Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Meningococcal B Recombinant Vaccine When Administered Concomitantly With Routine Vaccines to Healthy Infants of 2 Months of Age and Older, in Taiwan.

A Phase 3, Open Label, Randomized, Controlled, Multi-Center Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Meningococcal B Recombinant Vaccine When Administered Concomitantly With Routine Vaccines to Healthy Infants in Taiwan.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02173704

Enrollment

225

Registered

2014-06-25

Start date

2014-09-11

Completion date

2016-06-17

Last updated

2020-08-25

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

Conditions

Meningococcal Disease, Infections, Meningococcal

Keywords

Meningitis, Infants, Meningococcal B Recombinant Vaccine

Brief summary

Assess the safety and immunogenicity of a 3-dose schedule (at 2, 4, 6 months) of GSK Biologicals' Meningococcal B recombinant vaccine followed by a booster at 12 months when concomitantly administered with routine vaccines in healthy infants in Taiwan.

Interventions

BIOLOGICALBexsero®

Four doses administered in the anterolateral area of the right or left thigh.

BIOLOGICALRoutine vaccines

Infanrix-IPV + Hib®, Prevenar-13®, Engerix-B®, Priorix® and Varilrix® administered in the anterolateral area of the right or left thigh.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

55 Days to 89 Days

Healthy volunteers

Yes

Inclusion criteria

1. healthy 2-month old infants (55-89 days, inclusive), who were born after full term pregnancy with an estimated gestational age ≥ 37 weeks and a birth weight ≥ 2.5 kg; 2. for whom a parent/legal guardian has given written informed consent after the nature of the study has been explained; 3. available for all the visits scheduled in the study; 4. in good health as determined by medical history, physical examination and clinical judgment of the investigator.

Exclusion criteria

1. History of any meningococcal vaccine administration; 2. Prior vaccination with any Diphtheria, Tetanus, Pertussis (acellular or whole cell), Polio (either Inactivated or Oral), Haemophilus influenzae type b (Hib), Pneumococcal, MMR or varicella antigens; 3. Previous ascertained or suspected disease caused by N. meningitidis; 4. Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis; 5. History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component; 6. Significant acute or chronic infection within the previous 7 days or body temperature higher or equal to 38C degrees within the previous day; 7. Antibiotics within 6 days prior to enrollment; 8. Any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, insulin dependent diabetes mellitus Type I, cardiac disease, hepatic disease, progressive neurological disease or seizure, either associated with fever or as part of an underlying neurological disorder or syndrome, autoimmune disease, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition); 9. Known or suspected impairment/alteration of the immune system, immunosuppressive therapy, use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids since birth; 10. Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation; 11. Receipt of, or intent to immunize with any other vaccine(s) (with the exception of rotavirus vaccine, influenza vaccine and second HepB vaccine), within 28 days prior and throughout the study period. Furthermore, subjects must have received HepB vaccine preferably at 0, 1 month of age, with the second dose at least 14 days prior to study vaccination. Influenza vaccine should be administered at least 14 days before or 14 days after study vaccination; Rotavirus vaccine may be administered during the study as per local practice. 12. Participation in another clinical trial since birth or planned for during study; 13. Family members and household members of research staff; 14. Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Subjects With Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B Strains	At Day 1 and at one month after the third vaccination (Day 152)	Percentage of subjects with hSBA titer ≥ 1:5 at 1 month following the third vaccination (at 7 months of age) against the indicator strains H44/76, 5/99, NZ98/254 and strain M10713 when Bexsero® was given concomitantly with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13® and Engerix-B®).
Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 1:4 Against Neisseria Meningitidis Serogroup B Strains	At Day 1 and at one month after third vaccination (Day 152)	Percentage of subjects with hSBA titer ≥ 1:4 at 1 month after third vaccination (at 7 months of age) against the indicator strains H44/76, 5/99, NZ98/254 and strain M10713 when Bexsero® was given concomitantly with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13® and Engerix-B®).

Secondary

Measure	Time frame	Description
hSBA Geometric Mean Ratios (GMRs) Against Neisseria Meningitidis Serogroup B Strains.	At Day 1, Day 152, Day 305 and Day 335	GMRs of post-vaccination versus pre-vaccination of hSBA titer against the indicator strains H44/76, 5/99, NZ98/254 and strain M10713 were evaluated at one month after the third vaccination with Bexsero® vaccine and concomitant routine vaccines (Infanrix-IPV+Hib®, Prevenar-13® and Engerix®) (Day 152) compared to baseline (Day 1) or at one month after the booster dose of Bexsero® vaccine with routine vaccines (Priorix®, Varilrix®) (Day 335) compared to prior to the booster dose (Day 305).
Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines	At Day 1,Day 152,Day 305, Day 335	Percentages of subjects with hSBA titers ≥1:8 against N.meningitidis serogroup B strains, at one month after concomitant administration of third primary dose of Bexsero® with routine vaccines \[Infanrix-IPV + Hib®, Prevenar-13® and Engerix-B®\] and at one month after concomitant administration of Bexsero® booster dose with routine vaccines \[Priorix® and Varilrix® vaccine\],as compared to when only routine vaccines were administered.
Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	From day 1 (6 hours) to day 7 after each vaccination (1st, 2nd, 3rd and 4th vaccination)	Number of subjects reporting solicited local AEs following concomitant administration of Bexsero® vaccine with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13® and Engerix-B® at 2, 4 and 6 months of age and Priorix® and Varilrix® at 12 months of age)compared to when only routine vaccines were administered alone at 2,4,6 and 12 months. Solicited local symptoms assessed were Erythema, Induration, Swelling and Tenderness.
Percentage of Subjects With hSBA Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B, When Bexsero® Booster Was Given With Routine Vaccines (Priorix® + Varilrix® Vaccines)	At Day 305 and Day 335	Percentage of subjects with hSBA titer ≥ 1:5 before booster vaccination and after booster vaccination when Bexsero® booster dose was given with routine vaccines (Priorix® + Varilrix® vaccine) as compared to when only routine vaccines were administered.
Number of Subjects Reporting Solicited Systemic AEs After Receiving Priorix® and Varilrix® Routine Vaccines (With and Without Bexsero® Vaccine) at 12 Months of Age.	From Day 1 to Day 28 after vaccination	Number of subjects who reported solicited systemic AEs reported after the administration of Varilrix® and Priorix® vaccines (with and without Bexsero® vaccine) at 12 months of age. Solicited systemic AEs assessed were Rash, Lymphadenopathy and Fever. This analysis was conducted for a prolonged period of 28 Days following Varilrix® and Priorix® administration.
Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination With Routine Vaccines	From day 1 to day 7 after each vaccination	Number of subjects reporting any unsolicited AEs following concomitant administration of Bexsero® vaccine with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13®, Engerix-B® or Priorix® and Varilrix®) compared to when only routine vaccines were administered alone.
Number of Subjects Reporting Serious Adverse Events (SAEs), Medically Attended AEs (MAEs) and AEs Leading to Premature Withdrawal and Death and AEs Leading to Hospitalization.	Throughout the study period (Day 1 to Day 335)	Number of subjects reporting SAEs, medically attended AEs and AEs leading to premature withdrawal from the study and leading to death and AEs leading to hospitalization following concomitant administration of Bexsero® vaccine with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13®, Engerix-B®, Priorix® and Varilrix®) compared to when only routine vaccines were administered alone. SAEs assessed included medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Possibly or probably related SAE were SAEs assessed by the investigator as related to the vaccination. Medically attended AEs were events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason.
Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	From day 1 (6 hours) to day 7 after each vaccination	Number of subjects reporting solicited systemic AEs following concomitant administration of Bexsero® vaccine with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13® and Engerix-B® at 2, 4 and 6 months of age and Priorix® and Varilrix® at 12 months of age) compared to when only routine vaccines were alone, at 2, 4, 6 and 12 months. Systemic solicited symptoms assessed were Change in Eating Habits, Diarrhea, Irritability, Persistent Crying, Rash, Sleepiness, Vomiting and Fever (body temperature ≥ 38.0 °C)
hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines	At Day 1, Day 152, Day 305 and Day 335	hSBA GMTs against the indicator strains H44/76, 5/99, NZ98/254 and strain M10713 was evaluated at baseline (2 months of age, Day 1), 1 month after the third vaccination with Bexsero® with concomitant routine vaccines (Infanrix-IPV+Hib®, Prevenar-13®, Engerix®) (7 months of age, Day 152) or prior to the booster dose of Bexsero® with routine vaccines (Priorix®, Varilrix®) (12 months of age, Day 305) and 1 month after the booster dose (13 months of age, Day 335), as compared to when only routine vaccines were administered.

Countries

Taiwan

Participant flow

Recruitment details

Subjects were recruited from 2 sites in Taiwan

Pre-assignment details

All subjects were enrolled

Participants by arm

Arm	Count
Bexsero + Routine Group Subjects received three doses of Bexsero® vaccine at 2, 4, 6 months followed by a booster dose at 12 months, concomitantly administered with routine vaccines (i.e. combined Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® at 6 months of age; Priorix® and Varilrix® at 12 months of age.	150
Routine Group Subjects received routine vaccines Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® vaccine at 6 months; Priorix® and Varilrix® vaccines at 12 months of age.	75
Total	225

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	1	0
Overall Study	Lost to Follow-up	1	0
Overall Study	Other	1	0
Overall Study	Protocol Violation	1	0
Overall Study	Withdrawal by Subject	9	4

Baseline characteristics

Characteristic	Bexsero + Routine Group	Routine Group	Total
Age, Continuous	67.9 Days STANDARD_DEVIATION 6.46	68.9 Days STANDARD_DEVIATION 6.86	68.3 Days STANDARD_DEVIATION 6.6
Sex: Female, Male Female	82 Participants	27 Participants	109 Participants
Sex: Female, Male Male	68 Participants	48 Participants	116 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 148	0 / 73
other Total, other adverse events	148 / 148	72 / 73
serious Total, serious adverse events	13 / 145	8 / 72

Outcome results

Primary

Percentage of Subjects With Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B Strains

Percentage of subjects with hSBA titer ≥ 1:5 at 1 month following the third vaccination (at 7 months of age) against the indicator strains H44/76, 5/99, NZ98/254 and strain M10713 when Bexsero® was given concomitantly with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13® and Engerix-B®).

Time frame: At Day 1 and at one month after the third vaccination (Day 152)

Population: Analysis was done on Full Analysis Population (FAS) population day 152, which included all subjects in the exposed set who received at least one dose of a study vaccination and provided immunogenicity data at relevant time points.

Arm	Measure	Group	Value (NUMBER)
Bexsero + Routine Group	Percentage of Subjects With Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B Strains	M10713 strain [Day 1]	10 Percentages of subjects
Bexsero + Routine Group	Percentage of Subjects With Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B Strains	H44/76 strain [Day 1]	0 Percentages of subjects
Bexsero + Routine Group	Percentage of Subjects With Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B Strains	NZ98/254 strain [Day 1]	0 Percentages of subjects
Bexsero + Routine Group	Percentage of Subjects With Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B Strains	H44/76 strain [Day 152]	100 Percentages of subjects
Bexsero + Routine Group	Percentage of Subjects With Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B Strains	M10713 strain [Day 152]	59 Percentages of subjects
Bexsero + Routine Group	Percentage of Subjects With Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B Strains	5/99 strain [Day 1]	1 Percentages of subjects
Bexsero + Routine Group	Percentage of Subjects With Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B Strains	NZ98/254 strain [Day 152]	79 Percentages of subjects
Bexsero + Routine Group	Percentage of Subjects With Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B Strains	5/99 strain [Day 152]	100 Percentages of subjects
Routine Group	Percentage of Subjects With Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B Strains	NZ98/254 strain [Day 152]	0 Percentages of subjects
Routine Group	Percentage of Subjects With Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B Strains	M10713 strain [Day 1]	19 Percentages of subjects
Routine Group	Percentage of Subjects With Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B Strains	M10713 strain [Day 152]	8 Percentages of subjects
Routine Group	Percentage of Subjects With Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B Strains	NZ98/254 strain [Day 1]	0 Percentages of subjects
Routine Group	Percentage of Subjects With Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B Strains	5/99 strain [Day 152]	0 Percentages of subjects
Routine Group	Percentage of Subjects With Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B Strains	H44/76 strain [Day 1]	0 Percentages of subjects
Routine Group	Percentage of Subjects With Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B Strains	H44/76 strain [Day 152]	0 Percentages of subjects
Routine Group	Percentage of Subjects With Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B Strains	5/99 strain [Day 1]	1 Percentages of subjects

Comparison: Statistical analysis 5/99 strain: The power to reject the null hypothesis associated with the primary objective for strain 5/99 was 99%.95% CI: [97.2, 100]Exact test of binomial proportion

Comparison: Statistical analysis NZ98/254 strain: The power to reject the null hypothesis associated with the primary objective for strain NZ98/25 was 94%.95% CI: [71.4, 85.8]Exact test of binomial proportion

Primary

Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 1:4 Against Neisseria Meningitidis Serogroup B Strains

Percentage of subjects with hSBA titer ≥ 1:4 at 1 month after third vaccination (at 7 months of age) against the indicator strains H44/76, 5/99, NZ98/254 and strain M10713 when Bexsero® was given concomitantly with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13® and Engerix-B®).

Time frame: At Day 1 and at one month after third vaccination (Day 152)

Population: Analysis was done on Full Analysis Set (FAS) population day 152. The FAS population included all subjects in the exposed set who received at least one dose of a study vaccination and provided immunogenicity data at relevant time points.

Arm	Measure	Group	Value (NUMBER)
Bexsero + Routine Group	Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 1:4 Against Neisseria Meningitidis Serogroup B Strains	H44/76 strain [Day 1]	0 Percentage of subjects
Bexsero + Routine Group	Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 1:4 Against Neisseria Meningitidis Serogroup B Strains	H44/76 strain [Day 152]	100 Percentage of subjects
Bexsero + Routine Group	Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 1:4 Against Neisseria Meningitidis Serogroup B Strains	5/99 strain [Day 1]	1 Percentage of subjects
Bexsero + Routine Group	Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 1:4 Against Neisseria Meningitidis Serogroup B Strains	5/99 strain [Day 152]	100 Percentage of subjects
Bexsero + Routine Group	Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 1:4 Against Neisseria Meningitidis Serogroup B Strains	M10713 strain [Day 1]	11 Percentage of subjects
Bexsero + Routine Group	Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 1:4 Against Neisseria Meningitidis Serogroup B Strains	M10713 strain [Day 152]	71 Percentage of subjects
Bexsero + Routine Group	Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 1:4 Against Neisseria Meningitidis Serogroup B Strains	NZ98/254 strain [Day 1]	0 Percentage of subjects
Bexsero + Routine Group	Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 1:4 Against Neisseria Meningitidis Serogroup B Strains	NZ98/254 strain [Day 152]	87 Percentage of subjects
Routine Group	Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 1:4 Against Neisseria Meningitidis Serogroup B Strains	NZ98/254 strain [Day 152]	0 Percentage of subjects
Routine Group	Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 1:4 Against Neisseria Meningitidis Serogroup B Strains	H44/76 strain [Day 1]	0 Percentage of subjects
Routine Group	Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 1:4 Against Neisseria Meningitidis Serogroup B Strains	M10713 strain [Day 1]	25 Percentage of subjects
Routine Group	Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 1:4 Against Neisseria Meningitidis Serogroup B Strains	H44/76 strain [Day 152]	0 Percentage of subjects
Routine Group	Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 1:4 Against Neisseria Meningitidis Serogroup B Strains	NZ98/254 strain [Day 1]	0 Percentage of subjects
Routine Group	Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 1:4 Against Neisseria Meningitidis Serogroup B Strains	5/99 strain [Day 1]	1 Percentage of subjects
Routine Group	Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 1:4 Against Neisseria Meningitidis Serogroup B Strains	M10713 strain [Day 152]	8 Percentage of subjects
Routine Group	Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 1:4 Against Neisseria Meningitidis Serogroup B Strains	5/99 strain [Day 152]	0 Percentage of subjects

Secondary

hSBA Geometric Mean Ratios (GMRs) Against Neisseria Meningitidis Serogroup B Strains.

GMRs of post-vaccination versus pre-vaccination of hSBA titer against the indicator strains H44/76, 5/99, NZ98/254 and strain M10713 were evaluated at one month after the third vaccination with Bexsero® vaccine and concomitant routine vaccines (Infanrix-IPV+Hib®, Prevenar-13® and Engerix®) (Day 152) compared to baseline (Day 1) or at one month after the booster dose of Bexsero® vaccine with routine vaccines (Priorix®, Varilrix®) (Day 335) compared to prior to the booster dose (Day 305).

Time frame: At Day 1, Day 152, Day 305 and Day 335

Population: Analysis was performed on the FAS population, which included all subjects in the exposed set who received at least one dose of a study vaccination and provided immunogenicity data at relevant time points.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Bexsero + Routine Group	hSBA Geometric Mean Ratios (GMRs) Against Neisseria Meningitidis Serogroup B Strains.	M10713 strain [Day 152/Day 1]	5.69 Ratio
Bexsero + Routine Group	hSBA Geometric Mean Ratios (GMRs) Against Neisseria Meningitidis Serogroup B Strains.	H44/76 strain [Day 152/Day 1]	71 Ratio
Bexsero + Routine Group	hSBA Geometric Mean Ratios (GMRs) Against Neisseria Meningitidis Serogroup B Strains.	M10713 strain [Day 335/Day 305]	12 Ratio
Bexsero + Routine Group	hSBA Geometric Mean Ratios (GMRs) Against Neisseria Meningitidis Serogroup B Strains.	5/99 strain [Day 152/Day 1]	875 Ratio
Bexsero + Routine Group	hSBA Geometric Mean Ratios (GMRs) Against Neisseria Meningitidis Serogroup B Strains.	NZ98/254 strain [Day 152/Day 1]	9.18 Ratio
Bexsero + Routine Group	hSBA Geometric Mean Ratios (GMRs) Against Neisseria Meningitidis Serogroup B Strains.	5/99 strain [Day 335/Day 305]	2110 Ratio
Bexsero + Routine Group	hSBA Geometric Mean Ratios (GMRs) Against Neisseria Meningitidis Serogroup B Strains.	NZ98/254 strain [Day 335/Day 305]	25 Ratio
Bexsero + Routine Group	hSBA Geometric Mean Ratios (GMRs) Against Neisseria Meningitidis Serogroup B Strains.	H44/76 strain [Day 335/Day 305]	155 Ratio
Routine Group	hSBA Geometric Mean Ratios (GMRs) Against Neisseria Meningitidis Serogroup B Strains.	NZ98/254 strain [Day 335/Day 305]	1 Ratio
Routine Group	hSBA Geometric Mean Ratios (GMRs) Against Neisseria Meningitidis Serogroup B Strains.	H44/76 strain [Day 152/Day 1]	0.99 Ratio
Routine Group	hSBA Geometric Mean Ratios (GMRs) Against Neisseria Meningitidis Serogroup B Strains.	H44/76 strain [Day 335/Day 305]	1.07 Ratio
Routine Group	hSBA Geometric Mean Ratios (GMRs) Against Neisseria Meningitidis Serogroup B Strains.	5/99 strain [Day 335/Day 305]	0.97 Ratio
Routine Group	hSBA Geometric Mean Ratios (GMRs) Against Neisseria Meningitidis Serogroup B Strains.	M10713 strain [Day 152/Day 1]	0.68 Ratio
Routine Group	hSBA Geometric Mean Ratios (GMRs) Against Neisseria Meningitidis Serogroup B Strains.	M10713 strain [Day 335/Day 305]	0.91 Ratio
Routine Group	hSBA Geometric Mean Ratios (GMRs) Against Neisseria Meningitidis Serogroup B Strains.	NZ98/254 strain [Day 152/Day 1]	1.02 Ratio
Routine Group	hSBA Geometric Mean Ratios (GMRs) Against Neisseria Meningitidis Serogroup B Strains.	5/99 strain [Day 152/Day 1]	0.97 Ratio

Secondary

hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines

hSBA GMTs against the indicator strains H44/76, 5/99, NZ98/254 and strain M10713 was evaluated at baseline (2 months of age, Day 1), 1 month after the third vaccination with Bexsero® with concomitant routine vaccines (Infanrix-IPV+Hib®, Prevenar-13®, Engerix®) (7 months of age, Day 152) or prior to the booster dose of Bexsero® with routine vaccines (Priorix®, Varilrix®) (12 months of age, Day 305) and 1 month after the booster dose (13 months of age, Day 335), as compared to when only routine vaccines were administered.

Time frame: At Day 1, Day 152, Day 305 and Day 335

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Bexsero + Routine Group	hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines	H44/76 strain [Day 1]	1.01 Titer
Bexsero + Routine Group	hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines	H44/76 strain [Day 152]	72 Titer
Bexsero + Routine Group	hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines	H44/76 strain [Day 305]	11 Titer
Bexsero + Routine Group	hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines	H44/76 strain [Day 335]	157 Titer
Bexsero + Routine Group	hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines	5/99 strain [Day 1]	1.08 Titer
Bexsero + Routine Group	hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines	5/99 strain [Day 152]	963 Titer
Bexsero + Routine Group	hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines	5/99 strain [Day 305]	205 Titer
Bexsero + Routine Group	hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines	5/99 strain [Day 335]	2315 Titer
Bexsero + Routine Group	hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines	M10713 strain [Day 1]	1.36 Titer
Bexsero + Routine Group	hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines	M10713 strain [Day 152]	8.41 Titer
Bexsero + Routine Group	hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines	M10713 strain [Day 305]	2.18 Titer
Bexsero + Routine Group	hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines	M10713 strain [Day 335]	17 Titer
Bexsero + Routine Group	hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines	NZ98/254 strain [Day 1]	1.01 Titer
Bexsero + Routine Group	hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines	NZ98/254 strain [Day 152]	9.2 Titer
Bexsero + Routine Group	hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines	NZ98/254 strain [Day 305]	1.91 Titer
Bexsero + Routine Group	hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines	NZ98/254 strain [Day 335]	26 Titer
Routine Group	hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines	NZ98/254 strain [Day 335]	1 Titer
Routine Group	hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines	H44/76 strain [Day 1]	1.02 Titer
Routine Group	hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines	M10713 strain [Day 1]	1.75 Titer
Routine Group	hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines	H44/76 strain [Day 152]	1.01 Titer
Routine Group	hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines	NZ98/254 strain [Day 1]	1 Titer
Routine Group	hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines	H44/76 strain [Day 305]	1.26 Titer
Routine Group	hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines	M10713 strain [Day 152]	1.25 Titer
Routine Group	hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines	H44/76 strain [Day 335]	1.1 Titer
Routine Group	hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines	NZ98/254 strain [Day 305]	1.04 Titer
Routine Group	hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines	5/99 strain [Day 1]	1.03 Titer
Routine Group	hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines	M10713 strain [Day 305]	1.6 Titer
Routine Group	hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines	5/99 strain [Day 152]	1 Titer
Routine Group	hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines	NZ98/254 strain [Day 152]	1.02 Titer
Routine Group	hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines	5/99 strain [Day 305]	1.1 Titer
Routine Group	hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines	M10713 strain [Day 335]	1.58 Titer
Routine Group	hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines	5/99 strain [Day 335]	1 Titer

Secondary

Number of Subjects Reporting Serious Adverse Events (SAEs), Medically Attended AEs (MAEs) and AEs Leading to Premature Withdrawal and Death and AEs Leading to Hospitalization.

Number of subjects reporting SAEs, medically attended AEs and AEs leading to premature withdrawal from the study and leading to death and AEs leading to hospitalization following concomitant administration of Bexsero® vaccine with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13®, Engerix-B®, Priorix® and Varilrix®) compared to when only routine vaccines were administered alone. SAEs assessed included medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Possibly or probably related SAE were SAEs assessed by the investigator as related to the vaccination. Medically attended AEs were events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason.

Time frame: Throughout the study period (Day 1 to Day 335)

Population: Analysis was done on Safety set population (unsolicited AEs). The safety set population (unsolicited AEs) included all subjects in the Exposed Population who had postvaccination unsolicited AE records.

Arm	Measure	Group	Value (NUMBER)
Bexsero + Routine Group	Number of Subjects Reporting Serious Adverse Events (SAEs), Medically Attended AEs (MAEs) and AEs Leading to Premature Withdrawal and Death and AEs Leading to Hospitalization.	Medically attended AEs	131 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Serious Adverse Events (SAEs), Medically Attended AEs (MAEs) and AEs Leading to Premature Withdrawal and Death and AEs Leading to Hospitalization.	AEs leading to death	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Serious Adverse Events (SAEs), Medically Attended AEs (MAEs) and AEs Leading to Premature Withdrawal and Death and AEs Leading to Hospitalization.	Any SAEs	13 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Serious Adverse Events (SAEs), Medically Attended AEs (MAEs) and AEs Leading to Premature Withdrawal and Death and AEs Leading to Hospitalization.	At least possible related SAEs	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Serious Adverse Events (SAEs), Medically Attended AEs (MAEs) and AEs Leading to Premature Withdrawal and Death and AEs Leading to Hospitalization.	AEs resulting in premature withdrawal	4 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Serious Adverse Events (SAEs), Medically Attended AEs (MAEs) and AEs Leading to Premature Withdrawal and Death and AEs Leading to Hospitalization.	AEs leading to hospitalization	13 Number of participants
Routine Group	Number of Subjects Reporting Serious Adverse Events (SAEs), Medically Attended AEs (MAEs) and AEs Leading to Premature Withdrawal and Death and AEs Leading to Hospitalization.	AEs resulting in premature withdrawal	0 Number of participants
Routine Group	Number of Subjects Reporting Serious Adverse Events (SAEs), Medically Attended AEs (MAEs) and AEs Leading to Premature Withdrawal and Death and AEs Leading to Hospitalization.	Medically attended AEs	66 Number of participants
Routine Group	Number of Subjects Reporting Serious Adverse Events (SAEs), Medically Attended AEs (MAEs) and AEs Leading to Premature Withdrawal and Death and AEs Leading to Hospitalization.	At least possible related SAEs	0 Number of participants
Routine Group	Number of Subjects Reporting Serious Adverse Events (SAEs), Medically Attended AEs (MAEs) and AEs Leading to Premature Withdrawal and Death and AEs Leading to Hospitalization.	AEs leading to death	0 Number of participants
Routine Group	Number of Subjects Reporting Serious Adverse Events (SAEs), Medically Attended AEs (MAEs) and AEs Leading to Premature Withdrawal and Death and AEs Leading to Hospitalization.	AEs leading to hospitalization	8 Number of participants
Routine Group	Number of Subjects Reporting Serious Adverse Events (SAEs), Medically Attended AEs (MAEs) and AEs Leading to Premature Withdrawal and Death and AEs Leading to Hospitalization.	Any SAEs	8 Number of participants

Secondary

Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.

Number of subjects reporting solicited local AEs following concomitant administration of Bexsero® vaccine with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13® and Engerix-B® at 2, 4 and 6 months of age and Priorix® and Varilrix® at 12 months of age)compared to when only routine vaccines were administered alone at 2,4,6 and 12 months. Solicited local symptoms assessed were Erythema, Induration, Swelling and Tenderness.

Time frame: From day 1 (6 hours) to day 7 after each vaccination (1st, 2nd, 3rd and 4th vaccination)

Population: Analysis was done on Safety set population (solicited AEs).The safety set population (solicited AEs) included all subjects in the Exposed Population who provided postvaccination reactogenicity data.

Arm	Measure	Group	Value (NUMBER)
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Erythema (4th Priorix®)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Tenderness (2nd Infanrix-IPV + Hib®)	45 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Swelling (3rd Infanrix-IPV+Hib®)	20 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Tenderness (4th Priorix®)	37 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Erythema (4th Varilrix®)	32 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Erythema (4th Varilrix®)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Induration (4th Varilrix®)	14 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Swelling (4th Varilrix®)	21 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Swelling (4th Varilrix®)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Tenderness (4th Varilrix®)	41 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Tenderness (4th Varilrix®)	3 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3Induration(1st Infanrix-IPV+Hib®)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Erythema (1st Prevenar-13®)	26 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Erythema (1st Prevenar-13®)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Induration (1st Prevenar-13®)	29 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Induration (1st Prevenar-13®)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Swelling (1st Prevenar-13®)	11 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Swelling (1st Prevenar-13®)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Tenderness (1st Prevenar-13®)	50 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Tenderness (1st Prevenar-13®)	3 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Erythema (2nd Bexsero®)	59 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Erythema (2nd Bexsero®)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Swelling (2nd Bexsero®)	35 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Swelling (2nd Bexsero®)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Induration (2nd Bexsero®)	51 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Induration (2nd Bexsero®)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Tenderness (2nd Bexsero®)	67 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Tenderness (2nd Bexsero®)	5 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Erythema (2nd Infanrix-IPV + Hib®)	39 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Erythema(2nd Infanrix-IPV+Hib®)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Swelling (2nd Infanrix-IPV + Hib®)	18 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Swelling(2nd Infanrix-IPV+Hib®)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Erythema (1st Bexsero®)	54 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Erythema (1st Bexsero®)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Swelling (1st Bexsero®)	34 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Swelling (1st Bexsero®)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Induration (1st Bexsero®)	63 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Induration (1st Bexsero®)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Tenderness (1st Bexsero®)	8 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Erythema (1st Infanrix-IPV + Hib®)	26 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Erythema(1st Infanrix-IPV+Hib®)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Swelling (1st Infanrix-IPV + Hib®)	15 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Swelling(1st Infanrix-IPV+Hib®)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Tenderness (1st Infanrix-IPV + Hib®)	45 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3Tenderness(1st Infanrix-IPV+Hib®)	2 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Induration(1st Infanrix-IPV + Hib®)	23 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Induration (2nd Infanrix-IPV + Hib®)	23 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3Induration(2nd Infanrix-IPV+Hib®)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3Tenderness(2nd Infanrix-IPV+Hib®)	3 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Erythema (2nd Prevenar-13®)	35 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Erythema (2nd Prevenar-13®)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Induration (2nd Prevenar-13®)	18 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Induration (2nd Prevenar-13®)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Swelling (2nd Prevenar-13®)	12 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Swelling (2nd Prevenar-13®)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Tenderness (2nd Prevenar-13®)	44 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Tenderness (2nd Prevenar-13®)	3 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Erythema (3rd Engerix-B®)	33 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Erythema (3rd Engerix-B®)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Induration (3rd Engerix-B®)	33 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Induration (3rd Engerix-B®)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Swelling (3rd Engerix-B®)	25 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Swelling (3rd Engerix-B®)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Tenderness (3rd Engerix-B®)	45 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Tenderness (3rd Engerix-B®)	3 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Erythema (3rd Bexsero®)	55 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Erythema (3rd Bexsero®)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Induration (3rd Bexsero®)	57 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Induration (3rd Bexsero®)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Swelling (3rd Bexsero®)	49 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Swelling (3rd Bexsero®)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Tenderness (3rd Bexsero®)	68 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Tenderness (3rd Bexsero®)	6 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Tenderness (4th Priorix®)	3 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Induration (4th Varilrix®)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Swelling (3rd Infanrix-IPV+Hib®)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Erythema (3rd Infanrix-IPV+Hib®)	28 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Erythema (3rd Infanrix-IPV+Hib®)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Induration(3rd Infanrix-IPV+Hib®)	25 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3Induration(3rd Infanrix-IPV+Hib®)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Tenderness (3rd Infanrix-IPV+ Hib®)	42 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3Tenderness(3rd Infanrix-IPV+Hib®)	2 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Erythema (3rd Prevenar-13®)	27 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Erythema (3rd Prevenar-13®)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Induration (3rd Prevenar-13®)	21 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Induration (3rd Prevenar-13®)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Swelling (3rd Prevenar-13®)	17 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Swelling (3rd Prevenar-13®)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Tenderness (3rd Prevenar-13®)	45 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Tenderness (3rd Prevenar-13®)	3 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Erythema (4th Bexsero®)	53 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Erythema (4th Bexsero®)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Swelling (4th Bexsero®)	44 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Swelling (4th Bexsero®)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Induration (4th Bexsero®)	56 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Induration(4th Bexsero®)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Tenderness (4th Bexsero®)	66 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Tenderness (4th Bexsero®)	6 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Erythema (4th Priorix®)	24 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Tenderness (1st Bexsero®)	75 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Induration (4th Priorix®)	15 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Induration (4th Priorix®)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Swelling (4th Priorix®)	19 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Swelling (4th Priorix®)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Swelling (3rd Infanrix-IPV+Hib®)	10 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Swelling (2nd Prevenar-13®)	6 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Swelling (3rd Infanrix-IPV+Hib®)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Erythema (1st Prevenar-13®)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Erythema (3rd Infanrix-IPV+Hib®)	15 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Erythema(1st Infanrix-IPV+Hib®)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Erythema (3rd Infanrix-IPV+Hib®)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Induration (1st Prevenar-13®)	15 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Induration(3rd Infanrix-IPV+Hib®)	16 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Induration (3rd Engerix-B®)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3Induration(3rd Infanrix-IPV+Hib®)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Induration (1st Prevenar-13®)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Tenderness (3rd Infanrix-IPV+ Hib®)	8 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Swelling (1st Infanrix-IPV + Hib®)	3 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3Tenderness(3rd Infanrix-IPV+Hib®)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Swelling (1st Prevenar-13®)	4 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Erythema (3rd Prevenar-13®)	12 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Swelling (2nd Prevenar-13®)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Erythema (3rd Prevenar-13®)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Swelling (1st Prevenar-13®)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Induration (3rd Prevenar-13®)	11 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Swelling(1st Infanrix-IPV+Hib®)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Induration (3rd Prevenar-13®)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Tenderness (1st Prevenar-13®)	12 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Swelling (3rd Prevenar-13®)	4 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Tenderness (4th Priorix®)	6 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Swelling (3rd Prevenar-13®)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Tenderness (1st Prevenar-13®)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Tenderness (3rd Prevenar-13®)	9 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Tenderness (1st Infanrix-IPV + Hib®)	12 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Tenderness (3rd Prevenar-13®)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Tenderness (2nd Prevenar-13®)	9 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3Tenderness(1st Infanrix-IPV+Hib®)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Swelling (3rd Engerix-B®)	6 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Tenderness (2nd Prevenar-13®)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Induration (2nd Infanrix-IPV + Hib®)	16 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Tenderness (3rd Engerix-B®)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3Induration(2nd Infanrix-IPV+Hib®)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Tenderness (2nd Infanrix-IPV + Hib®)	10 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Erythema (2nd Infanrix-IPV + Hib®)	12 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Erythema (4th Priorix®)	13 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Erythema (3rd Engerix-B®)	12 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Erythema (4th Priorix®)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Erythema(2nd Infanrix-IPV+Hib®)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3Tenderness(2nd Infanrix-IPV+Hib®)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Induration (4th Priorix®)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Swelling (2nd Infanrix-IPV + Hib®)	6 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Swelling (4th Priorix®)	4 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Swelling (3rd Engerix-B®)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Swelling (4th Priorix®)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Swelling(2nd Infanrix-IPV+Hib®)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Tenderness (4th Priorix®)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Erythema (2nd Prevenar-13®)	12 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Erythema (4th Varilrix®)	14 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Erythema (3rd Engerix-B®)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Erythema (4th Varilrix®)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Erythema (2nd Prevenar-13®)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Induration (4th Varilrix®)	7 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Induration (4th Varilrix®)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Induration (4th Priorix®)	6 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Swelling (4th Varilrix®)	6 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Induration (2nd Prevenar-13®)	8 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Swelling (4th Varilrix®)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Induration (3rd Engerix-B®)	17 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Tenderness (4th Varilrix®)	5 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Induration (2nd Prevenar-13®)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Tenderness (4th Varilrix®)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Induration(1st Infanrix-IPV + Hib®)	11 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Tenderness (3rd Engerix-B®)	7 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3Induration(1st Infanrix-IPV+Hib®)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Erythema (1st Infanrix-IPV + Hib®)	3 Number of participants
Routine Group	Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Erythema (1st Prevenar-13®)	9 Number of participants

Secondary

Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.

Number of subjects reporting solicited systemic AEs following concomitant administration of Bexsero® vaccine with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13® and Engerix-B® at 2, 4 and 6 months of age and Priorix® and Varilrix® at 12 months of age) compared to when only routine vaccines were alone, at 2, 4, 6 and 12 months. Systemic solicited symptoms assessed were Change in Eating Habits, Diarrhea, Irritability, Persistent Crying, Rash, Sleepiness, Vomiting and Fever (body temperature ≥ 38.0 °C)

Time frame: From day 1 (6 hours) to day 7 after each vaccination

Arm	Measure	Group	Value (NUMBER)
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Change in Eating Habits (1st vacc)	92 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade3 Change in Eating Habits(1st vacc)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Change in Eating Habits (2nd vacc)	72 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade3 Change in Eating Habits(2nd vacc)	2 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Change in Eating Habits (3rd vacc)	72 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Diarrhea (1st vacc)	28 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Diarrhea (1st vacc)	2 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Diarrhea (2nd vacc)	30 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Diarrhea (2nd vacc)	1 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Irritability (1st vacc)	111 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Irritability (1st vacc)	3 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Irritability (2nd vacc)	5 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Irritability (3rd vacc)	94 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Persistent Crying (1st vacc)	96 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Persistent Crying (1st vacc)	5 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Persistent Crying (2nd vacc)	5 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Persistent Crying (3rd vacc)	72 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Persistent Crying (3rd vacc)	3 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Rash (1st vacc)	18 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Rash (1st vacc)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Rash (2nd vacc)	18 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Rash (2nd vacc)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Rash (3rd vacc)	16 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Sleepiness (1st vacc)	79 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Sleepiness (1st vacc)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Sleepiness (2nd vacc)	66 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Sleepiness (2nd vacc)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Sleepiness (3rd vacc)	49 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Sleepiness (3rd vacc)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Vomiting (1st vacc)	21 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Vomiting (1st vacc)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Vomiting (2nd vacc)	16 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Vomiting (2nd vacc)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Vomiting (3rd vacc)	15 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Vomiting (3rd vacc)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Fever (1st vacc)	71 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Fever (3rd vacc)	68 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Change in Eating Habits (4th vacc)	58 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade3 Change in Eating Habits(4th vacc)	2 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Diarrhea (4th vacc)	27 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Diarrhea (4th vacc)	1 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Irritability (4th vacc)	71 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Irritability (4th vacc)	2 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Persistent Crying (4th vacc)	58 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Persistent Crying (4th vacc)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Rash (4th vacc)	25 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Rash (4th vacc)	1 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Sleepiness (4th vacc)	36 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Sleepiness (4th vacc)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Vomiting (4th vacc)	10 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Vomiting (4th vacc)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Fever (4th vacc)	60 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Lymphadenopathy (4th vacc)	1 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Fever (2nd vacc)	72 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade3 Change in Eating Habits(3rd vacc)	1 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Diarrhea (3rd vacc)	19 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Diarrhea (3rd vacc)	0 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Irritability (2nd vacc)	90 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Irritability (3rd vacc)	3 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Persistent Crying (2nd vacc)	82 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Rash (3rd vacc)	1 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Irritability (4th vacc)	16 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Change in Eating Habits (1st vacc)	26 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Sleepiness (3rd vacc)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade3 Change in Eating Habits(1st vacc)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Sleepiness (4th vacc)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Change in Eating Habits (2nd vacc)	21 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Vomiting (1st vacc)	6 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade3 Change in Eating Habits(2nd vacc)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Irritability (4th vacc)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Change in Eating Habits (3rd vacc)	17 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade3 Change in Eating Habits(3rd vacc)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Vomiting (1st vacc)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Diarrhea (1st vacc)	8 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Rash (3rd vacc)	4 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Diarrhea (1st vacc)	1 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Vomiting (2nd vacc)	9 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Diarrhea (2nd vacc)	9 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Persistent Crying (4th vacc)	15 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Diarrhea (2nd vacc)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Diarrhea (3rd vacc)	4 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Diarrhea (3rd vacc)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Vomiting (2nd vacc)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Irritability (1st vacc)	32 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Vomiting (4th vacc)	6 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Irritability (1st vacc)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Irritability (2nd vacc)	31 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Vomiting (3rd vacc)	7 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Irritability (2nd vacc)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Persistent Crying (4th vacc)	1 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Irritability (3rd vacc)	28 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Irritability (3rd vacc)	1 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Vomiting (3rd vacc)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Lymphadenopathy (4th vacc)	1 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Persistent Crying (1st vacc)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Persistent Crying (2nd vacc)	23 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Fever (1st vacc)	11 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Persistent Crying (2nd vacc)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Fever (2nd vacc)	11 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Persistent Crying (3rd vacc)	28 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Rash (4th vacc)	9 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Persistent Crying (3rd vacc)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Fever (3rd vacc)	12 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Rash (1st vacc)	4 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Vomiting (4th vacc)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Rash (1st vacc)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Change in Eating Habits (4th vacc)	19 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Rash (2nd vacc)	8 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Rash (4th vacc)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Rash (2nd vacc)	1 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade3 Change in Eating Habits(4th vacc)	1 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Rash (3rd vacc)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Persistent Crying (1st vacc)	30 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Sleepiness (1st vacc)	33 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Diarrhea (4th vacc)	10 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Sleepiness (1st vacc)	1 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Sleepiness (4th vacc)	9 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Sleepiness (2nd vacc)	21 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Diarrhea (4th vacc)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Grade 3 Sleepiness (2nd vacc)	0 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Fever (4th vacc)	6 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.	Any Sleepiness (3rd vacc)	13 Number of participants

Secondary

Number of Subjects Reporting Solicited Systemic AEs After Receiving Priorix® and Varilrix® Routine Vaccines (With and Without Bexsero® Vaccine) at 12 Months of Age.

Number of subjects who reported solicited systemic AEs reported after the administration of Varilrix® and Priorix® vaccines (with and without Bexsero® vaccine) at 12 months of age. Solicited systemic AEs assessed were Rash, Lymphadenopathy and Fever. This analysis was conducted for a prolonged period of 28 Days following Varilrix® and Priorix® administration.

Time frame: From Day 1 to Day 28 after vaccination

Arm	Measure	Group	Value (NUMBER)
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic AEs After Receiving Priorix® and Varilrix® Routine Vaccines (With and Without Bexsero® Vaccine) at 12 Months of Age.	Grade 3 rash (4th vacc)	5 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic AEs After Receiving Priorix® and Varilrix® Routine Vaccines (With and Without Bexsero® Vaccine) at 12 Months of Age.	Fever (temperature ≥ 38.0°C)	91 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic AEs After Receiving Priorix® and Varilrix® Routine Vaccines (With and Without Bexsero® Vaccine) at 12 Months of Age.	Lymphadenopathy (4th vacc)	34 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic AEs After Receiving Priorix® and Varilrix® Routine Vaccines (With and Without Bexsero® Vaccine) at 12 Months of Age.	Grade 3 fever (temperature ≥ 40.0°C)	2 Number of participants
Bexsero + Routine Group	Number of Subjects Reporting Solicited Systemic AEs After Receiving Priorix® and Varilrix® Routine Vaccines (With and Without Bexsero® Vaccine) at 12 Months of Age.	Any Rash (4th vacc)	50 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic AEs After Receiving Priorix® and Varilrix® Routine Vaccines (With and Without Bexsero® Vaccine) at 12 Months of Age.	Grade 3 fever (temperature ≥ 40.0°C)	5 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic AEs After Receiving Priorix® and Varilrix® Routine Vaccines (With and Without Bexsero® Vaccine) at 12 Months of Age.	Any Rash (4th vacc)	24 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic AEs After Receiving Priorix® and Varilrix® Routine Vaccines (With and Without Bexsero® Vaccine) at 12 Months of Age.	Grade 3 rash (4th vacc)	5 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic AEs After Receiving Priorix® and Varilrix® Routine Vaccines (With and Without Bexsero® Vaccine) at 12 Months of Age.	Lymphadenopathy (4th vacc)	21 Number of participants
Routine Group	Number of Subjects Reporting Solicited Systemic AEs After Receiving Priorix® and Varilrix® Routine Vaccines (With and Without Bexsero® Vaccine) at 12 Months of Age.	Fever (temperature ≥ 38.0°C)	33 Number of participants

Secondary

Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination With Routine Vaccines

Number of subjects reporting any unsolicited AEs following concomitant administration of Bexsero® vaccine with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13®, Engerix-B® or Priorix® and Varilrix®) compared to when only routine vaccines were administered alone.

Time frame: From day 1 to day 7 after each vaccination

Arm	Measure	Group	Value (NUMBER)
Bexsero + Routine Group	Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination With Routine Vaccines	Any AEs (2nd vacc)	30 Number of subjects
Bexsero + Routine Group	Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination With Routine Vaccines	Any AEs (1st vacc)	46 Number of subjects
Bexsero + Routine Group	Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination With Routine Vaccines	At least possible related AEs (2nd vacc)	22 Number of subjects
Bexsero + Routine Group	Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination With Routine Vaccines	Any AEs (booster)	43 Number of subjects
Bexsero + Routine Group	Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination With Routine Vaccines	Any AEs (3rd vacc)	51 Number of subjects
Bexsero + Routine Group	Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination With Routine Vaccines	At least possible related AEs (1st vacc)	35 Number of subjects
Bexsero + Routine Group	Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination With Routine Vaccines	At least possible related AEs (3rd vacc)	45 Number of subjects
Bexsero + Routine Group	Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination With Routine Vaccines	At least possible related AEs (booster)	37 Number of subjects
Routine Group	Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination With Routine Vaccines	At least possible related AEs (booster)	4 Number of subjects
Routine Group	Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination With Routine Vaccines	Any AEs (booster)	9 Number of subjects
Routine Group	Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination With Routine Vaccines	Any AEs (1st vacc)	8 Number of subjects
Routine Group	Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination With Routine Vaccines	At least possible related AEs (1st vacc)	6 Number of subjects
Routine Group	Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination With Routine Vaccines	Any AEs (2nd vacc)	7 Number of subjects
Routine Group	Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination With Routine Vaccines	At least possible related AEs (2nd vacc)	5 Number of subjects
Routine Group	Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination With Routine Vaccines	Any AEs (3rd vacc)	18 Number of subjects
Routine Group	Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination With Routine Vaccines	At least possible related AEs (3rd vacc)	7 Number of subjects

Secondary

Percentage of Subjects With hSBA Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B, When Bexsero® Booster Was Given With Routine Vaccines (Priorix® + Varilrix® Vaccines)

Percentage of subjects with hSBA titer ≥ 1:5 before booster vaccination and after booster vaccination when Bexsero® booster dose was given with routine vaccines (Priorix® + Varilrix® vaccine) as compared to when only routine vaccines were administered.

Time frame: At Day 305 and Day 335

Population: Analysis was done on FAS population Day 335. The FAS population included all subjects in the exposed set who received at least one dose of a study vaccination and provided immunogenicity data at relevant time points.

Arm	Measure	Group	Value (NUMBER)
Bexsero + Routine Group	Percentage of Subjects With hSBA Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B, When Bexsero® Booster Was Given With Routine Vaccines (Priorix® + Varilrix® Vaccines)	H44/76 strain [Day 305]	81 Percentage of subjects
Bexsero + Routine Group	Percentage of Subjects With hSBA Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B, When Bexsero® Booster Was Given With Routine Vaccines (Priorix® + Varilrix® Vaccines)	H44/76 strain [Day 335]	99 Percentage of subjects
Bexsero + Routine Group	Percentage of Subjects With hSBA Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B, When Bexsero® Booster Was Given With Routine Vaccines (Priorix® + Varilrix® Vaccines)	5/99 strain [Day 305]	99 Percentage of subjects
Bexsero + Routine Group	Percentage of Subjects With hSBA Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B, When Bexsero® Booster Was Given With Routine Vaccines (Priorix® + Varilrix® Vaccines)	5/99 strain [Day 335]	99 Percentage of subjects
Bexsero + Routine Group	Percentage of Subjects With hSBA Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B, When Bexsero® Booster Was Given With Routine Vaccines (Priorix® + Varilrix® Vaccines)	M10713 strain [Day 305]	22 Percentage of subjects
Bexsero + Routine Group	Percentage of Subjects With hSBA Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B, When Bexsero® Booster Was Given With Routine Vaccines (Priorix® + Varilrix® Vaccines)	M10713 strain [Day 335]	92 Percentage of subjects
Bexsero + Routine Group	Percentage of Subjects With hSBA Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B, When Bexsero® Booster Was Given With Routine Vaccines (Priorix® + Varilrix® Vaccines)	NZ98/254 strain [Day 305]	17 Percentage of subjects
Bexsero + Routine Group	Percentage of Subjects With hSBA Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B, When Bexsero® Booster Was Given With Routine Vaccines (Priorix® + Varilrix® Vaccines)	NZ98/254 strain [Day 335]	94 Percentage of subjects
Routine Group	Percentage of Subjects With hSBA Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B, When Bexsero® Booster Was Given With Routine Vaccines (Priorix® + Varilrix® Vaccines)	NZ98/254 strain [Day 335]	0 Percentage of subjects
Routine Group	Percentage of Subjects With hSBA Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B, When Bexsero® Booster Was Given With Routine Vaccines (Priorix® + Varilrix® Vaccines)	H44/76 strain [Day 305]	2 Percentage of subjects
Routine Group	Percentage of Subjects With hSBA Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B, When Bexsero® Booster Was Given With Routine Vaccines (Priorix® + Varilrix® Vaccines)	M10713 strain [Day 305]	11 Percentage of subjects
Routine Group	Percentage of Subjects With hSBA Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B, When Bexsero® Booster Was Given With Routine Vaccines (Priorix® + Varilrix® Vaccines)	H44/76 strain [Day 335]	2 Percentage of subjects
Routine Group	Percentage of Subjects With hSBA Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B, When Bexsero® Booster Was Given With Routine Vaccines (Priorix® + Varilrix® Vaccines)	NZ98/254 strain [Day 305]	1 Percentage of subjects
Routine Group	Percentage of Subjects With hSBA Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B, When Bexsero® Booster Was Given With Routine Vaccines (Priorix® + Varilrix® Vaccines)	5/99 strain [Day 305]	1 Percentage of subjects
Routine Group	Percentage of Subjects With hSBA Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B, When Bexsero® Booster Was Given With Routine Vaccines (Priorix® + Varilrix® Vaccines)	M10713 strain [Day 335]	13 Percentage of subjects
Routine Group	Percentage of Subjects With hSBA Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B, When Bexsero® Booster Was Given With Routine Vaccines (Priorix® + Varilrix® Vaccines)	5/99 strain [Day 335]	0 Percentage of subjects

Comparison: Statistical analysis H44/76 strain: The null hypothesis associated with the primary objective is that the proportion of subjects with hSBA titers ≥ 1:5 one month after the third dose of the Bexsero® vaccine was ≤ 0.70. Assuming the results for the three strains are independent, the power to reject the null hypothesis associated with the primary objectives to demonstrate sufficiency of response (for all three strains was 92%.95% CI: [95.7, 99.98]Exact test of binomial proportion

Comparison: Statistical analysis 5/99 strain: The power to reject the null hypothesis associated with the secondary objective for strain 5/99 was 99%.95% CI: [94.7, 99.82]Exact test for binomial proportion

Comparison: Statistical analysis NZ98/254 strain: The power to reject the null hypothesis associated with the secondary objective for strain NZ98/254 was 99%.95% CI: [88.7, 97.4]Exact test for binomial proportions

Secondary

Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines

Percentages of subjects with hSBA titers ≥1:8 against N.meningitidis serogroup B strains, at one month after concomitant administration of third primary dose of Bexsero® with routine vaccines \[Infanrix-IPV + Hib®, Prevenar-13® and Engerix-B®\] and at one month after concomitant administration of Bexsero® booster dose with routine vaccines \[Priorix® and Varilrix® vaccine\],as compared to when only routine vaccines were administered.

Time frame: At Day 1,Day 152,Day 305, Day 335

Population: Analysis was done on FAS population, which included all subjects in the exposed set who received at least one dose of a study vaccination and provided immunogenicity data at relevant time points.

Arm	Measure	Group	Value (NUMBER)
Bexsero + Routine Group	Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines	M10713 strain (Day 305)	15 Percentages of subjects
Bexsero + Routine Group	Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines	NZ98/254 strain (Day 305)	9 Percentages of subjects
Bexsero + Routine Group	Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines	H44/76 strain (Day 1)	0 Percentages of subjects
Bexsero + Routine Group	Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines	H44/76 strain (Day 152)	100 Percentages of subjects
Bexsero + Routine Group	Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines	H44/76 strain (Day 305)	66 Percentages of subjects
Bexsero + Routine Group	Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines	H44/76 strain (Day 335)	99 Percentages of subjects
Bexsero + Routine Group	Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines	5/99 strain (Day 1)	1 Percentages of subjects
Bexsero + Routine Group	Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines	5/99 strain (Day 152)	100 Percentages of subjects
Bexsero + Routine Group	Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines	5/99 strain (Day 305)	99 Percentages of subjects
Bexsero + Routine Group	Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines	5/99 strain (Day 335)	99 Percentages of subjects
Bexsero + Routine Group	Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines	M10713 strain (Day 1)	3 Percentages of subjects
Bexsero + Routine Group	Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines	M10713 strain (Day 152)	49 Percentages of subjects
Bexsero + Routine Group	Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines	M10713 strain (Day 335)	77 Percentages of subjects
Bexsero + Routine Group	Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines	NZ98/254 strain (Day 1)	0 Percentages of subjects
Bexsero + Routine Group	Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines	NZ98/254 strain (Day 152)	59 Percentages of subjects
Bexsero + Routine Group	Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines	NZ98/254 strain (Day 335)	86 Percentages of subjects
Routine Group	Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines	NZ98/254 strain (Day 305)	0 Percentages of subjects
Routine Group	Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines	5/99 strain (Day 335)	0 Percentages of subjects
Routine Group	Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines	NZ98/254 strain (Day 1)	0 Percentages of subjects
Routine Group	Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines	H44/76 strain (Day 1)	0 Percentages of subjects
Routine Group	Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines	M10713 strain (Day 1)	8 Percentages of subjects
Routine Group	Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines	H44/76 strain (Day 152)	0 Percentages of subjects
Routine Group	Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines	NZ98/254 strain (Day 335)	0 Percentages of subjects
Routine Group	Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines	H44/76 strain (Day 305)	2 Percentages of subjects
Routine Group	Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines	M10713 strain (Day 152)	5 Percentages of subjects
Routine Group	Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines	H44/76 strain (Day 335)	0 Percentages of subjects
Routine Group	Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines	M10713 strain (Day 305)	3 Percentages of subjects
Routine Group	Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines	5/99 strain (Day 1)	0 Percentages of subjects
Routine Group	Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines	NZ98/254 strain (Day 152)	0 Percentages of subjects
Routine Group	Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines	5/99 strain (Day 152)	0 Percentages of subjects
Routine Group	Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines	M10713 strain (Day 335)	6 Percentages of subjects
Routine Group	Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines	5/99 strain (Day 305)	1 Percentages of subjects

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026

Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Meningococcal B Recombinant Vaccine When Administered Concomitantly With Routine Vaccines to Healthy Infants of 2 Months of Age and Older, in Taiwan.

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Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Percentage of Subjects With Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B Strains

Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 1:4 Against Neisseria Meningitidis Serogroup B Strains

hSBA Geometric Mean Ratios (GMRs) Against Neisseria Meningitidis Serogroup B Strains.

hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines

Number of Subjects Reporting Serious Adverse Events (SAEs), Medically Attended AEs (MAEs) and AEs Leading to Premature Withdrawal and Death and AEs Leading to Hospitalization.

Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.

Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.

Number of Subjects Reporting Solicited Systemic AEs After Receiving Priorix® and Varilrix® Routine Vaccines (With and Without Bexsero® Vaccine) at 12 Months of Age.

Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination With Routine Vaccines

Percentage of Subjects With hSBA Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B, When Bexsero® Booster Was Given With Routine Vaccines (Priorix® + Varilrix® Vaccines)

Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines