| Primary | Number of Subjects With Vaccine Response to Meningococcal Serogroup C Serum Based on a Bactericidal Assay Using Baby Rabbit Complement (rSBA-MenC) Antibody | Vaccine response to MenC was defined as: -for initially seronegative subjects [i.e. rSBA-MenC titer below (<) 1:8], antibody titer greater than or equal to (≥) 1:32; -for initially seropositive (i.e. rSBA-MenC titer ≥ 1:8), antibody titer post-vaccination ≥ 4-fold the pre-vaccination antibody titer. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available. | Posted | | Count of Participants | | Participants | | One month after vaccination (Month 1) | | | | ID | Title | Description |
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| OG000 | Nimenrix Group | Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0. | | OG001 | Menjugate Group | Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0. |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| To demonstrate the non-inferiority of the Nimenrix group compared to the Menjugate group, two-sided standardized asymptotic 95% confidence interval (CI) for the groups difference [Nimenrix group minus Menjugate group] in the percentages of subjects with bactericidal vaccine response to MenC was computed. | | | | | Difference in percentage | -0.88 | | | 2-Sided | 95 | -5.25 | 5.75 | | | | | Non-Inferiority | Criterion for non-inferiority evaluation: The lower limit (LL) of the two-sided standardized asymptotic 95% CI for the group difference (Nimenrix Group minus Menjugate Group) in the percentages of subjects with vaccine response to rSBA-MenC is greater than or equal to (≥) the pre-defined clinical limit of -10%. |
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| Secondary | Meningococcal Serogroup A (rSBA) Antibody Titers by Serogroup | Antibody titers were presented as geometric mean titers (GMTs). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | Prior to (Month 0) and one month after vaccination (Month 1) | | | | ID | Title | Description |
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| OG000 | Nimenrix Group | Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0. | | OG001 | Menjugate Group | Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0. |
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| Secondary | Anti-meningococcal Serogroup Polysaccharides (Anti-PS) Antibody Concentrations | Anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations were presented as geometric mean concentrations (GMCs) and tabulated as micrograms per milliliter (μg/mL). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | Prior to (Month 0) and one month after vaccination (Month 1) | | | | ID | Title | Description |
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| OG000 | Nimenrix Group | Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0. | | OG001 | Menjugate Group | Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0. |
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| Secondary | Number of Subjects Between 2 and 5 Years of Age With Any and Grade 3 Solicited Local Symptoms | Solicited symptoms assessed were: pain, redness and swelling. Any = occurrence of any local symptom regardless of their intensity grade. Grade 3 Pain = cried when limb was moved/spontaneously painful. Grade 3 Redness and Swelling= redness/swelling spreading beyond (>) 30 millimeters (mm). | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with their symptom sheets filled in, for whom data were available. | Posted | | Count of Participants | | Participants | | During the 4-day (Days 0-3) post-vaccination period | | | | ID | Title | Description |
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| OG000 | Nimenrix Group (< 6 Years) | Healthy male or female subjects between, and including 2 to 5 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0. | | OG001 | Menjugate Group (< 6 Years) | Healthy male or female subjects between, and including 2 to 5 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0. |
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| Secondary | Number of Subjects Between 6 and 10 Years of Age With Any and Grade 3 Solicited Local Symptoms | Solicited symptoms assessed were: pain, redness and swelling. Any = occurrence of any local symptom regardless of their intensity grade. Grade 3 Pain = pain that prevented normal activity. Grade 3 Redness and Swelling= redness/swelling spreading beyond (>) 50 millimeters (mm). | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with their symptom sheets filled in, for whom data were available. | Posted | | Count of Participants | | Participants | | During the 4-day (Days 0-3) post-vaccination period | | | | ID | Title | Description |
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| OG000 | Nimenrix Group (≥ 6 Years) | Healthy male or female subjects between, and including 6 and 10 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0. | | OG001 | Menjugate Group (≥ 6 Years) | Healthy male or female subjects between, and including 6 and 10 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0. |
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| Secondary | Number of Subjects Between 2 and 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Solicited general symptoms assessed were drowsiness, fever [defined as oral temperature ≥ 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the general symptom regardless of intensity grade and relationship to vaccination. Grade 3 Symptom = symptom that prevented normal activity. Grade 3 Loss of appetite = did not eat at all. Grade 3 Fever = fever > 39.5°C. Related = general symptoms assessed by the investigator as causally related to vaccination | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with their symptom sheets filled in, for whom data were available. | Posted | | Count of Participants | | Participants | | During the 4-day (Days 0-3) post-vaccination period | | | | ID | Title | Description |
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| OG000 | Nimenrix Group (< 6 Years) | Healthy male or female subjects between, and including 2 to 5 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0. | | OG001 | Menjugate Group (< 6 Years) | Healthy male or female subjects between, and including 2 to 5 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0. |
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| Secondary | Number of Subjects Between 6 and 10 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Solicited general symptoms assessed were drowsiness, fever [defined as oral temperature ≥ 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the general symptom regardless of intensity grade and relationship to vaccination. Grade 3 Symptom = symptom that prevented normal activity. Grade 3 Loss of appetite = did not eat at all. Grade 3 Fever = fever > 39.5°C. Related = general symptoms assessed by the investigator as causally related to vaccination | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with their symptom sheets filled in, for whom data were available. | Posted | | Count of Participants | | Participants | | During the 4-day (Days 0-3) post-vaccination period | | | | ID | Title | Description |
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| OG000 | Nimenrix Group (≥ 6 Years) | Healthy male or female subjects between, and including 6 and 10 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0. | | OG001 | Menjugate Group (≥ 6 Years) | Healthy male or female subjects between, and including 6 and 10 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0. |
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| Secondary | Number of Subjects Reporting Specific Adverse Events | Specific AEs included: - rash (hives, idiopathic thrombocytopenic purpura, petechiae); - new onset of chronic illness(es) (NOCI) (e.g. autoimmune disorders, asthma, type I diabetes and allergies); - conditions prompting emergency room (ER) visits. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available. | Posted | | Count of Participants | | Participants | | Up to 6 months after vaccination (Month 6) | | | | ID | Title | Description |
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| OG000 | Nimenrix Group | Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0. | | OG001 | Menjugate Group | Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0. |
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| 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available. | Posted | | Count of Participants | | Participants | | During the 31-day (Days 0-30) post-vaccination period | | | | ID | Title | Description |
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| OG000 | Nimenrix Group | Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0. | | OG001 | Menjugate Group | Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0. |
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| Secondary | Number of Subjects With Any Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available. | Posted | | Count of Participants | | Participants | | Up to six months after vaccination (Month 6) | | | | ID | Title | Description |
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| OG000 | Nimenrix Group | Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0. | | OG001 | Menjugate Group | Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0. |
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