Infections, Meningococcal
Conditions
Keywords
Safety, Routine infancy vaccination, Meningococcal vaccine, Immunogenicity, Pneumococcal vaccine
Brief summary
The purpose of this study is to demonstrate, in 12-23 months old subjects, the non-inferiority of meningococcal vaccine GSK134612 and pneumococcal vaccine GSK1024850A when co-administered, compared to each vaccine administered individually.
Detailed description
Multi-center study with 3 parallel groups. One group will receive 2 vaccines injections at the same visit (pneumococcal+ meningococcal), one group will receive a pneumococcal vaccine followed one month later by a meningococcal vaccine, and the last group will receive the meningococcal vaccine followed one month later by the pneumococcal vaccine. All subjects will have one blood sample taken before vaccination and one blood sample taken one month after each vaccination (i.e. the first group will have 2 blood samples taken, and the other two groups will have 3 blood sample taken)
Interventions
BIOLOGICALMeningococcal vaccine GSK134612
Single dose intramuscular injection.
BIOLOGICALPneumococcal vaccine GSK1024850A
Single dose intramuscular injection.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to 23 Months
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol. * A male or female between, and including, 12 and 23 months of age at the time of the first booster vaccination, who previously participated in study 109661 conducted in Mexico or in study 109861 conducted in Taiwan and who received 3 doses of the GSK1024850A vaccine. * Written informed consent obtained from the parent or guardian of the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine(s), or planned use during the study period. * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of vaccine(s) and 30 days after the last dose of vaccine(s). * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). * Previous vaccination with a meningococcal vaccine. * Previous administration of a fourth dose of a pneumococcal vaccine * Previous vaccination with tetanus toxoid within the last month (including also tetanus toxoid given as part of Hib-TT conjugate vaccine). * History of meningococcal or pneumococcal invasive disease. * History of reactions or allergic disease likely to be exacerbated by any component of the vaccines. * Hypersensitivity reaction due to previous vaccination with GSK1024850A vaccine. * History of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or progressive neurological disease. * Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing required). * A family history of congenital or hereditary immunodeficiency, unless the child has previously been documented, through laboratory testing, to have normal immune function. * Major congenital defects or serious chronic illness. * Acute disease at the time of enrolment. * Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti-pneumococcal Antibody Concentrations | At Month 1 | Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL). Anti-pneumococcal serotypes assessed were Anti-1, Anti-4, Anti-5, Anti-6B, Anti-7F, Anti-9V, Anti-14, Anti-18C, Anti-19F and Anti-23F via the 22F-inhibition Enzyme Linked Immunosorbent Assay (ELISA). |
| 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-Men-Y) Antibody Titers Greater Than or Equal to (≥) the Cut-off Value | At Month 1 | The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. |
| rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Men-Y Antibody Titers | At Month 1 | Antibody titers are presented as geometric mean titers (GMTs) and are measured in titers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cross-reactive Anti-pneumococcal Antibody Concentrations | Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2) | Concentrations are presented as geometric mean concentrations (GMCs), expressed in µg/mL. The pneumococcal serotypes assessed were 6A and 19A (anti-6A and anti-19A) via the 22F-inhibition ELISA. GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose. |
| Opsonophagocytic Titers Against Pneumococcal Serotypes | Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2) | Opsonophagocytic titers are presented as geometric mean titers (GMTs). The pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPSONO-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). GMTs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose. |
| rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers | Before vaccination (PRE) and at one month post dose 2 (Month 2) | Antibody titers are presented as geometric mean titers (GMTs) and measured in titers. GMTs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose. |
| Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations | Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2) | Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL). GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose. |
| Anti-tetanus (Anti-T) Antibody Concentrations | Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2) | Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL). GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Within the 4-day (Days 0-3) post-vaccination period after each dose | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. |
| Anti-pneumococcal Antibody Concentrations | Before vaccination (PRE) and at one month post dose 2 (Month 2) | Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL). The pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) via 22F-inhibition ELISA. GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose. |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) | Within the 31-day (Day 0-30) post-vaccination period after each dose | 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. |
| Number of Subjects With Serious Adverse Events (SAEs) | Throughout the entire study duration (Day 0-Month 7) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Number of Subjects Reporting Rash | Throughout the entire study duration (Day 0-Month 7) | Rash-like symptoms assessed were hives, idiopathic thrombocytopenic purpura, petechiae. |
| Number of Subjects With New Onset Chronic Illnesses (NOCIs) | Throughout the entire study duration (Day 0-Month 7) | NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. |
| Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits | Throughout the entire study duration (Day 0-Month 7) | Among AEs prompting emergency room visits were: infections, injuries, skin diseases, gastrointestinal symptoms. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Within the 4-day (Days 0-3) post-vaccination period after each dose | Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature \[defined as rectally temperature equal to or above (≥) 38.0 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activities. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever higher than (\>) 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination. |
| Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes | Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2) | Opsonophagocytic titers are presented as geometric mean titers (GMTs). The pneumococcal serotypes assessed were 6A and 19A (OPSONO-6A and OPSONO-19A). GMTs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose. |
| Anti-protein D (Anti-PD) Antibody Concentrations | Before vaccination (PRE), at one month post dose 1(Month 1) and at one month post dose 2 (Month 2) | Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose. |
Countries
Mexico, Taiwan
Participant flow
Pre-assignment details
3 subjects have not been contacted for the Extended Safety Follow Up phase, out of which 2 subjects have not been contacted due to lost to follow-up (1 subject in Nimenrix + Synflorix Group and 1 subject in Nimenrix Group) and 1 subject due to consent withdrawal (Synflorix Group).
Participants by arm
| Arm | Count |
|---|---|
| Nimenrix + Synflorix Group Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine. | 182 |
| Nimenrix Group Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine. | 91 |
| Synflorix Group Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine. | 90 |
| Total | 363 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Active Phase | Lost to Follow-up | 1 | 0 | 0 |
| Active Phase | Other | 0 | 0 | 4 |
| Active Phase | Withdrawal by Subject | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Nimenrix + Synflorix Group | Nimenrix Group | Synflorix Group | Total |
|---|---|---|---|---|
| Age, Continuous | 17.2 Months STANDARD_DEVIATION 1.97 | 17.2 Months STANDARD_DEVIATION 1.88 | 17.4 Months STANDARD_DEVIATION 1.86 | 17.25 Months STANDARD_DEVIATION 1.92 |
| Race/Ethnicity, Customized Asian - East Asian heritage | 91 Participants | 45 Participants | 44 Participants | 180 Participants |
| Race/Ethnicity, Customized Hispanic | 91 Participants | 46 Participants | 46 Participants | 183 Participants |
| Sex: Female, Male Female | 83 Participants | 56 Participants | 47 Participants | 186 Participants |
| Sex: Female, Male Male | 99 Participants | 35 Participants | 43 Participants | 177 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 182 | 0 / 91 | 0 / 90 |
| other Total, other adverse events | 154 / 182 | 81 / 91 | 76 / 90 |
| serious Total, serious adverse events | 6 / 182 | 3 / 91 | 4 / 90 |
Outcome results
Primary
Anti-pneumococcal Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL). Anti-pneumococcal serotypes assessed were Anti-1, Anti-4, Anti-5, Anti-6B, Anti-7F, Anti-9V, Anti-14, Anti-18C, Anti-19F and Anti-23F via the 22F-inhibition Enzyme Linked Immunosorbent Assay (ELISA).
Time frame: At Month 1
Population: The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. The primary outcome concerns the Nimenrix + Synflorix Group and the Synflorix Group.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix + Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-1 | 3.43 μg/mL |
| Nimenrix + Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-4 | 6.86 μg/mL |
| Nimenrix + Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-5 | 4.97 μg/mL |
| Nimenrix + Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-6B | 2.91 μg/mL |
| Nimenrix + Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-7F | 5.32 μg/mL |
| Nimenrix + Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-9V | 4.70 μg/mL |
| Nimenrix + Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-14 | 8.89 μg/mL |
| Nimenrix + Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-18C | 9.81 μg/mL |
| Nimenrix + Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-19F | 19.16 μg/mL |
| Nimenrix + Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-23F | 4.46 μg/mL |
| Nimenrix Group | Anti-pneumococcal Antibody Concentrations | Anti-19F | 1.39 μg/mL |
| Nimenrix Group | Anti-pneumococcal Antibody Concentrations | Anti-1 | 0.33 μg/mL |
| Nimenrix Group | Anti-pneumococcal Antibody Concentrations | Anti-9V | 0.79 μg/mL |
| Nimenrix Group | Anti-pneumococcal Antibody Concentrations | Anti-7F | 0.88 μg/mL |
| Nimenrix Group | Anti-pneumococcal Antibody Concentrations | Anti-4 | 0.52 μg/mL |
| Nimenrix Group | Anti-pneumococcal Antibody Concentrations | Anti-23F | 0.59 μg/mL |
| Nimenrix Group | Anti-pneumococcal Antibody Concentrations | Anti-18C | 0.73 μg/mL |
| Nimenrix Group | Anti-pneumococcal Antibody Concentrations | Anti-5 | 0.54 μg/mL |
| Nimenrix Group | Anti-pneumococcal Antibody Concentrations | Anti-14 | 1.16 μg/mL |
| Nimenrix Group | Anti-pneumococcal Antibody Concentrations | Anti-6B | 0.53 μg/mL |
| Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-18C | 19.48 μg/mL |
| Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-6B | 3.14 μg/mL |
| Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-7F | 5.10 μg/mL |
| Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-9V | 4.74 μg/mL |
| Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-19F | 20.79 μg/mL |
| Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-14 | 9.00 μg/mL |
| Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-1 | 3.60 μg/mL |
| Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-23F | 3.79 μg/mL |
| Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-4 | 6.98 μg/mL |
| Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-5 | 5.07 μg/mL |
Comparison: Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 1 antibody concentrations.95% CI: [0.72, 1.05]
Comparison: Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 4 antibody concentrations.95% CI: [0.84, 1.26]
Comparison: Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 5 antibody concentrations.95% CI: [0.74, 1.1]
Comparison: Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 6B antibody concentrations.95% CI: [0.66, 1.07]
Comparison: Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 7F antibody concentrations.95% CI: [0.84, 1.2]
Comparison: Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 9V antibody concentrations.95% CI: [0.78, 1.14]
Comparison: Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 14 antibody concentrations.95% CI: [0.78, 1.23]
Comparison: Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 18C antibody concentrations.95% CI: [0.41, 0.67]
Comparison: Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 19F antibody concentrations.95% CI: [0.68, 1.08]
Comparison: Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 23F antibody concentrations.95% CI: [0.83, 1.38]
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-Men-Y) 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.
Time frame: At Month 1
Population: The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. The primary outcome concerns the Nimenrix + Synflorix Group and the Nimenrix Group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix + Synflorix 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-Men-Y) Antibody Titers Greater Than or Equal to (≥) the Cut-off Value | rSBA-MenA | 173 Participants |
| Nimenrix + Synflorix 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-Men-Y) Antibody Titers Greater Than or Equal to (≥) the Cut-off Value | rSBA-MenC | 173 Participants |
| Nimenrix + Synflorix 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-Men-Y) Antibody Titers Greater Than or Equal to (≥) the Cut-off Value | rSBA-MenW-135 | 174 Participants |
| Nimenrix + Synflorix 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-Men-Y) Antibody Titers Greater Than or Equal to (≥) the Cut-off Value | rSBA-MenY | 173 Participants |
| Nimenrix 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-Men-Y) Antibody Titers Greater Than or Equal to (≥) the Cut-off Value | rSBA-MenY | 80 Participants |
| Nimenrix 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-Men-Y) Antibody Titers Greater Than or Equal to (≥) the Cut-off Value | rSBA-MenA | 78 Participants |
| Nimenrix 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-Men-Y) Antibody Titers Greater Than or Equal to (≥) the Cut-off Value | rSBA-MenW-135 | 79 Participants |
| Nimenrix 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-Men-Y) Antibody Titers Greater Than or Equal to (≥) the Cut-off Value | rSBA-MenC | 79 Participants |
| Synflorix 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-Men-Y) Antibody Titers Greater Than or Equal to (≥) the Cut-off Value | rSBA-MenY | 48 Participants |
| Synflorix 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-Men-Y) Antibody Titers Greater Than or Equal to (≥) the Cut-off Value | rSBA-MenC | 9 Participants |
| Synflorix 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-Men-Y) Antibody Titers Greater Than or Equal to (≥) the Cut-off Value | rSBA-MenW-135 | 40 Participants |
| Synflorix 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-Men-Y) Antibody Titers Greater Than or Equal to (≥) the Cut-off Value | rSBA-MenA | 23 Participants |
Comparison: Demonstration of non-inferiority of Nimenrix conjugate vaccine when co-administered with Synflorix vaccine versus Nimenrix conjugate vaccine given alone (Synflorix vaccine was administered 1 month later) in terms of serum bactericidal assay using rabbit complement against Neisseria meningitides serogroup A (rSBA-MenA).95% CI: [-1.09, 8.15]
Comparison: Demonstration of non-inferiority of Nimenrix conjugate vaccine when co-administered with Synflorix vaccine versus Nimenrix conjugate vaccine given alone (Synflorix vaccine was administered 1 month later) in terms of serum bactericidal assay using rabbit complement against Neisseria meningitides serogroup C (rSBA-MenC).95% CI: [-2.11, 6.22]
Comparison: Demonstration of non-inferiority of Nimenrix conjugate vaccine when co-administered with Synflorix vaccine versus Nimenrix conjugate vaccine given alone (Synflorix vaccine was administered 1 month later) in terms of serum bactericidal assay using rabbit complement against Neisseria meningitides serogroup W-135 (rSBA-MenW-135).95% CI: [-0.94, 6.76]
Comparison: Demonstration of non-inferiority of Nimenrix conjugate vaccine when co-administered with Synflorix vaccine versus Nimenrix conjugate vaccine given alone (Synflorix vaccine was administered 1 month later) in terms of serum bactericidal assay using rabbit complement against Neisseria meningitides serogroup Y (rSBA-MenY).95% CI: [-2.18, 4.6]
Primary
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Men-Y Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs) and are measured in titers.
Time frame: At Month 1
Population: The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. The primary outcome concerns the Nimenrix + Synflorix Group and the Nimenrix Group.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix + Synflorix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Men-Y Antibody Titers | rSBA-MenW- 135 | 11731.0 Titers |
| Nimenrix + Synflorix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Men-Y Antibody Titers | rSBA-MenA | 6673.7 Titers |
| Nimenrix + Synflorix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Men-Y Antibody Titers | rSBA-MenY | 6797.8 Titers |
| Nimenrix + Synflorix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Men-Y Antibody Titers | rSBA-MenC | 2496.6 Titers |
| Nimenrix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Men-Y Antibody Titers | rSBA-MenW- 135 | 8407.7 Titers |
| Nimenrix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Men-Y Antibody Titers | rSBA-MenC | 2044.0 Titers |
| Nimenrix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Men-Y Antibody Titers | rSBA-MenA | 5016.6 Titers |
| Nimenrix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Men-Y Antibody Titers | rSBA-MenY | 5606.2 Titers |
| Synflorix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Men-Y Antibody Titers | rSBA-MenC | 6.4 Titers |
| Synflorix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Men-Y Antibody Titers | rSBA-MenA | 23.5 Titers |
| Synflorix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Men-Y Antibody Titers | rSBA-MenY | 68.4 Titers |
| Synflorix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Men-Y Antibody Titers | rSBA-MenW- 135 | 35.8 Titers |
Secondary
Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL). GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.
Time frame: Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)
Population: The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix + Synflorix Group | Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSA, PRE | 0.18 μg/mL |
| Nimenrix + Synflorix Group | Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSA, M1 | 56.44 μg/mL |
| Nimenrix + Synflorix Group | Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSC, PRE | 0.16 μg/mL |
| Nimenrix + Synflorix Group | Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSC, M1 | 24.11 μg/mL |
| Nimenrix + Synflorix Group | Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSW-135, PRE | 0.15 μg/mL |
| Nimenrix + Synflorix Group | Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSW-135, M1 | 12.11 μg/mL |
| Nimenrix + Synflorix Group | Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSY, PRE | 0.15 μg/mL |
| Nimenrix + Synflorix Group | Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSY, M1 | 12.03 μg/mL |
| Nimenrix Group | Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSW-135, M1 | 11.68 μg/mL |
| Nimenrix Group | Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSC, M1 | 24.54 μg/mL |
| Nimenrix Group | Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSW-135, M2 | 11.38 μg/mL |
| Nimenrix Group | Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSY, M1 | 10.78 μg/mL |
| Nimenrix Group | Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSY, M2 | 10.22 μg/mL |
| Nimenrix Group | Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSA, PRE | 0.17 μg/mL |
| Nimenrix Group | Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSW-135, PRE | 0.16 μg/mL |
| Nimenrix Group | Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSY, PRE | 0.17 μg/mL |
| Nimenrix Group | Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSA, M1 | 41.94 μg/mL |
| Nimenrix Group | Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSC, PRE | 0.15 μg/mL |
| Nimenrix Group | Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSA, M2 | 18.88 μg/mL |
| Nimenrix Group | Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSC, M2 | 11.56 μg/mL |
| Synflorix Group | Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSA, M2 | 19.80 μg/mL |
| Synflorix Group | Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSC, PRE | 0.16 μg/mL |
| Synflorix Group | Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSY, M2 | 8.47 μg/mL |
| Synflorix Group | Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSC, M1 | 0.16 μg/mL |
| Synflorix Group | Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSC, M2 | 9.62 μg/mL |
| Synflorix Group | Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSW-135, PRE | 0.15 μg/mL |
| Synflorix Group | Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSY, M1 | 0.15 μg/mL |
| Synflorix Group | Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSW-135, M1 | 0.15 μg/mL |
| Synflorix Group | Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSW-135, M2 | 6.75 μg/mL |
| Synflorix Group | Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSA, PRE | 0.20 μg/mL |
| Synflorix Group | Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSA, M1 | 0.19 μg/mL |
| Synflorix Group | Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSY, PRE | 0.16 μg/mL |
Secondary
Anti-pneumococcal Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL). The pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) via 22F-inhibition ELISA. GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.
Time frame: Before vaccination (PRE) and at one month post dose 2 (Month 2)
Population: The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix + Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-5, PRE | 0.61 μg/mL |
| Nimenrix + Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-19F, PRE | 1.36 μg/mL |
| Nimenrix + Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-9V, PRE | 0.79 μg/mL |
| Nimenrix + Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-4, PRE | 0.45 μg/mL |
| Nimenrix + Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-7F, PRE | 0.79 μg/mL |
| Nimenrix + Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-6B, PRE | 0.57 μg/mL |
| Nimenrix + Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-1, PRE | 0.31 μg/mL |
| Nimenrix + Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-18C, PRE | 0.79 μg/mL |
| Nimenrix + Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-23F, PRE | 0.62 μg/mL |
| Nimenrix + Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-14, PRE | 1.30 μg/mL |
| Nimenrix Group | Anti-pneumococcal Antibody Concentrations | Anti-4, PRE | 0.57 μg/mL |
| Nimenrix Group | Anti-pneumococcal Antibody Concentrations | Anti-1, PRE | 0.33 μg/mL |
| Nimenrix Group | Anti-pneumococcal Antibody Concentrations | Anti-1, M2 | 4.19 μg/mL |
| Nimenrix Group | Anti-pneumococcal Antibody Concentrations | Anti-4, M2 | 7.80 μg/mL |
| Nimenrix Group | Anti-pneumococcal Antibody Concentrations | Anti-5, PRE | 0.55 μg/mL |
| Nimenrix Group | Anti-pneumococcal Antibody Concentrations | Anti-5, M2 | 4.65 μg/mL |
| Nimenrix Group | Anti-pneumococcal Antibody Concentrations | Anti-6B, PRE | 0.53 μg/mL |
| Nimenrix Group | Anti-pneumococcal Antibody Concentrations | Anti-6B, M2 | 2.95 μg/mL |
| Nimenrix Group | Anti-pneumococcal Antibody Concentrations | Anti-7F, PRE | 0.95 μg/mL |
| Nimenrix Group | Anti-pneumococcal Antibody Concentrations | Anti-7F, M2 | 6.49 μg/mL |
| Nimenrix Group | Anti-pneumococcal Antibody Concentrations | Anti-9V, PRE | 0.85 μg/mL |
| Nimenrix Group | Anti-pneumococcal Antibody Concentrations | Anti-9V, M2 | 5.31 μg/mL |
| Nimenrix Group | Anti-pneumococcal Antibody Concentrations | Anti-14, PRE | 1.37 μg/mL |
| Nimenrix Group | Anti-pneumococcal Antibody Concentrations | Anti-14, M2 | 10.60 μg/mL |
| Nimenrix Group | Anti-pneumococcal Antibody Concentrations | Anti-18C, PRE | 0.82 μg/mL |
| Nimenrix Group | Anti-pneumococcal Antibody Concentrations | Anti-18C, M2 | 7.78 μg/mL |
| Nimenrix Group | Anti-pneumococcal Antibody Concentrations | Anti-19F, PRE | 1.35 μg/mL |
| Nimenrix Group | Anti-pneumococcal Antibody Concentrations | Anti-19F, M2 | 16.90 μg/mL |
| Nimenrix Group | Anti-pneumococcal Antibody Concentrations | Anti-23F, PRE | 0.67 μg/mL |
| Nimenrix Group | Anti-pneumococcal Antibody Concentrations | Anti-23F, M2 | 5.25 μg/mL |
| Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-4, M2 | 4.05 μg/mL |
| Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-19F, PRE | 1.08 μg/mL |
| Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-14, PRE | 1.29 μg/mL |
| Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-23F, PRE | 0.53 μg/mL |
| Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-14, M2 | 6.79 μg/mL |
| Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-4, PRE | 0.49 μg/mL |
| Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-19F, M2 | 12.35 μg/mL |
| Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-6B, PRE | 0.48 μg/mL |
| Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-18C, PRE | 0.87 μg/mL |
| Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-6B, M2 | 2.18 μg/mL |
| Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-5, M2 | 3.22 μg/mL |
| Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-1, PRE | 0.24 μg/mL |
| Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-7F, PRE | 0.71 μg/mL |
| Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-18C, M2 | 14.14 μg/mL |
| Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-7F, M2 | 3.85 μg/mL |
| Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-5, PRE | 0.48 μg/mL |
| Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-1, M2 | 2.32 μg/mL |
| Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-9V, PRE | 0.75 μg/mL |
| Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-23F, M2 | 2.72 μg/mL |
| Synflorix Group | Anti-pneumococcal Antibody Concentrations | Anti-9V, M2 | 3.07 μg/mL |
Secondary
Anti-protein D (Anti-PD) Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.
Time frame: Before vaccination (PRE), at one month post dose 1(Month 1) and at one month post dose 2 (Month 2)
Population: The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix + Synflorix Group | Anti-protein D (Anti-PD) Antibody Concentrations | Anti-PD, PRE | 588.4 EL.U/mL |
| Nimenrix + Synflorix Group | Anti-protein D (Anti-PD) Antibody Concentrations | Anti-PD, M1 | 2340.3 EL.U/mL |
| Nimenrix Group | Anti-protein D (Anti-PD) Antibody Concentrations | Anti-PD, M1 | 632.6 EL.U/mL |
| Nimenrix Group | Anti-protein D (Anti-PD) Antibody Concentrations | Anti-PD, PRE | 633.4 EL.U/mL |
| Nimenrix Group | Anti-protein D (Anti-PD) Antibody Concentrations | Anti-PD, M2 | 2921.6 EL.U/mL |
| Synflorix Group | Anti-protein D (Anti-PD) Antibody Concentrations | Anti-PD, M1 | 2452.3 EL.U/mL |
| Synflorix Group | Anti-protein D (Anti-PD) Antibody Concentrations | Anti-PD, M2 | 1854.3 EL.U/mL |
| Synflorix Group | Anti-protein D (Anti-PD) Antibody Concentrations | Anti-PD, PRE | 514.6 EL.U/mL |
Secondary
Anti-tetanus (Anti-T) Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL). GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.
Time frame: Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)
Population: The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix + Synflorix Group | Anti-tetanus (Anti-T) Antibody Concentrations | Anti-T, PRE | 0.499 IU/mL |
| Nimenrix + Synflorix Group | Anti-tetanus (Anti-T) Antibody Concentrations | Anti-T, M1 | 18.446 IU/mL |
| Nimenrix Group | Anti-tetanus (Anti-T) Antibody Concentrations | Anti-T, M1 | 18.137 IU/mL |
| Nimenrix Group | Anti-tetanus (Anti-T) Antibody Concentrations | Anti-T, PRE | 0.566 IU/mL |
| Nimenrix Group | Anti-tetanus (Anti-T) Antibody Concentrations | Anti-T, M2 | 16.643 IU/mL |
| Synflorix Group | Anti-tetanus (Anti-T) Antibody Concentrations | Anti-T, M1 | 4.412 IU/mL |
| Synflorix Group | Anti-tetanus (Anti-T) Antibody Concentrations | Anti-T, M2 | 13.773 IU/mL |
| Synflorix Group | Anti-tetanus (Anti-T) Antibody Concentrations | Anti-T, PRE | 0.502 IU/mL |
Secondary
Cross-reactive Anti-pneumococcal Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in µg/mL. The pneumococcal serotypes assessed were 6A and 19A (anti-6A and anti-19A) via the 22F-inhibition ELISA. GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.
Time frame: Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)
Population: The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix + Synflorix Group | Cross-reactive Anti-pneumococcal Antibody Concentrations | Anti-6A, PRE | 0.25 μg/mL |
| Nimenrix + Synflorix Group | Cross-reactive Anti-pneumococcal Antibody Concentrations | Anti-6A, M1 | 1.54 μg/mL |
| Nimenrix + Synflorix Group | Cross-reactive Anti-pneumococcal Antibody Concentrations | Anti-19A, PRE | 0.17 μg/mL |
| Nimenrix + Synflorix Group | Cross-reactive Anti-pneumococcal Antibody Concentrations | Anti-19A, M1 | 2.00 μg/mL |
| Nimenrix Group | Cross-reactive Anti-pneumococcal Antibody Concentrations | Anti-6A, M2 | 1.59 μg/mL |
| Nimenrix Group | Cross-reactive Anti-pneumococcal Antibody Concentrations | Anti-19A, M2 | 2.21 μg/mL |
| Nimenrix Group | Cross-reactive Anti-pneumococcal Antibody Concentrations | Anti-19A, M1 | 0.22 μg/mL |
| Nimenrix Group | Cross-reactive Anti-pneumococcal Antibody Concentrations | Anti-6A, PRE | 0.25 μg/mL |
| Nimenrix Group | Cross-reactive Anti-pneumococcal Antibody Concentrations | Anti-19A, PRE | 0.18 μg/mL |
| Nimenrix Group | Cross-reactive Anti-pneumococcal Antibody Concentrations | Anti-6A, M1 | 0.28 μg/mL |
| Synflorix Group | Cross-reactive Anti-pneumococcal Antibody Concentrations | Anti-19A, M1 | 2.50 μg/mL |
| Synflorix Group | Cross-reactive Anti-pneumococcal Antibody Concentrations | Anti-6A, M1 | 2.07 μg/mL |
| Synflorix Group | Cross-reactive Anti-pneumococcal Antibody Concentrations | Anti-6A, M2 | 1.30 μg/mL |
| Synflorix Group | Cross-reactive Anti-pneumococcal Antibody Concentrations | Anti-19A, PRE | 0.16 μg/mL |
| Synflorix Group | Cross-reactive Anti-pneumococcal Antibody Concentrations | Anti-19A, M2 | 1.51 μg/mL |
| Synflorix Group | Cross-reactive Anti-pneumococcal Antibody Concentrations | Anti-6A, PRE | 0.26 μg/mL |
Secondary
Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits
Among AEs prompting emergency room visits were: infections, injuries, skin diseases, gastrointestinal symptoms.
Time frame: Throughout the entire study duration (Day 0-Month 7)
Population: The analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix + Synflorix Group | Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits | 13 Participants |
| Nimenrix Group | Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits | 10 Participants |
| Synflorix Group | Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits | 9 Participants |
Secondary
Number of Subjects Reporting Rash
Rash-like symptoms assessed were hives, idiopathic thrombocytopenic purpura, petechiae.
Time frame: Throughout the entire study duration (Day 0-Month 7)
Population: The analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix + Synflorix Group | Number of Subjects Reporting Rash | 9 Participants |
| Nimenrix Group | Number of Subjects Reporting Rash | 10 Participants |
| Synflorix Group | Number of Subjects Reporting Rash | 5 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Time frame: Within the 4-day (Days 0-3) post-vaccination period after each dose
Population: The analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with the symptoms sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix + Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1, Nimenrix | 56 Participants |
| Nimenrix + Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1, Synflorix | 70 Participants |
| Nimenrix + Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2, Synflorix | 0 Participants |
| Nimenrix + Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1, Synflorix | 90 Participants |
| Nimenrix + Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1, Synflorix | 3 Participants |
| Nimenrix + Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2, Nimenrix | 0 Participants |
| Nimenrix + Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1, Nimenrix | 14 Participants |
| Nimenrix + Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1, Nimenrix | 66 Participants |
| Nimenrix + Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2, Synflorix | 0 Participants |
| Nimenrix + Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2, Synflorix | 0 Participants |
| Nimenrix + Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1, Nimenrix | 3 Participants |
| Nimenrix + Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2, Synflorix | 0 Participants |
| Nimenrix + Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1, Synflorix | 14 Participants |
| Nimenrix + Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2, Synflorix | 0 Participants |
| Nimenrix + Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1, Nimenrix | 87 Participants |
| Nimenrix + Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1, Synflorix | 54 Participants |
| Nimenrix + Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2, Synflorix | 0 Participants |
| Nimenrix + Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2, Nimenrix | 0 Participants |
| Nimenrix + Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1, Nimenrix | 3 Participants |
| Nimenrix + Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2, Nimenrix | 0 Participants |
| Nimenrix + Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2, Nimenrix | 0 Participants |
| Nimenrix + Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2, Nimenrix | 0 Participants |
| Nimenrix + Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3, Dose 2, Nimenrix | 0 Participants |
| Nimenrix + Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1, Synflorix | 2 Participants |
| Nimenrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3, Dose 2, Nimenrix | 0 Participants |
| Nimenrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2, Synflorix | 29 Participants |
| Nimenrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2, Synflorix | 3 Participants |
| Nimenrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1, Synflorix | 0 Participants |
| Nimenrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2, Nimenrix | 0 Participants |
| Nimenrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1, Synflorix | 0 Participants |
| Nimenrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2, Nimenrix | 0 Participants |
| Nimenrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2, Synflorix | 38 Participants |
| Nimenrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1, Nimenrix | 31 Participants |
| Nimenrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2, Synflorix | 1 Participants |
| Nimenrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2, Nimenrix | 0 Participants |
| Nimenrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1, Nimenrix | 1 Participants |
| Nimenrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1, Nimenrix | 40 Participants |
| Nimenrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1, Synflorix | 0 Participants |
| Nimenrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1, Synflorix | 0 Participants |
| Nimenrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1, Nimenrix | 37 Participants |
| Nimenrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1, Nimenrix | 4 Participants |
| Nimenrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1, Nimenrix | 1 Participants |
| Nimenrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2, Synflorix | 43 Participants |
| Nimenrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2, Synflorix | 8 Participants |
| Nimenrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1, Synflorix | 0 Participants |
| Nimenrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2, Nimenrix | 0 Participants |
| Nimenrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2, Nimenrix | 0 Participants |
| Nimenrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1, Synflorix | 0 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2, Nimenrix | 34 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1, Synflorix | 47 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1, Synflorix | 6 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1, Nimenrix | 0 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1, Nimenrix | 0 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1, Synflorix | 32 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1, Synflorix | 4 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1, Nimenrix | 0 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1, Nimenrix | 0 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1, Synflorix | 42 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1, Synflorix | 3 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1, Nimenrix | 0 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1, Nimenrix | 0 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2, Synflorix | 0 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2, Synflorix | 0 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3, Dose 2, Nimenrix | 2 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2, Synflorix | 0 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2, Synflorix | 0 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2, Nimenrix | 24 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2, Nimenrix | 1 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2, Synflorix | 0 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2, Synflorix | 0 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2, Nimenrix | 30 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2, Nimenrix | 2 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature \[defined as rectally temperature equal to or above (≥) 38.0 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activities. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever higher than (\>) 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: Within the 4-day (Days 0-3) post-vaccination period after each dose
Population: The analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with the symptoms sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix + Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 1 | 55 Participants |
| Nimenrix + Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 1 | 1 Participants |
| Nimenrix + Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 1 | 55 Participants |
| Nimenrix + Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 1 | 72 Participants |
| Nimenrix + Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 1 | 2 Participants |
| Nimenrix + Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 1 | 65 Participants |
| Nimenrix + Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 1 | 59 Participants |
| Nimenrix + Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 1 | 2 Participants |
| Nimenrix + Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 1 | 46 Participants |
| Nimenrix + Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 1 | 25 Participants |
| Nimenrix + Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 1 | 0 Participants |
| Nimenrix + Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 1 | 24 Participants |
| Nimenrix + Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 2 | 0 Participants |
| Nimenrix + Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 2 | 0 Participants |
| Nimenrix + Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 2 | 0 Participants |
| Nimenrix + Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 2 | 0 Participants |
| Nimenrix + Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 2 | 0 Participants |
| Nimenrix + Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 2 | 0 Participants |
| Nimenrix + Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 2 | 0 Participants |
| Nimenrix + Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 2 | 0 Participants |
| Nimenrix + Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 2 | 0 Participants |
| Nimenrix + Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 2 | 0 Participants |
| Nimenrix + Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 2 | 0 Participants |
| Nimenrix + Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 2 | 0 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 2 | 18 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 1 | 21 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 2 | 25 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 2 | 1 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 1 | 0 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 1 | 0 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 2 | 20 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 1 | 18 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 2 | 1 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 2 | 1 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 1 | 33 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 1 | 10 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 2 | 30 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 1 | 0 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 2 | 22 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 1 | 10 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 1 | 30 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 1 | 18 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 2 | 16 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 1 | 22 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 2 | 35 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 2 | 22 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 1 | 0 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 2 | 0 Participants |
| Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 1 | 1 Participants |
| Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 1 | 28 Participants |
| Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 1 | 15 Participants |
| Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 1 | 0 Participants |
| Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 2 | 0 Participants |
| Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 1 | 15 Participants |
| Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 2 | 0 Participants |
| Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 2 | 17 Participants |
| Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 2 | 0 Participants |
| Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 2 | 20 Participants |
| Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 2 | 15 Participants |
| Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 2 | 9 Participants |
| Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 2 | 29 Participants |
| Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 1 | 35 Participants |
| Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 1 | 1 Participants |
| Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 2 | 1 Participants |
| Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 1 | 34 Participants |
| Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 2 | 11 Participants |
| Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 1 | 43 Participants |
| Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 1 | 1 Participants |
| Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 2 | 25 Participants |
| Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 1 | 40 Participants |
| Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 1 | 33 Participants |
| Synflorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 2 | 22 Participants |
Secondary
Number of Subjects With Any Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time frame: Within the 31-day (Day 0-30) post-vaccination period after each dose
Population: The analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix + Synflorix Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | Any AE(s) post-Dose 1 | 82 Participants |
| Nimenrix + Synflorix Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | Any AE(s) post-Dose 2 | 0 Participants |
| Nimenrix Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | Any AE(s) post-Dose 1 | 39 Participants |
| Nimenrix Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | Any AE(s) post-Dose 2 | 40 Participants |
| Synflorix Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | Any AE(s) post-Dose 1 | 42 Participants |
| Synflorix Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | Any AE(s) post-Dose 2 | 31 Participants |
Secondary
Number of Subjects With New Onset Chronic Illnesses (NOCIs)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Time frame: Throughout the entire study duration (Day 0-Month 7)
Population: The analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix + Synflorix Group | Number of Subjects With New Onset Chronic Illnesses (NOCIs) | 0 Participants |
| Nimenrix Group | Number of Subjects With New Onset Chronic Illnesses (NOCIs) | 1 Participants |
| Synflorix Group | Number of Subjects With New Onset Chronic Illnesses (NOCIs) | 0 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: Throughout the entire study duration (Day 0-Month 7)
Population: The analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix + Synflorix Group | Number of Subjects With Serious Adverse Events (SAEs) | 6 Participants |
| Nimenrix Group | Number of Subjects With Serious Adverse Events (SAEs) | 3 Participants |
| Synflorix Group | Number of Subjects With Serious Adverse Events (SAEs) | 4 Participants |
Secondary
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes
Opsonophagocytic titers are presented as geometric mean titers (GMTs). The pneumococcal serotypes assessed were 6A and 19A (OPSONO-6A and OPSONO-19A). GMTs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.
Time frame: Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)
Population: The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix + Synflorix Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes | OPSONO-6A, PRE | 55.8 Titers |
| Nimenrix + Synflorix Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes | OPSONO-6A, M1 | 355.2 Titers |
| Nimenrix + Synflorix Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes | OPSONO-19A, PRE | 5.3 Titers |
| Nimenrix + Synflorix Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes | OPSONO-19A, M1 | 100.2 Titers |
| Nimenrix Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes | OPSONO-6A, M2 | 566.0 Titers |
| Nimenrix Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes | OPSONO-19A, M2 | 203.2 Titers |
| Nimenrix Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes | OPSONO-19A, M1 | 6.3 Titers |
| Nimenrix Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes | OPSONO-6A, PRE | 73.1 Titers |
| Nimenrix Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes | OPSONO-19A, PRE | 5.9 Titers |
| Nimenrix Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes | OPSONO-6A, M1 | 59.4 Titers |
| Synflorix Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes | OPSONO-19A, M1 | 214.5 Titers |
| Synflorix Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes | OPSONO-6A, M1 | 696.6 Titers |
| Synflorix Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes | OPSONO-6A, M2 | 284.1 Titers |
| Synflorix Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes | OPSONO-19A, PRE | 7.0 Titers |
| Synflorix Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes | OPSONO-19A, M2 | 86.8 Titers |
| Synflorix Group | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes | OPSONO-6A, PRE | 127.6 Titers |
Secondary
Opsonophagocytic Titers Against Pneumococcal Serotypes
Opsonophagocytic titers are presented as geometric mean titers (GMTs). The pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPSONO-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). GMTs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.
Time frame: Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)
Population: The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix + Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-4, PRE | 13.7 Titers |
| Nimenrix + Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-14, M1 | 3178.4 Titers |
| Nimenrix + Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-1, PRE | 6.6 Titers |
| Nimenrix + Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-14, PRE | 329.5 Titers |
| Nimenrix + Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-6B, PRE | 37.4 Titers |
| Nimenrix + Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-19F, M1 | 2074.7 Titers |
| Nimenrix + Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-9V, M1 | 2697.7 Titers |
| Nimenrix + Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-6B, M1 | 678.9 Titers |
| Nimenrix + Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-4, M1 | 2638.7 Titers |
| Nimenrix + Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-9V, PRE | 728.3 Titers |
| Nimenrix + Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-23F, M1 | 3808.8 Titers |
| Nimenrix + Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-7F, M1 | 5485.4 Titers |
| Nimenrix + Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-7F, PRE | 1795.6 Titers |
| Nimenrix + Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-19F, PRE | 33.5 Titers |
| Nimenrix + Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-1, M1 | 395.3 Titers |
| Nimenrix + Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-18C, M1 | 1969.9 Titers |
| Nimenrix + Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-5, PRE | 12.9 Titers |
| Nimenrix + Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-23F, PRE | 262.3 Titers |
| Nimenrix + Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-18C, PRE | 13.9 Titers |
| Nimenrix + Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-5, M1 | 362.1 Titers |
| Nimenrix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-23F, M2 | 3432.4 Titers |
| Nimenrix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-1, PRE | 5.8 Titers |
| Nimenrix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-1, M1 | 8.2 Titers |
| Nimenrix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-1, M2 | 200.8 Titers |
| Nimenrix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-4, PRE | 14.9 Titers |
| Nimenrix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-4, M1 | 10.3 Titers |
| Nimenrix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-4, M2 | 2536.5 Titers |
| Nimenrix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-5, PRE | 10.8 Titers |
| Nimenrix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-5, M1 | 11.0 Titers |
| Nimenrix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-5, M2 | 233.3 Titers |
| Nimenrix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-6B, PRE | 26.1 Titers |
| Nimenrix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-6B, M1 | 56.1 Titers |
| Nimenrix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-6B, M2 | 1112.1 Titers |
| Nimenrix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-7F, PRE | 1588.3 Titers |
| Nimenrix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-7F, M1 | 2051.2 Titers |
| Nimenrix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-7F, M2 | 5235.8 Titers |
| Nimenrix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-9V, PRE | 627.7 Titers |
| Nimenrix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-9V, M1 | 445.2 Titers |
| Nimenrix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-9V, M2 | 2709.7 Titers |
| Nimenrix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-14, PRE | 324.7 Titers |
| Nimenrix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-14, M1 | 214.3 Titers |
| Nimenrix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-14, M2 | 2563.7 Titers |
| Nimenrix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-18C, PRE | 10.5 Titers |
| Nimenrix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-18C, M1 | 8.2 Titers |
| Nimenrix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-18C, M2 | 1229.9 Titers |
| Nimenrix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-19F, PRE | 34.2 Titers |
| Nimenrix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-19F, M1 | 57.3 Titers |
| Nimenrix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-19F, M2 | 2110.4 Titers |
| Nimenrix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-23F, PRE | 98.1 Titers |
| Nimenrix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-23F, M1 | 199.0 Titers |
| Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-14, PRE | 320.5 Titers |
| Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-5, M1 | 332.7 Titers |
| Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-1, PRE | 6.2 Titers |
| Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-14, M1 | 3914.0 Titers |
| Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-19F, M2 | 1260.4 Titers |
| Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-14, M2 | 2149.0 Titers |
| Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-5, PRE | 12.7 Titers |
| Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-23F, M2 | 3284.2 Titers |
| Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-18C, PRE | 13.2 Titers |
| Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-4, M2 | 1427.7 Titers |
| Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-1, M2 | 238.0 Titers |
| Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-18C, M1 | 5616.8 Titers |
| Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-23F, M1 | 3794.6 Titers |
| Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-18C, M2 | 4190.1 Titers |
| Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-7F, PRE | 1843.1 Titers |
| Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-6B, M2 | 560.6 Titers |
| Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-4, M1 | 3621.3 Titers |
| Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-7F, M1 | 5421.5 Titers |
| Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-23F, PRE | 460.2 Titers |
| Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-7F, M2 | 4444.3 Titers |
| Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-6B, M1 | 1158.7 Titers |
| Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-19F, PRE | 32.9 Titers |
| Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-9V, PRE | 1269.8 Titers |
| Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-6B, PRE | 42.7 Titers |
| Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-4, PRE | 24.9 Titers |
| Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-9V, M1 | 4862.0 Titers |
| Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-1, M1 | 438.6 Titers |
| Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-9V, M2 | 3392.6 Titers |
| Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-5, M2 | 308.9 Titers |
| Synflorix Group | Opsonophagocytic Titers Against Pneumococcal Serotypes | Opsono-19F, M1 | 2534.2 Titers |
Secondary
rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs) and measured in titers. GMTs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.
Time frame: Before vaccination (PRE) and at one month post dose 2 (Month 2)
Population: The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix + Synflorix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers | rSBA-MenA, PRE | 15.2 Titers |
| Nimenrix + Synflorix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers | rSBA-MenC, PRE | 5.8 Titers |
| Nimenrix + Synflorix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers | rSBA-MenW, PRE | 46.4 Titers |
| Nimenrix + Synflorix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers | rSBA-MenY, PRE | 66.0 Titers |
| Nimenrix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers | rSBA-MenC, M2 | 1834.6 Titers |
| Nimenrix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers | rSBA-MenW, M2 | 5817.6 Titers |
| Nimenrix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers | rSBA-MenC, PRE | 6.1 Titers |
| Nimenrix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers | rSBA-MenY, M2 | 4669.5 Titers |
| Nimenrix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers | rSBA-MenY, PRE | 74.4 Titers |
| Nimenrix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers | rSBA-MenA, PRE | 15.3 Titers |
| Nimenrix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers | rSBA-MenW, PRE | 32.7 Titers |
| Nimenrix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers | rSBA-MenA, M2 | 4746.8 Titers |
| Synflorix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers | rSBA-MenW, PRE | 39.6 Titers |
| Synflorix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers | rSBA-MenY, PRE | 77.0 Titers |
| Synflorix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers | rSBA-MenC, PRE | 7.7 Titers |
| Synflorix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers | rSBA-MenC, M2 | 1579.9 Titers |
| Synflorix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers | rSBA-MenA, M2 | 5288.0 Titers |
| Synflorix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers | rSBA-MenW, M2 | 7666.8 Titers |
| Synflorix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers | rSBA-MenY, M2 | 6461.1 Titers |
| Synflorix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers | rSBA-MenA, PRE | 39.4 Titers |