjugate Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-18C ≥ 0.2 µg/mL Day 0 (N=40;40;37;47;47)	6 Subjects
Menjugate Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-14 ≥ 0.2 µg/mL Month 10 (N=68;67;64;69;61)	5 Subjects
Menjugate Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-23F ≥ 0.2 µg/mL Month 10 (N=73;69;63;75;65)	0 Subjects
Menjugate Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-18C ≥ 0.2 µg/mL Month 5 (N=67;71;72;65;67)	2 Subjects
Menjugate Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-14 ≥ 0.2 µg/mL Month 5 (N=65;65;68;49;65)	7 Subjects
Menjugate Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-23F ≥ 0.2 µg/mL Month 5 (N=66;68;70;59;66)	0 Subjects
Menjugate Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-18C ≥ 0.2 µg/mL Month 10 (N=48;52;51;53;46)	0 Subjects
Menjugate Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-6B ≥ 0.2 µg/mL Month 10 (N=69;63;62;71;62)	0 Subjects
Menjugate Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-6B ≥ 0.2 µg/mL Month 5 (N=68;70;69;63;65)	1 Subjects
Menjugate Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-19F ≥ 0.2 µg/mL Day 0 (N=42;42;36;50;45)	22 Subjects
Menjugate Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-19F ≥ 0.2 µg/mL Month 5 (N=65;67;66;56;65)	2 Subjects
Menjugate Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-19F ≥ 0.05 µg/mL Day 0 (N=42;42;36;50;45))	37 Subjects
Menjugate Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-18C ≥ 0.05 µg/mL Month 10 (N=48;52;51;53;46)	0 Subjects
Menjugate Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-19F ≥ 0.05 µg/mL Month 5 (N=65;67;66;56;65)	7 Subjects
Menjugate Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-18C ≥ 0.05 µg/mL Month 5 (N=67;71;72;65;67)	5 Subjects
Menjugate Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-4 ≥ 0.2 µg/mL Month 10 (N=70;68;66;69;64)	1 Subjects
Menjugate Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-19F ≥ 0.05 µg/mL Month 10 (N=73;71;65;77;63)	14 Subjects
Menjugate Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-18C ≥ 0.05 µg/mL Day 0 (N=40;40;37;47;47)	23 Subjects
Menjugate Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-23F ≥ 0.05 µg/mL Day 0 (N=41;43;38;48;48)	19 Subjects
Menjugate Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-14 ≥ 0.05 µg/mL Month 10 (N=68;67;64;69;61)	13 Subjects
Menjugate Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-14 ≥ 0.05 µg/mL Day 0 (N=31;33;31;41;43)	37 Subjects
Menjugate Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-23F ≥ 0.05 µg/mL Month 5 (N=66;68;70;59;66)	3 Subjects
ActHIB Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-4 ≥ 0.05 µg/mL Month 10 (N=70;68;66;69;64)	64 Subjects
ActHIB Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-23F ≥ 0.05 µg/mL Month 5 (N=66;68;70;59;66)	63 Subjects
ActHIB Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-19F ≥ 0.2 µg/mL Day 0 (N=42;42;36;50;45)	15 Subjects
ActHIB Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-6B ≥ 0.05 µg/mL Day 0 (N=44;41;39;49;49)	23 Subjects
ActHIB Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-23F ≥ 0.05 µg/mL Month 10 (N=73;69;63;75;65)	63 Subjects
ActHIB Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-18C ≥ 0.05 µg/mL Month 10 (N=48;52;51;53;46)	45 Subjects
ActHIB Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-9V ≥ 0.05 µg/mL Month 5 (N=68;71;71;62;67)	66 Subjects
ActHIB Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-19F ≥ 0.2 µg/mL Month 10 (N=73;71;65;77;63)	45 Subjects
ActHIB Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-18C ≥ 0.2 µg/mL Day 0 (N=40;40;37;47;47)	10 Subjects
ActHIB Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-4 ≥ 0.2 µg/mL Day 0 (N=44;43;39;51;46)	2 Subjects
ActHIB Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-14 ≥ 0.2 µg/mL Month 10 (N=68;67;64;69;61)	60 Subjects
ActHIB Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-9V ≥ 0.05 µg/mL Day 0 (N=46;42;40;52;48)	18 Subjects
ActHIB Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-18C ≥ 0.05 µg/mL Day 0 (N=40;40;37;47;47)	25 Subjects
ActHIB Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-14 ≥ 0.05 µg/mL Month 10 (N=68;67;64;69;61)	61 Subjects
ActHIB Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-4 ≥ 0.2 µg/mL Month 5 (N=69;70;69;58;66)	66 Subjects
ActHIB Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-19F ≥ 0.05 µg/mL Day 0 (N=42;42;36;50;45))	28 Subjects
ActHIB Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-4 ≥ 0.2 µg/mL Month 10 (N=70;68;66;69;64)	53 Subjects
ActHIB Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-14 ≥ 0.05 µg/mL Day 0 (N=31;33;31;41;43)	39 Subjects
ActHIB Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-18C ≥ 0.2 µg/mL Month 5 (N=67;71;72;65;67)	65 Subjects
ActHIB Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-6B ≥ 0.2 µg/mL Day 0 (N=44;41;39;49;49)	8 Subjects
ActHIB Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-6B ≥ 0.05 µg/mL Month 10 (N=69;63;62;71;62)	55 Subjects
ActHIB Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-6B ≥ 0.2 µg/mL Month 5 (N=68;70;69;63;65)	56 Subjects
ActHIB Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-23F ≥ 0.2 µg/mL Month 10 (N=73;69;63;75;65)	52 Subjects
ActHIB Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-14 ≥ 0.05 µg/mL Month 5 (N=65;65;68;49;65)	65 Subjects
ActHIB Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-6B ≥ 0.2 µg/mL Month 10 (N=69;63;62;71;62)	42 Subjects
ActHIB Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-18C ≥ 0.05 µg/mL Month 5 (N=67;71;72;65;67)	66 Subjects
ActHIB Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-9V ≥ 0.2 µg/mL Day 0 (N=46;42;40;52;48)	8 Subjects
ActHIB Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-6B ≥ 0.05 µg/mL Month 5 (N=68;70;69;63;65)	60 Subjects
ActHIB Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-19F ≥ 0.2 µg/mL Month 5 (N=65;67;66;56;65)	63 Subjects
ActHIB Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-23F ≥ 0.2 µg/mL Day 0 (N=41;43;38;48;48)	8 Subjects
ActHIB Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-18C ≥ 0.2 µg/mL Month 10 (N=48;52;51;53;46)	42 Subjects
ActHIB Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-9V ≥ 0.2 µg/mL Month 5 (N=68;71;71;62;67)	66 Subjects
ActHIB Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-19F ≥ 0.05 µg/mL Month 10 (N=73;71;65;77;63)	61 Subjects
ActHIB Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-19F ≥ 0.05 µg/mL Month 5 (N=65;67;66;56;65)	65 Subjects
ActHIB Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-9V ≥ 0.2 µg/mL Month 10 (N=60;60;56;63;56)	56 Subjects
ActHIB Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-4 ≥ 0.05 µg/mL Month 5 (N=69;70;69;58;66)	66 Subjects
ActHIB Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-23F ≥ 0.2 µg/mL Month 5 (N=66;68;70;59;66)	62 Subjects
ActHIB Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-9V ≥ 0.05 µg/mL Month 10 (N=60;60;56;63;56)	56 Subjects
ActHIB Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-23F ≥ 0.05 µg/mL Day 0 (N=41;43;38;48;48)	22 Subjects
ActHIB Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-14 ≥ 0.2 µg/mL Day 0 (N=31;33;31;41;43)	30 Subjects
ActHIB Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-4 ≥ 0.05 µg/mL Day 0 (N=44;43;39;51;46)	10 Subjects
ActHIB Group	Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values	Anti-14 ≥ 0.2 µg/mL Month 5 (N=65;65;68;49;65)	64 Subjects

Secondary

Number of Subjects With Anti-polysaccharide C (PSC) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)

The cut-off concentration assessed was 30 micrograms per milliliter (µg/mL).

Arm	Measure	Group	Value (NUMBER)
MenHibrix Formulation 1 Group	Number of Subjects With Anti-polysaccharide C (PSC) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)	Day 0 (N= 54; 54; 49; 56; 56)	5 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-polysaccharide C (PSC) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)	Month 5 (N= 63; 65; 61; 62; 63)	63 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-polysaccharide C (PSC) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)	Month 10 (N= 63; 68; 61; 74; 67)	63 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-polysaccharide C (PSC) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)	Month 11 (N= 71; 70; 71; 76; 71)	71 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-polysaccharide C (PSC) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)	Day 0 (N= 54; 54; 49; 56; 56)	5 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-polysaccharide C (PSC) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)	Month 11 (N= 71; 70; 71; 76; 71)	70 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-polysaccharide C (PSC) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)	Month 5 (N= 63; 65; 61; 62; 63)	65 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-polysaccharide C (PSC) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)	Month 10 (N= 63; 68; 61; 74; 67)	68 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-polysaccharide C (PSC) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)	Month 11 (N= 71; 70; 71; 76; 71)	71 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-polysaccharide C (PSC) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)	Month 5 (N= 63; 65; 61; 62; 63)	61 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-polysaccharide C (PSC) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)	Month 10 (N= 63; 68; 61; 74; 67)	61 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-polysaccharide C (PSC) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)	Day 0 (N= 54; 54; 49; 56; 56)	6 Subjects
Menjugate Group	Number of Subjects With Anti-polysaccharide C (PSC) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)	Day 0 (N= 54; 54; 49; 56; 56)	5 Subjects
Menjugate Group	Number of Subjects With Anti-polysaccharide C (PSC) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)	Month 5 (N= 63; 65; 61; 62; 63)	62 Subjects
Menjugate Group	Number of Subjects With Anti-polysaccharide C (PSC) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)	Month 11 (N= 71; 70; 71; 76; 71)	76 Subjects
Menjugate Group	Number of Subjects With Anti-polysaccharide C (PSC) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)	Month 10 (N= 63; 68; 61; 74; 67)	74 Subjects
ActHIB Group	Number of Subjects With Anti-polysaccharide C (PSC) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)	Month 11 (N= 71; 70; 71; 76; 71)	69 Subjects
ActHIB Group	Number of Subjects With Anti-polysaccharide C (PSC) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)	Month 10 (N= 63; 68; 61; 74; 67)	1 Subjects
ActHIB Group	Number of Subjects With Anti-polysaccharide C (PSC) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)	Month 5 (N= 63; 65; 61; 62; 63)	1 Subjects
ActHIB Group	Number of Subjects With Anti-polysaccharide C (PSC) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)	Day 0 (N= 54; 54; 49; 56; 56)	4 Subjects

Secondary

Number of Subjects With Anti-polysaccharide Y (PSY) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)

The cut-off concentration assessed was 30 micrograms per milliliter (µg/mL).

Arm	Measure	Group	Value (NUMBER)
MenHibrix Formulation 1 Group	Number of Subjects With Anti-polysaccharide Y (PSY) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)	Day 0 (N= 51; 51; 47; 56; 54)	3 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-polysaccharide Y (PSY) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)	Month 5 (N= 67; 70; 72; 66; 69)	67 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-polysaccharide Y (PSY) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)	Month 10 (N= 70; 69; 71; 76; 67)	70 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-polysaccharide Y (PSY) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)	Month 11 (N= 69; 71; 71; 77; 71)	69 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-polysaccharide Y (PSY) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)	Day 0 (N= 51; 51; 47; 56; 54)	4 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-polysaccharide Y (PSY) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)	Month 11 (N= 69; 71; 71; 77; 71)	71 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-polysaccharide Y (PSY) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)	Month 5 (N= 67; 70; 72; 66; 69)	70 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-polysaccharide Y (PSY) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)	Month 10 (N= 70; 69; 71; 76; 67)	69 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-polysaccharide Y (PSY) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)	Month 11 (N= 69; 71; 71; 77; 71)	71 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-polysaccharide Y (PSY) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)	Month 5 (N= 67; 70; 72; 66; 69)	72 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-polysaccharide Y (PSY) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)	Month 10 (N= 70; 69; 71; 76; 67)	70 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-polysaccharide Y (PSY) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)	Day 0 (N= 51; 51; 47; 56; 54)	3 Subjects
Menjugate Group	Number of Subjects With Anti-polysaccharide Y (PSY) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)	Day 0 (N= 51; 51; 47; 56; 54)	7 Subjects
Menjugate Group	Number of Subjects With Anti-polysaccharide Y (PSY) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)	Month 5 (N= 67; 70; 72; 66; 69)	2 Subjects
Menjugate Group	Number of Subjects With Anti-polysaccharide Y (PSY) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)	Month 11 (N= 69; 71; 71; 77; 71)	70 Subjects
Menjugate Group	Number of Subjects With Anti-polysaccharide Y (PSY) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)	Month 10 (N= 70; 69; 71; 76; 67)	0 Subjects
ActHIB Group	Number of Subjects With Anti-polysaccharide Y (PSY) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)	Month 11 (N= 69; 71; 71; 77; 71)	64 Subjects
ActHIB Group	Number of Subjects With Anti-polysaccharide Y (PSY) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)	Month 10 (N= 70; 69; 71; 76; 67)	1 Subjects
ActHIB Group	Number of Subjects With Anti-polysaccharide Y (PSY) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)	Month 5 (N= 67; 70; 72; 66; 69)	0 Subjects
ActHIB Group	Number of Subjects With Anti-polysaccharide Y (PSY) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)	Day 0 (N= 51; 51; 47; 56; 54)	7 Subjects

Secondary

Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values

The cut-off concentrations assessed were 0.15 micrograms per milliliter (µg/mL) and 1 µg/mL.

Arm	Measure	Group	Value (NUMBER)
MenHibrix Formulation 1 Group	Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values	Day 0 ≥ 0.15 µg/mL (N= 68; 70; 67; 67; 73)	29 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values	Month 5 ≥ 0.15 µg/mL (N= 74; 76; 70; 74; 74)	74 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values	Month 10 ≥ 0.15 µg/mL (N= 70; 72; 73; 76; 70)	70 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values	Month 11 ≥ 0.15 µg/mL (N= 68; 73; 71; 79; 72)	68 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values	Day 0 ≥ 1 µg/mL (N= 68; 70; 67; 67; 73)	7 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values	Month 5 ≥ 1 µg/mL (N= 74; 76; 70; 74; 74)	72 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values	Month 10 ≥ 1 µg/mL (N= 70; 72; 73; 76; 70)	46 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values	Month 11 ≥ 1 µg/mL (N= 68; 73; 71; 79; 72)	67 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values	Month 10 ≥ 0.15 µg/mL (N= 70; 72; 73; 76; 70)	71 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values	Month 5 ≥ 1 µg/mL (N= 74; 76; 70; 74; 74)	75 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values	Day 0 ≥ 0.15 µg/mL (N= 68; 70; 67; 67; 73)	37 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values	Month 11 ≥ 0.15 µg/mL (N= 68; 73; 71; 79; 72)	72 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values	Month 5 ≥ 0.15 µg/mL (N= 74; 76; 70; 74; 74)	76 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values	Month 11 ≥ 1 µg/mL (N= 68; 73; 71; 79; 72)	69 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values	Day 0 ≥ 1 µg/mL (N= 68; 70; 67; 67; 73)	10 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values	Month 10 ≥ 1 µg/mL (N= 70; 72; 73; 76; 70)	42 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values	Month 10 ≥ 1 µg/mL (N= 70; 72; 73; 76; 70)	36 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values	Month 11 ≥ 1 µg/mL (N= 68; 73; 71; 79; 72)	65 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values	Month 11 ≥ 0.15 µg/mL (N= 68; 73; 71; 79; 72)	71 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values	Month 5 ≥ 1 µg/mL (N= 74; 76; 70; 74; 74)	65 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values	Month 10 ≥ 0.15 µg/mL (N= 70; 72; 73; 76; 70)	72 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values	Month 5 ≥ 0.15 µg/mL (N= 74; 76; 70; 74; 74)	70 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values	Day 0 ≥ 0.15 µg/mL (N= 68; 70; 67; 67; 73)	41 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values	Day 0 ≥ 1 µg/mL (N= 68; 70; 67; 67; 73)	6 Subjects
Menjugate Group	Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values	Month 5 ≥ 0.15 µg/mL (N= 74; 76; 70; 74; 74)	73 Subjects
Menjugate Group	Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values	Month 10 ≥ 0.15 µg/mL (N= 70; 72; 73; 76; 70)	71 Subjects
Menjugate Group	Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values	Month 11 ≥ 0.15 µg/mL (N= 68; 73; 71; 79; 72)	78 Subjects
Menjugate Group	Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values	Day 0 ≥ 1 µg/mL (N= 68; 70; 67; 67; 73)	6 Subjects
Menjugate Group	Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values	Month 5 ≥ 1 µg/mL (N= 74; 76; 70; 74; 74)	66 Subjects
Menjugate Group	Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values	Month 11 ≥ 1 µg/mL (N= 68; 73; 71; 79; 72)	57 Subjects
Menjugate Group	Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values	Day 0 ≥ 0.15 µg/mL (N= 68; 70; 67; 67; 73)	32 Subjects
Menjugate Group	Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values	Month 10 ≥ 1 µg/mL (N= 70; 72; 73; 76; 70)	39 Subjects
ActHIB Group	Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values	Month 11 ≥ 0.15 µg/mL (N= 68; 73; 71; 79; 72)	71 Subjects
ActHIB Group	Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values	Month 11 ≥ 1 µg/mL (N= 68; 73; 71; 79; 72)	58 Subjects
ActHIB Group	Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values	Month 10 ≥ 0.15 µg/mL (N= 70; 72; 73; 76; 70)	68 Subjects
ActHIB Group	Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values	Month 10 ≥ 1 µg/mL (N= 70; 72; 73; 76; 70)	41 Subjects
ActHIB Group	Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values	Day 0 ≥ 0.15 µg/mL (N= 68; 70; 67; 67; 73)	37 Subjects
ActHIB Group	Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values	Month 5 ≥ 1 µg/mL (N= 74; 76; 70; 74; 74)	70 Subjects
ActHIB Group	Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values	Month 5 ≥ 0.15 µg/mL (N= 74; 76; 70; 74; 74)	74 Subjects
ActHIB Group	Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values	Day 0 ≥ 1 µg/mL (N= 68; 70; 67; 67; 73)	8 Subjects

Secondary

Number of Subjects With rSBA-MenY Titers Greater Than or Equal to 1:8

The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.

Time frame: Prior to vaccination (Day 0), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.

Arm	Measure	Group	Value (NUMBER)
MenHibrix Formulation 1 Group	Number of Subjects With rSBA-MenY Titers Greater Than or Equal to 1:8	Month 10 (N= 69; 69; 70; 71; 68)	61 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With rSBA-MenY Titers Greater Than or Equal to 1:8	Day 0 (N= 68; 65; 58; 63; 66)	4 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With rSBA-MenY Titers Greater Than or Equal to 1:8	Month 11 (N= 68; 71; 70; 77; 71)	68 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With rSBA-MenY Titers Greater Than or Equal to 1:8	Month 10 (N= 69; 69; 70; 71; 68)	55 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With rSBA-MenY Titers Greater Than or Equal to 1:8	Day 0 (N= 68; 65; 58; 63; 66)	7 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With rSBA-MenY Titers Greater Than or Equal to 1:8	Month 11 (N= 68; 71; 70; 77; 71)	71 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With rSBA-MenY Titers Greater Than or Equal to 1:8	Month 10 (N= 69; 69; 70; 71; 68)	60 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With rSBA-MenY Titers Greater Than or Equal to 1:8	Day 0 (N= 68; 65; 58; 63; 66)	5 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With rSBA-MenY Titers Greater Than or Equal to 1:8	Month 11 (N= 68; 71; 70; 77; 71)	69 Subjects
Menjugate Group	Number of Subjects With rSBA-MenY Titers Greater Than or Equal to 1:8	Day 0 (N= 68; 65; 58; 63; 66)	9 Subjects
Menjugate Group	Number of Subjects With rSBA-MenY Titers Greater Than or Equal to 1:8	Month 11 (N= 68; 71; 70; 77; 71)	32 Subjects
Menjugate Group	Number of Subjects With rSBA-MenY Titers Greater Than or Equal to 1:8	Month 10 (N= 69; 69; 70; 71; 68)	17 Subjects
ActHIB Group	Number of Subjects With rSBA-MenY Titers Greater Than or Equal to 1:8	Month 10 (N= 69; 69; 70; 71; 68)	22 Subjects
ActHIB Group	Number of Subjects With rSBA-MenY Titers Greater Than or Equal to 1:8	Day 0 (N= 68; 65; 58; 63; 66)	4 Subjects
ActHIB Group	Number of Subjects With rSBA-MenY Titers Greater Than or Equal to 1:8	Month 11 (N= 68; 71; 70; 77; 71)	38 Subjects

Secondary

Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8

The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.

Time frame: Prior to vaccination (Day 0), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.

Arm	Measure	Group	Value (NUMBER)
MenHibrix Formulation 1 Group	Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8	Day 0 (N= 68; 66; 63; 66; 70)	2 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8	Month 11 (N= 69; 73; 71; 79; 66)	69 Subjects
MenHibrix Formulation 1 Group	Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8	Month 10 (N= 69; 71; 73; 74; 68)	67 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8	Month 10 (N= 69; 71; 73; 74; 68)	70 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8	Day 0 (N= 68; 66; 63; 66; 70)	6 Subjects
MenHibrix Formulation 2 Group	Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8	Month 11 (N= 69; 73; 71; 79; 66)	73 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8	Month 10 (N= 69; 71; 73; 74; 68)	70 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8	Day 0 (N= 68; 66; 63; 66; 70)	2 Subjects
MenHibrix Formulation 3 Group	Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8	Month 11 (N= 69; 73; 71; 79; 66)	71 Subjects
Menjugate Group	Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8	Day 0 (N= 68; 66; 63; 66; 70)	3 Subjects
Menjugate Group	Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8	Month 11 (N= 69; 73; 71; 79; 66)	77 Subjects
Menjugate Group	Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8	Month 10 (N= 69; 71; 73; 74; 68)	67 Subjects
ActHIB Group	Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8	Month 10 (N= 69; 71; 73; 74; 68)	6 Subjects
ActHIB Group	Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8	Day 0 (N= 68; 66; 63; 66; 70)	1 Subjects
ActHIB Group	Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8	Month 11 (N= 69; 73; 71; 79; 66)	18 Subjects

Secondary

Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers

Titers were presented as geometric mean titers (GMTs) expressed as the reciprocal of the dilution resulting in 50 percent inhibition.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
MenHibrix Formulation 1 Group	Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers	Day 0 (N= 68; 66; 63; 66; 70)	4.3 Titer
MenHibrix Formulation 1 Group	Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers	Month 5 (N= 69; 76; 72; 74; 76)	1293.1 Titer
MenHibrix Formulation 1 Group	Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers	Month 10 (N= 69; 71; 73; 74; 68)	260.5 Titer
MenHibrix Formulation 1 Group	Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers	Month 11 (N= 69; 73; 71; 79; 66)	1985.5 Titer
MenHibrix Formulation 2 Group	Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers	Day 0 (N= 68; 66; 63; 66; 70)	5.2 Titer
MenHibrix Formulation 2 Group	Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers	Month 11 (N= 69; 73; 71; 79; 66)	919.5 Titer
MenHibrix Formulation 2 Group	Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers	Month 5 (N= 69; 76; 72; 74; 76)	1065.6 Titer
MenHibrix Formulation 2 Group	Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers	Month 10 (N= 69; 71; 73; 74; 68)	214.2 Titer
MenHibrix Formulation 3 Group	Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers	Month 11 (N= 69; 73; 71; 79; 66)	1530.4 Titer
MenHibrix Formulation 3 Group	Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers	Month 5 (N= 69; 76; 72; 74; 76)	968.4 Titer
MenHibrix Formulation 3 Group	Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers	Month 10 (N= 69; 71; 73; 74; 68)	199.8 Titer
MenHibrix Formulation 3 Group	Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers	Day 0 (N= 68; 66; 63; 66; 70)	4.2 Titer
Menjugate Group	Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers	Day 0 (N= 68; 66; 63; 66; 70)	4.2 Titer
Menjugate Group	Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers	Month 5 (N= 69; 76; 72; 74; 76)	1931.9 Titer
Menjugate Group	Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers	Month 11 (N= 69; 73; 71; 79; 66)	774.8 Titer
Menjugate Group	Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers	Month 10 (N= 69; 71; 73; 74; 68)	170.8 Titer
ActHIB Group	Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers	Month 11 (N= 69; 73; 71; 79; 66)	9.0 Titer
ActHIB Group	Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers	Month 10 (N= 69; 71; 73; 74; 68)	4.9 Titer
ActHIB Group	Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers	Month 5 (N= 69; 76; 72; 74; 76)	4.2 Titer
ActHIB Group	Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers	Day 0 (N= 68; 66; 63; 66; 70)	4.1 Titer

Secondary

Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers

Titers were presented as geometric mean titers (GMTs) expressed as the reciprocal of the dilution resulting in 50 percent inhibition.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
MenHibrix Formulation 1 Group	Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers	Day 0 (N= 68; 65; 58; 63; 66)	4.6 Titer
MenHibrix Formulation 1 Group	Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers	Month 5 (N= 67; 68; 69; 68; 74)	843.5 Titer
MenHibrix Formulation 1 Group	Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers	Month 10 (N= 69; 69; 70; 71; 68)	114.5 Titer
MenHibrix Formulation 1 Group	Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers	Month 11 (N= 68; 71; 70; 77; 71)	1838.0 Titer
MenHibrix Formulation 2 Group	Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers	Day 0 (N= 68; 65; 58; 63; 66)	5.6 Titer
MenHibrix Formulation 2 Group	Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers	Month 11 (N= 68; 71; 70; 77; 71)	1539.8 Titer
MenHibrix Formulation 2 Group	Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers	Month 5 (N= 67; 68; 69; 68; 74)	1020.0 Titer
MenHibrix Formulation 2 Group	Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers	Month 10 (N= 69; 69; 70; 71; 68)	139.6 Titer
MenHibrix Formulation 3 Group	Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers	Month 11 (N= 68; 71; 70; 77; 71)	1653.8 Titer
MenHibrix Formulation 3 Group	Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers	Month 5 (N= 67; 68; 69; 68; 74)	741.8 Titer
MenHibrix Formulation 3 Group	Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers	Month 10 (N= 69; 69; 70; 71; 68)	129.9 Titer
MenHibrix Formulation 3 Group	Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers	Day 0 (N= 68; 65; 58; 63; 66)	5.1 Titer
Menjugate Group	Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers	Day 0 (N= 68; 65; 58; 63; 66)	6.3 Titer
Menjugate Group	Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers	Month 5 (N= 67; 68; 69; 68; 74)	6.9 Titer
Menjugate Group	Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers	Month 11 (N= 68; 71; 70; 77; 71)	18.8 Titer
Menjugate Group	Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers	Month 10 (N= 69; 69; 70; 71; 68)	10.0 Titer
ActHIB Group	Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers	Month 11 (N= 68; 71; 70; 77; 71)	32.0 Titer
ActHIB Group	Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers	Month 10 (N= 69; 69; 70; 71; 68)	13.4 Titer
ActHIB Group	Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers	Month 5 (N= 67; 68; 69; 68; 74)	7.3 Titer
ActHIB Group	Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers	Day 0 (N= 68; 65; 58; 63; 66)	4.9 Titer

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

Dose Ranging Study of Combined Haemophilus Influenzae Type B-Meningococcal Serogroups CY (Hib-MenCY-TT) Vaccine

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Brief summary

Related papers

Interventions

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Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

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Participant flow

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Number of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 1 Milligram Per Milliliter

Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8

Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers Greater Than or Equal to 1:8

Anti-diphtheria Antibody Concentrations

Anti- FHA Antibody Concentrations

Anti- HBs Antibody Concentrations

Anti-pneumococcal Antibody Concentrations

Anti-poliovirus Types 1, 2 and 3 Antibody Titers

Anti-polysaccharide C (PSC) Antibody Concentration

Anti-polysaccharide Y (PSY) Antibody Concentration

Anti-PRN Antibody Concentrations

Anti-PRP Antibody Concentration

Anti- PT Antibody Concentrations

Anti-tetanus Antibody Concentrations

Number of Subjects Reporting Serious Adverse Events After Administration of the Polysaccharide Challenge Dose

Number of Subjects Reporting Serious Adverse Events During the Primary Vaccination Course

Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose

Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course

Number of Subjects Reporting Unsolicited Adverse Events After Administration of the Polysaccharide Challenge Dose

Number of Subjects Reporting Unsolicited Adverse Events During the Primary Vaccination Course

Number of Subjects Seroprotected for Anti-diphtheria Antibodies

Number of Subjects Seroprotected for Anti-hepatitis B (HBs) Antibodies

Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies

Number of Subjects Seroprotected for Anti-tetanus Antibodies

Number of Subjects Seroseropositive for Anti-filamentus Haemagglutinin (FHA) Antibodies

Number of Subjects Seroseropositive for Anti-pertactin (PRN) Antibodies

Number of Subjects Seroseropositive for Anti-pertussis Toxoid (PT) Antibodies

Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values

Number of Subjects With Anti-polysaccharide C (PSC) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)

Number of Subjects With Anti-polysaccharide Y (PSY) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)

Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values

Number of Subjects With rSBA-MenY Titers Greater Than or Equal to 1:8

Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8

Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers

Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers