| Primary | Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA) | The analysis was performed for the serogroups -MenA, -MenC -MenW-135 and -MenY. Antibody titers tabulated as geometric mean titers (GMTs), were obtained by serum bactericidal assay using rabbit complement and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The primary outcome results only refer to Nimenrix+Boostrix Group and Nimenrix Group. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity will included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccine dose. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | One month after Nimenrix vaccination (i.e. Month 1 for Nimenrix+Boostrix and Nimenrix Groups and Month 2 for Boostrix Group) | | | | ID | Title | Description |
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| OG000 | Nimenrix + Boostrix Group | Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle. | | OG001 | Nimenrix Group | Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle. | | OG002 | Boostrix Group | Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle. |
| | | Title | Denominators | Categories |
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| rSBA-MenA | - ParticipantsOG000225
- ParticipantsOG001222
- ParticipantsOG002223
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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 Nimenrix co-administered with Boostrix (Nimenrix+Boostrix Group) compared to Nimenrix administered alone (Nimenrix Group) with respect to serum bactericidal assay using rabbit complement (rSBA) geometric mean titers (GMTs) for serogroup A, one month after Nimenrix vaccination. | ANCOVA | | | | Adjusted GMT ratio | 1.19 | | | 2-Sided | 95 | 0.97 | 1.48 | | | | | Non-Inferiority | Non-inferiority was defined as the lower limit (LL) of the two-sided standardised asymptotic 95% confidence interval (CI) for rSBA GMT ratios for serogroup A between the two groups (Nimenrix+Boostrix Group minus Nimenrix Group) being greater than or equal to (≥) the pre-defined limit of 0.5. |
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| Primary | Number of Subjects With Anti-D and Anti-T Concentrations Above the Cut-off Value | The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL). The reference cut-off value was an antibody concentration ≥ 1 IU/mL. The primary outcome results only refer to Nimenrix+Boostrix Group and Boostrix Group. | The analysis was performed on the ATP cohort for immunogenicity will included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccine dose. | Posted | | Count of Participants | | Participants | | One month after Boostrix vaccination (i.e. Month 1) | | | | ID | Title | Description |
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| OG000 | Nimenrix + Boostrix Group | Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle. | | OG001 | Boostrix Group | Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle. |
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| Primary | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | The antibody concentrations were tabulated as adjusted geometric mean concentrations (GMCs) and expressed as international units per millilitre (IU/mL). The primary outcome results only refer to Nimenrix+Boostrix Group and Boostrix Group | The analysis was performed on the ATP cohort for immunogenicity will included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccine dose. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | One month after Boostrix vaccination (i.e. Month 1) | | | | ID | Title | Description |
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| OG000 | Nimenrix + Boostrix Group | Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle. | | OG001 | Boostrix Group | Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle. |
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| Secondary | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres Above the Cut-off Values | The reference cut-off values of the assay were rSBA-Men antibody concentrations ≥ 1:128 and ≥ 1:8. | The analysis was performed on the ATP cohort for immunogenicity will included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccine dose. | Posted | | Count of Participants | | Participants | | Prior to (i.e. Month 0 for Nimenrix+Boostrix and Nimenrix Groups and Month 1 for Boostrix Group) and one month after Nimenrix vaccination (i.e. Month 1 for Nimenrix+Boostrix and Nimenrix Groups and Month 2 for Boostrix Group) | | | | ID | Title | Description |
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| OG000 | Nimenrix + Boostrix Group | Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle. | | OG001 | Nimenrix Group | Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle. | | OG002 |
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| Secondary | Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies | rSBA vaccine response for serogroups A, C, W-135 and Y was defined as:
- For initially seronegative subjects (pre-vaccination titer below the cut-off of 1:8): number of subjects with rSBA antibody titers ≥ 1:32 one month after vaccination.
- For initially seropositive subjects (pre-vaccination titer ≥ 1:8): number of subjects with rSBA antibody titers at least four times the pre-vaccination antibody titers, one month after vaccination.
| The analysis was performed on the ATP cohort for immunogenicity will included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccine dose. | Posted | | Count of Participants | | Participants | | One month after Nimenrix vaccination (i.e. Month 1 for Nimenrix+Boostrix and Nimenrix Groups and Month 2 for Boostrix Group) | | | | ID | Title | Description |
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| OG000 | Nimenrix + Boostrix Group | Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle. | | OG001 | Nimenrix Group | Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle. |
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| Secondary | Anti-D Antibody Concentrations | The antibody concentrations were tabulated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL). | The analysis was performed on the ATP cohort for immunogenicity will included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccine dose. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | Prior to (PRE i.e. Month 0 for Nimenrix + Boostrix Group and Boostrix Group and Month 1 for Nimenrix Group) and one month after Boostrix vaccination (POST i.e. Month 1 for Nimenrix + Boostrix Group and Boostrix Group and Month 2 for Nimenrix Group) | | | | ID | Title | Description |
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| OG000 | Nimenrix + Boostrix Group | Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle. | | OG001 | Nimenrix Group | Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle. | | OG002 |
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| Secondary | Anti-T Antibody Concentrations | The antibody concentrations were tabulated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL). | The analysis was performed on the ATP cohort for immunogenicity will included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccine dose. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | Prior to (i.e. Month 0 for Nimenrix + Boostrix Group and Boostrix Group and Month 1 for Nimenrix Group), one month after Nimenrix vaccination and one month after Boostrix vaccination | | | | ID | Title | Description |
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| OG000 | Nimenrix + Boostrix Group | Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle. | | OG001 | Nimenrix Group | Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle. | | OG002 | Boostrix Group |
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| Secondary | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Above the Cut-off Value | The reference cut-off value of the assay was an antibody concentration ≥ 5.0 ELISA units per milliliter (EL.U/mL) | The analysis was performed on the ATP cohort for immunogenicity will included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccine dose. | Posted | | Count of Participants | | Participants | | Prior to (i.e. Month 0 for Nimenrix + Boostrix Group and Boostrix Group and Month 1 for Nimenrix Group) and one month after Boostrix vaccination (i.e. Month 1 for Nimenrix + Boostrix Group and Boostrix Group and Month 2 for Nimenrix Group) | | | | ID | Title | Description |
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| OG000 | Nimenri+ Boostrix Group | Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle. | | OG001 | Nimenrix Group | Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle. | |
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| Secondary | Booster Responses for Anti-PT, Anti-FHA and Anti-PRN Concentrations | Booster response to the pertussis components is defined as:
- For initially seronegative subjects, antibody concentration ≥ 4*cut_off (IU/mL) at one month post-vaccination;
- For initially seropositive subjects with pre-vaccination antibody concentration < 4*cut_off (IU/mL) : antibody concentration at one month post-vaccination ≥ 4 fold the pre-vaccination antibody concentration;
- For initially seropositive subjects with pre-vaccination antibody concentration ≥ 4*cut_off (IU/mL) : antibody concentration at one month post-vaccination ≥ 2 fold the pre-vaccination antibody concentration.
| The analysis was performed on the ATP cohort for immunogenicity will included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccine dose. | Posted | | Count of Participants | | Participants | | One month after Boostrix vaccination (i.e. Month 1 for Nimenrix + Boostrix Group and Boostrix Group and Month 2 for Nimenrix Group) | | | | ID | Title | Description |
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| OG000 | Nimenrix + Boostrix Group | Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle. | | OG001 | Nimenrix Group | Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle. |
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| Secondary | Number of Subjects Reporting 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 = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Results are presented across doses, after each vaccination (with Nimenrix, Boostrix, total). | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Count of Participants | | Participants | | During the 4-day (Days 0-3) following each vaccination | | | | ID | Title | Description |
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| OG000 | Nimenrix + Boostrix Group | Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle. | | OG001 | Nimenrix Group | Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle. | | OG002 | Boostrix Group |
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| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. Results are presented across doses. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Count of Participants | | Participants | | During the 4-day (Days 0-3) period following each vaccination | | | | ID | Title | Description |
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| OG000 | Nimenrix + Boostrix Group | Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle. | | OG001 | Nimenrix Group | Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle. | |
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| Secondary | Number of Subjects With New Onset of Chronic Diseases (NOCDs) | NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Count of Participants | | Participants | | Throughout the study (Month 0 up to Month 2) | | | | ID | Title | Description |
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| OG000 | Nimenrix + Boostrix Group | Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle. | | OG001 | Nimenrix Group | Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle. | | OG002 | Boostrix Group | Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle. |
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| Secondary | Number of Subjects With Unsolicited Adverse Events AE(s) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Count of Participants | | Participants | | During the 31-day (Days 0-30) post-vaccination period | | | | ID | Title | Description |
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| OG000 | Nimenrix + Boostrix Group | Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle. | | OG001 | Nimenrix Group | Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle. |
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| Secondary | Number of Subjects With Serious Adverse Events SAE(s) | 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. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented. | Posted | | Count of Participants | | Participants | | Throughout the study (Month 0 up to Month 2) | | | | ID | Title | Description |
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| OG000 | Nimenrix + Boostrix Group | Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle. | | OG001 | Nimenrix Group | Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle. | | OG002 | Boostrix Group | Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle. |
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