Infections, Meningococcal
Conditions
Keywords
Meningococcal serogroups A, C, W-135 and/or Y diseases, Conjugate vaccine, Immunogenicity, Meningococcal vaccine, Persistence, Non-inferiority
Brief summary
This study has 2 phases, a vaccination phase and a long-term follow-up phase. In the vaccination phase of this study, the new meningococcal vaccine 134612 will be evaluated in children using Mencevax™ ACWY (in children above 2 years) or Meningitec™ (in children below 2 years) as controls. In the long-term follow-up phase of the study, the long-term protection offered by the vaccines will be assessed up to 5 years after vaccination. Subjects will be randomized in the primary vaccination phase of the study; no new subjects will be enrolled during the long-term follow-up phase of the study.
Detailed description
Subjects will be enrolled in 3 age strata. Subjects including and above two years of age will receive either GSK Biologicals meningococcal vaccine 134612 or Mencevax™ ACWY, subjects below two years of age will receive either GSK Biologicals meningococcal vaccine 134612 or Meningitec™. All subjects will have 7 blood samples taken: prior and one month after vaccination and one, two, three, four and five years after vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.
Interventions
BIOLOGICALGSK Biolgicals' meningococcal vaccine 134612 (Nimenrix)
One intramuscular dose.
BIOLOGICALMencevax™ ACWY
One subcutaneous dose.
BIOLOGICALMeningitec™
One intramuscular dose.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 10 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that their parent or guardian can and will comply with the requirements of the protocol. * A male or female between, and including, 1 through 10 years of age at the time of vaccination. * Written informed consent obtained from the parent or guardian of the subject. * Free of obvious health problems as established by medical history and clinical examination before entering into the study. * Previously completed routine childhood vaccinations to the best of his/her parents/guardians' knowledge.
Exclusion criteria
For the primary phase: * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period. * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. * Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine(s). * Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W, and/or Y (for subjects below 6 years) or within the last five previous years (for subjects 6 years old or above). * Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C, W, and/or Y. * Previous vaccination with tetanus toxoid containing vaccine within the last 28 days. * History of meningococcal disease due to serogroup A, C, W, or Y. * Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. * A family history of congenital or hereditary immunodeficiency. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * Major congenital defects or serious chronic illness. * History of any neurologic disorders or seizures. * Acute disease at the time of enrolment. * Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period. For the long term persistence phase: * History of meningococcal serogroup A, C, W, and/or Y disease. * Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine not planned in the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies Vaccine Response | One Month after vaccination | Vaccine response was defined as: * for initially seronegative subjects, post vaccination rSBA titer ≥ 1:32 * for initially seropositive subjects, at least 4-fold increase in rSBA titer from pre to post vaccination. |
| Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | Prior to (PRE) vaccination | The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory. |
| Percentage of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | Prior to (PRE) to vaccination | The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Prior to (PRE) and one month after vaccination [PI(M1)] | The cut-off value for the anti-polysaccharide concentrations were greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL. |
| Anti-PS Antibody Concentrations | Prior to (PRE) and one month after vaccination [PI(M1)] | Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). |
| Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Prior to (PRE) and one month after vaccination [PI(M1)] | The cut-off value for the anti-polysaccharide concentrations were greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and (≥) 2.0 μg/mL. |
| Number of Subjects With Anti-tetanus (Anti-TT) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Prior to (PRE) and one month after vaccination [PI(M1)] | The cut-off value for the anti-TT concentrations was greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). |
| Anti-TT Antibody Concentrations | Prior to (PRE) and one month after vaccination [PI(M1)] | Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL). |
| Number of Subjects With Anti-TT Antibody Concentrations | Prior to (PRE) and one month after vaccination [PI(M1)] | Cut-off values assessed were greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). |
| Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value | Prior to (PRE) and one month after vaccination [PI(M1)] | The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4. |
| hSBA Antibody Titers | Prior to (PRE) and one month after vaccination [PI(M1)] | Antibody titers are presented as geometric mean titers (GMTs). |
| Number of Subjects With hSBA Antibody Titers ≥ the Cut-off Value | Prior to (PRE) and one month after vaccination [PI(M1)] | The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4. |
| Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)] | The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory. |
| Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)] | The cut-off value for the anti-polysaccharide concentrations was ≥ 0.3 μg/mL. |
| Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | Prior to (PRE) and one month after vaccination [PI(M1)] | The cut-off value for the rSBA titers was greater than or equal to (≥) 1:128. This analysis was performed by the GSK Biologicals' laboratory. |
| Number of Subjects With hSBA Antibody Titers ≥ to the Cut-off Value | Prior to (PRE), one month post vaccination [PI(M1)] and Persistence Year 1 [PI(M12)] | The cut-off value for the hSBA titers was greater or equal to (≥) 1:4. |
| rSBA Antibody Titers (HPA Laboratory Assay) | At Persistence Year 4 [PI(M48)] | Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the Health Protection Agency (HPA) laboratory. |
| Number of Subjects With Solicited Local Symptoms | During the 4-day (Day 0-3) follow-up period | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) (1 - \< 2 years of age and 2 - \< 6 years of age groups) and 50 mm (6 - \< 11 years of age groups) of injection site, respectively. |
| Number of Subjects With Solicited General Symptoms | During the 4-day (Day 0-3) follow-up period | Assessed solicited general symptoms were drowsiness, fever \[defined as rectal temperature equal to or above 38.0 degrees Celsius (°C)\], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination. |
| Number of Subjects With Rash | From administration of the vaccine dose until 6 months later | Rash assessed included hives, idiopathic thrombocytopenic purpura and petechiae. |
| Number of Subjects With New Onset of Chronic Illnesses (NOCIs) | From administration of the vaccine dose until 6 months later | NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. |
| Number of Subjects With Adverse Events (AEs) Resulting in an Emergency Room (ER) Visit | From administration of the vaccine dose until 6 months later | Among AEs prompting emergency room visits were: infections, injuries, skin diseases and respiratory diseases. |
| Number of Subjects With Unsolicited AEs | During the 31-day (Days 0-30) post-vaccination period | 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. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. |
| Number of Subjects With Serious Adverse Events (SAEs) | Up to 6 Months after vaccination | 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 SAE(s) | From 6 Months after vaccination up to Year 1 | 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 hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | Prior to (PRE), one month post vaccination [PI(M1)] and Persistence Year 1 [PI(M12)] | The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4. |
| rSBA Antibody Titers | Prior to (PRE) and one month after vaccination [PI(M1)] | Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory. |
| Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values | Prior to (PRE) and one month after vaccination [PI(M1)] | The cut-off value for the rSBA titers were greater than or equal to ≥ 1:8 and ≥ 1:128. These analyses were performed by the GSK Biologicals' laboratory. |
Countries
Finland
Participant flow
Pre-assignment details
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Participants by arm
| Arm | Count |
|---|---|
| Nimenrix 1-2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Nimenrix™ vaccine administrated intramuscularly (IM) by injection in the non-dominant deltoid or the thigh region. | 229 |
| Nimenrix 2-11 Years of Age Group Subjects from 2 to 11 years of age who received one dose of Nimenrix™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region. | 231 |
| Meningitec 1-2 Years of Age Group Subjects from 1 to 2 years of age who received one dose of Meningitec™ vaccine administrated IM by injection in the non-dominant deltoid or the thigh region. | 75 |
| Mencevax 2-11 Years of Age Group Subjects from 2 to 11 years of age who received one dose Mencevax™ vaccine administrated subcutaneous by injection in the non-dominant upper arm. | 78 |
| Total | 613 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Primary Phase | Adverse Event | 0 | 1 | 0 | 0 |
| Primary Phase | Lost to Follow-up | 4 | 0 | 2 | 0 |
| Primary Phase | Withdrawal by Subject | 1 | 2 | 1 | 0 |
Baseline characteristics
| Characteristic | Nimenrix 1-2 Years of Age Group | Nimenrix 2-11 Years of Age Group | Meningitec 1-2 Years of Age Group | Mencevax 2-11 Years of Age Group | Total |
|---|---|---|---|---|---|
| Age, Continuous | 19.1 Months STANDARD_DEVIATION 2.96 | 71.9 Months STANDARD_DEVIATION 31.19 | 19.3 Months STANDARD_DEVIATION 3.07 | 71.8 Months STANDARD_DEVIATION 30.9 | 45.73 Months STANDARD_DEVIATION 34.44 |
| Race/Ethnicity, Customized Geographic ancestry African heritage/African American | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian-East Asian heritage | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Geographic ancestry Unspecified | 3 Participants | 3 Participants | 1 Participants | 2 Participants | 9 Participants |
| Race/Ethnicity, Customized Geographic ancestry White-Arabic/North African heritage | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Geographic ancestry White-Caucasian/European heritage | 224 Participants | 225 Participants | 74 Participants | 76 Participants | 599 Participants |
| Sex: Female, Male Female | 116 Participants | 115 Participants | 39 Participants | 37 Participants | 307 Participants |
| Sex: Female, Male Male | 113 Participants | 116 Participants | 36 Participants | 41 Participants | 306 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 229 | 0 / 231 | 0 / 75 | 0 / 78 |
| other Total, other adverse events | 193 / 229 | 192 / 231 | 64 / 75 | 67 / 78 |
| serious Total, serious adverse events | 5 / 229 | 2 / 231 | 7 / 75 | 1 / 78 |
Outcome results
Primary
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.
Time frame: Prior to (PRE) vaccination
Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA | 81 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC | 80 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 | 59 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY | 115 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY | 41 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA | 26 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 | 24 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC | 19 Participants |
Primary
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.
Time frame: One month after vaccination [PI(M1)]
Population: The analysis was performed on subjects of 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA | 222 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC | 220 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 | 222 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY | 222 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY | 49 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA | 22 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 | 27 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC | 67 Participants |
Comparison: To evaluate the non-inferiority of the vaccine response induced by Nimenrix™ conjugate vaccine when compared to the licensed Meningitec™ vaccine for MenC as measured by rSBA.95% CI: [-0.27, 7.89]
Primary
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies Vaccine Response
Vaccine response was defined as: * for initially seronegative subjects, post vaccination rSBA titer ≥ 1:32 * for initially seropositive subjects, at least 4-fold increase in rSBA titer from pre to post vaccination.
Time frame: One Month after vaccination
Population: The analysis was performed on subjects of 2 years and above from the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies Vaccine Response | rSBA-MenA | 182 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies Vaccine Response | rSBA-MenC | 200 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies Vaccine Response | rSBA-MenW-135 | 199 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies Vaccine Response | rSBA-MenY | 217 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies Vaccine Response | rSBA-MenY | 58 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies Vaccine Response | rSBA-MenA | 57 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies Vaccine Response | rSBA-MenW-135 | 65 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies Vaccine Response | rSBA-MenC | 56 Participants |
Comparison: To evaluate the non-inferiority of Nimenrix™ conjugate vaccine compared to Mencevax™ plain polysaccharide vaccine in terms of the vaccine response (VRR) to MenA. Response to a vaccine antigen component was defined as: For initially seronegative subject, post-vaccination serum bactericidal assay using rabbit complement (rSBA) titer ≥ 1:32. For initially seropositive subject, at least 4-fold increase in rSBA-MenA titer from pre to post vaccination.95% CI: [1.15, 16.04]
Comparison: To evaluate the non-inferiority of Nimenrix™ conjugate vaccine compared to Mencevax™ plain polysaccharide vaccine in terms of the vaccine response (VRR) to MenC. Response to a vaccine antigen component was defined as: For initially seronegative subject, post-vaccination serum bactericidal assay using rabbit complement (rSBA) titer ≥ 1:32. For initially seropositive subject, at least 4-fold increase in rSBA-MenC titer from pre to post vaccination.95% CI: [4.79, 24.32]
Comparison: To evaluate the non-inferiority of Nimenrix™ conjugate vaccine compared to Mencevax™ plain polysaccharide vaccine in terms of the vaccine response (VRR) to MenW-135. Response to a vaccine antigen component was defined as: For initially seronegative subject, post-vaccination serum bactericidal assay using rabbit complement (rSBA) titer ≥ 1:32. For initially seropositive subject, at least 4-fold increase in rSBA-MenW-135 titer from pre to post vaccination.95% CI: [1.51, 12.21]
Comparison: To evaluate the non-inferiority of Nimenrix™ conjugate vaccine compared to Mencevax™ plain polysaccharide vaccine in terms of the vaccine response (VRR) to MenY. Response to a vaccine antigen component was defined as: For initially seronegative subject, post-vaccination serum bactericidal assay using rabbit complement (rSBA) titer ≥ 1:32. For initially seropositive subject, at least 4-fold increase in rSBA-MenY titer from pre to post vaccination.95% CI: [8.99, 26.78]
Primary
Percentage of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.
Time frame: Prior to (PRE) to vaccination
Population: The analysis was performed on subjects of 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Percentage of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA | 42.4 Percentage |
| Nimenrix 2-11 Years of Age Primary Phase Group | Percentage of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC | 39.4 Percentage |
| Nimenrix 2-11 Years of Age Primary Phase Group | Percentage of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 | 28.4 Percentage |
| Nimenrix 2-11 Years of Age Primary Phase Group | Percentage of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY | 55.3 Percentage |
| Mencevax 2-11 Years of Age Primary Phase Group | Percentage of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY | 61.2 Percentage |
| Mencevax 2-11 Years of Age Primary Phase Group | Percentage of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA | 40.0 Percentage |
| Mencevax 2-11 Years of Age Primary Phase Group | Percentage of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 | 38.7 Percentage |
| Mencevax 2-11 Years of Age Primary Phase Group | Percentage of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC | 31.1 Percentage |
Primary
Percentage of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.
Time frame: One month after vaccination [PI(M1)]
Population: The analysis was performed on subjects of 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Percentage of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA | 100 Percentage |
| Nimenrix 2-11 Years of Age Primary Phase Group | Percentage of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC | 100 Percentage |
| Nimenrix 2-11 Years of Age Primary Phase Group | Percentage of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 | 100 Percentage |
| Nimenrix 2-11 Years of Age Primary Phase Group | Percentage of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY | 100 Percentage |
| Mencevax 2-11 Years of Age Primary Phase Group | Percentage of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY | 74.2 Percentage |
| Mencevax 2-11 Years of Age Primary Phase Group | Percentage of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA | 34.9 Percentage |
| Mencevax 2-11 Years of Age Primary Phase Group | Percentage of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 | 42.9 Percentage |
| Mencevax 2-11 Years of Age Primary Phase Group | Percentage of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC | 98.5 Percentage |
Secondary
Anti-PS Antibody Concentrations
Antibody concentrations are presented as GMCs and expressed in μg/mL.
Time frame: Prior to (PRE), one month post vaccination [PI(M1)] and at Persistence Year 1 [PI(M12)]
Population: The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSC (PI[M1]) | 13.34 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSA (PRE) | 0.19 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSA (PI[M1]) | 35.95 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSA (PI[M12]) | 2.33 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSC (PRE) | 0.2 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSC (PI[M12]) | 0.76 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSW-135 (PRE) | 0.15 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSW-135 (PI[M1]) | 6.26 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSW-135 (PI[M12]) | 1.94 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSY (PRE) | 0.15 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSY (PI[M1]) | 11.2 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSY (PI[M12]) | 2.76 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSY (PI[M1]) | 15.45 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSC (PI[M1]) | 14.53 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSW-135 (PRE) | 0.15 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSA (PRE) | 0.2 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSY (PRE) | 0.15 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSA (PI[M1]) | 10.34 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSW-135 (PI[M1]) | 4.62 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSA (PI[M12]) | 4.05 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSY (PI[M12]) | 5.77 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSC (PRE) | 0.19 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSW-135 (PI[M12]) | 2.21 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSC (PI[M12]) | 4.4 μg/mL |
Secondary
Anti-PS Antibody Concentrations
Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).
Time frame: Prior to (PRE) and one month after vaccination [PI(M1)]
Population: The analysis was performed on subjects of 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSA (PRE) | 0.17 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSA [PI(M1)] | 33.36 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSC (PRE) | 0.16 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSC [PI(M1)] | 13.47 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSW-135 (PRE) | 0.15 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSW-135 [PI(M1)] | 6.86 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSY (PRE) | 0.15 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSY [PI(M1)] | 10.35 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSY [PI(M1)] | 0.15 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSA (PRE) | 0.18 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSW-135 (PRE) | 0.15 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSA [PI(M1)] | 0.17 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSY (PRE) | 0.16 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSC (PRE) | 0.16 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSW-135 [PI(M1)] | 0.15 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSC [PI(M1)] | 8.29 μg/mL |
Secondary
Anti-PS Antibody Concentrations
Antibody concentrations are presented as GMCs and expressed in micrograms per milliliter (μg/mL).
Time frame: Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]
Population: The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSA (PRE) | 0.18 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSA (PI[M1]) | 34.76 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSA (PI[M12]) | 2.27 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSA (PI[M24]) | 1.52 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSC (PRE) | 0.2 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSC (PI[M1]) | 12.94 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSC (PI[M12]) | 0.75 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSC (PI[M24]) | 0.54 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSW-135 (PRE) | 0.15 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSW-135 (PI[M1]) | 6.16 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSW-135 (PI[M12]) | 1.9 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSW-135 (PI[M24]) | 1.15 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSY (PRE) | 0.16 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSY (PI[M1]) | 11.1 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSY (PI[M12]) | 2.73 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSY (PI[M24]) | 1.72 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSY (PI[M24]) | 2.9 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSA (PRE) | 0.21 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSW-135 (PRE) | 0.15 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSA (PI[M1]) | 11.2 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSY (PRE) | 0.15 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSA (PI[M12]) | 4.62 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSW-135 (PI[M1]) | 4.5 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSA (PI[M24]) | 2.93 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSY (PI[M12]) | 5.8 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSC (PRE) | 0.2 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSW-135 (PI[M12]) | 2.28 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSC (PI[M1]) | 15.28 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSY (PI[M1]) | 14.91 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSC (PI[M12]) | 4.98 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSW-135 (PI[M24]) | 1.32 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSC (PI[M24]) | 2.81 μg/mL |
Secondary
Anti-PS Antibody Concentrations
Antibody concentrations were presented as micrograms per milliliter (μg/mL).
Time frame: Prior to (PRE) and one month post vaccination [PI(M1)]
Population: The analysis was performed on subjects of 2 years and above from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSY, PI(M1) | 11.35 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSW-135, PRE | 0.15 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSW-135, PI(M1) | 6.35 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSY, PRE | 0.16 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSA, PRE | 0.19 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSA, PI(M1) | 36.35 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSC, PRE | 0.2 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSC, PI(M1) | 13.33 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSY, PI(M1) | 15.45 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSC, PI(M1) | 14.53 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSA, PI(M1) | 10.34 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSW-135, PRE | 0.15 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSA, PRE | 0.2 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSW-135, PI(M1) | 4.62 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSC, PRE | 0.19 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSY, PRE | 0.15 μg/mL |
Secondary
Anti-PS Antibody Concentrations
Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).
Time frame: Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]
Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSA (PRE) | 0.16 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSA (PI[M1]) | 32.63 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSA (PI[M12]) | 1.08 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSA (PI[M24]) | 0.59 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSC (PRE) | 0.16 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSC (PI[M1]) | 13.58 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSC (PI[M12]) | 0.39 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSC (PI[M24]) | 0.26 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSW-135 (PRE) | 0.15 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSW-135 (PI[M1]) | 6.58 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSW-135 (PI[M12]) | 1.33 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSW-135 (PI[M24]) | 0.65 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSY (PRE) | 0.15 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSY (PI[M1]) | 10.22 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSY (PI[M12]) | 1.95 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSY (PI[M24]) | 1.12 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSY (PI[M24]) | 0.16 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSA (PRE) | 0.19 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSW-135 (PRE) | 0.15 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSA (PI[M1]) | 0.18 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSY (PRE) | 0.16 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSA (PI[M12]) | 0.16 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSW-135 (PI[M1]) | 0.15 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSA (PI[M24]) | 0.19 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSY (PI[M12]) | 0.15 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSC (PRE) | 0.16 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSW-135 (PI[M12]) | 0.15 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSC (PI[M1]) | 9.16 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSY (PI[M1]) | 0.15 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSC (PI[M12]) | 0.36 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSW-135 (PI[M24]) | 0.15 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSC (PI[M24]) | 0.24 μg/mL |
Secondary
Anti-PS Antibody Concentrations
Antibody concentrations are presented as GMCs and expressed in micrograms per milliliter (μg/mL).
Time frame: Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]
Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSA (PRE) | 0.17 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSA (PI[M1]) | 33.31 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSA (PI[M12]) | 1.07 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSC (PRE) | 0.16 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSC (PI[M1]) | 13.44 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSC (PI[M12]) | 0.39 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSW-135 (PRE) | 0.15 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSW-135 (PI[M1]) | 6.87 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSW-135 (PI[M12]) | 1.33 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSY (PRE) | 0.15 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSY (PI[M1]) | 10.21 μg/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSY (PI[M12]) | 1.97 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSY (PI[M1]) | 0.15 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSA (PRE) | 0.18 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSW-135 (PRE) | 0.15 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSA (PI[M1]) | 0.17 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSY (PRE) | 0.16 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSA (PI[M12]) | 0.17 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSW-135 (PI[M1]) | 0.15 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSC (PRE) | 0.16 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSY (PI[M12]) | 0.16 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSC (PI[M1]) | 8.53 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSW-135 (PI[M12]) | 0.15 μg/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-PS Antibody Concentrations | Anti-PSC (PI[M12]) | 0.34 μg/mL |
Secondary
Anti-TT Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL).
Time frame: Prior to (PRE) and one month after vaccination [PI(M1)]
Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-TT Antibody Concentrations | Anti-TT (PRE) | 1.226 IU/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-TT Antibody Concentrations | Anti-TT [PI(M1)] | 14.199 IU/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-TT Antibody Concentrations | Anti-TT (PRE) | 0.57 IU/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-TT Antibody Concentrations | Anti-TT [PI(M1)] | 1.341 IU/mL |
Secondary
Anti-TT Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL).
Time frame: Prior to (PRE) and one month post vaccination [PI(M1)]
Population: The analysis was performed on subjects of 2 years and above from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-TT Antibody Concentrations | Anti-TT, PRE | 1.541 IU/mL |
| Nimenrix 2-11 Years of Age Primary Phase Group | Anti-TT Antibody Concentrations | Anti-TT, PI(M1) | 20.951 IU/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-TT Antibody Concentrations | Anti-TT, PRE | 2.103 IU/mL |
| Mencevax 2-11 Years of Age Primary Phase Group | Anti-TT Antibody Concentrations | Anti-TT, PI(M1) | 1.74 IU/mL |
Secondary
hSBA Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs).
Time frame: Prior to (PRE) and one month after vaccination [PI(M1)]
Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA, PRE | 2 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hBA-MenA, PI(M1) | 59 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC, PRE | 2.1 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC, PI(M1) | 190 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135, PRE | 2.1 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135, PI(M1) | 38.8 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY, PRE | 2.2 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY, PI(M1) | 24.4 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY, PI(M1) | 2.4 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA, PRE | 2.2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135, PRE | 2.2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hBA-MenA, PI(M1) | 2.3 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY, PRE | 2.1 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC, PRE | 2.1 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135, PI(M1) | 2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC, PI(M1) | 21.2 Titers |
Secondary
hSBA Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs).
Time frame: Prior to (PRE), one month post vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]
Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PRE) | 2 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PI[M1]) | 57.6 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PI[M12]) | 3.6 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PRE) | 2.1 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PI[M1]) | 187 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PI[M12]) | 88.7 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PRE) | 2.1 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PI[M1]) | 38.5 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PI[M12]) | 225.1 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PRE) | 2.2 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PI[M1]) | 23.8 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PI[M12]) | 105.1 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PI[M1]) | 2.5 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PRE) | 2.2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PRE) | 2.2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PI[M1]) | 2.2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PRE) | 2.1 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PI[M12]) | 2.2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PI[M1]) | 2.1 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PRE) | 2.1 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PI[M12]) | 3.2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PI[M1]) | 22 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PI[M12]) | 2.4 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PI[M12]) | 12.2 Titers |
Secondary
hSBA Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs).
Time frame: Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)] and Persistence Year 5 [PI(M60)]
Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PRE) | 2 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PI[M1]) | 252 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PI[M48]) | 370.2 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PRE) | 2 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PI[M1]) | 78.5 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PI[M12]) | 4.1 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PI[M24]) | 6.7 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PI[M36]) | 4.4 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PI[M48]) | 8.8 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PI[M60]) | 5.2 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PI[M12]) | 180.1 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PI[M24]) | 137.9 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PI[M36]) | 337.9 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PI[M60]) | 216.5 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PRE) | 2.2 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PI[M1]) | 81.3 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PI[M12]) | 300.5 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PI[M24]) | 168.2 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PI[M36]) | 70.2 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PI[M48]) | 76.9 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PI[M60]) | 59.7 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PRE) | 2.1 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PI[M1]) | 46.1 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PI[M12]) | 160 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PI[M24]) | 121.9 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PI[M36]) | 53.9 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PI[M48]) | 74.6 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PI[M60]) | 70.6 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PI[M60]) | 108.7 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PRE) | 2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PI[M60]) | 5.1 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PI[M1]) | 38.7 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PRE) | 2.3 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PI[M60]) | 11.6 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PI[M36]) | 7.1 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PRE) | 2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PI[M1]) | 2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PI[M1]) | 2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PRE) | 2.6 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PI[M12]) | 2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PI[M12]) | 2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PI[M24]) | 2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PI[M24]) | 8.7 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PI[M36]) | 2.3 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PI[M24]) | 3.1 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PI[M48]) | 2.9 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PI[M1]) | 2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PI[M60]) | 3.6 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PI[M36]) | 2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PI[M12]) | 10.8 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PI[M48]) | 10 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PI[M24]) | 33.4 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PI[M48]) | 2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PI[M36]) | 57.9 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PI[M48]) | 91.9 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PI[M12]) | 3 Titers |
Secondary
hSBA Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs).
Time frame: Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)]
Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PI[M1]) | 57.7 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PRE) | 2.1 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PRE) | 2.1 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PI[M1]) | 41.7 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PI[M24]) | 4.9 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PI[M1]) | 192.5 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PI[M12]) | 227.9 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PRE) | 2 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PI[M24]) | 116.5 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PI[M12]) | 105.9 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PI[M36]) | 44.5 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PI[M36]) | 3.3 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PI[M48]) | 48.3 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PI[M24]) | 72.5 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PRE) | 2.1 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PI[M1]) | 22.5 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PI[M12]) | 3.4 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PI[M12]) | 108.8 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PI[M24]) | 76.3 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PI[M36]) | 84.8 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PI[M36]) | 43.0 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PI[M48]) | 6 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PI[M48]) | 42.1 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PI[M48]) | 51.4 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PI[M48]) | 13.5 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PRE) | 2.2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PI[M1]) | 2.3 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PI[M12]) | 2.1 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PI[M24]) | 2.3 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PI[M36]) | 2.1 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PI[M48]) | 3.1 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PRE) | 2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PI[M1]) | 45 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PI[M12]) | 28.6 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PI[M24]) | 27.1 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PI[M36]) | 32.4 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PI[M48]) | 32.4 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PRE) | 2.1 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PRE) | 2.1 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PI[M1]) | 2.1 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PI[M12]) | 2.3 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PI[M24]) | 3.7 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PI[M36]) | 2.8 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PI[M48]) | 2.8 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PI[M1]) | 2.6 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PI[M24]) | 6.6 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PI[M36]) | 5.9 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PI[M12]) | 3.8 Titers |
Secondary
hSBA Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs).
Time frame: Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)] and Persistence Year 3 [PI(M36)]
Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 3, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 3 time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PRE) | 2 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PI[M1]) | 56.9 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PI[M12]) | 3.4 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PI[M24]) | 4.9 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PI[M36]) | 3.3 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PRE) | 2.1 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PI[M1]) | 182.7 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PI[M12]) | 95.1 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PI[M24]) | 62.9 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PI[M36]) | 65.1 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PRE) | 2.1 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PI[M1]) | 39.1 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PI[M12]) | 218.9 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PI[M24]) | 112.8 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PI[M36]) | 40.8 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PRE) | 2.1 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PI[M1]) | 24.8 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PI[M12]) | 103.5 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PI[M24]) | 70.4 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PI[M36]) | 37.3 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PI[M12]) | 3.7 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PRE) | 2.3 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PRE) | 2.2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PI[M1]) | 2.4 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PRE) | 2.1 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PI[M12]) | 2.2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PI[M1]) | 2.1 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PI[M24]) | 2.3 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PI[M36]) | 6 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PI[M36]) | 2.2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PI[M12]) | 2.1 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PRE) | 2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PI[M1]) | 2.8 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PI[M1]) | 44.1 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PI[M24]) | 3.1 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PI[M12]) | 23.8 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PI[M24]) | 6.7 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PI[M24]) | 18.8 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PI[M36]) | 3 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PI[M36]) | 32.5 Titers |
Secondary
hSBA Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs).
Time frame: Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]
Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PRE) | 2 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PI[M1]) | 58.8 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PI[M12]) | 3.6 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PI[M24]) | 5.1 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PRE) | 2.1 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PI[M1]) | 185.4 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PI[M12]) | 88.6 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PI[M24]) | 55.6 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PRE) | 2.1 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PI[M1]) | 38.7 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PI[M12]) | 218.8 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PI[M24]) | 111.4 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PRE) | 2.1 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PI[M1]) | 23.1 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PI[M12]) | 99.8 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PI[M24]) | 72.5 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PI[M24]) | 5 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PRE) | 2.2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PRE) | 2.1 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PI[M1]) | 2.2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PRE) | 2.1 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PI[M12]) | 2.2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PI[M1]) | 2.1 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PI[M24]) | 2.3 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PI[M12]) | 3.7 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PRE) | 2.1 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PI[M12]) | 2.6 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PI[M1]) | 26.7 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PI[M1]) | 2.6 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PI[M12]) | 14.7 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PI[M24]) | 2.9 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PI[M24]) | 11.8 Titers |
Secondary
hSBA Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs).
Time frame: Prior to (PRE) and one month post vaccination [PI(M1)]
Population: The analysis was performed on subjects from 6 to below 11 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PRE) | 2.1 Titer |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PRE) | 3.2 Titer |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PRE) | 5.1 Titer |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PI[M1]) | 134.2 Titer |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PI[M1]) | 57.0 Titer |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PRE) | 5.6 Titer |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PI[M1]) | 93.7 Titer |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PI[M1]) | 154.8 Titer |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PI[M1]) | 12.5 Titer |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PRE) | 2.2 Titer |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PI[M1]) | 4.1 Titer |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PRE) | 4.4 Titer |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PI[M1]) | 13.1 Titer |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PRE) | 2.6 Titer |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PI[M1]) | 5.8 Titer |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PRE) | 6.1 Titer |
Secondary
hSBA Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs).
Time frame: Prior to (PRE), one month after vaccination [PI(M1)] and at Persistence Year 1 [PI(M12)]
Population: The analysis was performed on subjects from 6 to below 11 years of age from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PRE) | 2.1 Titer |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PI[M1]) | 53.4 Titer |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PI[M12]) | 3.5 Titer |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PRE) | 4.7 Titer |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PI[M1]) | 155.8 Titer |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PI[M12]) | 129.5 Titer |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PRE) | 3.0 Titer |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PI[M1]) | 133.5 Titer |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PI[M12]) | 256.7 Titer |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PRE) | 5.3 Titer |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PI[M1]) | 95.1 Titer |
| Nimenrix 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PI[M12]) | 265.0 Titer |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PI[M1]) | 12.5 Titer |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PRE) | 2.2 Titer |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PRE) | 2.6 Titer |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PI[M1]) | 4.1 Titer |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PRE) | 6.1 Titer |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenA (PI[M12]) | 2.5 Titer |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PI[M1]) | 5.8 Titer |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PRE) | 4.4 Titer |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenY (PI[M12]) | 9.3 Titer |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PI[M1]) | 13.1 Titer |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenW-135 (PI[M12]) | 3.4 Titer |
| Mencevax 2-11 Years of Age Primary Phase Group | hSBA Antibody Titers | hSBA-MenC (PI[M12]) | 7.7 Titer |
Secondary
Number of Subjects With Adverse Events (AEs) Resulting in an Emergency Room (ER) Visit
Among AEs prompting emergency room visits were: infections, injuries, skin diseases and respiratory diseases.
Time frame: From administration of the vaccine dose until 6 months later
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Adverse Events (AEs) Resulting in an Emergency Room (ER) Visit | 21 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Adverse Events (AEs) Resulting in an Emergency Room (ER) Visit | 8 Participants |
| Nimenrix 6- 11 Years of Age Group | Number of Subjects With Adverse Events (AEs) Resulting in an Emergency Room (ER) Visit | 15 Participants |
| Meningitec 1- 2 Years of Age Group | Number of Subjects With Adverse Events (AEs) Resulting in an Emergency Room (ER) Visit | 5 Participants |
Secondary
Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value
The cut-off value for the anti-polysaccharide concentrations were greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL.
Time frame: Prior to (PRE) and one month after vaccination [PI(M1)]
Population: The analysis was performed on subjects of 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSA [PI(M1)] ≥ 2.0 μg/mL | 162 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSC (PRE) ≥ 2.0 μg/mL | 1 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSW-135 (PRE) ≥ 0.3 μg/mL | 2 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSA (PRE) ≥ 0.3 μg/mL | 10 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSA (PRE) ≥ 2.0 μg/mL | 2 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSA [PI(M1)] ≥ 0.3 μg/mL | 162 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSC (PRE) ≥ 0.3 μg/mL | 3 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSC [PI(M1)] ≥ 0.3 μg/mL | 168 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSC [PI(M1)] ≥ 2.0 μg/mL | 166 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSW-135 (PRE) ≥ 2.0 μg/mL | 1 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSW-135 [PI(M1)] ≥ 0.3 μg/mL | 143 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSW-135 [PI(M1)] ≥ 2.0 μg/mL | 131 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSY (PRE) ≥ 0.3 μg/mL | 1 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSY (PRE) ≥ 2.0 μg/mL | 0 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSY [PI(M1)] ≥ 0.3 μg/mL | 152 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSY [PI(M1)] ≥ 2.0 μg/mL | 147 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSW-135 [PI(M1)] ≥ 2.0 μg/mL | 0 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSC [PI(M1)] ≥ 0.3 μg/mL | 51 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSC (PRE) ≥ 2.0 μg/mL | 1 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSC [PI(M1)] ≥ 2.0 μg/mL | 50 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSY [PI(M1)] ≥ 2.0 μg/mL | 0 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSW-135 (PRE) ≥ 0.3 μg/mL | 0 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSW-135 (PRE) ≥ 2.0 μg/mL | 0 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSY (PRE) ≥ 0.3 μg/mL | 1 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSA (PRE) ≥ 0.3 μg/mL | 4 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSY [PI(M1)] ≥ 0.3 μg/mL | 0 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSA (PRE) ≥ 2.0 μg/mL | 1 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSW-135 [PI(M1)] ≥ 0.3 μg/mL | 0 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSA [PI(M1)] ≥ 0.3 μg/mL | 2 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSA [PI(M1)] ≥ 2.0 μg/mL | 1 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSY (PRE) ≥ 2.0 μg/mL | 0 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSC (PRE) ≥ 0.3 μg/mL | 1 Participants |
Secondary
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value
The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL).
Time frame: Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]
Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSC (PRE) | 3 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSW-135 (PRE) | 2 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSW-135 (PI[M1]) | 138 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSA (PI[M1]) | 155 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSW-135 (PI[M12]) | 124 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSC (PI[M1]) | 161 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSY (PRE) | 1 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSA (PI[M12]) | 118 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSY (PI[M1]) | 145 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSC (PI[M12]) | 73 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSY (PI[M12]) | 153 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSA (PRE) | 9 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSY (PI[M12]) | 2 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSA (PRE) | 4 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSA (PI[M1]) | 2 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSW-135 (PRE) | 0 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSA (PI[M12]) | 3 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSC (PRE) | 1 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSC (PI[M1]) | 49 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSC (PI[M12]) | 17 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSW-135 (PI[M1]) | 0 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSW-135 (PI[M12]) | 0 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSY (PRE) | 1 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSY (PI[M1]) | 0 Participants |
Secondary
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value
The cut-off value for the anti-polysaccharide concentrations were greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and (≥) 2.0 μg/mL.
Time frame: Prior to (PRE) and one month after vaccination [PI(M1)]
Population: The analysis was performed on subjects of 2 years and above from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSA ≥0.3μg/mL, PRE | 29 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSA ≥0.3μg/mL, PI(M1) | 224 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSA ≥2.0μg/mL, PRE | 9 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSA ≥2.0μg/mL, PI(M1) | 224 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSC ≥0.3μg/mL , PRE | 28 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSC ≥0.3μg/mL, PI(M1) | 224 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSC ≥2.0μg/mL, PRE | 9 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSC ≥2.0μg/mL, PI(M1) | 223 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSW-135 ≥0.3μg/mL, PRE | 3 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSW-135 ≥0.3μg/mL, PI(M1) | 224 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSW-135 ≥2.0μg/mL, PRE | 0 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSW-135 ≥2.0μg/mL, PI(M1) | 197 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSY ≥0.3μg/mL, PRE | 6 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSY ≥0.3μg/mL, PI(M1) | 225 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSY ≥2.0μg/mL, PRE | 1 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSY ≥2.0μg/mL, PI(M1) | 217 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSY ≥2.0μg/mL, PI(M1) | 71 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSA ≥0.3μg/mL, PRE | 12 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSW-135 ≥0.3μg/mL, PRE | 1 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSA ≥0.3μg/mL, PI(M1) | 73 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSY ≥0.3μg/mL, PRE | 0 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSA ≥2.0μg/mL, PRE | 2 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSW-135 ≥0.3μg/mL, PI(M1) | 72 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSA ≥2.0μg/mL, PI(M1) | 68 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSY ≥2.0μg/mL, PRE | 0 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSC ≥0.3μg/mL , PRE | 6 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSW-135 ≥2.0μg/mL, PRE | 0 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSC ≥0.3μg/mL, PI(M1) | 74 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSY ≥0.3μg/mL, PI(M1) | 72 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSC ≥2.0μg/mL, PRE | 2 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSW-135 ≥2.0μg/mL, PI(M1) | 54 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSC ≥2.0μg/mL, PI(M1) | 71 Participants |
Secondary
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value
The cut-off value for the anti-polysaccharide concentrations was ≥ 0.3 micrograms per milliliter (μg/mL).
Time frame: Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]
Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSA (PRE) | 7 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSA (PI[M1]) | 143 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSA (PI[M12]) | 109 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSA (PI[M24]) | 107 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSC (PRE) | 3 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSC (PI[M1]) | 148 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSC (PI[M12]) | 68 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSC (PI[M24]) | 38 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSW-135 (PRE) | 1 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSW-135 (PI[M1]) | 129 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSW-135 (PI[M12]) | 114 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSW-135 (PI[M24]) | 98 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSY (PRE) | 1 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSY (PI[M1]) | 135 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSY (PI[M12]) | 140 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSY (PI[M24]) | 144 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSY (PI[M24]) | 1 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSA (PRE) | 4 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSW-135 (PRE) | 0 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSA (PI[M1]) | 2 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSY (PRE) | 1 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSA (PI[M12]) | 2 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSW-135 (PI[M1]) | 0 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSA (PI[M24]) | 7 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSY (PI[M12]) | 1 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSC (PRE) | 1 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSW-135 (PI[M12]) | 0 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSC (PI[M1]) | 35 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSY (PI[M1]) | 0 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSC (PI[M12]) | 15 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSW-135 (PI[M24]) | 0 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-PSC (PI[M24]) | 6 Participants |
Secondary
Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value
The cut-off value for the anti-polysaccharide concentrations was ≥ 0.3 micrograms per milliliter (μg/mL).
Time frame: Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]
Population: The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSA (PRE) | 24 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSA (PI[M1]) | 208 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSA (PI[M12]) | 201 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSA (PI[M24]) | 187 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSC (PRE) | 29 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSC (PI[M1]) | 208 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSC (PI[M12]) | 163 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSC (PI[M24]) | 131 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSW-135 (PRE) | 3 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSW-135 (PI[M1]) | 208 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSW-135 (PI[M12]) | 198 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSW-135 (PI[M24]) | 181 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSY (PRE) | 5 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSY (PI[M1]) | 209 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSY (PI[M12]) | 205 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSY (PI[M24]) | 198 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSY (PI[M24]) | 50 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSA (PRE) | 11 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSW-135 (PRE) | 1 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSA (PI[M1]) | 58 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSY (PRE) | 0 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSA (PI[M12]) | 54 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSW-135 (PI[M1]) | 57 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSA (PI[M24]) | 54 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSY (PI[M12]) | 56 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSC (PRE) | 6 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSW-135 (PI[M12]) | 52 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSC (PI[M1]) | 59 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSY (PI[M1]) | 56 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSC (PI[M12]) | 58 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSW-135 (PI[M24]) | 52 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSC (PI[M24]) | 57 Participants |
Secondary
Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value
The cut-off value for the anti-polysaccharide concentrations was ≥ 0.3 μg/mL.
Time frame: Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]
Population: The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSW-135 (PRE) | 2 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSA (PI[M1]) | 213 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSW-135 (PI[M1]) | 213 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSC (PRE) | 29 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSW-135 (PI[M12]) | 206 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSA (PRE) | 26 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSY (PRE) | 4 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSC (PI[M1]) | 213 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSY (PI[M1]) | 214 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSC (PI[M12]) | 169 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSY (PI[M12]) | 213 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSA (PI[M12]) | 209 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSY (PI[M12]) | 71 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSA (PRE) | 12 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSA (PI[M1]) | 73 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSA (PI[M12]) | 70 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSC (PRE) | 6 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSC (PI[M12]) | 74 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSW-135 (PRE) | 1 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSW-135 (PI[M1]) | 72 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSW-135 (PI[M12]) | 65 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSY (PRE) | 0 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSY (PI[M1]) | 72 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value | Anti-PSC (PI[M1]) | 74 Participants |
Secondary
Number of Subjects With Anti-tetanus (Anti-TT) Antibody Concentrations Greater Than or Equal to the Cut-off Value
The cut-off value for the anti-TT concentrations was greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
Time frame: Prior to (PRE) and one month after vaccination [PI(M1)]
Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-tetanus (Anti-TT) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-TT (PRE) | 18 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-tetanus (Anti-TT) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-TT [PI(M1)] | 30 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-tetanus (Anti-TT) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-TT (PRE) | 5 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-tetanus (Anti-TT) Antibody Concentrations Greater Than or Equal to the Cut-off Value | Anti-TT [PI(M1)] | 4 Participants |
Secondary
Number of Subjects With Anti-TT Antibody Concentrations
Cut-off values assessed were greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
Time frame: Prior to (PRE) and one month after vaccination [PI(M1)]
Population: The analysis was performed on subjects of 2 years and above from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-TT Antibody Concentrations | Anti-TT, PRE | 19 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-TT Antibody Concentrations | Anti-TT, PI(M1) | 32 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-TT Antibody Concentrations | Anti-TT, PRE | 4 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Anti-TT Antibody Concentrations | Anti-TT, PI(M1) | 7 Participants |
Secondary
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.
Time frame: Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]
Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PRE) | 3 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PI[M1]) | 180 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PI[M12]) | 42 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PI[M24]) | 73 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PRE) | 2 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PI[M1]) | 196 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PI[M12]) | 179 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PI[M24]) | 179 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PRE) | 2 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PI[M1]) | 130 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PI[M12]) | 156 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PI[M24]) | 171 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PRE) | 6 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PI[M1]) | 121 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PI[M12]) | 183 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PI[M24]) | 157 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PI[M24]) | 13 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PRE) | 3 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PRE) | 2 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PI[M1]) | 2 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PRE) | 2 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PI[M12]) | 3 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PI[M1]) | 1 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PI[M24]) | 6 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PI[M12]) | 8 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PRE) | 1 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PI[M12]) | 3 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PI[M1]) | 38 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PI[M1]) | 3 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PI[M12]) | 28 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PI[M24]) | 5 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PI[M24]) | 28 Participants |
Secondary
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.
Time frame: Prior to (PRE), one month post vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]
Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PRE) | 3 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PI[M1]) | 196 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PI[M12]) | 47 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PRE) | 3 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PI[M1]) | 213 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PI[M12]) | 192 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PRE) | 2 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PI[M1]) | 141 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PI[M12]) | 172 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PRE) | 7 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PI[M1]) | 131 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PI[M12]) | 200 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PI[M1]) | 3 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PRE) | 3 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PRE) | 3 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PI[M1]) | 3 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PRE) | 2 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PI[M12]) | 3 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PI[M1]) | 1 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PRE) | 1 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PI[M12]) | 8 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PI[M1]) | 48 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PI[M12]) | 3 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PI[M12]) | 34 Participants |
Secondary
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.
Time frame: Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)] and Persistence Year 3 [PI(M36)]
Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 3, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 3 time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PI[M1]) | 159 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PI[M36]) | 147 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PI[M36]) | 37 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PRE) | 2 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PRE) | 1 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PI[M1]) | 112 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PRE) | 2 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PI[M12]) | 141 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PI[M12]) | 35 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PI[M24]) | 147 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PI[M1]) | 174 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PI[M36]) | 131 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PI[M36]) | 117 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PRE) | 5 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PI[M12]) | 159 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PI[M1]) | 110 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PI[M24]) | 62 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PI[M12]) | 163 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PI[M24]) | 158 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PI[M24]) | 133 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PI[M24]) | 23 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PI[M36]) | 9 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PRE) | 3 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PI[M1]) | 3 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PI[M12]) | 2 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PI[M24]) | 5 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PI[M36]) | 2 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PRE) | 0 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PI[M1]) | 31 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PI[M12]) | 24 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PI[M24]) | 12 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PI[M36]) | 25 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PRE) | 2 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PI[M1]) | 1 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PI[M12]) | 1 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PI[M24]) | 4 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PI[M36]) | 3 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PRE) | 2 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PI[M1]) | 3 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PI[M12]) | 6 Participants |
Secondary
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.
Time frame: Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)] and Persistence Year 5 [PI(M60)]
Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PRE) | 1 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PI[M36]) | 15 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PI[M1]) | 37 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PI[M1]) | 48 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PI[M12]) | 41 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PI[M1]) | 48 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PI[M24]) | 40 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PI[M12]) | 45 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PI[M36]) | 39 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PI[M48]) | 23 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PI[M48]) | 38 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PI[M24]) | 43 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PI[M60]) | 38 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PI[M24]) | 21 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PRE) | 2 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PI[M36]) | 46 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PI[M1]) | 40 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PI[M60]) | 16 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PI[M12]) | 47 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PI[M48]) | 44 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PI[M24]) | 38 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PI[M12]) | 12 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PI[M36]) | 33 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PI[M60]) | 45 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PI[M48]) | 36 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PRE) | 0 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PI[M60]) | 36 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PRE) | 0 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PI[M60]) | 4 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PRE) | 0 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PI[M1]) | 0 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PI[M12]) | 0 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PI[M24]) | 0 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PI[M36]) | 1 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PI[M48]) | 2 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PI[M60]) | 3 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PRE) | 0 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PI[M1]) | 9 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PI[M12]) | 5 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PI[M24]) | 7 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PI[M36]) | 7 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PI[M48]) | 7 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PI[M60]) | 10 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PRE) | 1 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PI[M1]) | 0 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PI[M12]) | 0 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PI[M24]) | 1 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PI[M36]) | 0 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PI[M48]) | 0 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PI[M60]) | 2 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PRE) | 2 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PI[M1]) | 0 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PI[M12]) | 1 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PI[M24]) | 4 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PI[M36]) | 4 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PI[M48]) | 4 Participants |
Secondary
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.
Time frame: Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)]
Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PI[M36]) | 32 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PI[M12]) | 135 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PRE) | 0 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PI[M1]) | 137 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PI[M12]) | 29 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PI[M24]) | 53 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PI[M1]) | 149 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PI[M48]) | 57 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PRE) | 2 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PI[M24]) | 135 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PI[M36]) | 129 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PI[M48]) | 126 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PRE) | 2 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PI[M1]) | 100 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PI[M12]) | 118 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PI[M24]) | 129 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PI[M36]) | 114 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PI[M48]) | 117 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PRE) | 5 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PI[M1]) | 93 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PI[M12]) | 141 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PI[M24]) | 119 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PI[M36]) | 102 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PI[M48]) | 100 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PI[M36]) | 7 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PI[M1]) | 25 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PRE) | 1 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PI[M12]) | 22 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PRE) | 1 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PRE) | 2 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PI[M1]) | 1 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PI[M1]) | 1 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PI[M24]) | 10 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PI[M12]) | 1 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PI[M12]) | 1 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PI[M24]) | 4 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PI[M1]) | 2 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PI[M36]) | 1 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PI[M24]) | 5 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA (PI[M48]) | 8 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PI[M48]) | 12 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PRE) | 0 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PI[M36]) | 2 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PI[M24]) | 22 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY (PI[M12]) | 5 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PI[M36]) | 21 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135 (PI[M48]) | 3 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC (PI[M48]) | 24 Participants |
Secondary
Number of Subjects With hSBA Antibody Titers ≥ the Cut-off Value
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.
Time frame: Prior to (PRE) and one month after vaccination [PI(M1)]
Population: The analysis was performed on subjects from 6 to below 11 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers ≥ the Cut-off Value | hSBA-MenA (PRE) | 2 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers ≥ the Cut-off Value | hSBA-MenA (PI[M1]) | 91 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers ≥ the Cut-off Value | hSBA-MenC (PRE) | 35 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers ≥ the Cut-off Value | hSBA-MenC (PI[M1]) | 96 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers ≥ the Cut-off Value | hSBA-MenW-135 (PRE) | 13 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers ≥ the Cut-off Value | hSBA-MenW-135 (PI[M1]) | 102 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers ≥ the Cut-off Value | hSBA-MenY (PRE) | 24 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers ≥ the Cut-off Value | hSBA-MenY (PI[M1]) | 79 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers ≥ the Cut-off Value | hSBA-MenY (PI[M1]) | 14 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers ≥ the Cut-off Value | hSBA-MenA (PRE) | 2 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers ≥ the Cut-off Value | hSBA-MenW-135 (PRE) | 2 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers ≥ the Cut-off Value | hSBA-MenA (PI[M1]) | 9 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers ≥ the Cut-off Value | hSBA-MenY (PRE) | 8 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers ≥ the Cut-off Value | hSBA-MenC (PRE) | 9 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers ≥ the Cut-off Value | hSBA-MenW-135 (PI[M1]) | 12 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers ≥ the Cut-off Value | hSBA-MenC (PI[M1]) | 15 Participants |
Secondary
Number of Subjects With hSBA Antibody Titers ≥ to the Cut-off Value
The cut-off value for the hSBA titers was greater or equal to (≥) 1:4.
Time frame: Prior to (PRE), one month post vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]
Population: The analysis was performed on subjects from 6 to below 11 years of age from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers ≥ to the Cut-off Value | hSBA-MenA (PRE) | 2 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers ≥ to the Cut-off Value | hSBA-MenA (PI[M1]) | 85 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers ≥ to the Cut-off Value | hSBA-MenA (PI[M12]) | 19 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers ≥ to the Cut-off Value | hSBA-MenC (PRE]) | 32 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers ≥ to the Cut-off Value | hSBA-MenC (PI[M1]) | 90 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers ≥ to the Cut-off Value | hSBA-MenC (PI[M12]) | 100 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers ≥ to the Cut-off Value | hSBA-MenW-135 (PRE) | 10 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers ≥ to the Cut-off Value | hSBA-MenW-135 (PI[M1]) | 98 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers ≥ to the Cut-off Value | hSBA-MenW-135 (PI[M12]) | 103 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers ≥ to the Cut-off Value | hSBA-MenY (PRE) | 22 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers ≥ to the Cut-off Value | hSBA-MenY (PI[M1]) | 75 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers ≥ to the Cut-off Value | hSBA-MenY (PI[M12]) | 105 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers ≥ to the Cut-off Value | hSBA-MenY (PI[M1]) | 14 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers ≥ to the Cut-off Value | hSBA-MenA (PRE) | 2 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers ≥ to the Cut-off Value | hSBA-MenW-135 (PRE) | 2 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers ≥ to the Cut-off Value | hSBA-MenA (PI[M1]) | 9 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers ≥ to the Cut-off Value | hSBA-MenY (PRE) | 8 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers ≥ to the Cut-off Value | hSBA-MenA (PI[M12]) | 4 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers ≥ to the Cut-off Value | hSBA-MenW-135 (PI[M1]) | 12 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers ≥ to the Cut-off Value | hSBA-MenC (PRE]) | 9 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers ≥ to the Cut-off Value | hSBA-MenY (PI[M12]) | 12 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers ≥ to the Cut-off Value | hSBA-MenC (PI[M1]) | 15 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers ≥ to the Cut-off Value | hSBA-MenW-135 (PI[M12]) | 4 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With hSBA Antibody Titers ≥ to the Cut-off Value | hSBA-MenC (PI[M12]) | 10 Participants |
Secondary
Number of Subjects With New Onset of Chronic Illnesses (NOCIs)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Time frame: From administration of the vaccine dose until 6 months later
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With New Onset of Chronic Illnesses (NOCIs) | 1 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With New Onset of Chronic Illnesses (NOCIs) | 0 Participants |
| Nimenrix 6- 11 Years of Age Group | Number of Subjects With New Onset of Chronic Illnesses (NOCIs) | 2 Participants |
| Meningitec 1- 2 Years of Age Group | Number of Subjects With New Onset of Chronic Illnesses (NOCIs) | 4 Participants |
Secondary
Number of Subjects With Rash
Rash assessed included hives, idiopathic thrombocytopenic purpura and petechiae.
Time frame: From administration of the vaccine dose until 6 months later
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Rash | 10 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Rash | 6 Participants |
| Nimenrix 6- 11 Years of Age Group | Number of Subjects With Rash | 9 Participants |
| Meningitec 1- 2 Years of Age Group | Number of Subjects With Rash | 1 Participants |
Secondary
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the Health Protection Agency (HPA) laboratory.
Time frame: At Persistence Year 4 [PI(M48)]
Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PI[M48]) | 93 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PI[M48]) | 46 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PI[M48]) | 78 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PI[M48]) | 84 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PI[M48]) | 9 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PI[M48]) | 0 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PI[M48]) | 0 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PI[M48]) | 8 Participants |
Secondary
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:128. This analysis was performed by the GSK Biologicals' laboratory.
Time frame: Prior to (PRE) and one month after vaccination [PI(M1)]
Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA, PRE | 59 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135, PRE | 38 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC, PRE | 29 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135, PI(M1) | 222 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA, PI(M1) | 222 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY, PRE | 77 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC, PI(M1) | 218 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY, PI(M1) | 221 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC, PI(M1) | 56 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA, PRE | 20 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA, PI(M1) | 16 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC, PRE | 4 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY, PI(M1) | 31 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135, PRE | 16 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135, PI(M1) | 18 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY, PRE | 28 Participants |
Secondary
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.
Time frame: Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]
Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PRE) | 80 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PI[M1]) | 216 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PI[M12]) | 210 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PRE) | 78 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PI[M1]) | 214 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PI[M12]) | 203 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PRE) | 57 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PI[M1]) | 216 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PI[M12]) | 216 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PRE) | 113 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PI[M1]) | 216 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PI[M12]) | 214 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PI[M1]) | 48 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PRE) | 26 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PRE) | 23 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PI[M1]) | 21 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PRE) | 40 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PI[M12]) | 16 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PI[M1]) | 26 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PRE) | 20 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PI[M12]) | 42 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PI[M1]) | 66 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PI[M12]) | 38 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PI[M12]) | 50 Participants |
Secondary
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.
Time frame: Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]
Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PRE) | 73 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PI[M1]) | 199 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PI[M12]) | 193 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PI[M24]) | 188 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PRE) | 72 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PI[M1]) | 197 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PI[M12]) | 188 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PI[M24]) | 185 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PRE) | 54 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PI[M1]) | 199 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PI[M12]) | 198 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PI[M24]) | 198 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PRE) | 104 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PI[M1]) | 199 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PI[M12]) | 196 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PI[M24]) | 193 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PI[M24]) | 37 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PRE) | 21 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PRE) | 16 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PI[M1]) | 18 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PRE) | 31 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PI[M12]) | 13 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PI[M1]) | 19 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PI[M24]) | 30 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PI[M12]) | 35 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PRE) | 16 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PI[M12]) | 29 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PI[M1]) | 50 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PI[M1]) | 38 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PI[M12]) | 47 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PI[M24]) | 24 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PI[M24]) | 38 Participants |
Secondary
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.
Time frame: Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)] and Persistence Year 3 [PI(M36)]
Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 3, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 3 time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PRE) | 65 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PI[M1]) | 177 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PI[M12]) | 172 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PI[M24]) | 164 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PI[M36]) | 168 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PRE) | 71 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PI[M1]) | 175 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PI[M12]) | 169 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PI[M24]) | 171 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PI[M36]) | 158 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PRE) | 50 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PI[M1]) | 177 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PI[M12]) | 176 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PI[M24]) | 172 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PI[M36]) | 172 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PRE) | 96 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PI[M1]) | 177 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PI[M12]) | 175 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PI[M24]) | 168 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PI[M36]) | 174 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PI[M12]) | 24 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PRE) | 15 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PRE) | 11 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PI[M1]) | 10 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PRE) | 24 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PI[M12]) | 7 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PI[M1]) | 14 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PI[M24]) | 21 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PI[M36]) | 33 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PI[M36]) | 27 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PI[M12]) | 22 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PRE) | 12 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PI[M1]) | 29 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PI[M1]) | 36 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PI[M24]) | 15 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PI[M12]) | 35 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PI[M24]) | 27 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PI[M24]) | 36 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PI[M36]) | 24 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PI[M36]) | 36 Participants |
Secondary
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the Health Protection Agency (HPA) laboratory.
Time frame: Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)] and Persistence Year 5 [PI(M60)]
Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PI[M48]) | 29 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PI[M60]) | 36 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PI[M48]) | 44 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PI[M60]) | 38 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PI[M48]) | 27 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PI[M60]) | 17 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PI[M48]) | 28 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PI[M60]) | 21 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PI[M60]) | 2 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PI[M48]) | 0 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PI[M48]) | 0 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PI[M60]) | 0 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PI[M48]) | 3 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PI[M48]) | 8 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PI[M60]) | 2 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PI[M60]) | 7 Participants |
Secondary
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.
Time frame: Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)] and Persistence Year 4 [PI(M48)]
Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PRE) | 62 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PI[M48]) | 125 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PI[M48]) | 133 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PI[M12]) | 148 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PI[M12]) | 152 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PRE) | 57 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PI[M24]) | 148 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PI[M1]) | 152 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PI[M36]) | 146 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PI[M1]) | 150 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PI[M48]) | 133 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PI[M24]) | 142 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PRE) | 83 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PI[M12]) | 146 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PI[M1]) | 152 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PI[M1]) | 152 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PI[M12]) | 151 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PI[M24]) | 148 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PI[M24]) | 146 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PI[M36]) | 143 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PI[M36]) | 148 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PI[M36]) | 147 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PI[M48]) | 134 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PRE) | 44 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PI[M48]) | 23 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PRE) | 8 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PRE) | 11 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PI[M1]) | 7 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PI[M12]) | 6 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PI[M24]) | 19 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PI[M36]) | 22 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PI[M48]) | 21 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PRE) | 13 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PI[M1]) | 29 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PI[M12]) | 29 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PI[M24]) | 31 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PI[M36]) | 30 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PI[M48]) | 27 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PI[M1]) | 12 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PI[M12]) | 17 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PI[M24]) | 12 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PI[M36]) | 20 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PI[M48]) | 18 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PRE) | 21 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PI[M1]) | 25 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PI[M12]) | 22 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PI[M24]) | 23 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PI[M36]) | 27 Participants |
Secondary
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory, on the ATP cohort for persistence Year 5.
Time frame: Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)]
Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PRE) | 15 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PI[M1]) | 49 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PI[M12]) | 48 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PI[M24]) | 48 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PI[M36]) | 45 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PI[M48]) | 40 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PRE) | 17 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PI[M1]) | 48 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PI[M12]) | 47 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PI[M24]) | 49 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PI[M36]) | 46 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PI[M48]) | 43 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PRE) | 14 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PI[M1]) | 49 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PI[M12]) | 48 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PI[M24]) | 48 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PI[M36]) | 45 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PI[M48]) | 37 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PRE) | 30 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PI[M1]) | 49 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PI[M12]) | 48 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PI[M24]) | 48 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PI[M36]) | 47 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PI[M48]) | 39 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PI[M36]) | 8 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PRE) | 5 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PRE) | 3 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PI[M1]) | 3 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PRE) | 8 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PI[M12]) | 1 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PI[M1]) | 3 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PI[M24]) | 7 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PI[M24]) | 10 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PI[M36]) | 9 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PI[M12]) | 7 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenA (PI[M48]) | 7 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PI[M1]) | 8 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PRE) | 3 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PI[M24]) | 4 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PI[M1]) | 11 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PI[M48]) | 8 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PI[M12]) | 10 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PI[M36]) | 5 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PI[M24]) | 11 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenY (PI[M12]) | 8 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PI[M36]) | 10 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenW-135 (PI[M48]) | 5 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value | rSBA-MenC (PI[M48]) | 9 Participants |
Secondary
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.
Time frame: Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)] and Persistence Year 3 [PI(M36)]
Population: The analysis was performed on subjects from of 2 years and above from the ATP cohort for persistence Year 3, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 3 time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PRE) | 109 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI[M1]) | 196 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI[M12]) | 195 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI[M24]) | 193 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI[M36]) | 192 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PRE) | 118 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI[M1]) | 196 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI[M12]) | 195 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI[M24]) | 195 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI[M36]) | 189 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PRE) | 107 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI[M1]) | 196 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI[M12]) | 196 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI[M24]) | 194 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI[M36]) | 196 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PRE) | 127 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI[M1]) | 196 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI[M12]) | 196 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI[M24]) | 195 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI[M36]) | 195 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI[M12]) | 32 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PRE) | 20 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PRE) | 22 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI[M1]) | 37 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PRE) | 19 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI[M12]) | 34 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI[M1]) | 37 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI[M24]) | 33 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI[M36]) | 30 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI[M36]) | 31 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI[M12]) | 37 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PRE) | 26 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI[M1]) | 37 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI[M1]) | 37 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI[M24]) | 30 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI[M12]) | 34 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI[M24]) | 30 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI[M24]) | 37 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI[M36]) | 29 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI[M36]) | 31 Participants |
Secondary
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
The cut-off value for the rSBA titers was ≥ 1:8. This analysis was performed by the GSK Biologicals' laboratory.
Time frame: Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]
Population: The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PRE) | 113 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PRE) | 115 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PRE) | 125 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI[M1]) | 209 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI[M12]) | 208 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI[M12]) | 207 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI[M24]) | 209 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI[M1]) | 209 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PRE) | 138 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI[M1]) | 209 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI[M1]) | 209 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI[M12]) | 207 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI[M12]) | 208 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI[M24]) | 208 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI[M24]) | 210 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI[M24]) | 207 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI[M24]) | 41 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PRE) | 32 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI[M1]) | 59 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI[M12]) | 53 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI[M24]) | 51 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PRE) | 34 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI[M1]) | 59 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI[M12]) | 49 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI[M24]) | 39 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PRE) | 32 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI[M12]) | 59 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI[M24]) | 46 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PRE) | 31 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI[M1]) | 59 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI[M12]) | 52 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI[M1]) | 59 Participants |
Secondary
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.
Time frame: Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]
Population: The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI[M1]) | 214 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PRE) | 113 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PRE) | 128 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI[M1]) | 214 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PRE) | 118 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI[M12]) | 216 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI[M1]) | 214 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PRE) | 141 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI[M12]) | 215 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI[M1]) | 214 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI[M12]) | 214 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI[M12]) | 216 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI[M12]) | 52 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PRE) | 40 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI[M1]) | 75 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI[M12]) | 64 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PRE) | 36 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI[M1]) | 74 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI[M12]) | 64 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PRE) | 39 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI[M1]) | 75 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI[M12]) | 75 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PRE) | 42 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI[M1]) | 75 Participants |
Secondary
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the Health Protection Agency (HPA) laboratory.
Time frame: At Persistence Year 4 [PI(M48)]
Population: The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI[M48]) | 157 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI[M48]) | 94 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI[M48]) | 169 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI[M48]) | 151 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI[M48]) | 2 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI[M48]) | 5 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI[M48]) | 4 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI[M48]) | 12 Participants |
Secondary
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.
Time frame: Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)] and Persistence Year 4 [PI(M48)]
Population: The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI[M24]) | 186 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI[M12]) | 188 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI[M12]) | 188 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI[M24]) | 186 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI[M48]) | 182 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI[M36]) | 185 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI[M24]) | 185 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI[M48]) | 188 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PRE) | 105 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI[M12]) | 187 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI[M1]) | 187 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI[M36]) | 185 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI[M12]) | 188 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PRE) | 104 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI[M24]) | 185 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI[M48]) | 188 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI[M36]) | 182 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI[M36]) | 181 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI[M48]) | 188 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PRE) | 123 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PRE) | 112 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI[M1]) | 187 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI[M1]) | 187 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI[M1]) | 187 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI[M1]) | 29 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI[M12]) | 28 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI[M24]) | 29 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI[M36]) | 27 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI[M48]) | 26 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PRE) | 19 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI[M1]) | 29 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI[M12]) | 29 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI[M24]) | 22 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI[M36]) | 22 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI[M48]) | 22 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PRE) | 14 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI[M1]) | 29 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI[M12]) | 26 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI[M24]) | 23 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI[M36]) | 24 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PRE) | 14 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI[M1]) | 29 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI[M12]) | 26 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI[M24]) | 25 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI[M36]) | 24 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI[M48]) | 24 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PRE) | 22 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI[M48]) | 24 Participants |
Secondary
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the Health Protection Agency (HPA) laboratory.
Time frame: Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)] and Persistence Year 5 [PI(M60)]
Population: The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI[M48]) | 86 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI[M60]) | 89 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI[M48]) | 96 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI[M60]) | 89 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI[M48]) | 92 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI[M60]) | 77 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI[M48]) | 85 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI[M60]) | 77 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI[M60]) | 1 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI[M48]) | 1 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI[M48]) | 2 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI[M60]) | 2 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI[M48]) | 1 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI[M48]) | 12 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI[M60]) | 0 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI[M60]) | 13 Participants |
Secondary
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory, on the ATP cohort for persistence Year 5.
Time frame: Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)]
Population: The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PRE) | 65 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI[M1]) | 98 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI[M12]) | 98 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI[M24]) | 97 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI[M36]) | 95 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI[M48]) | 97 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PRE) | 57 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI[M1]) | 98 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI[M12]) | 97 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI[M24]) | 98 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI[M36]) | 96 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI[M48]) | 97 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PRE) | 55 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI[M1]) | 98 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI[M12]) | 98 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI[M24]) | 98 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI[M36]) | 98 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI[M48]) | 97 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PRE) | 62 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI[M1]) | 98 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI[M12]) | 98 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI[M24]) | 98 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI[M36]) | 97 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI[M48]) | 97 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI[M36]) | 11 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PRE) | 4 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PRE) | 10 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI[M1]) | 13 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PRE) | 6 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI[M12]) | 12 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI[M1]) | 13 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI[M24]) | 11 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI[M24]) | 11 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI[M36]) | 12 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI[M12]) | 13 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI[M48]) | 11 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI[M1]) | 13 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PRE) | 12 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI[M24]) | 10 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI[M1]) | 13 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI[M48]) | 11 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI[M12]) | 12 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI[M36]) | 10 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI[M24]) | 13 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI[M12]) | 12 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI[M36]) | 13 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI[M48]) | 11 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI[M48]) | 13 Participants |
Secondary
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values
The cut-off value for the rSBA titers were greater than or equal to ≥ 1:8 and ≥ 1:128. These analyses were performed by the GSK Biologicals' laboratory.
Time frame: Prior to (PRE) and one month after vaccination [PI(M1)]
Population: The analysis was performed on subjects of 2 years and above from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values | rSBA-MenA (PRE) ≥ 1:8 | 124 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values | rSBA-MenA (PRE) ≥ 1:128 | 96 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values | rSBA-MenA (PI[M1]) ≥ 1:8 | 225 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values | rSBA-MenA (PI[M1]) ≥ 1:128 | 224 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values | rSBA-MenC (PRE) ≥ 1:8 | 133 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values | rSBA-MenC (PRE) ≥ 1:128 | 59 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values | rSBA-MenC (PI[M1]) ≥ 1:8 | 225 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values | rSBA-MenC (PI[M1]) ≥ 1:128 | 224 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values | rSBA-MenW-135 (PRE) ≥ 1:8 | 120 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values | rSBA-MenW-135 (PRE) ≥ 1:128 | 90 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values | rSBA-MenW-135 (PI[M1]) ≥ 1:8 | 225 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values | rSBA-MenW-135 (PI[M1]) ≥ 1:128 | 225 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values | rSBA-MenY (PRE) ≥ 1:8 | 147 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values | rSBA-MenY (PRE) ≥ 1:128 | 98 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values | rSBA-MenY (PI[M1]) ≥ 1:8 | 225 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values | rSBA-MenY (PI[M1]) ≥ 1:128 | 224 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values | rSBA-MenY (PI[M1]) ≥ 1:128 | 73 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values | rSBA-MenA (PRE) ≥ 1:8 | 40 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values | rSBA-MenW-135 (PRE) ≥ 1:8 | 39 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values | rSBA-MenA (PRE) ≥ 1:128 | 32 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values | rSBA-MenY (PRE) ≥ 1:8 | 42 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values | rSBA-MenA (PI[M1]) ≥ 1:8 | 75 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values | rSBA-MenW-135 (PRE) ≥ 1:128 | 24 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values | rSBA-MenA (PI[M1]) ≥ 1:128 | 75 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values | rSBA-MenY (PI[M1]) ≥ 1:8 | 75 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values | rSBA-MenC (PRE) ≥ 1:8 | 36 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values | rSBA-MenW-135 (PI[M1]) ≥ 1:8 | 75 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values | rSBA-MenC (PRE) ≥ 1:128 | 19 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values | rSBA-MenY (PRE) ≥ 1:128 | 28 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values | rSBA-MenC (PI[M1]) ≥ 1:8 | 74 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values | rSBA-MenW-135 (PI[M1]) ≥ 1:128 | 75 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values | rSBA-MenC (PI[M1]) ≥ 1:128 | 70 Participants |
Secondary
Number of Subjects With SAE(s)
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 6 Months following vaccination up to Year 5
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With SAE(s) | 0 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With SAE(s) | 0 Participants |
| Nimenrix 6- 11 Years of Age Group | Number of Subjects With SAE(s) | 0 Participants |
| Meningitec 1- 2 Years of Age Group | Number of Subjects With SAE(s) | 0 Participants |
Secondary
Number of Subjects With SAE(s)
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 6 Months after vaccination up to Year 1
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With SAE(s) | 0 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With SAE(s) | 0 Participants |
| Nimenrix 6- 11 Years of Age Group | Number of Subjects With SAE(s) | 0 Participants |
| Meningitec 1- 2 Years of Age Group | Number of Subjects With SAE(s) | 0 Participants |
Secondary
Number of Subjects With SAE(s)
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 6 Months after vaccination up to Year 2
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With SAE(s) | 0 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With SAE(s) | 0 Participants |
| Nimenrix 6- 11 Years of Age Group | Number of Subjects With SAE(s) | 0 Participants |
| Meningitec 1- 2 Years of Age Group | Number of Subjects With SAE(s) | 0 Participants |
Secondary
Number of Subjects With SAE(s)
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 6 Months following vaccination up to Year 3
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With SAE(s) | 0 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With SAE(s) | 0 Participants |
| Nimenrix 6- 11 Years of Age Group | Number of Subjects With SAE(s) | 0 Participants |
| Meningitec 1- 2 Years of Age Group | Number of Subjects With SAE(s) | 0 Participants |
Secondary
Number of Subjects With SAE(s)
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 6 Months following vaccination up to Year 4
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With SAE(s) | 0 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With SAE(s) | 0 Participants |
| Nimenrix 6- 11 Years of Age Group | Number of Subjects With SAE(s) | 0 Participants |
| Meningitec 1- 2 Years of Age Group | Number of Subjects With SAE(s) | 0 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
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: Up to 6 Months after vaccination
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Serious Adverse Events (SAEs) | 5 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Serious Adverse Events (SAEs) | 7 Participants |
| Nimenrix 6- 11 Years of Age Group | Number of Subjects With Serious Adverse Events (SAEs) | 2 Participants |
| Meningitec 1- 2 Years of Age Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
Secondary
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.
Time frame: Prior to (PRE) and one month after vaccination [PI(M1)]
Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA, PRE | 3 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value | hBA-MenA, PI(M1) | 203 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC, PRE | 3 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC, PI(M1) | 219 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135, PRE | 2 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135, PI(M1) | 145 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY, PRE | 7 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY, PI(M1) | 135 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY, PI(M1) | 3 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenA, PRE | 3 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135, PRE | 3 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value | hBA-MenA, PI(M1) | 4 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenY, PRE | 2 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC, PRE | 1 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenW-135, PI(M1) | 1 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value | hSBA-MenC, PI(M1) | 49 Participants |
Secondary
Number of Subjects With Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, fever \[defined as rectal temperature equal to or above 38.0 degrees Celsius (°C)\], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 4-day (Day 0-3) follow-up period
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fever >40.0˚C | 2 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Solicited General Symptoms | Related Drowsiness | 61 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Solicited General Symptoms | Grade 3 Irritability | 2 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Solicited General Symptoms | Related Loss of appetite | 52 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Solicited General Symptoms | Any Fever | 36 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Solicited General Symptoms | Grade 3 Drowsiness | 2 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Solicited General Symptoms | Any Loss of appetite | 54 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Solicited General Symptoms | Related Irritability | 85 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Solicited General Symptoms | Any Irritability | 88 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Solicited General Symptoms | Related Fever | 32 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Solicited General Symptoms | Any Drowsiness | 63 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Solicited General Symptoms | Grade 3 Loss of appetite | 2 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Solicited General Symptoms | Grade 3 Drowsiness | 0 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Solicited General Symptoms | Related Irritability | 18 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Solicited General Symptoms | Any Loss of appetite | 16 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Solicited General Symptoms | Any Drowsiness | 30 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Solicited General Symptoms | Related Drowsiness | 29 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Solicited General Symptoms | Related Loss of appetite | 16 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Solicited General Symptoms | Any Fever | 7 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fever >40.0˚C | 0 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Solicited General Symptoms | Related Fever | 7 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Solicited General Symptoms | Any Irritability | 18 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Solicited General Symptoms | Grade 3 Loss of appetite | 0 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Solicited General Symptoms | Grade 3 Irritability | 0 Participants |
| Nimenrix 6- 11 Years of Age Group | Number of Subjects With Solicited General Symptoms | Related Drowsiness | 45 Participants |
| Nimenrix 6- 11 Years of Age Group | Number of Subjects With Solicited General Symptoms | Related Loss of appetite | 29 Participants |
| Nimenrix 6- 11 Years of Age Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fever >40.0˚C | 0 Participants |
| Nimenrix 6- 11 Years of Age Group | Number of Subjects With Solicited General Symptoms | Grade 3 Drowsiness | 1 Participants |
| Nimenrix 6- 11 Years of Age Group | Number of Subjects With Solicited General Symptoms | Related Irritability | 21 Participants |
| Nimenrix 6- 11 Years of Age Group | Number of Subjects With Solicited General Symptoms | Related Fever | 11 Participants |
| Nimenrix 6- 11 Years of Age Group | Number of Subjects With Solicited General Symptoms | Grade 3 Loss of appetite | 1 Participants |
| Nimenrix 6- 11 Years of Age Group | Number of Subjects With Solicited General Symptoms | Any Loss of appetite | 31 Participants |
| Nimenrix 6- 11 Years of Age Group | Number of Subjects With Solicited General Symptoms | Grade 3 Irritability | 3 Participants |
| Nimenrix 6- 11 Years of Age Group | Number of Subjects With Solicited General Symptoms | Any Irritability | 23 Participants |
| Nimenrix 6- 11 Years of Age Group | Number of Subjects With Solicited General Symptoms | Any Drowsiness | 45 Participants |
| Nimenrix 6- 11 Years of Age Group | Number of Subjects With Solicited General Symptoms | Any Fever | 11 Participants |
| Meningitec 1- 2 Years of Age Group | Number of Subjects With Solicited General Symptoms | Any Loss of appetite | 17 Participants |
| Meningitec 1- 2 Years of Age Group | Number of Subjects With Solicited General Symptoms | Related Drowsiness | 25 Participants |
| Meningitec 1- 2 Years of Age Group | Number of Subjects With Solicited General Symptoms | Related Irritability | 29 Participants |
| Meningitec 1- 2 Years of Age Group | Number of Subjects With Solicited General Symptoms | Grade 3 Irritability | 0 Participants |
| Meningitec 1- 2 Years of Age Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fever >40.0˚C | 0 Participants |
| Meningitec 1- 2 Years of Age Group | Number of Subjects With Solicited General Symptoms | Grade 3 Drowsiness | 0 Participants |
| Meningitec 1- 2 Years of Age Group | Number of Subjects With Solicited General Symptoms | Grade 3 Loss of appetite | 0 Participants |
| Meningitec 1- 2 Years of Age Group | Number of Subjects With Solicited General Symptoms | Any Drowsiness | 25 Participants |
| Meningitec 1- 2 Years of Age Group | Number of Subjects With Solicited General Symptoms | Any Irritability | 29 Participants |
| Meningitec 1- 2 Years of Age Group | Number of Subjects With Solicited General Symptoms | Any Fever | 9 Participants |
| Meningitec 1- 2 Years of Age Group | Number of Subjects With Solicited General Symptoms | Related Fever | 9 Participants |
| Meningitec 1- 2 Years of Age Group | Number of Subjects With Solicited General Symptoms | Related Loss of appetite | 17 Participants |
| Mencevax 2- 6 Years of Age Group | Number of Subjects With Solicited General Symptoms | Related Irritability | 10 Participants |
| Mencevax 2- 6 Years of Age Group | Number of Subjects With Solicited General Symptoms | Any Drowsiness | 5 Participants |
| Mencevax 2- 6 Years of Age Group | Number of Subjects With Solicited General Symptoms | Grade 3 Drowsiness | 0 Participants |
| Mencevax 2- 6 Years of Age Group | Number of Subjects With Solicited General Symptoms | Related Drowsiness | 5 Participants |
| Mencevax 2- 6 Years of Age Group | Number of Subjects With Solicited General Symptoms | Any Fever | 2 Participants |
| Mencevax 2- 6 Years of Age Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fever >40.0˚C | 0 Participants |
| Mencevax 2- 6 Years of Age Group | Number of Subjects With Solicited General Symptoms | Related Fever | 2 Participants |
| Mencevax 2- 6 Years of Age Group | Number of Subjects With Solicited General Symptoms | Any Irritability | 11 Participants |
| Mencevax 2- 6 Years of Age Group | Number of Subjects With Solicited General Symptoms | Grade 3 Irritability | 0 Participants |
| Mencevax 2- 6 Years of Age Group | Number of Subjects With Solicited General Symptoms | Any Loss of appetite | 6 Participants |
| Mencevax 2- 6 Years of Age Group | Number of Subjects With Solicited General Symptoms | Grade 3 Loss of appetite | 0 Participants |
| Mencevax 2- 6 Years of Age Group | Number of Subjects With Solicited General Symptoms | Related Loss of appetite | 5 Participants |
| Mencevax 6- 11 Years of Age Group | Number of Subjects With Solicited General Symptoms | Grade 3 Irritability | 1 Participants |
| Mencevax 6- 11 Years of Age Group | Number of Subjects With Solicited General Symptoms | Any Irritability | 5 Participants |
| Mencevax 6- 11 Years of Age Group | Number of Subjects With Solicited General Symptoms | Related Fever | 0 Participants |
| Mencevax 6- 11 Years of Age Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fever >40.0˚C | 0 Participants |
| Mencevax 6- 11 Years of Age Group | Number of Subjects With Solicited General Symptoms | Related Loss of appetite | 5 Participants |
| Mencevax 6- 11 Years of Age Group | Number of Subjects With Solicited General Symptoms | Grade 3 Loss of appetite | 0 Participants |
| Mencevax 6- 11 Years of Age Group | Number of Subjects With Solicited General Symptoms | Any Fever | 1 Participants |
| Mencevax 6- 11 Years of Age Group | Number of Subjects With Solicited General Symptoms | Related Drowsiness | 8 Participants |
| Mencevax 6- 11 Years of Age Group | Number of Subjects With Solicited General Symptoms | Grade 3 Drowsiness | 0 Participants |
| Mencevax 6- 11 Years of Age Group | Number of Subjects With Solicited General Symptoms | Related Irritability | 4 Participants |
| Mencevax 6- 11 Years of Age Group | Number of Subjects With Solicited General Symptoms | Any Drowsiness | 8 Participants |
| Mencevax 6- 11 Years of Age Group | Number of Subjects With Solicited General Symptoms | Any Loss of appetite | 6 Participants |
Secondary
Number of Subjects With Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) (1 - \< 2 years of age and 2 - \< 6 years of age groups) and 50 mm (6 - \< 11 years of age groups) of injection site, respectively.
Time frame: During the 4-day (Day 0-3) follow-up period
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available for the vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Solicited Local Symptoms | Any Pain | 76 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain | 3 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Solicited Local Symptoms | Any Redness | 84 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness | 8 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Solicited Local Symptoms | Any Swelling | 36 Participants |
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling | 3 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain | 2 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness | 12 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling | 9 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Solicited Local Symptoms | Any Pain | 51 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Solicited Local Symptoms | Any Redness | 44 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Solicited Local Symptoms | Any Swelling | 29 Participants |
| Nimenrix 6- 11 Years of Age Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling | 14 Participants |
| Nimenrix 6- 11 Years of Age Group | Number of Subjects With Solicited Local Symptoms | Any Swelling | 42 Participants |
| Nimenrix 6- 11 Years of Age Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness | 19 Participants |
| Nimenrix 6- 11 Years of Age Group | Number of Subjects With Solicited Local Symptoms | Any Redness | 53 Participants |
| Nimenrix 6- 11 Years of Age Group | Number of Subjects With Solicited Local Symptoms | Any Pain | 84 Participants |
| Nimenrix 6- 11 Years of Age Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain | 7 Participants |
| Meningitec 1- 2 Years of Age Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness | 1 Participants |
| Meningitec 1- 2 Years of Age Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain | 0 Participants |
| Meningitec 1- 2 Years of Age Group | Number of Subjects With Solicited Local Symptoms | Any Redness | 24 Participants |
| Meningitec 1- 2 Years of Age Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling | 0 Participants |
| Meningitec 1- 2 Years of Age Group | Number of Subjects With Solicited Local Symptoms | Any Swelling | 11 Participants |
| Meningitec 1- 2 Years of Age Group | Number of Subjects With Solicited Local Symptoms | Any Pain | 20 Participants |
| Mencevax 2- 6 Years of Age Group | Number of Subjects With Solicited Local Symptoms | Any Pain | 39 Participants |
| Mencevax 2- 6 Years of Age Group | Number of Subjects With Solicited Local Symptoms | Any Swelling | 3 Participants |
| Mencevax 2- 6 Years of Age Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain | 1 Participants |
| Mencevax 2- 6 Years of Age Group | Number of Subjects With Solicited Local Symptoms | Any Redness | 8 Participants |
| Mencevax 2- 6 Years of Age Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness | 0 Participants |
| Mencevax 2- 6 Years of Age Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling | 0 Participants |
| Mencevax 6- 11 Years of Age Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness | 0 Participants |
| Mencevax 6- 11 Years of Age Group | Number of Subjects With Solicited Local Symptoms | Any Redness | 15 Participants |
| Mencevax 6- 11 Years of Age Group | Number of Subjects With Solicited Local Symptoms | Any Swelling | 6 Participants |
| Mencevax 6- 11 Years of Age Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling | 0 Participants |
| Mencevax 6- 11 Years of Age Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain | 1 Participants |
| Mencevax 6- 11 Years of Age Group | Number of Subjects With Solicited Local Symptoms | Any Pain | 39 Participants |
Secondary
Number of Subjects With Unsolicited 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. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time frame: During the 31-day (Days 0-30) post-vaccination period
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available for the vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | Number of Subjects With Unsolicited AEs | 121 Participants |
| Mencevax 2-11 Years of Age Primary Phase Group | Number of Subjects With Unsolicited AEs | 38 Participants |
| Nimenrix 6- 11 Years of Age Group | Number of Subjects With Unsolicited AEs | 83 Participants |
| Meningitec 1- 2 Years of Age Group | Number of Subjects With Unsolicited AEs | 24 Participants |
Secondary
rSBA Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.
Time frame: Prior to (PRE) and one month post vaccination [PI(M1)]
Population: The analysis was performed on subjects of 2 years and above from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PRE) | 33.5 Titer |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PRE) | 57.9 Titer |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M1]) | 7300.9 Titer |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M1]) | 2435.3 Titer |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PRE) | 43.1 Titer |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M1]) | 11777 Titer |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PRE) | 57.3 Titer |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M1]) | 6641.4 Titer |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M1]) | 1409.9 Titer |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PRE) | 40.1 Titer |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PRE) | 58.2 Titer |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PRE) | 45.5 Titer |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M1]) | 2033.4 Titer |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PRE) | 24.1 Titer |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M1]) | 2186.3 Titer |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M1]) | 750.2 Titer |
Secondary
rSBA Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the Health Protection Agency (HPA) laboratory.
Time frame: Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)] and at Persistence Year 5 [PI(M60)]
Population: The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M48]) | 123.5 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M60]) | 141.3 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M48]) | 118.3 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M60]) | 79.7 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M48]) | 1031.4 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M60]) | 208.5 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M48]) | 216.8 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M60]) | 143.3 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M60]) | 5.5 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M48]) | 5 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M48]) | 8.4 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M60]) | 4.7 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M48]) | 4.2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M48]) | 206.8 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M60]) | 4 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M60]) | 128 Titers |
Secondary
rSBA Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.
Time frame: Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]
Population: The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PRE) | 57.1 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M1]) | 7392.2 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M12]) | 2475.3 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M24]) | 1333.4 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PRE) | 35.4 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M1]) | 2475.6 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M12]) | 490.3 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M24]) | 256 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PRE) | 43.9 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M1]) | 11892.6 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M12]) | 2969.7 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M24]) | 1298 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PRE) | 58.3 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M1]) | 6594.5 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M12]) | 2115.5 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M24]) | 1530.2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M24]) | 96.9 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PRE) | 64.5 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PRE) | 46.2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M1]) | 2230.8 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PRE) | 40.9 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M12]) | 450.6 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M1]) | 2215 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M24]) | 202.5 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M12]) | 418 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PRE) | 33.7 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M12]) | 496.2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M1]) | 966.7 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M1]) | 1574.2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M12]) | 277 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M24]) | 144 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M24]) | 59.9 Titers |
Secondary
rSBA Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.
Time frame: Prior to (PRE) and one month after vaccination [PI(M1)]
Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA, PRE | 21.6 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA, PI(M1) | 3706.5 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC, PRE | 13.9 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC, PI(M1) | 878.7 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135, PRE | 11.3 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135, PI(M1) | 5394.6 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY, PRE | 33.8 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY, PI(M1) | 2823.8 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY, PI(M1) | 77.1 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA, PRE | 20.2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135, PRE | 16.5 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA, PI(M1) | 17.1 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY, PRE | 45.3 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC, PRE | 9.7 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135, PI(M1) | 20.3 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC, PI(M1) | 415 Titers |
Secondary
rSBA Antibody Titers
Antibody titers are presented as GMTs. This analysis was performed by the GSK Biologicals' laboratory.
Time frame: Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]
Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M12]) | 195.3 Titer |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M12]) | 967 Titer |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M1]) | 5386.9 Titer |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PRE) | 11.3 Titer |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M12]) | 855.1 Titer |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PRE) | 14 Titer |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PRE) | 34.6 Titer |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M1]) | 3684.2 Titer |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M1]) | 2836.5 Titer |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M1]) | 864.2 Titer |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M12]) | 766.4 Titer |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PRE) | 22.6 Titer |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M12]) | 65.1 Titer |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PRE) | 20.7 Titer |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M1]) | 16.9 Titer |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M12]) | 18.3 Titer |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PRE) | 10.2 Titer |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M1]) | 448.2 Titer |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PRE) | 15.5 Titer |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M1]) | 20.2 Titer |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M12]) | 36.7 Titer |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PRE) | 44.1 Titer |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M1]) | 78.1 Titer |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M12]) | 77.1 Titer |
Secondary
rSBA Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.
Time frame: Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]
Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 2, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 2 time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PRE) | 22.7 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M1]) | 3743 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M12]) | 961.4 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M24]) | 567.7 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PRE) | 13.7 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M1]) | 870.9 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M12]) | 203.9 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M24]) | 117.4 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PRE) | 11.5 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M1]) | 5424.4 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M12]) | 856.6 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M24]) | 415.9 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PRE) | 34 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M1]) | 2797.6 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M12]) | 749.4 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M24]) | 504.1 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M24]) | 93.5 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PRE) | 24 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PRE) | 13 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M1]) | 20 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PRE) | 44.6 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M12]) | 21.5 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M1]) | 17.6 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M24]) | 51.3 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M12]) | 82.7 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PRE) | 11.2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M12]) | 35.4 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M1]) | 626.4 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M1]) | 86 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M12]) | 163.7 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M24]) | 27.5 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M24]) | 57.7 Titers |
Secondary
rSBA Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs). The analysis was performed by the GSK Biologicals' laboratory.
Time frame: Prior to (PRE), one month post vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]
Population: The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 1, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 1 time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PRE) | 59.6 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M1]) | 7395.3 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M12]) | 2448.1 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PRE) | 34.4 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M1]) | 2488.5 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M12]) | 489.5 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PRE) | 41.6 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M1]) | 11943.7 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M12]) | 2983.3 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PRE) | 57.4 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M1]) | 6666.3 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M12]) | 2172.1 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M1]) | 1409.9 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PRE) | 58.2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PRE) | 40.1 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M1]) | 2033.4 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PRE) | 45.5 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M12]) | 358.5 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M1]) | 2186.3 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PRE) | 24.1 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M12]) | 332.4 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M1]) | 750.2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M12]) | 463 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M12]) | 113.5 Titers |
Secondary
rSBA Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.
Time frame: Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)] and Persistence Year 4 [PI(M48)]
Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PRE) | 14.9 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M1]) | 3911.7 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M12]) | 938.4 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M24]) | 533 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M36]) | 503 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M48]) | 623.9 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PRE) | 27.9 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M1]) | 922.5 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M12]) | 236.8 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M24]) | 162.5 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M36]) | 176.1 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M48]) | 141.9 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PRE) | 11.9 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M1]) | 5495.6 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M12]) | 900.8 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M24]) | 426.3 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M36]) | 454.9 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M48]) | 400.9 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PRE) | 37.9 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M1]) | 2839.7 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M12]) | 776.5 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M24]) | 539.2 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M36]) | 581.5 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M48]) | 524.2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M36]) | 220.9 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PRE) | 18.1 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PRE) | 10.9 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M1]) | 12.4 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PRE) | 52.7 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M12]) | 15.9 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M1]) | 19.8 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M24]) | 53.8 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M24]) | 100 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M36]) | 129.3 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M12]) | 36.5 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M48]) | 157.4 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M1]) | 123.9 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PRE) | 15.4 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M24]) | 24.1 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M1]) | 846.2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M48]) | 174.1 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M12]) | 233.9 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M36]) | 62.8 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M24]) | 185.3 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M12]) | 87.8 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M36]) | 210.3 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M48]) | 59.8 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M48]) | 150.5 Titers |
Secondary
rSBA Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.
Time frame: Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)] and at Persistence Year 3 [PI(M36)]
Population: The analysis was performed on subjects from of 2 years and above from the ATP cohort for persistence Year 3, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 3 time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PRE) | 58.4 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M1]) | 7513.7 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M12]) | 2533.4 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M24]) | 1352.7 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M36]) | 1184.2 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PRE) | 36.5 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M1]) | 2524.9 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M12]) | 509.4 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M24]) | 273.1 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M36]) | 244.3 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PRE) | 45.4 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M1]) | 12158.8 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M12]) | 3064.7 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M24]) | 1324.4 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M36]) | 1737.1 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PRE) | 55.4 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M1]) | 6655.7 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M12]) | 2164 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M24]) | 1556.4 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M36]) | 1551.6 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M12]) | 467.5 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PRE) | 69.8 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PRE) | 57.4 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M1]) | 2244.3 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PRE) | 37.2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M12]) | 576.2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M1]) | 2602.6 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M24]) | 240.1 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M36]) | 103.8 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M36]) | 218.8 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M12]) | 587 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PRE) | 61.3 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M1]) | 1813.8 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M1]) | 1433.7 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M24]) | 182.8 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M12]) | 437.6 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M24]) | 116.2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M24]) | 237.9 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M36]) | 112.9 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M36]) | 163.5 Titers |
Secondary
rSBA Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory, on the ATP cohort for persistence Year 5.
Time frame: Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)] and Persistence Year 4 [PI(M48)]
Population: The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M1]) | 9195.5 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PRE) | 50.5 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PRE) | 44.7 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M1]) | 13562 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M24]) | 1641.7 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M12]) | 3794.4 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M36]) | 1670.6 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M24]) | 1637.9 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M1]) | 3604.6 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M36]) | 2098.3 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PRE) | 64.3 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M48]) | 2178.4 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M12]) | 777.4 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PRE) | 54.3 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M36]) | 1318.4 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M1]) | 7167.2 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M24]) | 502.5 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M12]) | 2502.4 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M12]) | 3031.2 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M24]) | 1907.1 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M36]) | 514.4 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M48]) | 2365 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M48]) | 1736 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M48]) | 495.2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M12]) | 462.2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PRE) | 35.7 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M1]) | 2319 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M12]) | 491 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M24]) | 187.9 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M36]) | 219.9 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M48]) | 135.4 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PRE) | 114 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M1]) | 2361.1 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M12]) | 1002 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M24]) | 627.1 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M36]) | 865.2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M48]) | 742.7 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PRE) | 86.8 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M1]) | 2601 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M24]) | 137.4 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M36]) | 96.6 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M48]) | 100.6 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PRE) | 15.7 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M1]) | 2085.3 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M12]) | 322.7 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M24]) | 112.3 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M36]) | 92.2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M48]) | 83.3 Titers |
Secondary
rSBA Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs).This analysis was performed by the GSK Biologicals' laboratory.
Time frame: Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)] and Persistence Year 3 [PI(M36)]
Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 3, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 3 time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PRE) | 23 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M1]) | 3787.4 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M12]) | 974.4 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M24]) | 575.2 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M36]) | 518.6 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PRE) | 15.5 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M1]) | 887 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M12]) | 223.5 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M24]) | 141.2 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M36]) | 125.1 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PRE) | 11.7 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M1]) | 5563.5 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M12]) | 904.9 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M24]) | 439.3 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M36]) | 439.8 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PRE) | 37.4 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M1]) | 2875.6 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M12]) | 799.2 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M24]) | 532.8 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M36]) | 583.2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M12]) | 75.7 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PRE) | 21.8 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PRE) | 12.6 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M1]) | 14.4 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PRE) | 52.5 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M12]) | 17.6 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M1]) | 17.5 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M24]) | 56.5 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M36]) | 176 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M36]) | 117.1 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M12]) | 37.9 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PRE) | 12 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M1]) | 101.5 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M1]) | 727.6 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M24]) | 22.9 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M12]) | 218.3 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M24]) | 100.6 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M24]) | 158.6 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M36]) | 64.5 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M36]) | 185.7 Titers |
Secondary
rSBA Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs).This analysis was performed by the Health Protection Agency (HPA) laboratory.
Time frame: Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)] and Persistence Year 5 [PI(M60)]
Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M48]) | 35.1 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M60]) | 37.4 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M48]) | 109.7 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M60]) | 48.9 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M48]) | 50.8 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M60]) | 18.2 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M48]) | 44.9 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M60]) | 20.6 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M60]) | 11.7 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M48]) | 4 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M48]) | 4 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M60]) | 4 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M48]) | 12.1 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M48]) | 137.2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M60]) | 7.1 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M60]) | 26.5 Titers |
Secondary
rSBA Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory, on the ATP cohort for persistence Year 5.
Time frame: Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)]
Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 5, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 5 time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M1]) | 4931.9 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PRE) | 12.8 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PRE) | 10.7 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M1]) | 6805 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M24]) | 668.3 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M12]) | 956.5 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M1]) | 1115.3 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M24]) | 408.5 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PRE) | 22.6 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M36]) | 486 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M12]) | 352.4 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M48]) | 419 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M36]) | 578.5 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PRE) | 43.7 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M24]) | 229.5 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M1]) | 3555.6 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M12]) | 1224.2 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M12]) | 976.8 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M36]) | 472.4 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M24]) | 703 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M48]) | 782.4 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M36]) | 684 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M48]) | 729.9 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M48]) | 601.5 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M12]) | 49.4 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PRE) | 45.7 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M1]) | 16.7 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M12]) | 7.8 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M24]) | 119.5 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M36]) | 210.8 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M48]) | 392 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PRE) | 9.4 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M1]) | 536.8 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M12]) | 249.3 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M24]) | 215.6 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M36]) | 229.5 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M48]) | 332 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PRE) | 8.4 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M1]) | 12.2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M48]) | 189 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M24]) | 25.9 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M36]) | 52.9 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M48]) | 31.3 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PRE) | 99.6 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M1]) | 138.7 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M12]) | 148 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M24]) | 185.1 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M36]) | 242.2 Titers |
Secondary
rSBA Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the Health Protection Agency (HPA) laboratory.
Time frame: At Persistence Year 4 [PI(M48)]
Population: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M48]) | 25.7 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M48]) | 31.3 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M48]) | 11.2 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M48]) | 29.9 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M48]) | 11.4 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M48]) | 4 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M48]) | 12.5 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M48]) | 4 Titers |
Secondary
rSBA Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.
Time frame: Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)] and Persistence Year 4 [PI(M48)]
Population: The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PRE) | 35.8 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M1]) | 7593.9 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M12]) | 2556.2 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M24]) | 1317.2 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M36]) | 1154.1 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M48]) | 1932.3 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PRE) | 59.5 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M1]) | 2578.5 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M12]) | 510.1 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M24]) | 278.5 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M36]) | 255.7 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M48]) | 203.6 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PRE) | 47.4 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M1]) | 12275.6 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M12]) | 3083.8 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M24]) | 1324.2 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M36]) | 1748.3 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M48]) | 1807.5 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PRE) | 56.8 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M1]) | 6801.4 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M12]) | 2169.8 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M24]) | 1550.8 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M36]) | 1551.5 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M48]) | 1545.5 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M36]) | 101.6 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PRE) | 58.3 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PRE) | 63.7 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M1]) | 2075.1 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PRE) | 34.7 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M12]) | 488.7 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M1]) | 2428 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M24]) | 203.2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M24]) | 106.6 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M36]) | 193.8 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M12]) | 564.2 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenA (PI[M48]) | 182.8 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M1]) | 1696.6 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PRE) | 69.7 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M24]) | 149.4 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M1]) | 1371.7 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M48]) | 113.1 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M12]) | 444.8 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M36]) | 95.7 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M24]) | 307.4 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenY (PI[M12]) | 480.4 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M36]) | 260 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenW-135 (PI[M48]) | 93.4 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers | rSBA-MenC (PI[M48]) | 211.9 Titers |
Secondary
rSBA Antibody Titers (HPA Laboratory Assay)
Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the Health Protection Agency (HPA) laboratory.
Time frame: At Persistence Year 4 [PI(M48)]
Population: The analysis was performed on subjects of 2 years and above from the ATP cohort for persistence Year 4, which included all evaluable subjects who had received the vaccine during the vaccination stage and had available assay results for at least one tested antigen at the Year 4 time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers (HPA Laboratory Assay) | rSBA-MenA (PI[M48]) | 77.5 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers (HPA Laboratory Assay) | rSBA-MenC (PI[M48]) | 21.7 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers (HPA Laboratory Assay) | rSBA-MenW-135 (PI[M48]) | 671.1 Titers |
| Nimenrix 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers (HPA Laboratory Assay) | rSBA-MenY (PI[M48]) | 134.8 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers (HPA Laboratory Assay) | rSBA-MenY (PI[M48]) | 4.7 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers (HPA Laboratory Assay) | rSBA-MenA (PI[M48]) | 7.3 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers (HPA Laboratory Assay) | rSBA-MenW-135 (PI[M48]) | 7.6 Titers |
| Mencevax 2-11 Years of Age Primary Phase Group | rSBA Antibody Titers (HPA Laboratory Assay) | rSBA-MenC (PI[M48]) | 23.5 Titers |