Infections, Meningococcal
Conditions
Keywords
Young adults, Adolescents, Reactogenicity, Diphtheria, pertussis, Immunogenicity, Tetanus, Meningococcal vaccines, Safety, Neisseria meningitidis, Healthy
Brief summary
The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the meningococcal conjugate vaccine (MenACWY-TT) co-administered with Boostrix® versus each of the two vaccines given separately in healthy adolescents and young adults.
Interventions
BIOLOGICALMeningococcal vaccine GSK134612
One dose administered intramuscularly (IM) in the deltoid muscle of the arm.
BIOLOGICALBoostrix®
One dose administered intramuscularly (IM) in the deltoid of the right arm (in Co-ad Group) and left arm (in TdapACWY and ACWYTdap Groups).
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
11 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy subjects as established by medical history and clinical examination before entering into the study. * Subjects and subjects' parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * A male or female between, and including, 11 and 25 years of age at the time of the first vaccination. * Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the subject. * Written informed assent obtained from the subjects when applicable according to local regulations. * Female subjects of non-childbearing potential may be enrolled in the study. * Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy or ovariectomy. * Female subjects of childbearing potential may be enrolled in the study, if the subject: * has practiced adequate contraception for 30 days prior to vaccination, and * has a negative pregnancy test on the day of vaccination, and * has agreed to continue adequate contraception during the entire treatment period and for two months after completion of the vaccination series.
Exclusion criteria
* Child in care. * Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone ≥ 10 mg/day, or equivalent. Inhaled and topical steroids are allowed. * Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose of vaccine and ending 30 days after the last dose of vaccine, with the exception of licensed inactivated influenza vaccine. * 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. * Previous vaccination with a meningococcal vaccine. * History of meningococcal disease. * Vaccination with a DTP-containing vaccine within the previous five years. * History of serious allergic reaction following any other DTP-containing vaccine or any component of the study vaccines. * History of encephalopathy within seven days following administration of a previous dose of pertussis vaccine that is not attributable to another identifiable cause. * Temperature of ≥ 40.5°C (105°F) within 48 hours of receipt of a previous dose of DTP vaccine, not due to another identifiable cause. * Collapse or shock-like state within 48 hours of receipt of a previous dose of DTP vaccine. * Seizures with or without fever within three days of a previous dose of DTP vaccine. * Severe Arthus-type hypersensitivity reactions following a prior dose of tetanus toxoid (TT) within the previous ten years. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination during the study period. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s). * Progressive neurologic disorder, uncontrolled epilepsy or progressive encephalopathy. * History of any neurologic disorders or seizures, including Guillain-Barré syndrome (GBS). History of a simple, single febrile seizure is permitted. * Bleeding disorders, such as haemophilia or thrombocytopenia, or subjects on anticoagulant therapy. * 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. * Pregnant or lactating female. * Female planning to become pregnant or planning to discontinue contraceptive precautions. * Family history of congenital or hereditary immunodeficiency. * Major congenital defects or serious chronic illness. * Acute disease and/or fever at the time of enrolment. * Fever is defined as temperature ≥ 37.5°C /99.5°F for oral, axillary or tympanic route. * Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA) | One month after Nimenrix vaccination (i.e. Month 1 for Nimenrix+Boostrix and Nimenrix Groups and Month 2 for Boostrix Group) | 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. |
| Number of Subjects With Anti-D and Anti-T Concentrations Above the Cut-off Value | One month after Boostrix vaccination (i.e. Month 1) | 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. |
| Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | One month after Boostrix vaccination (i.e. Month 1) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti-T Antibody Concentrations | 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 | The antibody concentrations were tabulated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL). |
| Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Above the Cut-off Value | 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) | The reference cut-off value of the assay was an antibody concentration ≥ 5.0 ELISA units per milliliter (EL.U/mL) |
| Booster Responses for Anti-PT, Anti-FHA and Anti-PRN Concentrations | One month after Boostrix vaccination (i.e. Month 1 for Nimenrix + Boostrix Group and Boostrix Group and Month 2 for Nimenrix Group) | 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. |
| Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | During the 4-day (Days 0-3) following each vaccination | 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). |
| Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres Above the Cut-off Values | 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) | The reference cut-off values of the assay were rSBA-Men antibody concentrations ≥ 1:128 and ≥ 1:8. |
| Number of Subjects With New Onset of Chronic Diseases (NOCDs) | Throughout the study (Month 0 up to Month 2) | NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. |
| Number of Subjects With Unsolicited Adverse Events AE(s) | During the 31-day (Days 0-30) post-vaccination period | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. |
| Number of Subjects With Serious Adverse Events SAE(s) | Throughout the study (Month 0 up to Month 2) | 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 Any, Grade 3 and Related Solicited General Symptoms | During the 4-day (Days 0-3) period following each vaccination | 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. |
| Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies | One month after Nimenrix vaccination (i.e. Month 1 for Nimenrix+Boostrix and Nimenrix Groups and Month 2 for Boostrix Group) | 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. |
| Anti-D Antibody Concentrations | 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) | The antibody concentrations were tabulated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL). |
Countries
Dominican Republic, Germany, South Korea
Participant flow
Pre-assignment details
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms. Out of the 692 subjects enrolled in this study, one subject was eliminated due to not receiving vaccination, hence only 691 subject started the study.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 231 |
| 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. | 228 |
| 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. | 232 |
| Total | 691 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Nimenrix+ Boostrix Group | Nimenrix Group | Boostrix Group | Total |
|---|---|---|---|---|
| Age, Continuous | 18.1 Years STANDARD_DEVIATION 4.2 | 18.2 Years STANDARD_DEVIATION 4.5 | 18.3 Years STANDARD_DEVIATION 4.4 | 18.2 Years STANDARD_DEVIATION 4.4 |
| Race/Ethnicity, Customized Ethnicity Asian - East Asian Heritage | 111 Participants | 109 Participants | 111 Participants | 331 Participants |
| Race/Ethnicity, Customized Ethnicity Asian - South East Asian Heritage | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Ethnicity Other | 60 Participants | 59 Participants | 59 Participants | 178 Participants |
| Race/Ethnicity, Customized Ethnicity White - Caucasian / European Heritage | 60 Participants | 60 Participants | 61 Participants | 181 Participants |
| Sex: Female, Male Female | 128 Participants | 126 Participants | 146 Participants | 400 Participants |
| Sex: Female, Male Male | 103 Participants | 102 Participants | 86 Participants | 291 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 231 | 0 / 228 | 0 / 232 |
| other Total, other adverse events | 190 / 231 | 166 / 228 | 180 / 232 |
| serious Total, serious adverse events | 0 / 231 | 0 / 228 | 3 / 232 |
Outcome results
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.
Time frame: One month after Nimenrix vaccination (i.e. Month 1 for Nimenrix+Boostrix and Nimenrix Groups and Month 2 for Boostrix Group)
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix + Boostrix Group | Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA) | rSBA-MenC | 5092.5 EL.U/mL |
| Nimenrix + Boostrix Group | Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA) | rSBA-MenY | 7775.8 EL.U/mL |
| Nimenrix + Boostrix Group | Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA) | rSBA-MenW-135 | 9608.5 EL.U/mL |
| Nimenrix + Boostrix Group | Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA) | rSBA-MenA | 3415.3 EL.U/mL |
| Nimenrix Group | Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA) | rSBA-MenW-135 | 9052.8 EL.U/mL |
| Nimenrix Group | Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA) | rSBA-MenY | 6032.6 EL.U/mL |
| Nimenrix Group | Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA) | rSBA-MenC | 4597.6 EL.U/mL |
| Nimenrix Group | Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA) | rSBA-MenA | 2860.4 EL.U/mL |
| Boostrix Group | Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA) | rSBA-MenY | 4134.4 EL.U/mL |
| Boostrix Group | Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA) | rSBA-MenA | 1577.4 EL.U/mL |
| Boostrix Group | Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA) | rSBA-MenW-135 | 3164.6 EL.U/mL |
| Boostrix Group | Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA) | rSBA-MenC | 1912.6 EL.U/mL |
Comparison: 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.95% CI: [0.97, 1.48]ANCOVA
Comparison: 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 C, one month after Nimenrix vaccination.95% CI: [0.85, 1.47]ANCOVA
Comparison: 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 W-135, one month after Nimenrix vaccination.95% CI: [0.86, 1.32]ANCOVA
Comparison: 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 Y, one month after Nimenrix vaccination.95% CI: [1.02, 1.59]ANCOVA
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
Time frame: One month after Boostrix vaccination (i.e. Month 1)
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix + Boostrix Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PT | 53.6 IU/mL |
| Nimenrix + Boostrix Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-FHA | 316.9 IU/mL |
| Nimenrix + Boostrix Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PRN | 348.3 IU/mL |
| Nimenrix Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PT | 68.0 IU/mL |
| Nimenrix Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-FHA | 545.0 IU/mL |
| Nimenrix Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PRN | 499.0 IU/mL |
Comparison: To demonstrate the non-inferiority of Boostrix co-administered with Nimenrix (Nimenrix+Boostrix Group) compared to Boostrix administered alone (Boostrix Group) with respect to geometric mean concentrations (GMCs) of antibodies against pertussis toxoid (PT), one month after Boostrix vaccination.95% CI: [0.66, 0.89]ANCOVA
Comparison: To demonstrate the non-inferiority of Boostrix co-administered with Nimenrix (Nimenrix+Boostrix Group) compared to Boostrix administered alone (Boostrix Group) with respect to geometric mean concentrations (GMCs) of antibodies against filamentous haemagglutinin (FHA), one month after Boostrix vaccination.95% CI: [0.5, 0.65]ANCOVA
Comparison: To demonstrate the non-inferiority of Boostrix co-administered with Nimenrix (Nimenrix+Boostrix Group) compared to Boostrix administered alone (Boostrix Group) with respect to geometric mean concentrations (GMCs) of antibodies against pertactin (PRN), one month after Boostrix vaccination.95% CI: [0.59, 0.88]ANCOVA
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.
Time frame: One month after Boostrix vaccination (i.e. Month 1)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix + Boostrix Group | Number of Subjects With Anti-D and Anti-T Concentrations Above the Cut-off Value | Anti-D | 200 Participants |
| Nimenrix + Boostrix Group | Number of Subjects With Anti-D and Anti-T Concentrations Above the Cut-off Value | Anti-T | 224 Participants |
| Nimenrix Group | Number of Subjects With Anti-D and Anti-T Concentrations Above the Cut-off Value | Anti-D | 203 Participants |
| Nimenrix Group | Number of Subjects With Anti-D and Anti-T Concentrations Above the Cut-off Value | Anti-T | 223 Participants |
Comparison: To demonstrate the non-inferiority of Boostrix co-administered with Nimenrix (Nimenrix+Boostrix Group) compared to Boostrix administered alone (Boostrix Group) in terms of anti-diphtheria toxoid (anti-D) antibody concentrations one month after Boostrix vaccination.95% CI: [-7.88, 3.53]
Comparison: To demonstrate the non-inferiority of Boostrix co-administered with Nimenrix (Nimenrix+Boostrix Group) compared to Boostrix administered alone (Boostrix Group) in terms of anti-tetanus toxoid (anti-T) antibody concentrations one month after Boostrix vaccination.95% CI: [-2.48, 1.26]
Secondary
Anti-D Antibody Concentrations
The antibody concentrations were tabulated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL).
Time frame: 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)
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix + Boostrix Group | Anti-D Antibody Concentrations | Anti-D, PRE | 0.3 IU/mL |
| Nimenrix + Boostrix Group | Anti-D Antibody Concentrations | Anti-D, POST | 4.0 IU/mL |
| Nimenrix Group | Anti-D Antibody Concentrations | Anti-D, PRE | 0.3 IU/mL |
| Nimenrix Group | Anti-D Antibody Concentrations | Anti-D, POST | 4.6 IU/mL |
| Boostrix Group | Anti-D Antibody Concentrations | Anti-D, PRE | 0.3 IU/mL |
| Boostrix Group | Anti-D Antibody Concentrations | Anti-D, POST | 4.7 IU/mL |
Secondary
Anti-T Antibody Concentrations
The antibody concentrations were tabulated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL).
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix + Boostrix Group | Anti-T Antibody Concentrations | Anti-T, pre-vaccination | 0.6 IU/mL |
| Nimenrix + Boostrix Group | Anti-T Antibody Concentrations | Anti-T, Month 1 | 23.5 IU/mL |
| Nimenrix Group | Anti-T Antibody Concentrations | Anti-T, Month 1 | 18.5 IU/mL |
| Nimenrix Group | Anti-T Antibody Concentrations | Anti-T, pre-vaccination | 0.6 IU/mL |
| Nimenrix Group | Anti-T Antibody Concentrations | Anti-T, Month 2 | 13.0 IU/mL |
| Boostrix Group | Anti-T Antibody Concentrations | Anti-T, Month 1 | 13.5 IU/mL |
| Boostrix Group | Anti-T Antibody Concentrations | Anti-T, Month 2 | 16.3 IU/mL |
| Boostrix Group | Anti-T Antibody Concentrations | Anti-T, pre-vaccination | 0.7 IU/mL |
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.
Time frame: One month after Boostrix vaccination (i.e. Month 1 for Nimenrix + Boostrix Group and Boostrix Group and Month 2 for Nimenrix Group)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix + Boostrix Group | Booster Responses for Anti-PT, Anti-FHA and Anti-PRN Concentrations | Anti-FHA antibody (assay cut-off=2.046 IU/mL) | 208 Participants |
| Nimenrix + Boostrix Group | Booster Responses for Anti-PT, Anti-FHA and Anti-PRN Concentrations | Anti-PT antibody (assay cut-off=2.693 IU/mL) | 201 Participants |
| Nimenrix + Boostrix Group | Booster Responses for Anti-PT, Anti-FHA and Anti-PRN Concentrations | Anti-PRN antibody (assay cut-off=2.187 IU/mL) | 209 Participants |
| Nimenrix Group | Booster Responses for Anti-PT, Anti-FHA and Anti-PRN Concentrations | Anti-FHA antibody (assay cut-off=2.046 IU/mL) | 210 Participants |
| Nimenrix Group | Booster Responses for Anti-PT, Anti-FHA and Anti-PRN Concentrations | Anti-PT antibody (assay cut-off=2.693 IU/mL) | 188 Participants |
| Nimenrix Group | Booster Responses for Anti-PT, Anti-FHA and Anti-PRN Concentrations | Anti-PRN antibody (assay cut-off=2.187 IU/mL) | 198 Participants |
| Boostrix Group | Booster Responses for Anti-PT, Anti-FHA and Anti-PRN Concentrations | Anti-PT antibody (assay cut-off=2.693 IU/mL) | 201 Participants |
| Boostrix Group | Booster Responses for Anti-PT, Anti-FHA and Anti-PRN Concentrations | Anti-PRN antibody (assay cut-off=2.187 IU/mL) | 207 Participants |
| Boostrix Group | Booster Responses for Anti-PT, Anti-FHA and Anti-PRN Concentrations | Anti-FHA antibody (assay cut-off=2.046 IU/mL) | 213 Participants |
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).
Time frame: During the 4-day (Days 0-3) following each vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix + Boostrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain, post-Boostrix | 121 Participants |
| Nimenrix + Boostrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Total | 15 Participants |
| Nimenrix + Boostrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, post-Boostrix | 7 Participants |
| Nimenrix + Boostrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling, Total | 71 Participants |
| Nimenrix + Boostrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness, post-Boostrix | 61 Participants |
| Nimenrix + Boostrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, post-Boostrix | 1 Participants |
| Nimenrix + Boostrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Total | 5 Participants |
| Nimenrix + Boostrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling, post-Boostrix | 48 Participants |
| Nimenrix + Boostrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, post-Boostrix | 3 Participants |
| Nimenrix + Boostrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain, post-Nimenrix | 155 Participants |
| Nimenrix + Boostrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, post-Nimenrix | 13 Participants |
| Nimenrix + Boostrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness, Total | 81 Participants |
| Nimenrix + Boostrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness, post-Nimenrix | 64 Participants |
| Nimenrix + Boostrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, post-Nimenrix | 3 Participants |
| Nimenrix + Boostrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain, Total | 176 Participants |
| Nimenrix + Boostrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling, post-Nimenrix | 57 Participants |
| Nimenrix + Boostrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Total | 4 Participants |
| Nimenrix + Boostrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, post-Nimenrix | 3 Participants |
| Nimenrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling, post-Nimenrix | 51 Participants |
| Nimenrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain, post-Boostrix | 101 Participants |
| Nimenrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain, post-Nimenrix | 121 Participants |
| Nimenrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain, Total | 148 Participants |
| Nimenrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, post-Boostrix | 8 Participants |
| Nimenrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, post-Nimenrix | 5 Participants |
| Nimenrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, post-Nimenrix | 12 Participants |
| Nimenrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness, post-Boostrix | 54 Participants |
| Nimenrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling, Total | 71 Participants |
| Nimenrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, post-Nimenrix | 4 Participants |
| Nimenrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, post-Boostrix | 6 Participants |
| Nimenrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Total | 10 Participants |
| Nimenrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness, post-Nimenrix | 56 Participants |
| Nimenrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling, post-Boostrix | 47 Participants |
| Nimenrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Total | 9 Participants |
| Nimenrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness, Total | 75 Participants |
| Nimenrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, post-Boostrix | 5 Participants |
| Nimenrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Total | 19 Participants |
| Boostrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, post-Boostrix | 1 Participants |
| Boostrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain, Total | 167 Participants |
| Boostrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Total | 8 Participants |
| Boostrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness, Total | 76 Participants |
| Boostrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Total | 6 Participants |
| Boostrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Total | 7 Participants |
| Boostrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain, post-Nimenrix | 156 Participants |
| Boostrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, post-Nimenrix | 8 Participants |
| Boostrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness, post-Nimenrix | 65 Participants |
| Boostrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, post-Nimenrix | 5 Participants |
| Boostrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling, post-Nimenrix | 54 Participants |
| Boostrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, post-Nimenrix | 7 Participants |
| Boostrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain, post-Boostrix | 92 Participants |
| Boostrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, post-Boostrix | 0 Participants |
| Boostrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness, post-Boostrix | 39 Participants |
| Boostrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, post-Boostrix | 4 Participants |
| Boostrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling, post-Boostrix | 33 Participants |
| Boostrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling, Total | 68 Participants |
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.
Time frame: During the 4-day (Days 0-3) period following each vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix + Boostrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 75 Participants |
| Nimenrix + Boostrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 2 Participants |
| Nimenrix + Boostrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 70 Participants |
| Nimenrix + Boostrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms | 23 Participants |
| Nimenrix + Boostrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms | 2 Participants |
| Nimenrix + Boostrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms | 20 Participants |
| Nimenrix + Boostrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 51 Participants |
| Nimenrix + Boostrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 2 Participants |
| Nimenrix + Boostrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 49 Participants |
| Nimenrix + Boostrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Temperature | 14 Participants |
| Nimenrix + Boostrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature | 0 Participants |
| Nimenrix + Boostrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Temperature | 10 Participants |
| Nimenrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Temperature | 15 Participants |
| Nimenrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 77 Participants |
| Nimenrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 76 Participants |
| Nimenrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 67 Participants |
| Nimenrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 5 Participants |
| Nimenrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms | 25 Participants |
| Nimenrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature | 0 Participants |
| Nimenrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 67 Participants |
| Nimenrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 5 Participants |
| Nimenrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms | 2 Participants |
| Nimenrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms | 31 Participants |
| Nimenrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Temperature | 17 Participants |
| Boostrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms | 25 Participants |
| Boostrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms | 1 Participants |
| Boostrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Temperature | 11 Participants |
| Boostrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms | 18 Participants |
| Boostrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 65 Participants |
| Boostrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 2 Participants |
| Boostrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature | 0 Participants |
| Boostrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 81 Participants |
| Boostrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 4 Participants |
| Boostrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 53 Participants |
| Boostrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 70 Participants |
| Boostrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Temperature | 9 Participants |
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)
Time frame: 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)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix + Boostrix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Above the Cut-off Value | Anti-PT, PRE | 162 Participants |
| Nimenrix + Boostrix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Above the Cut-off Value | Anti-FHA, Month 1/Month 2 | 225 Participants |
| Nimenrix + Boostrix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Above the Cut-off Value | Anti-FHA, PRE | 222 Participants |
| Nimenrix + Boostrix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Above the Cut-off Value | Anti-PRN, Month 1/Month 2 | 223 Participants |
| Nimenrix + Boostrix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Above the Cut-off Value | Anti-PRN, PRE | 200 Participants |
| Nimenrix + Boostrix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Above the Cut-off Value | Anti-PT, Month 1/Month 2 | 221 Participants |
| Nimenrix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Above the Cut-off Value | Anti-FHA, PRE | 221 Participants |
| Nimenrix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Above the Cut-off Value | Anti-PRN, Month 1/Month 2 | 218 Participants |
| Nimenrix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Above the Cut-off Value | Anti-PT, PRE | 156 Participants |
| Nimenrix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Above the Cut-off Value | Anti-PT, Month 1/Month 2 | 220 Participants |
| Nimenrix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Above the Cut-off Value | Anti-FHA, Month 1/Month 2 | 220 Participants |
| Nimenrix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Above the Cut-off Value | Anti-PRN, PRE | 200 Participants |
| Boostrix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Above the Cut-off Value | Anti-PRN, PRE | 207 Participants |
| Boostrix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Above the Cut-off Value | Anti-FHA, Month 1/Month 2 | 223 Participants |
| Boostrix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Above the Cut-off Value | Anti-PT, PRE | 153 Participants |
| Boostrix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Above the Cut-off Value | Anti-PRN, Month 1/Month 2 | 221 Participants |
| Boostrix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Above the Cut-off Value | Anti-FHA, PRE | 220 Participants |
| Boostrix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Above the Cut-off Value | Anti-PT, Month 1/Month 2 | 223 Participants |
Secondary
Number of Subjects With New Onset of Chronic Diseases (NOCDs)
NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.
Time frame: Throughout the study (Month 0 up to Month 2)
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix + Boostrix Group | Number of Subjects With New Onset of Chronic Diseases (NOCDs) | 1 Participants |
| Nimenrix Group | Number of Subjects With New Onset of Chronic Diseases (NOCDs) | 5 Participants |
| Boostrix Group | Number of Subjects With New Onset of Chronic Diseases (NOCDs) | 3 Participants |
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.
Time frame: 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)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix + Boostrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres Above the Cut-off Values | rSBA-MenY ≥ 1:8 | 226 Participants |
| Nimenrix + Boostrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres Above the Cut-off Values | rSBA-MenA ≥ 1:128 | 48 Participants |
| Nimenrix + Boostrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres Above the Cut-off Values | rSBA-MenY ≥ 1:128 | 225 Participants |
| Nimenrix + Boostrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres Above the Cut-off Values | rSBA-MenW-135 ≥ 1:8 | 80 Participants |
| Nimenrix + Boostrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres Above the Cut-off Values | rSBA-MenC ≥ 1:128 | 224 Participants |
| Nimenrix + Boostrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres Above the Cut-off Values | rSBA-MenA ≥ 1:8 | 31 Participants |
| Nimenrix + Boostrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres Above the Cut-off Values | rSBA-MenW-135 ≥ 1:128 | 13 Participants |
| Nimenrix + Boostrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres Above the Cut-off Values | rSBA-MenC ≥ 1:8 | 226 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres Above the Cut-off Values | rSBA-MenW-135 ≥ 1:128 | 33 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres Above the Cut-off Values | rSBA-MenA ≥ 1:128 | 46 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres Above the Cut-off Values | rSBA-MenW-135 ≥ 1:8 | 56 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres Above the Cut-off Values | rSBA-MenY ≥ 1:8 | 219 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres Above the Cut-off Values | rSBA-MenA ≥ 1:8 | 29 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres Above the Cut-off Values | rSBA-MenC ≥ 1:8 | 220 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres Above the Cut-off Values | rSBA-MenY ≥ 1:128 | 218 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres Above the Cut-off Values | rSBA-MenC ≥ 1:128 | 220 Participants |
| Boostrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres Above the Cut-off Values | rSBA-MenY ≥ 1:8 | 222 Participants |
| Boostrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres Above the Cut-off Values | rSBA-MenA ≥ 1:128 | 33 Participants |
| Boostrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres Above the Cut-off Values | rSBA-MenC ≥ 1:128 | 220 Participants |
| Boostrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres Above the Cut-off Values | rSBA-MenW-135 ≥ 1:128 | 30 Participants |
| Boostrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres Above the Cut-off Values | rSBA-MenY ≥ 1:128 | 220 Participants |
| Boostrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres Above the Cut-off Values | rSBA-MenA ≥ 1:8 | 23 Participants |
| Boostrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres Above the Cut-off Values | rSBA-MenC ≥ 1:8 | 216 Participants |
| Boostrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres Above the Cut-off Values | rSBA-MenW-135 ≥ 1:8 | 70 Participants |
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.
Time frame: Throughout the study (Month 0 up to Month 2)
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix + Boostrix Group | Number of Subjects With Serious Adverse Events SAE(s) | 0 Participants |
| Nimenrix Group | Number of Subjects With Serious Adverse Events SAE(s) | 0 Participants |
| Boostrix Group | Number of Subjects With Serious Adverse Events SAE(s) | 3 Participants |
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.
Time frame: During the 31-day (Days 0-30) post-vaccination period
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix + Boostrix Group | Number of Subjects With Unsolicited Adverse Events AE(s) | 36 Participants |
| Nimenrix Group | Number of Subjects With Unsolicited Adverse Events AE(s) | 44 Participants |
| Boostrix Group | Number of Subjects With Unsolicited Adverse Events AE(s) | 58 Participants |
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.
Time frame: One month after Nimenrix vaccination (i.e. Month 1 for Nimenrix+Boostrix and Nimenrix Groups and Month 2 for Boostrix Group)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix + Boostrix Group | Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies | rSBA-MenA | 217 Participants |
| Nimenrix + Boostrix Group | Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies | rSBA-MenC | 225 Participants |
| Nimenrix + Boostrix Group | Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies | rSBA-MenW-135 | 225 Participants |
| Nimenrix + Boostrix Group | Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies | rSBA-MenY | 220 Participants |
| Nimenrix Group | Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies | rSBA-MenY | 214 Participants |
| Nimenrix Group | Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies | rSBA-MenA | 207 Participants |
| Nimenrix Group | Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies | rSBA-MenW-135 | 216 Participants |
| Nimenrix Group | Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies | rSBA-MenC | 210 Participants |
| Boostrix Group | Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies | rSBA-MenY | 212 Participants |
| Boostrix Group | Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies | rSBA-MenC | 215 Participants |
| Boostrix Group | Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies | rSBA-MenW-135 | 211 Participants |
| Boostrix Group | Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies | rSBA-MenA | 214 Participants |