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Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Co-administered With Pneumococcal and DTPa-HBV-IPV/Hib Vaccines

Immunogenicity and Safety of GSK Biologicals' Meningococcal Vaccine (GSK 134612) When Co-administered With a Pneumococcal Conjugate Vaccine and Infanrix Hexa™ in Healthy Infants

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01144663
Enrollment
2095
Registered
2010-06-15
Start date
2010-07-01
Completion date
2013-09-10
Last updated
2020-12-31

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

Conditions

Infections, Meningococcal, Meningococcal Vaccines

Keywords

Infants, conjugate vaccine, immunogenicity, meningococcal vaccine, non-inferiority, co-administration

Brief summary

The purpose of this study is to evaluate immunogenicity and safety of meningococcal conjugate vaccine GSK134612 compared to the licensed vaccines MenC-CRM197 and MenC-TT in infants of 2 months of age. Pneumococcal conjugate vaccine and DTPa-HBV-IPV/Hib vaccines will be co-administered.

Detailed description

The study consists of a primary vaccination phase and a booster vaccination phase. The Protocol Posting has been updated due to protocol amendment 2.

Interventions

BIOLOGICALNimenrix™

4- or 3-dose intramuscular injection

BIOLOGICALMenjugate®

3-dose intramuscular injection

BIOLOGICALNeisVac-CTM

3-dose intramuscular injection

BIOLOGICALInfanrix™ hexa

4-dose intramuscular injection

BIOLOGICALSynflorix™

4-dose intramuscular injection

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Weeks to 12 Weeks
Healthy volunteers
Yes

Inclusion criteria

All subjects must satisfy ALL the following criteria at study entry: * Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visit). * A male or female between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination. * Written informed consent obtained from the parent(s) or guardian of the subject. * Free of obvious health problems as established by medical history and clinical examination before entering into the study. * Born after a gestation period of at least 36 weeks.

Exclusion criteria

* Child in care. * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Extended administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone \>= 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed. * Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the first dose of vaccine(s) until 30 days after the last dose of vaccine(s) (i.e. booster dose), with the exception of rotavirus vaccine which can be administered at any time during the study, according to the national immunisation recommendations. MMR(V) vaccine, if recommended in national immunisation programs, can be given after the last blood sampling time point i.e. after Visit 6. Seasonal or pandemic influenza vaccine can be given at any time during the study, and according to the Summary of Product Characteristics and national recommendations. * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). * Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, Streptococcus pneumoniae, Neisseria meningitidis serogroups A, C, W-135 or Y with the exception of vaccines where the first dose may be given within the first two weeks of life according to the national recommendations (for example hepatitis B and BCG). * History of, or intercurrent, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b disease, pneumococcal and/or meningococcal disease. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * Family history of congenital or hereditary immunodeficiency. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s). * Major congenital defects or serious chronic illness. * History of any neurologic disorders or seizures (history of a single, simple febrile seizure is permitted). * Acute disease and/or fever at the time of enrolment. (Fever is defined as temperature ≥ 37.5°C (99.5°F) on oral, axillary or tympanic setting, or ≥ 38.0°C (100.4°F) on rectal setting). (Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator). \- Administration of immunoglobulins and/ or any blood products since birth or planned administration during the study period.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement Against Meningococcal Serogroups A, W-135 and Y (rSBA-MenA, rSBA-MenW-135 and rSBA-Y) Antibody Titers Greater Than or Equal to (≥) the Cut-off Value.One month after the final primary vaccination at Month 3The cut-off value for the rSBA-MenA, rSBA-MenW-135 and rSBA-Y titers was greater than or equal to (≥) 1:8. Indication of the immunogenicity of the 2-dose and 3-dose schedules: the lower limit of the two-sided exact 95% CI for the percentage of subjects with post-primary vaccination rSBA antibody titre ≥ 1:8 is greater than or equal to the pre-defined clinical limit of 80%.
Number of Subjects With rSBA-MenC Antibody Titers ≥ the Cut-off ValueOne month after the final primary vaccination at Month 3The cut-off value for rSBA-MenC titers was ≥ 1:8.

Secondary

MeasureTime frameDescription
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesPre-Booster dose at Month 10 and one month post-Booster dose at Month 11The cut-off values for the rSBA-Men antibody titers were greater than or equal to (≥) 1:8 and ≥ 1:128.
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValuesPre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3The cut-off values for hSBA antibody titers were greater than or equal to (≥) 1:4 and ≥ 1:8.
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitersPre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3Antibody titers were presented as geometric mean titers (GMTs).
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValuesPre-Booster dose at Month 10 and one month post-Booster dose at Month 11The cut-off values for hSBA antibody titers were greater than or equal to (≥) 1:4 and ≥ 1:8.
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesPre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3The cut-off values for anti-1, anti-4, anti-5, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19F and anti-23F concentrations were greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL) and ≥ 0.35 µg/mL
Anti-pneumococcal Serotypes Antibody ConcentrationsPre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3Anti-1, anti-4, anti-5, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19F and anti-23F antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in µg/mL.
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesPre-Booster dose at Month 10 and one month post-Booster dose at Month 11The cut-off values for anti-1, anti-4, anti-5, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19F and anti-23F concentrations were ≥ 0.15 µg/mL and ≥ 0.35 µg/mL
Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Concentrations ≥ the Cut-off ValuePre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3The cut-off value for anti-D and anti-T concentrations was greater than or equal to (≥) 0.1 IU/mL
Anti-D and Anti-T Antibody ConcentrationsPre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off ValuePre-Booster dose at Month 10 and one month post-Booster dose at Month 11The cut-off value for anti-D and anti-T concentrations was greater than or equal to (≥) 0.1 IU/mL
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Concentrations ≥ the Cut-off ValuePre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3The cut-off value for anti-PT, anti-FHA and anti-PRN concentrations was greater than or equal to (≥) 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Anti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsPre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in EL.U/mL.
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ the Cut-off ValuePre-Booster dose at Month 10 and one month post-Booster dose at Month 11The cut-off value for anti-PT, anti-FHA and anti-PRN concentrations was greater than or equal to (≥) 5 EL.U/mL.
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off ValuesPre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3The cut-off values for anti-HBs concentrations were greater than or equal to (≥) 10 milli-international units per milliliter (mIU/mL) and ≥ 100 mIU/mL.
Anti-HBs Antibody ConcentrationsPre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off ValuesPre-primary vaccination at Month 0The cut-off values for rSBA-Men antibody titers were greater than or equal to (≥) 1:8 and ≥ 1:128 at pre-vaccination
Number of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Concentrations ≥ the Cut-off ValuesPre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3The cut-off values for anti-PRP antibody concentrations were greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL) and ≥ 1.0 µg/mL.
Anti-PRP Antibody ConcentrationsPre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL).
Number of Subjects With Anti-PRP Antibody Concentrations Above the Cut-off ValuesPre-Booster dose at Month 10 and one month post-Booster dose at Month 11The cut-off values for anti-PRP antibody concentrations were greater than or equal to (≥) 0.15 µg/mL and ≥ 1.0 µg/mL.
Number of Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValuePre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3The cut-off value for anti-poliovirus type 1, 2 and 3 antibody concentrations was greater than or equal to (≥) 1:8.
Anti-polio Type 1, 2 and 3 Antibody TitersPre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3Antibody titers were presented as geometric mean titers (GMTs).
Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValuePre-Booster dose at Month 10 and one month post-Booster dose at Month 11The cut-off value for anti-poliovirus type 1, 2 and 3 antibody concentrations was greater than or equal to (≥) 1:8.
Number of Subjects With Any and Grade 3 Solicited Local SymptomsDuring the 8-day (Days 0-7) post-vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination)Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. For the Nimenrix 2, Menjugate and NeisVac-C groups, results corresponding to Dose 2 are for Infanrix hexa and Synflorix vaccination at Visit 2 (Month 1), while results corresponding to Dose 3 refer to the vaccination at Visit 3 (Month 2).
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationDuring the 8-day (Days 0-7) post-meningococcal vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination)Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationDuring the 8-day (Days 0-7) post-Infanrix hexa vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination)Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationDuring the 8-day (Days 0-7) post-Synflorix vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination)Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Number of Subjects With Any Unsolicited Adverse Events (AEs)Within 31-days (Days 0-30) post-each primary vaccination doseAn unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix™ VaccinationDuring the 8-day (Days 0-7) post-Synflorix™ booster vaccination periodAssessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Number of Subjects With Any, Grade 3 and Related Solicited General SymptomsDuring the 8-day (Days 0-7) post-vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination)Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature \[defined as rectal temperature greater than or equal to (≥) 38 degrees Celsius (°C)\]. Any = occurrence of any general symptoms, regardless of their intensity grade or relationship to study vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Not eating at all. Grade 3 Temperature= temperature above 40.0 (°C). Related = symptom assessed by the investigator as related to the vaccination. For the Nimenrix 2, Menjugate and NeisVac-C groups, results corresponding to Dose 2 are for Infanrix™ hexa and Synflorix™ vaccination at Visit 2 (Month 1), while results corresponding to Dose 3 refer to the vaccination at Visit 3 (Month 2).
Number of Subjects With Serious Adverse Events (SAEs)Throughout the entire study (from Day 0 to Month 16)Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Number of Subjects With New Onset of Chronic Illnesses (NOCIs)During 31-days (Days 0-30) post-each primary vaccination dose (Day 0 to Month 3) and from primary vaccination up to ESFU (Month 16)NOCIs assessed included asthma, autoimmune disorders, type 1 diabetes and allergies.
Number of Subjects With Anti-HBs Antibody Concentrations Above the Cut-off ValuesPre-Booster dose at Month 10 and one month post-Booster dose at Month 11The cut-off values for anti-HBs concentrations were greater than or equal to (≥) 10 mIU/mL and ≥ 100 mIU/mL.
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersPre-primary vaccination at Month 0Antibody titers were presented as geometric mean titers (GMTs).

Countries

Estonia, Germany, Spain

Participant flow

Participants by arm

ArmCount
Nimenrix 3 Group
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
528
Nimenrix 2 Group
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
524
Menjugate Group
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
516
NeisVac-C Group
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
527
Total2,095

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Booster Vaccination PhaseLost to Follow-up2130
Booster Vaccination PhaseMigrated/moved from study area1110
Booster Vaccination PhaseWithdrawal by Subject0011
Extended Safety Follow-Up (ESFU)Lost to Follow-up4650
Extended Safety Follow-Up (ESFU)Migrated/moved from study area1310
Extended Safety Follow-Up (ESFU)Withdrawal by Subject0011
Primary Vaccination PhaseAdverse Event1001
Primary Vaccination PhaseLost to Follow-up2012
Primary Vaccination PhaseMigrated/moved from study area4123
Primary Vaccination PhaseOther0102
Primary Vaccination PhaseProtocol Violation2010
Primary Vaccination PhaseSerious adverse event, fatal2010
Primary Vaccination PhaseWithdrawal by Subject95310

Baseline characteristics

CharacteristicTotalNeisVac-C GroupMenjugate GroupNimenrix 2 GroupNimenrix 3 Group
Age, Continuous8.65 Weeks
STANDARD_DEVIATION 1.52
8.6 Weeks
STANDARD_DEVIATION 1.49
8.7 Weeks
STANDARD_DEVIATION 1.53
8.6 Weeks
STANDARD_DEVIATION 1.52
8.7 Weeks
STANDARD_DEVIATION 1.54
Race/Ethnicity, Customized
Geographic ancestry
African heritage/African American
16 Participants1 Participants6 Participants4 Participants5 Participants
Race/Ethnicity, Customized
Geographic ancestry
American Indian or Alaskan Native
11 Participants2 Participants4 Participants4 Participants1 Participants
Race/Ethnicity, Customized
Geographic ancestry
Asian-Central/South Asian heritage
2 Participants0 Participants0 Participants1 Participants1 Participants
Race/Ethnicity, Customized
Geographic ancestry
Asian-East Asian heritage
3 Participants1 Participants1 Participants1 Participants0 Participants
Race/Ethnicity, Customized
Geographic ancestry
Asian-South East Asian heritage
1 Participants0 Participants0 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Geographic ancestry
Native Hawaiian or other Pacific Islander
1 Participants0 Participants1 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Geographic ancestry
Not specified
32 Participants7 Participants8 Participants9 Participants8 Participants
Race/Ethnicity, Customized
Geographic ancestry
White-Arabic/North African heritage
51 Participants21 Participants10 Participants8 Participants12 Participants
Race/Ethnicity, Customized
Geographic ancestry
White-Caucasian/European heritage
1978 Participants495 Participants486 Participants497 Participants500 Participants
Sex: Female, Male
Female
1043 Participants251 Participants264 Participants273 Participants255 Participants
Sex: Female, Male
Male
1052 Participants276 Participants252 Participants251 Participants273 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 5280 / 5240 / 5160 / 527
other
Total, other adverse events
512 / 528516 / 524506 / 516513 / 527
serious
Total, serious adverse events
54 / 52856 / 52445 / 51652 / 527

Outcome results

Primary

Number of Subjects With rSBA-MenC Antibody Titers ≥ the Cut-off Value

The cut-off value for rSBA-MenC titers was ≥ 1:8.

Time frame: One month after the final primary vaccination at Month 3

Population: The analysis was performed on the Primary ATP cohort for immunogenicity, which included all evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2)and with the blood sample schedule for Visit 4 (Month 3).

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Nimenrix 3 GroupNumber of Subjects With rSBA-MenC Antibody Titers ≥ the Cut-off Value459 Participants
Nimenrix 2 GroupNumber of Subjects With rSBA-MenC Antibody Titers ≥ the Cut-off Value450 Participants
Menjugate GroupNumber of Subjects With rSBA-MenC Antibody Titers ≥ the Cut-off Value453 Participants
NeisVac-C GroupNumber of Subjects With rSBA-MenC Antibody Titers ≥ the Cut-off Value457 Participants
Comparison: To demonstrate the non-inferiority of the Nimenrix 3 Group compared to the Menjugate Group, two-sided standardized asymptotic 95% CI (confidence interval) for the groups difference \[Nimenrix 3 Group minus Menjugate Group\] in the percentages of subjects with bactericidal vaccine response to MenC was computed.95% CI: [-1.17, 1.2]
Comparison: To demonstrate the non-inferiority of the Nimenrix 3 Group compared to the NeisVac-C Group, two-sided standardized asymptotic 95% CI for the groups difference \[Nimenrix 3 Group minus NeisVac-C Group\] in the percentages of subjects with bactericidal vaccine response to MenC was computed.95% CI: [-1.57, 0.4]
Comparison: To demonstrate the non-inferiority of the Nimenrix 2 Group compared to Menjugate Group, two-sided standardized asymptotic 95% CI for the groups difference \[Nimenrix 2 Group minus Menjugate Group\] in the percentages of subjects with bactericidal vaccine response to MenC was computed.95% CI: [-2.45, 0.43]
Comparison: To demonstrate the non-inferiority of the Nimenrix 2 Group compared to NeisVac-C Group, two-sided standardized asymptotic 95% CI for the groups difference \[Nimenrix 2 Group minus NeisVac-C Group\] in the percentages of subjects with bactericidal vaccine response to MenC was computed.95% CI: [-2.84, -0.48]
Primary

Percentage of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement Against Meningococcal Serogroups A, W-135 and Y (rSBA-MenA, rSBA-MenW-135 and rSBA-Y) Antibody Titers Greater Than or Equal to (≥) the Cut-off Value.

The cut-off value for the rSBA-MenA, rSBA-MenW-135 and rSBA-Y titers was greater than or equal to (≥) 1:8. Indication of the immunogenicity of the 2-dose and 3-dose schedules: the lower limit of the two-sided exact 95% CI for the percentage of subjects with post-primary vaccination rSBA antibody titre ≥ 1:8 is greater than or equal to the pre-defined clinical limit of 80%.

Time frame: One month after the final primary vaccination at Month 3

Population: The analysis was performed on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all subjects who complied with the protocol, who were administered a vaccine containing rSBA-MenA, rSBA-MenW-135 and rSBA-Y components (i.e. only Group Nimenrix 3 and Nimenrix 2) and with available data for the considered assay and time point.

ArmMeasureGroupValue (NUMBER)
Nimenrix 3 GroupPercentage of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement Against Meningococcal Serogroups A, W-135 and Y (rSBA-MenA, rSBA-MenW-135 and rSBA-Y) Antibody Titers Greater Than or Equal to (≥) the Cut-off Value.rSBA-MenA99.4 Percentage of Participants
Nimenrix 3 GroupPercentage of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement Against Meningococcal Serogroups A, W-135 and Y (rSBA-MenA, rSBA-MenW-135 and rSBA-Y) Antibody Titers Greater Than or Equal to (≥) the Cut-off Value.rSBA-MenW-13599.1 Percentage of Participants
Nimenrix 3 GroupPercentage of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement Against Meningococcal Serogroups A, W-135 and Y (rSBA-MenA, rSBA-MenW-135 and rSBA-Y) Antibody Titers Greater Than or Equal to (≥) the Cut-off Value.rSBA-MenY93.1 Percentage of Participants
Nimenrix 2 GroupPercentage of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement Against Meningococcal Serogroups A, W-135 and Y (rSBA-MenA, rSBA-MenW-135 and rSBA-Y) Antibody Titers Greater Than or Equal to (≥) the Cut-off Value.rSBA-MenW-13599.1 Percentage of Participants
Nimenrix 2 GroupPercentage of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement Against Meningococcal Serogroups A, W-135 and Y (rSBA-MenA, rSBA-MenW-135 and rSBA-Y) Antibody Titers Greater Than or Equal to (≥) the Cut-off Value.rSBA-MenA97.4 Percentage of Participants
Nimenrix 2 GroupPercentage of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement Against Meningococcal Serogroups A, W-135 and Y (rSBA-MenA, rSBA-MenW-135 and rSBA-Y) Antibody Titers Greater Than or Equal to (≥) the Cut-off Value.rSBA-MenY98.2 Percentage of Participants
Secondary

Anti-D and Anti-T Antibody Concentrations

Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).

Time frame: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3

Population: The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Nimenrix 3 GroupAnti-D and Anti-T Antibody ConcentrationsAnti-D, Month 32.171 IU/mL
Nimenrix 3 GroupAnti-D and Anti-T Antibody ConcentrationsAnti-D, Month 00.092 IU/mL
Nimenrix 3 GroupAnti-D and Anti-T Antibody ConcentrationsAnti-T, Month 00.484 IU/mL
Nimenrix 3 GroupAnti-D and Anti-T Antibody ConcentrationsAnti-T, Month 33.137 IU/mL
Nimenrix 2 GroupAnti-D and Anti-T Antibody ConcentrationsAnti-D, Month 00.098 IU/mL
Nimenrix 2 GroupAnti-D and Anti-T Antibody ConcentrationsAnti-T, Month 00.496 IU/mL
Nimenrix 2 GroupAnti-D and Anti-T Antibody ConcentrationsAnti-D, Month 32.64 IU/mL
Nimenrix 2 GroupAnti-D and Anti-T Antibody ConcentrationsAnti-T, Month 33.37 IU/mL
Menjugate GroupAnti-D and Anti-T Antibody ConcentrationsAnti-T, Month 00.727 IU/mL
Menjugate GroupAnti-D and Anti-T Antibody ConcentrationsAnti-D, Month 00.133 IU/mL
Menjugate GroupAnti-D and Anti-T Antibody ConcentrationsAnti-D, Month 33.005 IU/mL
Menjugate GroupAnti-D and Anti-T Antibody ConcentrationsAnti-T, Month 32.847 IU/mL
NeisVac-C GroupAnti-D and Anti-T Antibody ConcentrationsAnti-D, Month 32.488 IU/mL
NeisVac-C GroupAnti-D and Anti-T Antibody ConcentrationsAnti-T, Month 00.5 IU/mL
NeisVac-C GroupAnti-D and Anti-T Antibody ConcentrationsAnti-T, Month 34.339 IU/mL
NeisVac-C GroupAnti-D and Anti-T Antibody ConcentrationsAnti-D, Month 00.093 IU/mL
Secondary

Anti-D and Anti-T Antibody Concentrations

Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).

Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11

Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Nimenrix 3 GroupAnti-D and Anti-T Antibody ConcentrationsAnti-D, Month 100.292 IU/mL
Nimenrix 3 GroupAnti-D and Anti-T Antibody ConcentrationsAnti-D, Month 115.032 IU/mL
Nimenrix 3 GroupAnti-D and Anti-T Antibody ConcentrationsAnti-T, Month 100.832 IU/mL
Nimenrix 3 GroupAnti-D and Anti-T Antibody ConcentrationsAnti-T, Month 1110.234 IU/mL
Nimenrix 2 GroupAnti-D and Anti-T Antibody ConcentrationsAnti-D, Month 115.438 IU/mL
Nimenrix 2 GroupAnti-D and Anti-T Antibody ConcentrationsAnti-T, Month 100.780 IU/mL
Nimenrix 2 GroupAnti-D and Anti-T Antibody ConcentrationsAnti-T, Month 1111.004 IU/mL
Nimenrix 2 GroupAnti-D and Anti-T Antibody ConcentrationsAnti-D, Month 100.325 IU/mL
Menjugate GroupAnti-D and Anti-T Antibody ConcentrationsAnti-T, Month 100.684 IU/mL
Menjugate GroupAnti-D and Anti-T Antibody ConcentrationsAnti-D, Month 119.078 IU/mL
Menjugate GroupAnti-D and Anti-T Antibody ConcentrationsAnti-T, Month 118.400 IU/mL
Menjugate GroupAnti-D and Anti-T Antibody ConcentrationsAnti-D, Month 100.507 IU/mL
NeisVac-C GroupAnti-D and Anti-T Antibody ConcentrationsAnti-T, Month 1113.016 IU/mL
NeisVac-C GroupAnti-D and Anti-T Antibody ConcentrationsAnti-D, Month 116.437 IU/mL
NeisVac-C GroupAnti-D and Anti-T Antibody ConcentrationsAnti-D, Month 100.379 IU/mL
NeisVac-C GroupAnti-D and Anti-T Antibody ConcentrationsAnti-T, Month 100.956 IU/mL
Secondary

Anti-HBs Antibody Concentrations

Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).

Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11

Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Nimenrix 3 GroupAnti-HBs Antibody ConcentrationsAnti-HBs, Month 10150.5 mIU/mL
Nimenrix 3 GroupAnti-HBs Antibody ConcentrationsAnti-HBs, Month 113624.9 mIU/mL
Nimenrix 2 GroupAnti-HBs Antibody ConcentrationsAnti-HBs, Month 114129.8 mIU/mL
Nimenrix 2 GroupAnti-HBs Antibody ConcentrationsAnti-HBs, Month 10138.2 mIU/mL
Menjugate GroupAnti-HBs Antibody ConcentrationsAnti-HBs, Month 10196.6 mIU/mL
Menjugate GroupAnti-HBs Antibody ConcentrationsAnti-HBs, Month 114866.4 mIU/mL
NeisVac-C GroupAnti-HBs Antibody ConcentrationsAnti-HBs, Month 10141.9 mIU/mL
NeisVac-C GroupAnti-HBs Antibody ConcentrationsAnti-HBs, Month 113878.7 mIU/mL
Secondary

Anti-HBs Antibody Concentrations

Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).

Time frame: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3

Population: The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Nimenrix 3 GroupAnti-HBs Antibody ConcentrationsAnti-HBs, Month 012.0 mIU/mL
Nimenrix 3 GroupAnti-HBs Antibody ConcentrationsAnti-HBs, Month 3692.3 mIU/mL
Nimenrix 2 GroupAnti-HBs Antibody ConcentrationsAnti-HBs, Month 3732.2 mIU/mL
Nimenrix 2 GroupAnti-HBs Antibody ConcentrationsAnti-HBs, Month 013.7 mIU/mL
Menjugate GroupAnti-HBs Antibody ConcentrationsAnti-HBs, Month 011.3 mIU/mL
Menjugate GroupAnti-HBs Antibody ConcentrationsAnti-HBs, Month 3848.3 mIU/mL
NeisVac-C GroupAnti-HBs Antibody ConcentrationsAnti-HBs, Month 07.5 mIU/mL
NeisVac-C GroupAnti-HBs Antibody ConcentrationsAnti-HBs, Month 3729.5 mIU/mL
Secondary

Anti-pneumococcal Serotypes Antibody Concentrations

Anti-1, anti-4, anti-5, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19F and anti-23F antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in µg/mL.

Time frame: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3

Population: The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Nimenrix 3 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-18C, Month 32.14 µg/mL
Nimenrix 3 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-9V, Month 31.31 µg/mL
Nimenrix 3 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-4, Month 31.84 µg/mL
Nimenrix 3 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-18C, Month 00.13 µg/mL
Nimenrix 3 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-14, Month 00.50 µg/mL
Nimenrix 3 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-1, Month 00.09 µg/mL
Nimenrix 3 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-14, Month 37.55 µg/mL
Nimenrix 3 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-1, Month 31.36 µg/mL
Nimenrix 3 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-23F, Month 00.14 µg/mL
Nimenrix 3 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-5, Month 00.13 µg/mL
Nimenrix 3 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-5, Month 30.82 µg/mL
Nimenrix 3 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-19F, Month 33.01 µg/mL
Nimenrix 3 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-6B, Month 00.18 µg/mL
Nimenrix 3 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-23F, Month 30.96 µg/mL
Nimenrix 3 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-6B, Month 30.79 µg/mL
Nimenrix 3 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-4, Month 00.09 µg/mL
Nimenrix 3 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-19F, Month 00.15 µg/mL
Nimenrix 3 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-7F, Month 00.13 µg/mL
Nimenrix 3 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-7F, Month 31.91 µg/mL
Nimenrix 3 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-9V, Month 00.13 µg/mL
Nimenrix 2 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-18C, Month 31.77 µg/mL
Nimenrix 2 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-9V, Month 00.15 µg/mL
Nimenrix 2 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-23F, Month 00.14 µg/mL
Nimenrix 2 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-18C, Month 00.16 µg/mL
Nimenrix 2 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-5, Month 30.70 µg/mL
Nimenrix 2 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-9V, Month 31.12 µg/mL
Nimenrix 2 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-1, Month 00.10 µg/mL
Nimenrix 2 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-23F, Month 30.85 µg/mL
Nimenrix 2 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-7F, Month 31.84 µg/mL
Nimenrix 2 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-14, Month 00.61 µg/mL
Nimenrix 2 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-6B, Month 00.15 µg/mL
Nimenrix 2 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-14, Month 37.40 µg/mL
Nimenrix 2 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-7F, Month 00.17 µg/mL
Nimenrix 2 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-4, Month 31.56 µg/mL
Nimenrix 2 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-19F, Month 00.23 µg/mL
Nimenrix 2 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-4, Month 00.09 µg/mL
Nimenrix 2 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-6B, Month 30.90 µg/mL
Nimenrix 2 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-5, Month 00.12 µg/mL
Nimenrix 2 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-1, Month 31.13 µg/mL
Nimenrix 2 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-19F, Month 32.60 µg/mL
Menjugate GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-14, Month 00.59 µg/mL
Menjugate GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-1, Month 00.10 µg/mL
Menjugate GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-1, Month 31.26 µg/mL
Menjugate GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-4, Month 00.09 µg/mL
Menjugate GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-4, Month 31.77 µg/mL
Menjugate GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-5, Month 00.13 µg/mL
Menjugate GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-5, Month 30.77 µg/mL
Menjugate GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-6B, Month 00.15 µg/mL
Menjugate GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-6B, Month 31.08 µg/mL
Menjugate GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-7F, Month 00.16 µg/mL
Menjugate GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-7F, Month 32.13 µg/mL
Menjugate GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-9V, Month 00.13 µg/mL
Menjugate GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-9V, Month 31.22 µg/mL
Menjugate GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-14, Month 38.51 µg/mL
Menjugate GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-18C, Month 00.17 µg/mL
Menjugate GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-18C, Month 32.39 µg/mL
Menjugate GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-19F, Month 00.20 µg/mL
Menjugate GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-19F, Month 32.89 µg/mL
Menjugate GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-23F, Month 00.13 µg/mL
Menjugate GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-23F, Month 31.08 µg/mL
NeisVac-C GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-7F, Month 31.87 µg/mL
NeisVac-C GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-7F, Month 00.15 µg/mL
NeisVac-C GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-23F, Month 00.15 µg/mL
NeisVac-C GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-18C, Month 32.80 µg/mL
NeisVac-C GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-6B, Month 30.86 µg/mL
NeisVac-C GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-6B, Month 00.18 µg/mL
NeisVac-C GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-1, Month 31.02 µg/mL
NeisVac-C GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-19F, Month 00.19 µg/mL
NeisVac-C GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-5, Month 30.74 µg/mL
NeisVac-C GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-5, Month 00.12 µg/mL
NeisVac-C GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-1, Month 00.10 µg/mL
NeisVac-C GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-19F, Month 32.85 µg/mL
NeisVac-C GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-4, Month 31.60 µg/mL
NeisVac-C GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-14, Month 00.74 µg/mL
NeisVac-C GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-4, Month 00.09 µg/mL
NeisVac-C GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-14, Month 36.04 µg/mL
NeisVac-C GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-9V, Month 31.21 µg/mL
NeisVac-C GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-9V, Month 00.14 µg/mL
NeisVac-C GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-23F, Month 30.94 µg/mL
NeisVac-C GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-18C, Month 00.14 µg/mL
Secondary

Anti-pneumococcal Serotypes Antibody Concentrations

Anti-1, anti-4, anti-5, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19F and anti-23F antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in µg/mL.

Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11

Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Nimenrix 3 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-1, Month 100.19 µg/mL
Nimenrix 3 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-9V, Month 111.49 µg/mL
Nimenrix 3 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-4, Month 112.42 µg/mL
Nimenrix 3 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-18C, Month 100.33 µg/mL
Nimenrix 3 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-14, Month 101.69 µg/mL
Nimenrix 3 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-19F, Month 119.55 µg/mL
Nimenrix 3 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-14, Month 118.51 µg/mL
Nimenrix 3 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-1, Month 112.03 µg/mL
Nimenrix 3 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-23F, Month 100.39 µg/mL
Nimenrix 3 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-5, Month 100.32 µg/mL
Nimenrix 3 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-5, Month 110.89 µg/mL
Nimenrix 3 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-6B, Month 100.62 µg/mL
Nimenrix 3 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-23F, Month 113.74 µg/mL
Nimenrix 3 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-19F, Month 101.22 µg/mL
Nimenrix 3 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-6B, Month 112.91 µg/mL
Nimenrix 3 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-4, Month 100.27 µg/mL
Nimenrix 3 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-7F, Month 100.50 µg/mL
Nimenrix 3 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-18C, Month 112.30 µg/mL
Nimenrix 3 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-7F, Month 112.89 µg/mL
Nimenrix 3 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-9V, Month 100.27 µg/mL
Nimenrix 2 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-7F, Month 112.88 µg/mL
Nimenrix 2 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-9V, Month 100.23 µg/mL
Nimenrix 2 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-23F, Month 100.45 µg/mL
Nimenrix 2 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-18C, Month 100.33 µg/mL
Nimenrix 2 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-5, Month 110.87 µg/mL
Nimenrix 2 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-9V, Month 111.31 µg/mL
Nimenrix 2 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-1, Month 100.17 µg/mL
Nimenrix 2 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-19F, Month 101.26 µg/mL
Nimenrix 2 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-18C, Month 112.10 µg/mL
Nimenrix 2 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-14, Month 101.64 µg/mL
Nimenrix 2 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-4, Month 112.16 µg/mL
Nimenrix 2 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-6B, Month 100.64 µg/mL
Nimenrix 2 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-23F, Month 113.73 µg/mL
Nimenrix 2 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-14, Month 117.63 µg/mL
Nimenrix 2 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-7F, Month 100.52 µg/mL
Nimenrix 2 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-4, Month 100.27 µg/mL
Nimenrix 2 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-6B, Month 113.02 µg/mL
Nimenrix 2 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-5, Month 100.28 µg/mL
Nimenrix 2 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-1, Month 111.67 µg/mL
Nimenrix 2 GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-19F, Month 118.06 µg/mL
Menjugate GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-18C, Month 100.39 µg/mL
Menjugate GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-1, Month 100.20 µg/mL
Menjugate GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-1, Month 112.18 µg/mL
Menjugate GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-4, Month 100.31 µg/mL
Menjugate GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-4, Month 112.86 µg/mL
Menjugate GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-5, Month 100.30 µg/mL
Menjugate GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-5, Month 110.95 µg/mL
Menjugate GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-6B, Month 100.68 µg/mL
Menjugate GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-6B, Month 113.70 µg/mL
Menjugate GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-7F, Month 100.57 µg/mL
Menjugate GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-7F, Month 113.38 µg/mL
Menjugate GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-9V, Month 100.28 µg/mL
Menjugate GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-9V, Month 111.47 µg/mL
Menjugate GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-14, Month 101.74 µg/mL
Menjugate GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-14, Month 119.75 µg/mL
Menjugate GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-18C, Month 113.08 µg/mL
Menjugate GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-19F, Month 101.34 µg/mL
Menjugate GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-19F, Month 119.74 µg/mL
Menjugate GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-23F, Month 100.47 µg/mL
Menjugate GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-23F, Month 114.24 µg/mL
NeisVac-C GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-18C, Month 100.38 µg/mL
NeisVac-C GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-7F, Month 100.46 µg/mL
NeisVac-C GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-6B, Month 113.20 µg/mL
NeisVac-C GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-23F, Month 100.41 µg/mL
NeisVac-C GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-18C, Month 112.78 µg/mL
NeisVac-C GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-6B, Month 100.59 µg/mL
NeisVac-C GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-5, Month 110.84 µg/mL
NeisVac-C GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-1, Month 111.72 µg/mL
NeisVac-C GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-19F, Month 101.10 µg/mL
NeisVac-C GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-5, Month 100.27 µg/mL
NeisVac-C GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-1, Month 100.15 µg/mL
NeisVac-C GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-19F, Month 118.43 µg/mL
NeisVac-C GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-4, Month 112.12 µg/mL
NeisVac-C GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-4, Month 100.25 µg/mL
NeisVac-C GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-23F, Month 113.73 µg/mL
NeisVac-C GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-14, Month 101.42 µg/mL
NeisVac-C GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-14, Month 117.94 µg/mL
NeisVac-C GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-9V, Month 111.33 µg/mL
NeisVac-C GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-9V, Month 100.25 µg/mL
NeisVac-C GroupAnti-pneumococcal Serotypes Antibody ConcentrationsAnti-7F, Month 112.78 µg/mL
Secondary

Anti-polio Type 1, 2 and 3 Antibody Titers

Antibody titers were presented as geometric mean titers (GMTs).

Time frame: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3

Population: The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Nimenrix 3 GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-Polio 1, Month 032.7 Titers
Nimenrix 3 GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-Polio 1, Month 3279.6 Titers
Nimenrix 3 GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-Polio 2, Month 019.4 Titers
Nimenrix 3 GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-Polio 2, Month 3225.2 Titers
Nimenrix 3 GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-Polio 3, Month 011.5 Titers
Nimenrix 3 GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-Polio 3, Month 3642.7 Titers
Nimenrix 2 GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-Polio 3, Month 3675 Titers
Nimenrix 2 GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-Polio 2, Month 3244.8 Titers
Nimenrix 2 GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-Polio 1, Month 040.2 Titers
Nimenrix 2 GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-Polio 2, Month 028 Titers
Nimenrix 2 GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-Polio 1, Month 3317.9 Titers
Nimenrix 2 GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-Polio 3, Month 011.7 Titers
Menjugate GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-Polio 1, Month 3424.1 Titers
Menjugate GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-Polio 2, Month 017.4 Titers
Menjugate GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-Polio 2, Month 3274.5 Titers
Menjugate GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-Polio 3, Month 3674 Titers
Menjugate GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-Polio 3, Month 05.9 Titers
Menjugate GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-Polio 1, Month 028.1 Titers
NeisVac-C GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-Polio 3, Month 014.2 Titers
NeisVac-C GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-Polio 3, Month 3494.3 Titers
NeisVac-C GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-Polio 1, Month 3277.7 Titers
NeisVac-C GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-Polio 2, Month 3232.7 Titers
NeisVac-C GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-Polio 1, Month 030.7 Titers
NeisVac-C GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-Polio 2, Month 022.9 Titers
Secondary

Anti-polio Type 1, 2 and 3 Antibody Titers

Antibody titers were presented as geometric mean titers (GMTs).

Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11

Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Nimenrix 3 GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-polio 3, Month 10115.0 Titers
Nimenrix 3 GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-polio 1, Month 11909.8 Titers
Nimenrix 3 GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-polio 3, Month 111681.0 Titers
Nimenrix 3 GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-polio 2, Month 1093.7 Titers
Nimenrix 3 GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-polio 2, Month 111205.7 Titers
Nimenrix 3 GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-polio 1, Month 1074.9 Titers
Nimenrix 2 GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-polio 2, Month 1080.1 Titers
Nimenrix 2 GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-polio 1, Month 1084.7 Titers
Nimenrix 2 GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-polio 3, Month 10104.6 Titers
Nimenrix 2 GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-polio 2, Month 111306.3 Titers
Nimenrix 2 GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-polio 3, Month 112167.8 Titers
Nimenrix 2 GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-polio 1, Month 111070.9 Titers
Menjugate GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-polio 3, Month 112136.2 Titers
Menjugate GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-polio 1, Month 111524.5 Titers
Menjugate GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-polio 2, Month 112068.0 Titers
Menjugate GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-polio 2, Month 10112.5 Titers
Menjugate GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-polio 1, Month 10120.8 Titers
Menjugate GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-polio 3, Month 10155.2 Titers
NeisVac-C GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-polio 2, Month 1078.1 Titers
NeisVac-C GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-polio 1, Month 1090.0 Titers
NeisVac-C GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-polio 1, Month 111217.7 Titers
NeisVac-C GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-polio 3, Month 111852.2 Titers
NeisVac-C GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-polio 2, Month 111419.0 Titers
NeisVac-C GroupAnti-polio Type 1, 2 and 3 Antibody TitersAnti-polio 3, Month 10108.6 Titers
Secondary

Anti-PRP Antibody Concentrations

Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL).

Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11

Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Nimenrix 3 GroupAnti-PRP Antibody ConcentrationsAnti-PRP, Month 100.378 µg/mL
Nimenrix 3 GroupAnti-PRP Antibody ConcentrationsAnti-PRP, Month 1117.350 µg/mL
Nimenrix 2 GroupAnti-PRP Antibody ConcentrationsAnti-PRP, Month 1117.519 µg/mL
Nimenrix 2 GroupAnti-PRP Antibody ConcentrationsAnti-PRP, Month 100.400 µg/mL
Menjugate GroupAnti-PRP Antibody ConcentrationsAnti-PRP, Month 100.535 µg/mL
Menjugate GroupAnti-PRP Antibody ConcentrationsAnti-PRP, Month 1122.879 µg/mL
NeisVac-C GroupAnti-PRP Antibody ConcentrationsAnti-PRP, Month 100.535 µg/mL
NeisVac-C GroupAnti-PRP Antibody ConcentrationsAnti-PRP, Month 1123.973 µg/mL
Secondary

Anti-PRP Antibody Concentrations

Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL).

Time frame: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3

Population: The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Nimenrix 3 GroupAnti-PRP Antibody ConcentrationsAnti-PRP, Month 34.011 µg/mL
Nimenrix 3 GroupAnti-PRP Antibody ConcentrationsAnti-PRP, Month 00.158 µg/mL
Nimenrix 2 GroupAnti-PRP Antibody ConcentrationsAnti-PRP, Month 00.213 µg/mL
Nimenrix 2 GroupAnti-PRP Antibody ConcentrationsAnti-PRP, Month 33.573 µg/mL
Menjugate GroupAnti-PRP Antibody ConcentrationsAnti-PRP, Month 00.162 µg/mL
Menjugate GroupAnti-PRP Antibody ConcentrationsAnti-PRP, Month 32.752 µg/mL
NeisVac-C GroupAnti-PRP Antibody ConcentrationsAnti-PRP, Month 34.662 µg/mL
NeisVac-C GroupAnti-PRP Antibody ConcentrationsAnti-PRP, Month 00.162 µg/mL
Secondary

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

Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in EL.U/mL.

Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11

Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Nimenrix 3 GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-PT, Month 1011.0 EL.U/mL
Nimenrix 3 GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-PT, Month 1182.5 EL.U/mL
Nimenrix 3 GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-FHA, Month 1034.5 EL.U/mL
Nimenrix 3 GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-FHA, Month 11285.5 EL.U/mL
Nimenrix 3 GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-PRN, Month 1017.9 EL.U/mL
Nimenrix 3 GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-PRN, Month 11283.7 EL.U/mL
Nimenrix 2 GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-PRN, Month 11290.8 EL.U/mL
Nimenrix 2 GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-FHA, Month 11296.3 EL.U/mL
Nimenrix 2 GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-PT, Month 1011.1 EL.U/mL
Nimenrix 2 GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-FHA, Month 1033.1 EL.U/mL
Nimenrix 2 GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-PT, Month 1178.2 EL.U/mL
Nimenrix 2 GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-PRN, Month 1015.7 EL.U/mL
Menjugate GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-PT, Month 1184.7 EL.U/mL
Menjugate GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-FHA, Month 1037.4 EL.U/mL
Menjugate GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-FHA, Month 11305.9 EL.U/mL
Menjugate GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-PRN, Month 11291.7 EL.U/mL
Menjugate GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-PRN, Month 1019.9 EL.U/mL
Menjugate GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-PT, Month 1013.1 EL.U/mL
NeisVac-C GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-PRN, Month 1017.9 EL.U/mL
NeisVac-C GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-PRN, Month 11334.3 EL.U/mL
NeisVac-C GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-PT, Month 1182.7 EL.U/mL
NeisVac-C GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-FHA, Month 11302.9 EL.U/mL
NeisVac-C GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-PT, Month 1011.4 EL.U/mL
NeisVac-C GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-FHA, Month 1034.9 EL.U/mL
Secondary

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

Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in EL.U/mL.

Time frame: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3

Population: The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Nimenrix 3 GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-PT, Month 03.4 EL.U/mL
Nimenrix 3 GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-PT, Month 352.7 EL.U/mL
Nimenrix 3 GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-FHA, Month 09.7 EL.U/mL
Nimenrix 3 GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-FHA, Month 3124.3 EL.U/mL
Nimenrix 3 GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-PRN, Month 04 EL.U/mL
Nimenrix 3 GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-PRN, Month 3122 EL.U/mL
Nimenrix 2 GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-PRN, Month 3134.9 EL.U/mL
Nimenrix 2 GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-FHA, Month 3149.2 EL.U/mL
Nimenrix 2 GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-PT, Month 03.9 EL.U/mL
Nimenrix 2 GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-FHA, Month 013.2 EL.U/mL
Nimenrix 2 GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-PT, Month 356.3 EL.U/mL
Nimenrix 2 GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-PRN, Month 05 EL.U/mL
Menjugate GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-PT, Month 356.5 EL.U/mL
Menjugate GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-FHA, Month 011.4 EL.U/mL
Menjugate GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-FHA, Month 3139.1 EL.U/mL
Menjugate GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-PRN, Month 3118.2 EL.U/mL
Menjugate GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-PRN, Month 04.6 EL.U/mL
Menjugate GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-PT, Month 03.6 EL.U/mL
NeisVac-C GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-PRN, Month 04.7 EL.U/mL
NeisVac-C GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-PRN, Month 3132 EL.U/mL
NeisVac-C GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-PT, Month 356.4 EL.U/mL
NeisVac-C GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-FHA, Month 3132 EL.U/mL
NeisVac-C GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-PT, Month 04.1 EL.U/mL
NeisVac-C GroupAnti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsAnti-FHA, Month 011.9 EL.U/mL
Secondary

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

Antibody titers were presented as geometric mean titers (GMTs).

Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11

Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects who used hSBA complement and who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11).

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Nimenrix 3 GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenY, Month 1099.8 Titers
Nimenrix 3 GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenA, Month 1032.0 Titers
Nimenrix 3 GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenW-135, Month 10248.1 Titers
Nimenrix 3 GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenY, Month 112491.5 Titers
Nimenrix 3 GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenA, Month 111192.7 Titers
Nimenrix 3 GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenW-135, Month 113944.9 Titers
Nimenrix 3 GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenC, Month 10116.1 Titers
Nimenrix 3 GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenC, Month 114411.2 Titers
Nimenrix 2 GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenW-135, Month 115122.7 Titers
Nimenrix 2 GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenC, Month 114992.3 Titers
Nimenrix 2 GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenA, Month 111007.2 Titers
Nimenrix 2 GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenW-135, Month 10332.4 Titers
Nimenrix 2 GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenC, Month 10181.4 Titers
Nimenrix 2 GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenA, Month 1014.5 Titers
Nimenrix 2 GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenY, Month 112954.0 Titers
Nimenrix 2 GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenY, Month 10140.2 Titers
Menjugate GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenW-135, Month 102.0 Titers
Menjugate GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenA, Month 102.7 Titers
Menjugate GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenA, Month 113.9 Titers
Menjugate GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenC, Month 1076.8 Titers
Menjugate GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenC, Month 115438.2 Titers
Menjugate GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenW-135, Month 112.1 Titers
Menjugate GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenY, Month 102.2 Titers
Menjugate GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenY, Month 112.3 Titers
NeisVac-C GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenC, Month 10213.7 Titers
NeisVac-C GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenA, Month 114.2 Titers
NeisVac-C GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenY, Month 112.4 Titers
NeisVac-C GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenY, Month 102.4 Titers
NeisVac-C GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenA, Month 102.7 Titers
NeisVac-C GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenC, Month 115542.3 Titers
NeisVac-C GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenW-135, Month 102.3 Titers
NeisVac-C GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenW-135, Month 112.3 Titers
Secondary

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

Antibody titers were presented as geometric mean titers (GMTs).

Time frame: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3

Population: The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who used hSBA complement and who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3).

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Nimenrix 3 GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenA, Month 02.8 Titers
Nimenrix 3 GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenA, Month 3240.9 Titers
Nimenrix 3 GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenC, Month 03.9 Titers
Nimenrix 3 GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenC, Month 3765.6 Titers
Nimenrix 3 GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenW-135, Month 05 Titers
Nimenrix 3 GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenW-135, Month 3190.9 Titers
Nimenrix 3 GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenY, Month 08 Titers
Nimenrix 3 GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenY, Month 366.5 Titers
Nimenrix 2 GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenW-135, Month 3753.5 Titers
Nimenrix 2 GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenW-135, Month 04.7 Titers
Nimenrix 2 GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenA, Month 3157.2 Titers
Nimenrix 2 GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenY, Month 3328.1 Titers
Nimenrix 2 GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenY, Month 08 Titers
Nimenrix 2 GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenC, Month 31308.3 Titers
Nimenrix 2 GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenC, Month 03.6 Titers
Nimenrix 2 GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenA, Month 02.7 Titers
Menjugate GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenY, Month 07.1 Titers
Menjugate GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenC, Month 04.9 Titers
Menjugate GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenC, Month 33188.1 Titers
Menjugate GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenW-135, Month 05 Titers
Menjugate GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenW-135, Month 32.1 Titers
Menjugate GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenY, Month 32.4 Titers
Menjugate GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenA, Month 03 Titers
Menjugate GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenA, Month 32.5 Titers
NeisVac-C GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenC, Month 03.9 Titers
NeisVac-C GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenC, Month 32626.5 Titers
NeisVac-C GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenA, Month 32.3 Titers
NeisVac-C GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenA, Month 02.9 Titers
NeisVac-C GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenW-135, Month 03.7 Titers
NeisVac-C GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenY, Month 32.1 Titers
NeisVac-C GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenY, Month 08.1 Titers
NeisVac-C GrouphSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody TitershSBA-MenW-135, Month 32.1 Titers
Secondary

Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off Value

The cut-off value for anti-D and anti-T concentrations was greater than or equal to (≥) 0.1 IU/mL

Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11

Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Nimenrix 3 GroupNumber of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off ValueAnti-D, Month 1098 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off ValueAnti-D, Month 11116 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off ValueAnti-T, Month 10114 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off ValueAnti-T, Month 11116 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off ValueAnti-D, Month 11111 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off ValueAnti-T, Month 10111 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off ValueAnti-T, Month 11111 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off ValueAnti-D, Month 1098 Participants
Menjugate GroupNumber of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off ValueAnti-T, Month 10118 Participants
Menjugate GroupNumber of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off ValueAnti-D, Month 11118 Participants
Menjugate GroupNumber of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off ValueAnti-T, Month 11118 Participants
Menjugate GroupNumber of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off ValueAnti-D, Month 10116 Participants
NeisVac-C GroupNumber of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off ValueAnti-T, Month 11118 Participants
NeisVac-C GroupNumber of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off ValueAnti-D, Month 11118 Participants
NeisVac-C GroupNumber of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off ValueAnti-D, Month 10113 Participants
NeisVac-C GroupNumber of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off ValueAnti-T, Month 10117 Participants
Secondary

Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Concentrations ≥ the Cut-off Value

The cut-off value for anti-D and anti-T concentrations was greater than or equal to (≥) 0.1 IU/mL

Time frame: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3

Population: The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Nimenrix 3 GroupNumber of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Concentrations ≥ the Cut-off ValueAnti-D, Month 037 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Concentrations ≥ the Cut-off ValueAnti-D, Month 3117 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Concentrations ≥ the Cut-off ValueAnti-T, Month 0104 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Concentrations ≥ the Cut-off ValueAnti-T, Month 3117 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Concentrations ≥ the Cut-off ValueAnti-D, Month 3113 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Concentrations ≥ the Cut-off ValueAnti-T, Month 091 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Concentrations ≥ the Cut-off ValueAnti-T, Month 3113 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Concentrations ≥ the Cut-off ValueAnti-D, Month 043 Participants
Menjugate GroupNumber of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Concentrations ≥ the Cut-off ValueAnti-T, Month 0107 Participants
Menjugate GroupNumber of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Concentrations ≥ the Cut-off ValueAnti-D, Month 3123 Participants
Menjugate GroupNumber of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Concentrations ≥ the Cut-off ValueAnti-T, Month 3123 Participants
Menjugate GroupNumber of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Concentrations ≥ the Cut-off ValueAnti-D, Month 056 Participants
NeisVac-C GroupNumber of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Concentrations ≥ the Cut-off ValueAnti-T, Month 3114 Participants
NeisVac-C GroupNumber of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Concentrations ≥ the Cut-off ValueAnti-D, Month 3115 Participants
NeisVac-C GroupNumber of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Concentrations ≥ the Cut-off ValueAnti-D, Month 039 Participants
NeisVac-C GroupNumber of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Concentrations ≥ the Cut-off ValueAnti-T, Month 091 Participants
Secondary

Number of Subjects With Anti-HBs Antibody Concentrations Above the Cut-off Values

The cut-off values for anti-HBs concentrations were greater than or equal to (≥) 10 mIU/mL and ≥ 100 mIU/mL.

Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11

Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Nimenrix 3 GroupNumber of Subjects With Anti-HBs Antibody Concentrations Above the Cut-off ValuesAnti-HBs ≥ 10 mIU/mL, Month 1091 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-HBs Antibody Concentrations Above the Cut-off ValuesAnti-HBs ≥ 10 mIU/mL, Month 1195 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-HBs Antibody Concentrations Above the Cut-off ValuesAnti-HBs ≥ 100 mIU/mL, Month 1067 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-HBs Antibody Concentrations Above the Cut-off ValuesAnti-HBs ≥ 100 mIU/mL, Month 1193 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-HBs Antibody Concentrations Above the Cut-off ValuesAnti-HBs ≥ 10 mIU/mL, Month 1197 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-HBs Antibody Concentrations Above the Cut-off ValuesAnti-HBs ≥ 100 mIU/mL, Month 1058 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-HBs Antibody Concentrations Above the Cut-off ValuesAnti-HBs ≥ 100 mIU/mL, Month 1197 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-HBs Antibody Concentrations Above the Cut-off ValuesAnti-HBs ≥ 10 mIU/mL, Month 1086 Participants
Menjugate GroupNumber of Subjects With Anti-HBs Antibody Concentrations Above the Cut-off ValuesAnti-HBs ≥ 100 mIU/mL, Month 1075 Participants
Menjugate GroupNumber of Subjects With Anti-HBs Antibody Concentrations Above the Cut-off ValuesAnti-HBs ≥ 10 mIU/mL, Month 11103 Participants
Menjugate GroupNumber of Subjects With Anti-HBs Antibody Concentrations Above the Cut-off ValuesAnti-HBs ≥ 100 mIU/mL, Month 11102 Participants
Menjugate GroupNumber of Subjects With Anti-HBs Antibody Concentrations Above the Cut-off ValuesAnti-HBs ≥ 10 mIU/mL, Month 1096 Participants
NeisVac-C GroupNumber of Subjects With Anti-HBs Antibody Concentrations Above the Cut-off ValuesAnti-HBs ≥ 100 mIU/mL, Month 1197 Participants
NeisVac-C GroupNumber of Subjects With Anti-HBs Antibody Concentrations Above the Cut-off ValuesAnti-HBs ≥ 10 mIU/mL, Month 11100 Participants
NeisVac-C GroupNumber of Subjects With Anti-HBs Antibody Concentrations Above the Cut-off ValuesAnti-HBs ≥ 10 mIU/mL, Month 1094 Participants
NeisVac-C GroupNumber of Subjects With Anti-HBs Antibody Concentrations Above the Cut-off ValuesAnti-HBs ≥ 100 mIU/mL, Month 1065 Participants
Secondary

Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Values

The cut-off values for anti-HBs concentrations were greater than or equal to (≥) 10 milli-international units per milliliter (mIU/mL) and ≥ 100 mIU/mL.

Time frame: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3

Population: The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Nimenrix 3 GroupNumber of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off ValuesAnti-HBs ≥ 10 mIU/mL, Month 033 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off ValuesAnti-HBs ≥ 10 mIU/mL, Month 385 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off ValuesAnti-HBs ≥ 100 mIU/mL, Month 017 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off ValuesAnti-HBs ≥ 100 mIU/mL, Month 374 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off ValuesAnti-HBs ≥ 10 mIU/mL, Month 384 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off ValuesAnti-HBs ≥ 100 mIU/mL, Month 014 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off ValuesAnti-HBs ≥ 100 mIU/mL, Month 379 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off ValuesAnti-HBs ≥ 10 mIU/mL, Month 034 Participants
Menjugate GroupNumber of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off ValuesAnti-HBs ≥ 100 mIU/mL, Month 014 Participants
Menjugate GroupNumber of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off ValuesAnti-HBs ≥ 10 mIU/mL, Month 394 Participants
Menjugate GroupNumber of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off ValuesAnti-HBs ≥ 100 mIU/mL, Month 389 Participants
Menjugate GroupNumber of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off ValuesAnti-HBs ≥ 10 mIU/mL, Month 039 Participants
NeisVac-C GroupNumber of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off ValuesAnti-HBs ≥ 100 mIU/mL, Month 373 Participants
NeisVac-C GroupNumber of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off ValuesAnti-HBs ≥ 10 mIU/mL, Month 379 Participants
NeisVac-C GroupNumber of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off ValuesAnti-HBs ≥ 10 mIU/mL, Month 028 Participants
NeisVac-C GroupNumber of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off ValuesAnti-HBs ≥ 100 mIU/mL, Month 08 Participants
Secondary

Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Concentrations ≥ the Cut-off Value

The cut-off value for anti-PT, anti-FHA and anti-PRN concentrations was greater than or equal to (≥) 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

Time frame: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3

Population: The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Nimenrix 3 GroupNumber of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Concentrations ≥ the Cut-off ValueAnti-PT, Month 023 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Concentrations ≥ the Cut-off ValueAnti-PT, Month 3117 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Concentrations ≥ the Cut-off ValueAnti-FHA, Month 083 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Concentrations ≥ the Cut-off ValueAnti-FHA, Month 3117 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Concentrations ≥ the Cut-off ValueAnti-PRN, Month 031 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Concentrations ≥ the Cut-off ValueAnti-PRN, Month 3117 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Concentrations ≥ the Cut-off ValueAnti-PRN, Month 3112 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Concentrations ≥ the Cut-off ValueAnti-FHA, Month 3111 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Concentrations ≥ the Cut-off ValueAnti-PT, Month 032 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Concentrations ≥ the Cut-off ValueAnti-FHA, Month 085 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Concentrations ≥ the Cut-off ValueAnti-PT, Month 3111 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Concentrations ≥ the Cut-off ValueAnti-PRN, Month 039 Participants
Menjugate GroupNumber of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Concentrations ≥ the Cut-off ValueAnti-PT, Month 3122 Participants
Menjugate GroupNumber of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Concentrations ≥ the Cut-off ValueAnti-FHA, Month 093 Participants
Menjugate GroupNumber of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Concentrations ≥ the Cut-off ValueAnti-FHA, Month 3123 Participants
Menjugate GroupNumber of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Concentrations ≥ the Cut-off ValueAnti-PRN, Month 3122 Participants
Menjugate GroupNumber of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Concentrations ≥ the Cut-off ValueAnti-PRN, Month 044 Participants
Menjugate GroupNumber of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Concentrations ≥ the Cut-off ValueAnti-PT, Month 028 Participants
NeisVac-C GroupNumber of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Concentrations ≥ the Cut-off ValueAnti-PRN, Month 032 Participants
NeisVac-C GroupNumber of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Concentrations ≥ the Cut-off ValueAnti-PRN, Month 3115 Participants
NeisVac-C GroupNumber of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Concentrations ≥ the Cut-off ValueAnti-PT, Month 3115 Participants
NeisVac-C GroupNumber of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Concentrations ≥ the Cut-off ValueAnti-FHA, Month 3115 Participants
NeisVac-C GroupNumber of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Concentrations ≥ the Cut-off ValueAnti-PT, Month 031 Participants
NeisVac-C GroupNumber of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Concentrations ≥ the Cut-off ValueAnti-FHA, Month 078 Participants
Secondary

Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values

The cut-off values for anti-1, anti-4, anti-5, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19F and anti-23F concentrations were ≥ 0.15 µg/mL and ≥ 0.35 µg/mL

Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11

Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-1 ≥ 0.15 µg/mL, Month 1065 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-1 ≥ 0.35 µg/mL, Month 1021 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-1 ≥ 0.15 µg/mL, Month 11104 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-1 ≥ 0.35 µg/mL, Month 11102 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-4 ≥ 0.15 µg/mL, Month 1083 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-4 ≥ 0.35 µg/mL, Month 1038 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-4 ≥ 0.15 µg/mL, Month 11104 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-4 ≥ 0.35 µg/mL, Month 11104 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-5 ≥ 0.15 µg/mL, Month 1090 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-5 ≥ 0.35 µg/mL, Month 1044 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-5 ≥ 0.35 µg/mL, Month 1192 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-5 ≥ 0.15 µg/mL, Month 11101 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-6B ≥ 0.15 µg/mL, Month 1096 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-6B ≥ 0.35 µg/mL, Month 1071 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-6B ≥ 0.15 µg/mL, Month 11103 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-6B ≥ 0.35 µg/mL, Month 11103 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-7F ≥ 0.15 µg/mL, Month 1098 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-7F ≥ 0.35 µg/mL, Month 1076 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-7F ≥ 0.15 µg/mL, Month 11104 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-7F ≥ 0.35 µg/mL, Month 11104 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-9V ≥ 0.15 µg/mL, Month 1081 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-9V ≥ 0.35 µg/mL, Month 1042 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-9V ≥ 0.15 µg/mL, Month 11104 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-9V ≥ 0.35 µg/mL, Month 11102 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-14 ≥ 0.15 µg/mL, Month 10102 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-14 ≥ 0.35 µg/mL, Month 10100 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-14 ≥ 0.15 µg/mL, Month 11104 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-14 ≥ 0.35 µg/mL, Month 11104 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-18C ≥ 0.15 µg/mL, Month 1082 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-18C ≥ 0.35 µg/mL, Month 1045 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-18C ≥ 0.15 µg/mL, Month 11103 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-18C ≥ 0.35 µg/mL, Month 11103 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-19F ≥ 0.15 µg/mL, Month 10102 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-19F ≥ 0.35 µg/mL, Month 1096 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-19F ≥ 0.15 µg/mL, Month 11104 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-19F ≥ 0.35 µg/mL, Month 11104 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-23F ≥ 0.15 µg/mL, Month 1094 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-23F ≥ 0.35 µg/mL, Month 1058 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-23F ≥ 0.15 µg/mL, Month 11101 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-23F ≥ 0.35 µg/mL, Month 11101 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-18C ≥ 0.35 µg/mL, Month 1050 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-9V ≥ 0.15 µg/mL, Month 1082 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-19F ≥ 0.15 µg/mL, Month 10107 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-23F ≥ 0.35 µg/mL, Month 1061 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-19F ≥ 0.35 µg/mL, Month 11107 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-9V ≥ 0.35 µg/mL, Month 1030 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-4 ≥ 0.15 µg/mL, Month 11107 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-18C ≥ 0.15 µg/mL, Month 1089 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-5 ≥ 0.35 µg/mL, Month 1196 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-9V ≥ 0.15 µg/mL, Month 11107 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-6B ≥ 0.15 µg/mL, Month 11106 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-23F ≥ 0.35 µg/mL, Month 11106 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-14 ≥ 0.35 µg/mL, Month 11107 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-9V ≥ 0.35 µg/mL, Month 11105 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-5 ≥ 0.15 µg/mL, Month 11104 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-14 ≥ 0.15 µg/mL, Month 11107 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-14 ≥ 0.35 µg/mL, Month 10103 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-14 ≥ 0.15 µg/mL, Month 10106 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-4 ≥ 0.35 µg/mL, Month 1035 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-23F ≥ 0.15 µg/mL, Month 10103 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-18C ≥ 0.35 µg/mL, Month 11106 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-6B ≥ 0.35 µg/mL, Month 11105 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-5 ≥ 0.15 µg/mL, Month 1091 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-4 ≥ 0.15 µg/mL, Month 1087 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-23F ≥ 0.15 µg/mL, Month 11106 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-7F ≥ 0.15 µg/mL, Month 10103 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-6B ≥ 0.15 µg/mL, Month 10104 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-1 ≥ 0.35 µg/mL, Month 11104 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-19F ≥ 0.15 µg/mL, Month 11107 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-7F ≥ 0.35 µg/mL, Month 1078 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-5 ≥ 0.35 µg/mL, Month 1043 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-1 ≥ 0.15 µg/mL, Month 11106 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-4 ≥ 0.35 µg/mL, Month 11107 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-7F ≥ 0.15 µg/mL, Month 11107 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-19F ≥ 0.35 µg/mL, Month 1098 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-1 ≥ 0.35 µg/mL, Month 1020 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-18C ≥ 0.15 µg/mL, Month 11107 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-7F ≥ 0.35 µg/mL, Month 11107 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-6B ≥ 0.35 µg/mL, Month 1084 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-1 ≥ 0.15 µg/mL, Month 1064 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-19F ≥ 0.15 µg/mL, Month 10106 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-5 ≥ 0.15 µg/mL, Month 1198 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-5 ≥ 0.35 µg/mL, Month 1195 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-6B ≥ 0.15 µg/mL, Month 10104 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-6B ≥ 0.35 µg/mL, Month 1083 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-19F ≥ 0.35 µg/mL, Month 10103 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-6B ≥ 0.15 µg/mL, Month 11100 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-6B ≥ 0.35 µg/mL, Month 11100 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-23F ≥ 0.15 µg/mL, Month 1198 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-7F ≥ 0.15 µg/mL, Month 10106 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-7F ≥ 0.35 µg/mL, Month 1075 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-19F ≥ 0.15 µg/mL, Month 11100 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-7F ≥ 0.15 µg/mL, Month 11100 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-7F ≥ 0.35 µg/mL, Month 11100 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-9V ≥ 0.15 µg/mL, Month 1088 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-9V ≥ 0.35 µg/mL, Month 1043 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-19F ≥ 0.35 µg/mL, Month 11100 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-9V ≥ 0.15 µg/mL, Month 11100 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-9V ≥ 0.35 µg/mL, Month 1199 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-14 ≥ 0.15 µg/mL, Month 10106 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-14 ≥ 0.35 µg/mL, Month 1099 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-23F ≥ 0.15 µg/mL, Month 10102 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-14 ≥ 0.15 µg/mL, Month 11100 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-14 ≥ 0.35 µg/mL, Month 11100 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-18C ≥ 0.15 µg/mL, Month 1097 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-18C ≥ 0.35 µg/mL, Month 1054 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-23F ≥ 0.35 µg/mL, Month 1063 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-1 ≥ 0.15 µg/mL, Month 1072 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-1 ≥ 0.35 µg/mL, Month 1024 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-18C ≥ 0.15 µg/mL, Month 11100 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-1 ≥ 0.15 µg/mL, Month 1199 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-1 ≥ 0.35 µg/mL, Month 1197 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-4 ≥ 0.15 µg/mL, Month 1091 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-4 ≥ 0.35 µg/mL, Month 1048 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-18C ≥ 0.35 µg/mL, Month 11100 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-4 ≥ 0.15 µg/mL, Month 11100 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-4 ≥ 0.35 µg/mL, Month 1199 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-23F ≥ 0.35 µg/mL, Month 1198 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-5 ≥ 0.15 µg/mL, Month 1094 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-5 ≥ 0.35 µg/mL, Month 1048 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-5 ≥ 0.15 µg/mL, Month 1093 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-7F ≥ 0.35 µg/mL, Month 11104 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-4 ≥ 0.15 µg/mL, Month 11104 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-1 ≥ 0.15 µg/mL, Month 1057 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-19F ≥ 0.15 µg/mL, Month 11104 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-7F ≥ 0.15 µg/mL, Month 11104 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-18C ≥ 0.35 µg/mL, Month 11104 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-1 ≥ 0.35 µg/mL, Month 1010 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-6B ≥ 0.15 µg/mL, Month 10103 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-7F ≥ 0.35 µg/mL, Month 1078 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-5 ≥ 0.15 µg/mL, Month 11101 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-1 ≥ 0.15 µg/mL, Month 11103 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-18C ≥ 0.15 µg/mL, Month 11104 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-7F ≥ 0.15 µg/mL, Month 10104 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-4 ≥ 0.35 µg/mL, Month 11104 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-1 ≥ 0.35 µg/mL, Month 11101 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-23F ≥ 0.35 µg/mL, Month 1063 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-6B ≥ 0.35 µg/mL, Month 11104 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-19F ≥ 0.15 µg/mL, Month 10107 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-4 ≥ 0.15 µg/mL, Month 1094 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-14 ≥ 0.15 µg/mL, Month 10106 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-23F ≥ 0.35 µg/mL, Month 11104 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-19F ≥ 0.35 µg/mL, Month 10102 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-14 ≥ 0.35 µg/mL, Month 10103 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-6B ≥ 0.15 µg/mL, Month 11104 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-9V ≥ 0.35 µg/mL, Month 11102 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-5 ≥ 0.35 µg/mL, Month 1196 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-14 ≥ 0.15 µg/mL, Month 11104 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-23F ≥ 0.15 µg/mL, Month 10101 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-19F ≥ 0.35 µg/mL, Month 11104 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-4 ≥ 0.35 µg/mL, Month 1030 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-14 ≥ 0.35 µg/mL, Month 11104 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-9V ≥ 0.15 µg/mL, Month 11104 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-9V ≥ 0.35 µg/mL, Month 1033 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-5 ≥ 0.35 µg/mL, Month 1043 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-18C ≥ 0.15 µg/mL, Month 10101 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-9V ≥ 0.15 µg/mL, Month 1089 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-23F ≥ 0.15 µg/mL, Month 11104 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-6B ≥ 0.35 µg/mL, Month 1083 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off ValuesAnti-18C ≥ 0.35 µg/mL, Month 1058 Participants
Secondary

Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values

The cut-off values for anti-1, anti-4, anti-5, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19F and anti-23F concentrations were greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL) and ≥ 0.35 µg/mL

Time frame: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3

Population: The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-5 ≥ 0.35 µg/mL, Month 010 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-1 ≥ 0.35 µg/mL, Month 03 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-1 ≥ 0.15 µg/mL, Month 396 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-14 ≥ 0.35 µg/mL, Month 396 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-5 ≥ 0.15 µg/mL, Month 395 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-19F ≥ 0.15 µg/mL, Month 394 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-23F ≥ 0.35 µg/mL, Month 016 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-9V ≥ 0.15 µg/mL, Month 394 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-5 ≥ 0.35 µg/mL, Month 384 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-4 ≥ 0.35 µg/mL, Month 02 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-19F ≥ 0.35 µg/mL, Month 021 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-14 ≥ 0.15 µg/mL, Month 396 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-6B ≥ 0.15 µg/mL, Month 055 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-23F ≥ 0.15 µg/mL, Month 390 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-19F ≥ 0.35 µg/mL, Month 392 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-4 ≥ 0.15 µg/mL, Month 396 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-6B ≥ 0.35 µg/mL, Month 027 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-23F ≥ 0.35 µg/mL, Month 383 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-1 ≥ 0.35 µg/mL, Month 393 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-14 ≥ 0.35 µg/mL, Month 053 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-6B ≥ 0.15 µg/mL, Month 388 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-19F ≥ 0.15 µg/mL, Month 041 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-18C ≥ 0.35 µg/mL, Month 014 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-18C ≥ 0.15 µg/mL, Month 030 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-6B ≥ 0.35 µg/mL, Month 371 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-4 ≥ 0.35 µg/mL, Month 394 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-18C ≥ 0.15 µg/mL, Month 396 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-14 ≥ 0.15 µg/mL, Month 072 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-7F ≥ 0.15 µg/mL, Month 038 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-9V ≥ 0.15 µg/mL, Month 038 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-1 ≥ 0.15 µg/mL, Month 018 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-5 ≥ 0.15 µg/mL, Month 042 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-7F ≥ 0.35 µg/mL, Month 013 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-23F ≥ 0.15 µg/mL, Month 037 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-4 ≥ 0.15 µg/mL, Month 011 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-9V ≥ 0.35 µg/mL, Month 392 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-7F ≥ 0.15 µg/mL, Month 396 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-18C ≥ 0.35 µg/mL, Month 390 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-9V ≥ 0.35 µg/mL, Month 09 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-7F ≥ 0.35 µg/mL, Month 394 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-9V ≥ 0.15 µg/mL, Month 3102 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-19F ≥ 0.15 µg/mL, Month 061 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-18C ≥ 0.35 µg/mL, Month 3100 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-9V ≥ 0.35 µg/mL, Month 018 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-19F ≥ 0.35 µg/mL, Month 030 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-19F ≥ 0.15 µg/mL, Month 3100 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-9V ≥ 0.15 µg/mL, Month 044 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-19F ≥ 0.35 µg/mL, Month 394 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-4 ≥ 0.35 µg/mL, Month 02 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-23F ≥ 0.15 µg/mL, Month 038 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-7F ≥ 0.35 µg/mL, Month 399 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-23F ≥ 0.35 µg/mL, Month 013 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-18C ≥ 0.15 µg/mL, Month 044 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-23F ≥ 0.35 µg/mL, Month 383 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-23F ≥ 0.15 µg/mL, Month 399 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-4 ≥ 0.15 µg/mL, Month 3102 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-1 ≥ 0.35 µg/mL, Month 09 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-4 ≥ 0.35 µg/mL, Month 399 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-5 ≥ 0.15 µg/mL, Month 032 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-14 ≥ 0.35 µg/mL, Month 3103 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-5 ≥ 0.35 µg/mL, Month 05 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-5 ≥ 0.15 µg/mL, Month 3102 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-1 ≥ 0.15 µg/mL, Month 3102 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-14 ≥ 0.15 µg/mL, Month 3103 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-5 ≥ 0.35 µg/mL, Month 386 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-1 ≥ 0.15 µg/mL, Month 015 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-6B ≥ 0.15 µg/mL, Month 042 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-18C ≥ 0.15 µg/mL, Month 3101 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-14 ≥ 0.35 µg/mL, Month 057 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-6B ≥ 0.35 µg/mL, Month 019 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-6B ≥ 0.15 µg/mL, Month 395 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-1 ≥ 0.35 µg/mL, Month 395 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-14 ≥ 0.15 µg/mL, Month 069 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-6B ≥ 0.35 µg/mL, Month 382 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-7F ≥ 0.15 µg/mL, Month 043 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-18C ≥ 0.35 µg/mL, Month 018 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-9V ≥ 0.35 µg/mL, Month 399 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-7F ≥ 0.35 µg/mL, Month 018 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-7F ≥ 0.15 µg/mL, Month 3102 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-4 ≥ 0.15 µg/mL, Month 011 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-9V ≥ 0.15 µg/mL, Month 035 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-9V ≥ 0.35 µg/mL, Month 012 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-18C ≥ 0.35 µg/mL, Month 020 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-18C ≥ 0.35 µg/mL, Month 389 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-1 ≥ 0.15 µg/mL, Month 017 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-1 ≥ 0.35 µg/mL, Month 08 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-1 ≥ 0.15 µg/mL, Month 393 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-1 ≥ 0.35 µg/mL, Month 389 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-4 ≥ 0.15 µg/mL, Month 013 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-4 ≥ 0.35 µg/mL, Month 02 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-4 ≥ 0.15 µg/mL, Month 395 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-4 ≥ 0.35 µg/mL, Month 393 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-5 ≥ 0.15 µg/mL, Month 039 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-5 ≥ 0.35 µg/mL, Month 09 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-5 ≥ 0.15 µg/mL, Month 393 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-5 ≥ 0.35 µg/mL, Month 380 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-6B ≥ 0.15 µg/mL, Month 041 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-6B ≥ 0.35 µg/mL, Month 020 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-6B ≥ 0.15 µg/mL, Month 388 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-6B ≥ 0.35 µg/mL, Month 375 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-7F ≥ 0.15 µg/mL, Month 044 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-7F ≥ 0.35 µg/mL, Month 020 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-7F ≥ 0.15 µg/mL, Month 393 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-19F ≥ 0.15 µg/mL, Month 051 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-19F ≥ 0.35 µg/mL, Month 027 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-19F ≥ 0.15 µg/mL, Month 394 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-19F ≥ 0.35 µg/mL, Month 390 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-23F ≥ 0.15 µg/mL, Month 029 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-23F ≥ 0.35 µg/mL, Month 013 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-23F ≥ 0.15 µg/mL, Month 391 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-23F ≥ 0.35 µg/mL, Month 377 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-7F ≥ 0.35 µg/mL, Month 393 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-9V ≥ 0.15 µg/mL, Month 390 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-9V ≥ 0.35 µg/mL, Month 388 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-14 ≥ 0.15 µg/mL, Month 074 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-14 ≥ 0.35 µg/mL, Month 057 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-14 ≥ 0.15 µg/mL, Month 395 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-14 ≥ 0.35 µg/mL, Month 395 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-18C ≥ 0.15 µg/mL, Month 045 Participants
Menjugate GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-18C ≥ 0.15 µg/mL, Month 393 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-9V ≥ 0.15 µg/mL, Month 043 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-19F ≥ 0.35 µg/mL, Month 023 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-19F ≥ 0.15 µg/mL, Month 053 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-9V ≥ 0.35 µg/mL, Month 016 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-18C ≥ 0.35 µg/mL, Month 3101 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-7F ≥ 0.15 µg/mL, Month 3103 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-4 ≥ 0.15 µg/mL, Month 012 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-9V ≥ 0.15 µg/mL, Month 3103 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-7F ≥ 0.35 µg/mL, Month 016 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-7F ≥ 0.15 µg/mL, Month 049 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-1 ≥ 0.35 µg/mL, Month 391 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-9V ≥ 0.35 µg/mL, Month 399 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-6B ≥ 0.35 µg/mL, Month 381 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-6B ≥ 0.15 µg/mL, Month 390 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-18C ≥ 0.35 µg/mL, Month 010 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-14 ≥ 0.15 µg/mL, Month 080 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-6B ≥ 0.35 µg/mL, Month 026 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-6B ≥ 0.15 µg/mL, Month 050 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-1 ≥ 0.15 µg/mL, Month 3103 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-14 ≥ 0.35 µg/mL, Month 067 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-5 ≥ 0.35 µg/mL, Month 392 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-5 ≥ 0.15 µg/mL, Month 3101 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-1 ≥ 0.15 µg/mL, Month 018 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-14 ≥ 0.15 µg/mL, Month 3103 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-5 ≥ 0.35 µg/mL, Month 014 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-5 ≥ 0.15 µg/mL, Month 033 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-18C ≥ 0.15 µg/mL, Month 3103 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-14 ≥ 0.35 µg/mL, Month 3103 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-4 ≥ 0.15 µg/mL, Month 3103 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-4 ≥ 0.35 µg/mL, Month 01 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-23F ≥ 0.15 µg/mL, Month 398 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-23F ≥ 0.35 µg/mL, Month 018 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-1 ≥ 0.35 µg/mL, Month 08 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-23F ≥ 0.35 µg/mL, Month 386 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-23F ≥ 0.15 µg/mL, Month 040 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-18C ≥ 0.15 µg/mL, Month 043 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-7F ≥ 0.35 µg/mL, Month 3103 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-19F ≥ 0.35 µg/mL, Month 399 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-19F ≥ 0.15 µg/mL, Month 3102 Participants
NeisVac-C GroupNumber of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off ValuesAnti-4 ≥ 0.35 µg/mL, Month 399 Participants
Secondary

Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off Value

The cut-off value for anti-poliovirus type 1, 2 and 3 antibody concentrations was greater than or equal to (≥) 1:8.

Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11

Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Nimenrix 3 GroupNumber of Subjects With Anti-polio Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 1, Month 1074 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-polio Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 1, Month 1185 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-polio Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 2, Month 1069 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-polio Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 2, Month 1170 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-polio Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 3, Month 1057 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-polio Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 3, Month 1179 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-polio Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 3, Month 1167 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-polio Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 2, Month 1174 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-polio Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 1, Month 1063 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-polio Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 2, Month 1066 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-polio Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 1, Month 1185 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-polio Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 3, Month 1062 Participants
Menjugate GroupNumber of Subjects With Anti-polio Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 1, Month 1181 Participants
Menjugate GroupNumber of Subjects With Anti-polio Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 2, Month 1083 Participants
Menjugate GroupNumber of Subjects With Anti-polio Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 2, Month 1171 Participants
Menjugate GroupNumber of Subjects With Anti-polio Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 3, Month 1174 Participants
Menjugate GroupNumber of Subjects With Anti-polio Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 3, Month 1062 Participants
Menjugate GroupNumber of Subjects With Anti-polio Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 1, Month 1080 Participants
NeisVac-C GroupNumber of Subjects With Anti-polio Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 3, Month 1064 Participants
NeisVac-C GroupNumber of Subjects With Anti-polio Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 3, Month 1169 Participants
NeisVac-C GroupNumber of Subjects With Anti-polio Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 1, Month 1184 Participants
NeisVac-C GroupNumber of Subjects With Anti-polio Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 2, Month 1168 Participants
NeisVac-C GroupNumber of Subjects With Anti-polio Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 1, Month 1081 Participants
NeisVac-C GroupNumber of Subjects With Anti-polio Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 2, Month 1072 Participants
Secondary

Number of Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off Value

The cut-off value for anti-poliovirus type 1, 2 and 3 antibody concentrations was greater than or equal to (≥) 1:8.

Time frame: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3

Population: The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Nimenrix 3 GroupNumber of Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 1, Month 052 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 1, Month 391 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 2, Month 039 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 2, Month 381 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 3, Month 021 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 3, Month 393 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 3, Month 379 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 2, Month 370 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 1, Month 046 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 2, Month 040 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 1, Month 383 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 3, Month 021 Participants
Menjugate GroupNumber of Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 1, Month 389 Participants
Menjugate GroupNumber of Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 2, Month 044 Participants
Menjugate GroupNumber of Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 2, Month 381 Participants
Menjugate GroupNumber of Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 3, Month 387 Participants
Menjugate GroupNumber of Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 3, Month 011 Participants
Menjugate GroupNumber of Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 1, Month 054 Participants
NeisVac-C GroupNumber of Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 3, Month 023 Participants
NeisVac-C GroupNumber of Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 3, Month 377 Participants
NeisVac-C GroupNumber of Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 1, Month 384 Participants
NeisVac-C GroupNumber of Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 2, Month 370 Participants
NeisVac-C GroupNumber of Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 1, Month 046 Participants
NeisVac-C GroupNumber of Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off ValueAnti-Polio 2, Month 041 Participants
Secondary

Number of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Concentrations ≥ the Cut-off Values

The cut-off values for anti-PRP antibody concentrations were greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL) and ≥ 1.0 µg/mL.

Time frame: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3

Population: The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Nimenrix 3 GroupNumber of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Concentrations ≥ the Cut-off ValuesAnti-PRP ≥ 0.15 µg/mL, Month 046 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Concentrations ≥ the Cut-off ValuesAnti-PRP ≥ 0.15 µg/mL, Month 3119 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Concentrations ≥ the Cut-off ValuesAnti-PRP ≥ 1.0 µg/mL, Month 09 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Concentrations ≥ the Cut-off ValuesAnti-PRP ≥ 1.0 µg/mL, Month 3106 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Concentrations ≥ the Cut-off ValuesAnti-PRP ≥ 0.15 µg/mL, Month 3113 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Concentrations ≥ the Cut-off ValuesAnti-PRP ≥ 1.0 µg/mL, Month 019 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Concentrations ≥ the Cut-off ValuesAnti-PRP ≥ 1.0 µg/mL, Month 3101 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Concentrations ≥ the Cut-off ValuesAnti-PRP ≥ 0.15 µg/mL, Month 055 Participants
Menjugate GroupNumber of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Concentrations ≥ the Cut-off ValuesAnti-PRP ≥ 1.0 µg/mL, Month 010 Participants
Menjugate GroupNumber of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Concentrations ≥ the Cut-off ValuesAnti-PRP ≥ 0.15 µg/mL, Month 3121 Participants
Menjugate GroupNumber of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Concentrations ≥ the Cut-off ValuesAnti-PRP ≥ 1.0 µg/mL, Month 394 Participants
Menjugate GroupNumber of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Concentrations ≥ the Cut-off ValuesAnti-PRP ≥ 0.15 µg/mL, Month 046 Participants
NeisVac-C GroupNumber of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Concentrations ≥ the Cut-off ValuesAnti-PRP ≥ 1.0 µg/mL, Month 3106 Participants
NeisVac-C GroupNumber of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Concentrations ≥ the Cut-off ValuesAnti-PRP ≥ 0.15 µg/mL, Month 3113 Participants
NeisVac-C GroupNumber of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Concentrations ≥ the Cut-off ValuesAnti-PRP ≥ 0.15 µg/mL, Month 047 Participants
NeisVac-C GroupNumber of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Concentrations ≥ the Cut-off ValuesAnti-PRP ≥ 1.0 µg/mL, Month 07 Participants
Secondary

Number of Subjects With Anti-PRP Antibody Concentrations Above the Cut-off Values

The cut-off values for anti-PRP antibody concentrations were greater than or equal to (≥) 0.15 µg/mL and ≥ 1.0 µg/mL.

Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11

Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Nimenrix 3 GroupNumber of Subjects With Anti-PRP Antibody Concentrations Above the Cut-off ValuesAnti-PRP ≥ 0.15 µg/mL, Month 1092 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-PRP Antibody Concentrations Above the Cut-off ValuesAnti-PRP ≥ 0.15 µg/mL, Month 11116 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-PRP Antibody Concentrations Above the Cut-off ValuesAnti-PRP ≥ 1.0 µg/mL, Month 1023 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-PRP Antibody Concentrations Above the Cut-off ValuesAnti-PRP ≥ 1.0 µg/mL, Month 11113 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-PRP Antibody Concentrations Above the Cut-off ValuesAnti-PRP ≥ 0.15 µg/mL, Month 11112 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-PRP Antibody Concentrations Above the Cut-off ValuesAnti-PRP ≥ 1.0 µg/mL, Month 1020 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-PRP Antibody Concentrations Above the Cut-off ValuesAnti-PRP ≥ 1.0 µg/mL, Month 11112 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-PRP Antibody Concentrations Above the Cut-off ValuesAnti-PRP ≥ 0.15 µg/mL, Month 1091 Participants
Menjugate GroupNumber of Subjects With Anti-PRP Antibody Concentrations Above the Cut-off ValuesAnti-PRP ≥ 1.0 µg/mL, Month 1040 Participants
Menjugate GroupNumber of Subjects With Anti-PRP Antibody Concentrations Above the Cut-off ValuesAnti-PRP ≥ 0.15 µg/mL, Month 11119 Participants
Menjugate GroupNumber of Subjects With Anti-PRP Antibody Concentrations Above the Cut-off ValuesAnti-PRP ≥ 1.0 µg/mL, Month 11119 Participants
Menjugate GroupNumber of Subjects With Anti-PRP Antibody Concentrations Above the Cut-off ValuesAnti-PRP ≥ 0.15 µg/mL, Month 1091 Participants
NeisVac-C GroupNumber of Subjects With Anti-PRP Antibody Concentrations Above the Cut-off ValuesAnti-PRP ≥ 1.0 µg/mL, Month 11114 Participants
NeisVac-C GroupNumber of Subjects With Anti-PRP Antibody Concentrations Above the Cut-off ValuesAnti-PRP ≥ 0.15 µg/mL, Month 11118 Participants
NeisVac-C GroupNumber of Subjects With Anti-PRP Antibody Concentrations Above the Cut-off ValuesAnti-PRP ≥ 0.15 µg/mL, Month 10100 Participants
NeisVac-C GroupNumber of Subjects With Anti-PRP Antibody Concentrations Above the Cut-off ValuesAnti-PRP ≥ 1.0 µg/mL, Month 1031 Participants
Secondary

Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ the Cut-off Value

The cut-off value for anti-PT, anti-FHA and anti-PRN concentrations was greater than or equal to (≥) 5 EL.U/mL.

Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11

Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Nimenrix 3 GroupNumber of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ the Cut-off ValueAnti-PT, Month 10100 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ the Cut-off ValueAnti-PT, Month 11110 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ the Cut-off ValueAnti-FHA, Month 10112 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ the Cut-off ValueAnti-FHA, Month 11113 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ the Cut-off ValueAnti-PRN, Month 10105 Participants
Nimenrix 3 GroupNumber of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ the Cut-off ValueAnti-PRN, Month 11116 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ the Cut-off ValueAnti-PRN, Month 11110 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ the Cut-off ValueAnti-FHA, Month 11111 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ the Cut-off ValueAnti-PT, Month 1094 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ the Cut-off ValueAnti-FHA, Month 10106 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ the Cut-off ValueAnti-PT, Month 11109 Participants
Nimenrix 2 GroupNumber of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ the Cut-off ValueAnti-PRN, Month 1098 Participants
Menjugate GroupNumber of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ the Cut-off ValueAnti-PT, Month 11116 Participants
Menjugate GroupNumber of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ the Cut-off ValueAnti-FHA, Month 10118 Participants
Menjugate GroupNumber of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ the Cut-off ValueAnti-FHA, Month 11116 Participants
Menjugate GroupNumber of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ the Cut-off ValueAnti-PRN, Month 11118 Participants
Menjugate GroupNumber of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ the Cut-off ValueAnti-PRN, Month 10109 Participants
Menjugate GroupNumber of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ the Cut-off ValueAnti-PT, Month 10104 Participants
NeisVac-C GroupNumber of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ the Cut-off ValueAnti-PRN, Month 10105 Participants
NeisVac-C GroupNumber of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ the Cut-off ValueAnti-PRN, Month 11118 Participants
NeisVac-C GroupNumber of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ the Cut-off ValueAnti-PT, Month 11116 Participants
NeisVac-C GroupNumber of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ the Cut-off ValueAnti-FHA, Month 11116 Participants
NeisVac-C GroupNumber of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ the Cut-off ValueAnti-PT, Month 10102 Participants
NeisVac-C GroupNumber of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ the Cut-off ValueAnti-FHA, Month 10115 Participants
Secondary

Number of Subjects With Any and Grade 3 Solicited Local Symptoms

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. For the Nimenrix 2, Menjugate and NeisVac-C groups, results corresponding to Dose 2 are for Infanrix hexa and Synflorix vaccination at Visit 2 (Month 1), while results corresponding to Dose 3 refer to the vaccination at Visit 3 (Month 2).

Time frame: During the 8-day (Days 0-7) post-vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination)

Population: The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects during the primary phase, who had filled in their symptom sheets. For the considered assay and time point data was reported only for the Primary Vaccination doses.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Pain, Dose 132 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Pain, Dose 2212 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Pain, Across doses54 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Redness, Across doses18 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Pain, Dose 3168 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Pain, Dose 223 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Pain, Dose 1247 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Swelling, Dose 23 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Swelling, Dose 16 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Redness, Dose 2261 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Swelling, Across doses15 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Swelling, Dose 2211 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Redness, Dose 1241 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Redness, Dose 23 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Swelling, Dose 3210 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Redness, Dose 3247 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Swelling, Dose 1188 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Pain, Dose 313 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Pain, Across doses319 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Swelling, Dose 38 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Redness, Across doses363 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Redness, Dose 39 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Swelling, Across doses326 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Redness, Dose 19 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Swelling, Dose 3216 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Swelling, Dose 1182 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Swelling, Dose 36 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Pain, Across doses332 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Swelling, Across doses11 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Pain, Across doses67 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Swelling, Across doses318 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Swelling, Dose 14 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Redness, Across doses369 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Pain, Dose 133 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Pain, Dose 2210 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Pain, Dose 237 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Pain, Dose 1243 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Redness, Dose 2271 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Redness, Dose 25 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Redness, Dose 1229 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Swelling, Dose 2206 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Swelling, Dose 26 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Pain, Dose 3180 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Redness, Across doses15 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Redness, Dose 15 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Pain, Dose 318 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Redness, Dose 3265 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Redness, Dose 36 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Pain, Dose 1243 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Pain, Dose 128 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Pain, Across doses344 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Pain, Dose 2230 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Swelling, Dose 3252 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Redness, Across doses24 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Swelling, Dose 114 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Redness, Across doses391 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Pain, Dose 3180 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Redness, Dose 313 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Pain, Across doses48 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Swelling, Dose 1179 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Pain, Dose 315 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Redness, Dose 19 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Swelling, Across doses27 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Redness, Dose 210 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Swelling, Dose 311 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Redness, Dose 2283 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Redness, Dose 3308 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Swelling, Dose 2225 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Redness, Dose 1236 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Pain, Dose 223 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Swelling, Across doses343 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Swelling, Dose 214 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Swelling, Dose 210 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Pain, Dose 1233 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Pain, Dose 134 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Redness, Dose 1230 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Redness, Dose 15 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Swelling, Dose 1188 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Swelling, Dose 16 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Pain, Dose 2214 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Pain, Dose 229 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Redness, Dose 2284 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Redness, Dose 22 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Swelling, Dose 2210 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Swelling, Across doses24 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Redness, Across doses15 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Pain, Dose 3193 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Pain, Dose 322 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Redness, Dose 3274 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Redness, Dose 39 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Swelling, Dose 3218 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Swelling, Dose 313 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Pain, Across doses327 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Swelling, Across doses317 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsGrade 3 Pain, Across doses69 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local SymptomsAny Redness, Across doses371 Participants
Secondary

Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.

Time frame: During the 8-day (Days 0-7) post-Infanrix hexa vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination)

Population: The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects during the primary phase, who had filled in their symptom sheets. For the considered assay and time point data was reported only for the Primary Vaccination doses.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Pain, Dose 1212 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Swelling, Across doses12 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Swelling, Across doses297 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Pain, Across doses289 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Pain, Dose 39 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Redness, Across doses13 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Redness, Across doses336 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Pain, Across doses44 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Swelling, Dose 21 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Redness, Dose 21 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Redness, Dose 2232 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Redness, Dose 3228 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Pain, Dose 128 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Pain, Dose 218 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Pain, Dose 2184 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Redness, Dose 35 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Pain, Dose 3144 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Swelling, Dose 16 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Swelling, Dose 1148 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Swelling, Dose 3191 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Swelling, Dose 2182 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Redness, Dose 17 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Redness, Dose 1201 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Swelling, Dose 36 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Swelling, Dose 34 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Pain, Dose 1202 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Pain, Dose 128 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Pain, Dose 314 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Redness, Dose 3243 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Redness, Dose 34 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Swelling, Dose 3200 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Pain, Across doses311 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Pain, Across doses58 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Redness, Across doses344 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Redness, Across doses11 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Swelling, Across doses292 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Swelling, Across doses7 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Redness, Dose 1190 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Redness, Dose 13 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Swelling, Dose 1148 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Swelling, Dose 14 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Pain, Dose 2200 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Pain, Dose 234 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Redness, Dose 2250 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Redness, Dose 25 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Swelling, Dose 2185 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Swelling, Dose 23 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Pain, Dose 3159 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Swelling, Dose 311 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Swelling, Across doses25 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Redness, Dose 1191 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Swelling, Dose 3227 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Swelling, Dose 2208 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Redness, Dose 16 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Swelling, Dose 1128 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Redness, Dose 311 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Swelling, Dose 113 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Pain, Dose 3153 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Pain, Dose 2219 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Redness, Dose 3272 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Swelling, Dose 213 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Pain, Dose 222 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Redness, Dose 2264 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Pain, Dose 311 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Pain, Across doses43 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Pain, Dose 1208 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Redness, Across doses358 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Pain, Across doses314 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Redness, Dose 210 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Redness, Across doses19 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Swelling, Across doses308 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Pain, Dose 125 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Pain, Across doses310 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Swelling, Across doses294 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Swelling, Across doses21 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Pain, Dose 132 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Swelling, Dose 3197 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Pain, Dose 3175 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Redness, Across doses10 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Redness, Dose 1192 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Pain, Dose 227 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Pain, Dose 319 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Swelling, Dose 210 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Redness, Dose 12 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Redness, Dose 37 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Swelling, Dose 2195 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Redness, Across doses349 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Swelling, Dose 1147 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Redness, Dose 2265 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Pain, Dose 1210 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Swelling, Dose 311 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Swelling, Dose 14 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Redness, Dose 3247 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Redness, Dose 22 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Pain, Across doses63 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Pain, Dose 2198 Participants
Secondary

Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.

Time frame: During the 8-day (Days 0-7) post-Infanrix™ hexa booster vaccination period

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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Swelling212 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Swelling20 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Redness259 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade Pain35 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Redness29 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Pain240 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Redness24 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Swelling226 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Swelling18 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Pain241 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade Pain33 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Redness286 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Swelling244 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Redness32 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Redness282 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Pain242 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Swelling17 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade Pain39 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Swelling14 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade 3 Redness22 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Swelling240 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Pain221 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationAny Redness280 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa VaccinationGrade Pain23 Participants
Secondary

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

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.

Time frame: During the 8-day (Days 0-7) post-meningococcal vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination)

Population: The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects during the primary phase, who had filled in their symptom sheets. No data was applicable for the Nimenrix 2 Group, Menjugate Group and NeisVac-C Group since meningococcal vaccine was not given in Dose 2.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Swelling, Dose 11 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Redness, Across doses233 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Pain, Dose 3106 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Swelling, Dose 20 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Pain, Dose 2125 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Pain, Dose 118 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Swelling, Dose 277 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Redness, Dose 20 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Pain, Dose 29 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Swelling, Across doses1 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Pain, Across doses29 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Pain, Across doses229 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Redness, Dose 1132 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Pain, Dose 1161 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Swelling, Dose 30 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Swelling, Dose 3104 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Redness, Dose 12 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Swelling, Across doses154 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Redness, Dose 30 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Redness, Dose 2131 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Swelling, Dose 168 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Redness, Across doses2 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Redness, Dose 3162 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Pain, Dose 37 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Redness, Dose 3169 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Redness, Across doses1 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Pain, Dose 1155 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Pain, Dose 117 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Redness, Dose 1128 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Redness, Dose 11 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Swelling, Dose 162 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Swelling, Dose 10 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Pain, Dose 20 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Pain, Dose 20 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Redness, Dose 20 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Redness, Dose 20 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Swelling, Dose 20 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Swelling, Dose 20 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Pain, Dose 3124 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Pain, Dose 311 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Redness, Dose 30 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Swelling, Dose 3115 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Swelling, Dose 31 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Pain, Across doses202 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Pain, Across doses26 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Redness, Across doses206 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Swelling, Across doses136 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Swelling, Across doses1 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Swelling, Dose 30 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Swelling, Dose 20 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Swelling, Dose 13 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Pain, Across doses213 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Redness, Dose 12 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Pain, Dose 112 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Redness, Dose 3214 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Pain, Across doses19 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Redness, Across doses2 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Redness, Dose 30 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Pain, Dose 20 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Pain, Dose 39 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Pain, Dose 3130 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Redness, Dose 20 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Swelling, Across doses3 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Swelling, Dose 3137 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Redness, Across doses255 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Redness, Dose 20 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Swelling, Dose 187 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Pain, Dose 20 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Redness, Dose 1138 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Swelling, Dose 20 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Swelling, Across doses175 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Pain, Dose 1158 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Swelling, Dose 10 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Swelling, Dose 20 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Pain, Dose 3142 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Swelling, Dose 182 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Redness, Across doses2 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Pain, Dose 312 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Redness, Dose 11 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Redness, Dose 3197 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Swelling, Dose 34 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Redness, Dose 31 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Redness, Dose 1140 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Swelling, Dose 3130 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Pain, Dose 124 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Swelling, Across doses164 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Pain, Across doses212 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Pain, Across doses33 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Pain, Dose 1157 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Pain, Dose 20 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Swelling, Across doses4 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Redness, Dose 20 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Pain, Dose 20 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Redness, Dose 20 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Redness, Across doses233 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Swelling, Dose 20 Participants
Secondary

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

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.

Time frame: During the 8-day (Days 0-7) post-meningococcal booster vaccination period

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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Pain191 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Redness3 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Swelling133 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Swelling1 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Pain24 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Redness186 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Redness6 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Swelling152 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Swelling2 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Pain203 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Redness221 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Pain23 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Pain31 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Redness5 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Redness213 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Pain203 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Swelling158 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Swelling2 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Swelling165 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Pain181 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Redness4 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Swelling5 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationGrade 3 Pain18 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal VaccinationAny Redness228 Participants
Secondary

Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.

Time frame: During the 8-day (Days 0-7) post-Synflorix vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination)

Population: The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects during the primary phase, who had filled in their symptom sheets. For the considered assay and time point data was reported only for the primary vaccination doses.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Pain, Dose 3129 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Redness, Dose 34 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Redness, Dose 22 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Swelling, Dose 23 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Swelling, Dose 2154 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Redness, Across doses297 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Redness, Dose 3173 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Swelling, Across doses9 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Pain, Dose 310 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Pain, Dose 1218 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Pain, Dose 220 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Pain, Dose 129 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Pain, Across doses285 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Redness, Dose 1209 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Swelling, Across doses247 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Redness, Dose 14 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Pain, Across doses46 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Swelling, Dose 33 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Swelling, Dose 1135 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Swelling, Dose 14 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Swelling, Dose 3136 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Pain, Dose 2179 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Redness, Across doses8 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Redness, Dose 2197 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Pain, Dose 231 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Redness, Across doses322 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Swelling, Dose 3152 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Redness, Dose 21 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Redness, Dose 1184 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Redness, Dose 3213 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Pain, Dose 2186 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Swelling, Dose 2162 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Swelling, Dose 34 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Swelling, Dose 11 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Swelling, Dose 24 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Pain, Dose 313 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Redness, Dose 34 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Pain, Dose 3152 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Redness, Dose 12 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Swelling, Across doses259 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Swelling, Across doses7 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Pain, Across doses54 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Redness, Across doses7 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Pain, Dose 1201 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Redness, Dose 2216 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Pain, Across doses304 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Swelling, Dose 1136 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Pain, Dose 126 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Redness, Dose 2225 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Swelling, Dose 28 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Pain, Dose 310 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Redness, Across doses331 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Swelling, Across doses262 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Pain, Dose 1217 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Pain, Dose 126 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Redness, Dose 1196 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Redness, Dose 15 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Swelling, Dose 1130 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Swelling, Dose 110 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Pain, Dose 2203 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Pain, Dose 219 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Redness, Dose 25 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Swelling, Dose 2156 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Pain, Dose 3132 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Redness, Dose 3227 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Redness, Dose 36 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Swelling, Dose 3164 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Swelling, Dose 36 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Pain, Across doses312 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Pain, Across doses41 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Redness, Across doses12 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Swelling, Across doses16 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Pain, Dose 2189 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Swelling, Across doses237 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Redness, Dose 32 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Swelling, Dose 14 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Swelling, Dose 1120 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Redness, Across doses316 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Swelling, Dose 3146 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Redness, Dose 14 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Redness, Dose 1183 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Pain, Dose 225 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Swelling, Dose 35 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Pain, Dose 132 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Pain, Dose 1195 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Redness, Across doses7 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Swelling, Across doses13 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Pain, Across doses291 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Pain, Dose 3150 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Swelling, Dose 25 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Pain, Dose 318 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Swelling, Dose 2155 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Redness, Dose 21 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationGrade 3 Pain, Across doses61 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Redness, Dose 3209 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix VaccinationAny Redness, Dose 2235 Participants
Secondary

Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix™ Vaccination

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.

Time frame: During the 8-day (Days 0-7) post-Synflorix™ booster vaccination period

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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix™ VaccinationAny Swelling173 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix™ VaccinationGrade 3 Pain36 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix™ VaccinationGrade 3 Redness14 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix™ VaccinationAny Pain212 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix™ VaccinationGrade 3 Swelling5 Participants
Nimenrix 3 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix™ VaccinationAny Redness219 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix™ VaccinationGrade 3 Swelling5 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix™ VaccinationGrade 3 Redness9 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix™ VaccinationAny Pain215 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix™ VaccinationAny Redness243 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix™ VaccinationAny Swelling174 Participants
Nimenrix 2 GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix™ VaccinationGrade 3 Pain33 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix™ VaccinationGrade 3 Swelling4 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix™ VaccinationAny Redness242 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix™ VaccinationAny Pain227 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix™ VaccinationGrade 3 Pain33 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix™ VaccinationGrade 3 Redness20 Participants
Menjugate GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix™ VaccinationAny Swelling189 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix™ VaccinationAny Redness250 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix™ VaccinationGrade 3 Swelling10 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix™ VaccinationAny Swelling193 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix™ VaccinationGrade 3 Pain26 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix™ VaccinationAny Pain205 Participants
NeisVac-C GroupNumber of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix™ VaccinationGrade 3 Redness9 Participants
Secondary

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature \[defined as rectal temperature greater than or equal to (≥) 38 degrees Celsius (°C)\]. Any = occurrence of any general symptoms, regardless of their intensity grade or relationship to study vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Not eating at all. Grade 3 Temperature= temperature above 40.0 (°C). Related = symptom assessed by the investigator as related to the vaccination. For the Nimenrix 2, Menjugate and NeisVac-C groups, results corresponding to Dose 2 are for Infanrix™ hexa and Synflorix™ vaccination at Visit 2 (Month 1), while results corresponding to Dose 3 refer to the vaccination at Visit 3 (Month 2).

Time frame: During the 8-day (Days 0-7) post-vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination)

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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Irritability, Dose 154 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Irritability, Dose 1329 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Temperature, Dose 1128 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Temperature, Across doses203 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Loss of appetite, Across doses180 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Temperature, Dose 10 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Temperature, Dose 1166 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Loss of appetite, Dose 195 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Irritability, Dose 1199 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Loss of appetite, Dose 112 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Irritability, Across doses302 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Irritability, Across doses109 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Irritability, Across doses419 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Drowsiness, Across doses235 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Drowsiness, Dose 1298 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Drowsiness, Across doses376 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Temperature, Dose 371 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Drowsiness, Dose 122 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Loss of appetite, Dose 388 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Loss of appetite, Dose 314 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Irritability, Dose 252 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Loss of appetite, Dose 295 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Loss of appetite, Dose 1188 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Loss of appetite, Dose 3149 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Irritability, Dose 3165 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Irritability, Dose 337 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Drowsiness, Dose 3112 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Temperature, Across doses1 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Drowsiness, Dose 3181 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Temperature, Dose 2107 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Drowsiness, Dose 321 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Temperature, Dose 21 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Irritability, Dose 3259 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Temperature, Dose 2146 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Loss of appetite, Across doses295 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Loss of appetite, Dose 210 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Loss of appetite, Dose 2164 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Temperature, Dose 3106 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Drowsiness, Dose 2232 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Irritability, Dose 2208 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Temperature, Dose 30 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Drowsiness, Across doses45 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Irritability, Dose 2328 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Drowsiness, Dose 2133 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Loss of appetite, Across doses28 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Drowsiness, Dose 220 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Drowsiness, Dose 1163 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Temperature, Across doses272 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Temperature, Across doses2 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Irritability, Dose 1206 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Loss of appetite, Dose 1208 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Loss of appetite, Dose 111 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Loss of appetite, Dose 2103 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Temperature, Dose 2105 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Irritability, Dose 330 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Temperature, Dose 3127 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Temperature, Across doses208 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Irritability, Dose 141 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Drowsiness, Dose 2210 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Loss of appetite, Dose 1106 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Temperature, Dose 1162 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Temperature, Dose 10 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Temperature, Dose 1119 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Drowsiness, Dose 1167 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Irritability, Dose 1337 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Drowsiness, Dose 1282 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Drowsiness, Dose 122 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Drowsiness, Dose 220 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Drowsiness, Dose 2123 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Irritability, Dose 2312 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Irritability, Dose 235 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Irritability, Dose 2198 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Loss of appetite, Dose 2185 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Loss of appetite, Dose 26 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Temperature, Dose 2145 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Temperature, Dose 20 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Drowsiness, Dose 3194 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Drowsiness, Dose 37 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Drowsiness, Dose 3115 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Irritability, Dose 3279 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Irritability, Dose 3178 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Loss of appetite, Dose 3176 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Loss of appetite, Dose 311 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Loss of appetite, Dose 394 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Temperature, Dose 32 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Temperature, Dose 388 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Drowsiness, Across doses365 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Drowsiness, Across doses41 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Drowsiness, Across doses231 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Irritability, Across doses436 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Irritability, Across doses83 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Irritability, Across doses304 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Loss of appetite, Across doses325 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Loss of appetite, Across doses23 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Loss of appetite, Across doses194 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Temperature, Across doses274 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Drowsiness, Across doses235 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Drowsiness, Dose 3197 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Temperature, Across doses277 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Loss of appetite, Dose 383 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Temperature, Dose 1170 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Loss of appetite, Dose 26 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Loss of appetite, Across doses307 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Temperature, Dose 32 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Drowsiness, Dose 313 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Irritability, Dose 2194 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Loss of appetite, Dose 1196 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Irritability, Dose 1213 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Loss of appetite, Dose 19 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Irritability, Dose 244 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Irritability, Across doses86 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Temperature, Dose 379 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Loss of appetite, Dose 1111 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Irritability, Dose 145 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Drowsiness, Dose 3109 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Temperature, Across doses208 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Drowsiness, Dose 1285 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Temperature, Dose 10 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Loss of appetite, Dose 310 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Irritability, Dose 3271 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Temperature, Dose 21 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Temperature, Dose 1122 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Drowsiness, Across doses370 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Drowsiness, Dose 1163 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Temperature, Across doses3 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Irritability, Dose 332 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Loss of appetite, Across doses22 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Drowsiness, Across doses40 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Drowsiness, Dose 117 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Irritability, Across doses439 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Temperature, Dose 2158 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Irritability, Dose 1355 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Irritability, Dose 2319 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Drowsiness, Dose 2231 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Loss of appetite, Dose 2183 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Loss of appetite, Across doses186 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Loss of appetite, Dose 293 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Drowsiness, Dose 217 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Irritability, Across doses311 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Loss of appetite, Dose 3159 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Temperature, Dose 3112 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Drowsiness, Dose 2137 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Irritability, Dose 3164 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Temperature, Dose 2116 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Irritability, Across doses104 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Irritability, Dose 248 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Drowsiness, Across doses237 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Irritability, Dose 2212 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Temperature, Dose 1183 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Loss of appetite, Dose 2179 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Irritability, Dose 1235 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Loss of appetite, Dose 27 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Loss of appetite, Dose 2106 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Irritability, Dose 3262 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Temperature, Dose 2144 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Drowsiness, Dose 3112 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Irritability, Across doses441 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Drowsiness, Dose 3193 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Temperature, Dose 2110 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Irritability, Dose 154 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Drowsiness, Dose 314 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Temperature, Dose 21 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Loss of appetite, Dose 1117 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Irritability, Dose 339 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Temperature, Across doses220 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Irritability, Dose 3174 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Loss of appetite, Dose 3154 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Irritability, Dose 2320 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Loss of appetite, Dose 1219 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Loss of appetite, Dose 39 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Drowsiness, Dose 1178 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Loss of appetite, Dose 390 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Temperature, Dose 3114 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Temperature, Dose 31 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Drowsiness, Dose 1297 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Loss of appetite, Dose 18 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Loss of appetite, Across doses312 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Temperature, Dose 389 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Temperature, Dose 10 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Temperature, Across doses2 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Temperature, Across doses275 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Drowsiness, Across doses377 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Drowsiness, Dose 134 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Loss of appetite, Across doses182 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Irritability, Dose 1364 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Drowsiness, Dose 2211 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Drowsiness, Across doses47 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Drowsiness, Dose 212 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Irritability, Across doses325 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Temperature, Dose 1144 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Drowsiness, Dose 2132 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Loss of appetite, Across doses22 Participants
Secondary

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature \[defined as rectal temperature greater than or equal to (≥) 38 degrees Celsius (°C)\]. Any = occurrence of any general symptoms, regardless of their intensity grade or relationship to study vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Not eating at all. Grade 3 Temperature= temperature above 40.0 (°C). Related = symptom assessed by the investigator as related to the vaccination.

Time frame: During the 8-day (Days 0-7) post-booster vaccination period

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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Loss of appetite118 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Irritability180 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Drowsiness14 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Temperature (Rectally)2 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Drowsiness198 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Loss of appetite189 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Irritability41 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Irritability284 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Temperature (Rectally)187 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Loss of appetite12 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Drowsiness125 Participants
Nimenrix 3 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Temperature (Rectally)133 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Irritability296 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Loss of appetite114 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Drowsiness129 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Temperature (Rectally)2 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Temperature (Rectally)180 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Irritability37 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Drowsiness206 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Irritability197 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Drowsiness13 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Loss of appetite193 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Temperature (Rectally)132 Participants
Nimenrix 2 GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Loss of appetite21 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Drowsiness21 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Drowsiness119 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Irritability284 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Irritability37 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Irritability181 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Loss of appetite198 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Loss of appetite23 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Loss of appetite114 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Temperature (Rectally)186 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Temperature (Rectally)3 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Temperature (Rectally)122 Participants
Menjugate GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Drowsiness208 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Temperature (Rectally)7 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Loss of appetite27 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Loss of appetite195 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Drowsiness125 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Temperature (Rectally)125 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Irritability186 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Irritability45 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsGrade 3 Drowsiness18 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Drowsiness202 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Temperature (Rectally)170 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsRelated Loss of appetite121 Participants
NeisVac-C GroupNumber of Subjects With Any, Grade 3 and Related Solicited General SymptomsAny Irritability297 Participants
Secondary

Number of Subjects With Any Unsolicited Adverse Events (AEs)

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

Time frame: Within 31-days (Days 0-30) post-each primary vaccination dose

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Nimenrix 3 GroupNumber of Subjects With Any Unsolicited Adverse Events (AEs)293 Participants
Nimenrix 2 GroupNumber of Subjects With Any Unsolicited Adverse Events (AEs)273 Participants
Menjugate GroupNumber of Subjects With Any Unsolicited Adverse Events (AEs)291 Participants
NeisVac-C GroupNumber of Subjects With Any Unsolicited Adverse Events (AEs)280 Participants
Secondary

Number of Subjects With Any Unsolicited Adverse Events (AEs)

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

Time frame: Within 31-days (Days 0-30) post-booster vaccination period

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Nimenrix 3 GroupNumber of Subjects With Any Unsolicited Adverse Events (AEs)179 Participants
Nimenrix 2 GroupNumber of Subjects With Any Unsolicited Adverse Events (AEs)185 Participants
Menjugate GroupNumber of Subjects With Any Unsolicited Adverse Events (AEs)164 Participants
NeisVac-C GroupNumber of Subjects With Any Unsolicited Adverse Events (AEs)167 Participants
Secondary

Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off Values

The cut-off values for hSBA antibody titers were greater than or equal to (≥) 1:4 and ≥ 1:8.

Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11

Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects who used hSBA complement and who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11).

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Nimenrix 3 GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenC ≥ 1:4, Month 10184 Participants
Nimenrix 3 GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenA ≥ 1:8, Month 11210 Participants
Nimenrix 3 GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenA ≥ 1:4, Month 10142 Participants
Nimenrix 3 GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenA ≥ 1:8, Month 10141 Participants
Nimenrix 3 GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenA ≥ 1:4, Month 11210 Participants
Nimenrix 3 GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenC ≥ 1:8, Month 10184 Participants
Nimenrix 3 GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenC ≥ 1:4, Month 11212 Participants
Nimenrix 3 GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenC ≥ 1:8, Month 11212 Participants
Nimenrix 3 GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenW-135 ≥ 1:4, Month 10196 Participants
Nimenrix 3 GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenW-135 ≥ 1:8, Month 10196 Participants
Nimenrix 3 GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenW-135 ≥ 1:4, Month 11207 Participants
Nimenrix 3 GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenW-135 ≥ 1:8, Month 11207 Participants
Nimenrix 3 GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenY ≥ 1:4, Month 10185 Participants
Nimenrix 3 GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenY ≥ 1:8, Month 10185 Participants
Nimenrix 3 GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenY ≥ 1:4, Month 11206 Participants
Nimenrix 3 GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenY ≥ 1:8, Month 11206 Participants
Nimenrix 2 GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenC ≥ 1:4, Month 10198 Participants
Nimenrix 2 GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenW-135 ≥ 1:4, Month 10201 Participants
Nimenrix 2 GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenY ≥ 1:8, Month 11217 Participants
Nimenrix 2 GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenA ≥ 1:4, Month 11213 Participants
Nimenrix 2 GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenY ≥ 1:4, Month 11217 Participants
Nimenrix 2 GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenW-135 ≥ 1:8, Month 10201 Participants
Nimenrix 2 GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenA ≥ 1:8, Month 11213 Participants
Nimenrix 2 GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenW-135 ≥ 1:8, Month 11218 Participants
Nimenrix 2 GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenC ≥ 1:4, Month 11220 Participants
Nimenrix 2 GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenW-135 ≥ 1:4, Month 11218 Participants
Nimenrix 2 GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenY ≥ 1:8, Month 10204 Participants
Nimenrix 2 GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenA ≥ 1:8, Month 10119 Participants
Nimenrix 2 GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenA ≥ 1:4, Month 10119 Participants
Nimenrix 2 GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenC ≥ 1:8, Month 11220 Participants
Nimenrix 2 GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenC ≥ 1:8, Month 10198 Participants
Nimenrix 2 GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenY ≥ 1:4, Month 10204 Participants
Menjugate GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenW-135 ≥ 1:8, Month 113 Participants
Menjugate GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenC ≥ 1:4, Month 10160 Participants
Menjugate GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenC ≥ 1:8, Month 10160 Participants
Menjugate GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenY ≥ 1:8, Month 106 Participants
Menjugate GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenC ≥ 1:4, Month 11216 Participants
Menjugate GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenC ≥ 1:8, Month 11216 Participants
Menjugate GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenY ≥ 1:8, Month 117 Participants
Menjugate GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenW-135 ≥ 1:4, Month 101 Participants
Menjugate GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenW-135 ≥ 1:8, Month 101 Participants
Menjugate GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenY ≥ 1:4, Month 117 Participants
Menjugate GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenW-135 ≥ 1:4, Month 113 Participants
Menjugate GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenA ≥ 1:4, Month 1150 Participants
Menjugate GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenY ≥ 1:4, Month 106 Participants
Menjugate GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenA ≥ 1:4, Month 1028 Participants
Menjugate GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenA ≥ 1:8, Month 1026 Participants
Menjugate GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenA ≥ 1:8, Month 1150 Participants
NeisVac-C GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenY ≥ 1:8, Month 1112 Participants
NeisVac-C GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenA ≥ 1:8, Month 1026 Participants
NeisVac-C GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenA ≥ 1:4, Month 1155 Participants
NeisVac-C GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenC ≥ 1:8, Month 11219 Participants
NeisVac-C GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenC ≥ 1:8, Month 10196 Participants
NeisVac-C GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenY ≥ 1:8, Month 1010 Participants
NeisVac-C GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenC ≥ 1:4, Month 10196 Participants
NeisVac-C GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenA ≥ 1:4, Month 1026 Participants
NeisVac-C GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenY ≥ 1:4, Month 1010 Participants
NeisVac-C GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenC ≥ 1:4, Month 11219 Participants
NeisVac-C GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenA ≥ 1:8, Month 1155 Participants
NeisVac-C GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenW-135 ≥ 1:4, Month 116 Participants
NeisVac-C GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenY ≥ 1:4, Month 1112 Participants
NeisVac-C GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenW-135 ≥ 1:8, Month 106 Participants
NeisVac-C GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenW-135 ≥ 1:4, Month 106 Participants
NeisVac-C GroupNumber of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off ValueshSBA-MenW-135 ≥ 1:8, Month 116 Participants
Secondary

Number of Subjects With New Onset of Chronic Illnesses (NOCIs)

NOCIs assessed included asthma, autoimmune disorders, type 1 diabetes and allergies.

Time frame: From Booster vaccination (Month 10 to Month 11) up to ESFU (Month 16)

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Nimenrix 3 GroupNumber of Subjects With New Onset of Chronic Illnesses (NOCIs)2 Participants
Nimenrix 2 GroupNumber of Subjects With New Onset of Chronic Illnesses (NOCIs)2 Participants
Menjugate GroupNumber of Subjects With New Onset of Chronic Illnesses (NOCIs)5 Participants
NeisVac-C GroupNumber of Subjects With New Onset of Chronic Illnesses (NOCIs)3 Participants
Secondary

Number of Subjects With New Onset of Chronic Illnesses (NOCIs)

NOCIs assessed included asthma, autoimmune disorders, type 1 diabetes and allergies.

Time frame: During 31-days (Days 0-30) post-each primary vaccination dose (Day 0 to Month 3) and from primary vaccination up to ESFU (Month 16)

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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Nimenrix 3 GroupNumber of Subjects With New Onset of Chronic Illnesses (NOCIs)From primary vaccination up to ESFU contact14 Participants
Nimenrix 3 GroupNumber of Subjects With New Onset of Chronic Illnesses (NOCIs)Day 0 - Day 30 after each primary dose11 Participants
Nimenrix 2 GroupNumber of Subjects With New Onset of Chronic Illnesses (NOCIs)Day 0 - Day 30 after each primary dose6 Participants
Nimenrix 2 GroupNumber of Subjects With New Onset of Chronic Illnesses (NOCIs)From primary vaccination up to ESFU contact11 Participants
Menjugate GroupNumber of Subjects With New Onset of Chronic Illnesses (NOCIs)From primary vaccination up to ESFU contact15 Participants
Menjugate GroupNumber of Subjects With New Onset of Chronic Illnesses (NOCIs)Day 0 - Day 30 after each primary dose5 Participants
NeisVac-C GroupNumber of Subjects With New Onset of Chronic Illnesses (NOCIs)From primary vaccination up to ESFU contact11 Participants
NeisVac-C GroupNumber of Subjects With New Onset of Chronic Illnesses (NOCIs)Day 0 - Day 30 after each primary dose5 Participants
Secondary

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

The cut-off values for rSBA-Men antibody titers were greater than or equal to (≥) 1:8 and ≥ 1:128 at pre-vaccination

Time frame: Pre-primary vaccination at Month 0

Population: The analysis was performed on the Primary ATP cohort for immunogenicity, which included all evaluable subjects who complied with the vaccination schedule for a randomized subset of 50% subjects for each of the 4 serogroups in the investigational groups, and in a randomized subset of 50% and 25% subjects for MenC, MenA, MenW, MenY in control groups.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Nimenrix 3 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off ValuesrSBA-MenA ≥ 1:82 Participants
Nimenrix 3 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off ValuesrSBA-MenA ≥ 1:1281 Participants
Nimenrix 3 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off ValuesrSBA-MenC ≥ 1:812 Participants
Nimenrix 3 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off ValuesrSBA-MenC ≥ 1:1282 Participants
Nimenrix 3 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off ValuesrSBA-MenW-135 ≥ 1:88 Participants
Nimenrix 3 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off ValuesrSBA-MenW-135 ≥ 1:1280 Participants
Nimenrix 3 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off ValuesrSBA-MenY ≥ 1:86 Participants
Nimenrix 3 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off ValuesrSBA-MenY ≥ 1:1280 Participants
Nimenrix 2 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off ValuesrSBA-MenW-135 ≥ 1:1281 Participants
Nimenrix 2 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off ValuesrSBA-MenW-135 ≥ 1:812 Participants
Nimenrix 2 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off ValuesrSBA-MenA ≥ 1:1280 Participants
Nimenrix 2 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off ValuesrSBA-MenY ≥ 1:1283 Participants
Nimenrix 2 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off ValuesrSBA-MenY ≥ 1:86 Participants
Nimenrix 2 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off ValuesrSBA-MenC ≥ 1:1281 Participants
Nimenrix 2 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off ValuesrSBA-MenC ≥ 1:810 Participants
Nimenrix 2 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off ValuesrSBA-MenA ≥ 1:84 Participants
Menjugate GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off ValuesrSBA-MenY ≥ 1:88 Participants
Menjugate GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off ValuesrSBA-MenC ≥ 1:815 Participants
Menjugate GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off ValuesrSBA-MenC ≥ 1:1286 Participants
Menjugate GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off ValuesrSBA-MenW-135 ≥ 1:85 Participants
Menjugate GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off ValuesrSBA-MenW-135 ≥ 1:1281 Participants
Menjugate GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off ValuesrSBA-MenY ≥ 1:1281 Participants
Menjugate GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off ValuesrSBA-MenA ≥ 1:82 Participants
Menjugate GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off ValuesrSBA-MenA ≥ 1:1280 Participants
NeisVac-C GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off ValuesrSBA-MenC ≥ 1:814 Participants
NeisVac-C GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off ValuesrSBA-MenC ≥ 1:1285 Participants
NeisVac-C GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off ValuesrSBA-MenA ≥ 1:1280 Participants
NeisVac-C GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off ValuesrSBA-MenA ≥ 1:82 Participants
NeisVac-C GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off ValuesrSBA-MenW-135 ≥ 1:83 Participants
NeisVac-C GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off ValuesrSBA-MenY ≥ 1:1281 Participants
NeisVac-C GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off ValuesrSBA-MenY ≥ 1:83 Participants
NeisVac-C GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off ValuesrSBA-MenW-135 ≥ 1:1281 Participants
Secondary

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

The cut-off values for the rSBA-Men antibody titers were greater than or equal to (≥) 1:8 and ≥ 1:128.

Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11

Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11).

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Nimenrix 3 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenW-135 ≥ 1:8, Month 11433 Participants
Nimenrix 3 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenA ≥ 1:128, Month 10107 Participants
Nimenrix 3 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenA ≥ 1:8, Month 10300 Participants
Nimenrix 3 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenY ≥ 1:128, Month 11419 Participants
Nimenrix 3 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenW-135 ≥ 1:128, Month 10221 Participants
Nimenrix 3 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenW-135 ≥ 1:8, Month 10372 Participants
Nimenrix 3 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenC ≥ 1:128, Month 11432 Participants
Nimenrix 3 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenY ≥ 1:8, Month 10364 Participants
Nimenrix 3 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenW-135 ≥ 1:128, Month 11430 Participants
Nimenrix 3 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenC ≥ 1:8, Month 11437 Participants
Nimenrix 3 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenC ≥ 1:128, Month 10108 Participants
Nimenrix 3 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenY ≥ 1:128, Month 10126 Participants
Nimenrix 3 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenA ≥ 1:128, Month 11433 Participants
Nimenrix 3 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenC ≥ 1:8, Month 10324 Participants
Nimenrix 3 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenA ≥ 1:8, Month 11437 Participants
Nimenrix 3 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenY ≥ 1:8, Month 11436 Participants
Nimenrix 2 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenW-135 ≥ 1:128, Month 11457 Participants
Nimenrix 2 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenY ≥ 1:8, Month 10383 Participants
Nimenrix 2 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenY ≥ 1:128, Month 10168 Participants
Nimenrix 2 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenY ≥ 1:8, Month 11459 Participants
Nimenrix 2 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenY ≥ 1:128, Month 11445 Participants
Nimenrix 2 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenA ≥ 1:8, Month 10279 Participants
Nimenrix 2 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenA ≥ 1:128, Month 1099 Participants
Nimenrix 2 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenA ≥ 1:8, Month 11460 Participants
Nimenrix 2 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenA ≥ 1:128, Month 11456 Participants
Nimenrix 2 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenC ≥ 1:8, Month 10348 Participants
Nimenrix 2 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenC ≥ 1:128, Month 10183 Participants
Nimenrix 2 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenC ≥ 1:8, Month 11462 Participants
Nimenrix 2 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenC ≥ 1:128, Month 11454 Participants
Nimenrix 2 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenW-135 ≥ 1:8, Month 10417 Participants
Nimenrix 2 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenW-135 ≥ 1:128, Month 10254 Participants
Nimenrix 2 GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenW-135 ≥ 1:8, Month 11461 Participants
Menjugate GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenY ≥ 1:128, Month 1041 Participants
Menjugate GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenW-135 ≥ 1:8, Month 1134 Participants
Menjugate GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenC ≥ 1:128, Month 11426 Participants
Menjugate GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenA ≥ 1:128, Month 118 Participants
Menjugate GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenW-135 ≥ 1:128, Month 1131 Participants
Menjugate GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenY ≥ 1:128, Month 1137 Participants
Menjugate GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenC ≥ 1:128, Month 1079 Participants
Menjugate GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenC ≥ 1:8, Month 10229 Participants
Menjugate GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenY ≥ 1:8, Month 1054 Participants
Menjugate GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenA ≥ 1:8, Month 1026 Participants
Menjugate GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenA ≥ 1:8, Month 1121 Participants
Menjugate GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenY ≥ 1:8, Month 1145 Participants
Menjugate GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenW-135 ≥ 1:8, Month 1018 Participants
Menjugate GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenA ≥ 1:128, Month 1011 Participants
Menjugate GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenC ≥ 1:8, Month 11439 Participants
Menjugate GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenW-135 ≥ 1:128, Month 1016 Participants
NeisVac-C GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenY ≥ 1:128, Month 1037 Participants
NeisVac-C GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenA ≥ 1:128, Month 1112 Participants
NeisVac-C GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenW-135 ≥ 1:128, Month 1022 Participants
NeisVac-C GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenC ≥ 1:8, Month 10356 Participants
NeisVac-C GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenY ≥ 1:8, Month 1047 Participants
NeisVac-C GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenW-135 ≥ 1:8, Month 1027 Participants
NeisVac-C GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenC ≥ 1:128, Month 10195 Participants
NeisVac-C GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenC ≥ 1:8, Month 11459 Participants
NeisVac-C GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenW-135 ≥ 1:128, Month 1131 Participants
NeisVac-C GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenC ≥ 1:128, Month 11457 Participants
NeisVac-C GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenY ≥ 1:128, Month 1134 Participants
NeisVac-C GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenY ≥ 1:8, Month 1140 Participants
NeisVac-C GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenW-135 ≥ 1:8, Month 1137 Participants
NeisVac-C GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenA ≥ 1:8, Month 1023 Participants
NeisVac-C GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenA ≥ 1:128, Month 103 Participants
NeisVac-C GroupNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off ValuesrSBA-MenA ≥ 1:8, Month 1119 Participants
Secondary

Number of Subjects With Serious Adverse Events (SAEs)

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

Time frame: Throughout the entire study (from Day 0 to Month 16)

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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Nimenrix 3 GroupNumber of Subjects With Serious Adverse Events (SAEs)From Day 0 up to Month 1 post-primary vaccination1 Participants
Nimenrix 3 GroupNumber of Subjects With Serious Adverse Events (SAEs)From primary vaccination up to ESFU contact54 Participants
Nimenrix 2 GroupNumber of Subjects With Serious Adverse Events (SAEs)From primary vaccination up to ESFU contact56 Participants
Nimenrix 2 GroupNumber of Subjects With Serious Adverse Events (SAEs)From Day 0 up to Month 1 post-primary vaccination0 Participants
Menjugate GroupNumber of Subjects With Serious Adverse Events (SAEs)From Day 0 up to Month 1 post-primary vaccination0 Participants
Menjugate GroupNumber of Subjects With Serious Adverse Events (SAEs)From primary vaccination up to ESFU contact45 Participants
NeisVac-C GroupNumber of Subjects With Serious Adverse Events (SAEs)From Day 0 up to Month 1 post-primary vaccination0 Participants
NeisVac-C GroupNumber of Subjects With Serious Adverse Events (SAEs)From primary vaccination up to ESFU contact52 Participants
Secondary

Number of Subjects With Serious Adverse Events (SAEs)

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

Time frame: From Booster vaccination (Month 10) up to Extended Safety Follow-Up (ESFU) (Month 16)

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Nimenrix 3 GroupNumber of Subjects With Serious Adverse Events (SAEs)14 Participants
Nimenrix 2 GroupNumber of Subjects With Serious Adverse Events (SAEs)18 Participants
Menjugate GroupNumber of Subjects With Serious Adverse Events (SAEs)14 Participants
NeisVac-C GroupNumber of Subjects With Serious Adverse Events (SAEs)17 Participants
Secondary

Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off Values

The cut-off values for hSBA antibody titers were greater than or equal to (≥) 1:4 and ≥ 1:8.

Time frame: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3

Population: The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who used hSBA complement and who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3).

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Nimenrix 3 GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenW-135 ≥ 1:4, Month 3197 Participants
Nimenrix 3 GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenY ≥ 1:4, Month 3187 Participants
Nimenrix 3 GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenC ≥ 1:4, Month 043 Participants
Nimenrix 3 GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenY ≥ 1:8, Month 3185 Participants
Nimenrix 3 GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenW-135 ≥ 1:8, Month 3197 Participants
Nimenrix 3 GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenA ≥ 1:4, Month 3197 Participants
Nimenrix 3 GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenC ≥ 1:8, Month 043 Participants
Nimenrix 3 GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenA ≥ 1:4, Month 034 Participants
Nimenrix 3 GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenW-135 ≥ 1:4, Month 050 Participants
Nimenrix 3 GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenY ≥ 1:8, Month 073 Participants
Nimenrix 3 GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenC ≥ 1:4, Month 3213 Participants
Nimenrix 3 GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenW-135 ≥ 1:8, Month 049 Participants
Nimenrix 3 GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenA ≥ 1:8, Month 028 Participants
Nimenrix 3 GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenA ≥ 1:8, Month 3196 Participants
Nimenrix 3 GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenC ≥ 1:8, Month 3213 Participants
Nimenrix 3 GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenY ≥ 1:4, Month 073 Participants
Nimenrix 2 GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenC ≥ 1:8, Month 3215 Participants
Nimenrix 2 GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenW-135 ≥ 1:4, Month 046 Participants
Nimenrix 2 GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenW-135 ≥ 1:8, Month 3217 Participants
Nimenrix 2 GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenW-135 ≥ 1:8, Month 044 Participants
Nimenrix 2 GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenA ≥ 1:4, Month 3195 Participants
Nimenrix 2 GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenA ≥ 1:4, Month 031 Participants
Nimenrix 2 GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenY ≥ 1:4, Month 3209 Participants
Nimenrix 2 GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenA ≥ 1:8, Month 3195 Participants
Nimenrix 2 GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenC ≥ 1:4, Month 035 Participants
Nimenrix 2 GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenW-135 ≥ 1:4, Month 3217 Participants
Nimenrix 2 GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenY ≥ 1:8, Month 072 Participants
Nimenrix 2 GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenC ≥ 1:8, Month 035 Participants
Nimenrix 2 GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenY ≥ 1:8, Month 3209 Participants
Nimenrix 2 GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenC ≥ 1:4, Month 3215 Participants
Nimenrix 2 GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenY ≥ 1:4, Month 073 Participants
Nimenrix 2 GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenA ≥ 1:8, Month 019 Participants
Menjugate GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenA ≥ 1:8, Month 315 Participants
Menjugate GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenA ≥ 1:4, Month 041 Participants
Menjugate GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenA ≥ 1:8, Month 027 Participants
Menjugate GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenA ≥ 1:4, Month 321 Participants
Menjugate GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenC ≥ 1:4, Month 050 Participants
Menjugate GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenC ≥ 1:8, Month 049 Participants
Menjugate GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenC ≥ 1:4, Month 3202 Participants
Menjugate GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenC ≥ 1:8, Month 3202 Participants
Menjugate GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenW-135 ≥ 1:4, Month 054 Participants
Menjugate GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenW-135 ≥ 1:8, Month 052 Participants
Menjugate GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenW-135 ≥ 1:4, Month 36 Participants
Menjugate GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenW-135 ≥ 1:8, Month 34 Participants
Menjugate GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenY ≥ 1:4, Month 071 Participants
Menjugate GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenY ≥ 1:8, Month 071 Participants
Menjugate GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenY ≥ 1:4, Month 311 Participants
Menjugate GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenY ≥ 1:8, Month 311 Participants
NeisVac-C GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenC ≥ 1:8, Month 3226 Participants
NeisVac-C GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenC ≥ 1:4, Month 3226 Participants
NeisVac-C GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenA ≥ 1:8, Month 027 Participants
NeisVac-C GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenY ≥ 1:4, Month 078 Participants
NeisVac-C GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenC ≥ 1:8, Month 042 Participants
NeisVac-C GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenC ≥ 1:4, Month 044 Participants
NeisVac-C GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenA ≥ 1:4, Month 034 Participants
NeisVac-C GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenY ≥ 1:8, Month 077 Participants
NeisVac-C GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenA ≥ 1:8, Month 314 Participants
NeisVac-C GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenA ≥ 1:4, Month 318 Participants
NeisVac-C GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenY ≥ 1:8, Month 34 Participants
NeisVac-C GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenW-135 ≥ 1:4, Month 33 Participants
NeisVac-C GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenW-135 ≥ 1:8, Month 036 Participants
NeisVac-C GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenW-135 ≥ 1:4, Month 037 Participants
NeisVac-C GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenY ≥ 1:4, Month 35 Participants
NeisVac-C GroupNumber of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off ValueshSBA-MenW-135 ≥ 1:8, Month 33 Participants
Secondary

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

Antibody titers were presented as geometric mean titers (GMTs).

Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11

Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11).

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Nimenrix 3 GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenA, Month 1022.9 Titers
Nimenrix 3 GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenA, Month 111417.6 Titers
Nimenrix 3 GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenC, Month 1025.7 Titers
Nimenrix 3 GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenC, Month 111154.6 Titers
Nimenrix 3 GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenW-135, Month 1068.7 Titers
Nimenrix 3 GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenW-135, Month 111955.9 Titers
Nimenrix 3 GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenY, Month 1035.4 Titers
Nimenrix 3 GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenY, Month 11630.6 Titers
Nimenrix 2 GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenW-135, Month 112777.2 Titers
Nimenrix 2 GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenW-135, Month 1097.7 Titers
Nimenrix 2 GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenA, Month 111561.0 Titers
Nimenrix 2 GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenY, Month 11881.3 Titers
Nimenrix 2 GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenY, Month 1047.0 Titers
Nimenrix 2 GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenC, Month 111177.0 Titers
Nimenrix 2 GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenC, Month 1043.7 Titers
Nimenrix 2 GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenA, Month 1019.5 Titers
Menjugate GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenY, Month 106.5 Titers
Menjugate GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenC, Month 1016.0 Titers
Menjugate GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenC, Month 111051.4 Titers
Menjugate GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenW-135, Month 104.7 Titers
Menjugate GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenW-135, Month 115.5 Titers
Menjugate GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenY, Month 116.1 Titers
Menjugate GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenA, Month 104.7 Titers
Menjugate GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenA, Month 114.6 Titers
NeisVac-C GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenC, Month 1049.3 Titers
NeisVac-C GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenC, Month 111960.2 Titers
NeisVac-C GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenA, Month 114.7 Titers
NeisVac-C GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenA, Month 104.4 Titers
NeisVac-C GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenW-135, Month 105.0 Titers
NeisVac-C GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenY, Month 115.8 Titers
NeisVac-C GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenY, Month 106.0 Titers
NeisVac-C GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenW-135, Month 115.6 Titers
Secondary

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

Antibody titers were presented as geometric mean titers (GMTs).

Time frame: Pre-primary vaccination at Month 0

Population: The analysis was performed on the Primary ATP cohort for immunogenicity, which included all evaluable subjects who complied with the vaccination schedule for a randomized subset of 50% subjects for each of the 4 serogroups in the investigational groups, and in a randomized subset of 50% and 25% subjects for MenC, MenA, MenW, MenY in control groups.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Nimenrix 3 GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenA4.1 Titers
Nimenrix 3 GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenC4.4 Titers
Nimenrix 3 GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenW-1354.3 Titers
Nimenrix 3 GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenY4.2 Titers
Nimenrix 2 GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenC4.3 Titers
Nimenrix 2 GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenW-1354.4 Titers
Nimenrix 2 GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenY4.2 Titers
Nimenrix 2 GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenA4.1 Titers
Menjugate GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenW-1354.3 Titers
Menjugate GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenC4.9 Titers
Menjugate GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenY4.7 Titers
Menjugate GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenA4.1 Titers
NeisVac-C GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenY4.2 Titers
NeisVac-C GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenC4.7 Titers
NeisVac-C GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenA4.1 Titers
NeisVac-C GrouprSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody TitersrSBA-MenW-1354.3 Titers

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026