Acellular Pertussis, Tetanus, Diphtheria
Conditions
Keywords
tetanus, pertussis, Prophylaxis, meningococcus, diptheria
Brief summary
New immunization recommendations in the US include vaccination of adolescents against pertussis and meningococcal disease. The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention recommends that Tdap (Tetanus Toxoid, Reduced Diphtheria Toxoid And Acellular Pertussis Vaccine Adsorbed) and MCV4 (Meningococcal conjugate vaccine against serotypes A, C, Y and W-135) vaccines be administered to adolescents at the same office visit if vaccination with both vaccines is indicated. Therefore, this study is designed to evaluate the safety and immunogenicity of a booster vaccination with Boostrix co-administered with Menactra as compared to the administration of either vaccine alone in healthy adolescents 11 - 18 years of age.
Detailed description
A phase IV, randomized, partially blinded multicenter study to evaluate the safety and immunogenicity of a booster vaccination with GlaxoSmithKline's tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed \[Tdap Boostrix®\] co-administered intramuscularly with Aventis-Pasteur's meningococcal (serogroups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine (Menactra™) as compared to the administration of either vaccine alone in healthy adolescents 11-18 years of age. Experimental design: Prospective, randomized, controlled multicenter study with three groups: Group 1: Boostrix + Menactra on Day 0, blood samples at Month 0 and Month 1 Group 2: Boostrix on Day 0, Menactra at Month 1, blood samples at Month 0, Month 1, and Month 2 Group 3: Menactra on Day 0, Boostrix at Month 1, blood samples at Month 0, Month 1 and Month 2 Treatment allocation: randomized 1:1:1 Type of study: self-contained Duration of the study: Approximately one month for each subject in Group 1 and approximately two months for each subject in the Group 2 and Group 3.
Interventions
BIOLOGICALBoostrix®
GlaxoSmithKline (GSK) Biologicals' registered tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, containing 0.3 mg aluminum.
BIOLOGICALMenactra™
Aventis Pasteur's me ningococcal polysaccharide diphtheria toxoid conjugate vaccine containing Neisseria meningitidis serogroups, A, C, Y and W-135.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
11 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy subjects as established by medical history and history-directed physical examination before entering into the study. * Previously completed routine childhood vaccinations against diphtheria, tetanus and pertussis diseases according to the recommended vaccination schedule at the time. * Females of childbearing potential at the time of study entry are required to have a negative pregnancy test prior to administration of the dose of vaccine and are required to be abstinent or use adequate contraceptive precautions for one month prior to vaccination. Subjects also are required to agree to continue such precautions for two months after vaccination.
Exclusion criteria
* Administration of a pre-school booster of DTP vaccine within the previous 5 years * Administration of a diphteria-tetanus (Td) booster within the previous 5 years * Previous vaccination against N. meningitidis * Hypersensitivity to latex * History of serious allergic reaction (e.g. anaphylaxis) following any other tetanus toxoid, diphteria toxoid or pertussis-containing vaccine or any component of the study vaccines * History of encephalopathy (e.g. coma, decreased level of consciousness, prolonged seizures) within seven days of administration of a previous dose of pertussis vaccine taht is not attributable to another identifiable cause * Progressive neurologic disorder, uncontrolled epilepsy or progressive encephalopathy: pertussis vaccine should not be administered to individuals with these conditions until a treatment regimen has been established and the condition has stabilized * Previous history of Guillain-Barré syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | At Month 1 (post Boostrix vaccination) | Cut-off values assessed were greater than or equal to 1.0 international units per milliliter (IU/mL). |
| Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | At Month 1 (post Boostrix vaccination) | Concentrations were presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). |
| Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies | At Month 1 (post Boostrix vaccination) | Booster responses for anti-PT, anti-FHA and anti-PRN antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below the cut-off concentration of 5 EL.U/mL): antibody concentrations at least four times the cut-off (postvaccination concentration ≥ 20 EL.U/mL) one month after vaccination with the Boostrix vaccine; for initially seropositive subjects with pre-vaccination concentration ≥5 EL.U/mL and \< 20 EL.U/mL: an increase in antibody concentrations of at least four times the pre-vaccination concentration, one month after vaccination with the Boostrix vaccine; and for initially seropositive subjects with pre-vaccination concentration ≥ 20 EL.U/mL: an increase in antibody concentrations of at least two times the pre-vaccination concentration one month after vaccination with the Boostrix vaccine. |
| Number of Subjects With Vaccine Responses for Serum Bactericidal Assay Against Neisseria Meningitidis Serogroups A (rSBA-MenA), C (rSBA-MenC), Y (rSBA-MenY) and W-135 (rSBA-MenW-135) | One month post Boostrix vaccination ((Month 1 for Boostrix + Menactra Group and Month 2 for Menactra-Boostrix Group) | Vaccine responses for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below the cut-off titer of 8): antibody titers at least four times the cut-off (post-vaccination concentration ≥ 32) one month after vaccination with Menactra vaccination; and for initially seropositive subjects (pre-vaccination titer ≥ 8): antibody titers at least four times the pre-vaccination antibody titers, one month after vaccination with Menactra vaccine. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Booster Responses for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | At one month POST Boostrix vaccination (Month 1 for Boostrix + Menactra Group and Boostrix-Menactra Group/ Month 2 for Menactra-Boostrix Group) | Booster responses for anti-D and anti-T antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below the cut-off concentration of 0.1 IU/mL): antibody concentrations at least four times the cut-off (postvaccination concentration ≥ 0.4 IU/mL), one month after vaccination with the Boostrix vaccine; and for initially seropositive subjects (pre-vaccination concentration ≥ 0.1 IU/mL): an increase in antibody concentrations of at least four times the pre-vaccination concentration one month after vaccination with the Boostrix vaccine. |
| Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | PRE (Day 0) and one month POST Boostrix vaccination (Month 1 for Boostrix + Menactra Group and Boostrix-Menactra Group/ Month 2 for Menactra-Boostrix Group) | Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL). |
| Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies | At Month 2 (one month post Boostrix vaccination) | Booster responses for anti-PT, anti-FHA and anti-PRN antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below the cut-off concentration of 5 EL.U/mL): antibody concentrations at least four times the cut-off (postvaccination concentration ≥20 EL.U/mL) one month after vaccination with the Boostrix vaccine; for initially seropositive subjects with pre-vaccination concentration ≥5 EL.U/mL and \< 20 EL.U/mL: an increase in antibody concentrations of at least four times the pre-vaccination concentration, one month after vaccination with the Boostrix vaccine; and for initially seropositive subjects with pre-vaccination concentration ≥ 20 EL.U/mL: an increase in antibody concentrations of at least two times the pre-vaccination concentration one month after vaccination with the Boostrix vaccine. |
| Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | At Day 0 before (PRE) Boostrix vaccination | Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Within 4-days (Day 0-3) after each dose and across doses | Assessed solicited local symptoms were pain, redness and swelling. Any = any solicited local symptom irrespective of intensity grade. Grade 3 pain = pain that prevented normal activities. Grade 3 redness/swelling = redness/swelling with diameter ≥ 50 millimeters (mm). |
| Number of Subjects With Vaccine Responses for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies | At Month 2 (one month after vaccination with Menactra vaccine) | Vaccine responses for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below the cut-off titer of 8): antibody titers at least four times the cut-off (post-vaccination concentration ≥ 32) one month after vaccination with Menactra the vaccine, and for initially seropositive subjects (pre-vaccination titer ≥ 8): antibody titers at least four times the pre-vaccination antibody titers, one month after vaccination with the Menactra vaccine. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Within 4-days (Days 0-3) after each dose and across doses | Assessed solicited general symptoms were fatigue, fever \[defined as oral temperature equal to or above 37.5 degrees Celsius (°C)\], headache and gastrointestinal symptoms \[gastro sympt\]. Any = any solicited general symptom irrespective of intensity grade or relationship to vaccination. Grade 3 = symptoms that prevented normal activities. Grade 3 Fever = temperature higher than (\>) 39° C. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain. |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Within the 31-day (Days 0-30) period after each vaccination | 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. Such an AE, for example, prevented attendance at work/school and necessitated the administration of corrective therapy. Related = AE assessed by the investigator as related to the vaccination. |
| Number of Subjects With Serious Adverse Events (SAEs) | Throughout the entire study period (Day 0 - 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. |
| Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies | PRE (Day 0) and one month POST Menactra vaccination (Month 2 for Boostrix + Menactra Group and Boostrix-Menactra Group / Month 1 for Menactra-Boostrix Group) | Antibody titers are presented as geometric mean titers (GMTs). |
| Number of Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | At Day 0 (PRE) before Boostrix vaccination | Cut-off values assessed were greater than or equal to 1.0 international units per milliliter (IU/mL). |
| Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | At Month 2 (one month post Boostrix vaccination) | Cut-off values assessed were greater than or equal to 1.0 international units per milliliter (IU/mL). |
| Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens | PRE (Day 0) and POST Boostrix vaccination (Month 1 for Boostrix + Menactra Group and Boostrix-Menactra Group/ Month 2 for Menactra-Boostrix Group) | Cut-off values assessed were greater than or equal to 0.1 international units per milliliter (IU/m L). |
Countries
United States
Participant flow
Pre-assignment details
Out of 1344 subjects enrolled, only 1341 were vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| Boostrix + Menactra Group Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-administered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region. | 446 |
| Boostrix-Menactra Group Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region. | 446 |
| Menactra-Boostrix Group Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region. | 449 |
| Total | 1,341 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 7 | 2 |
| Overall Study | Other | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 2 | 1 |
| Overall Study | Serious Adverse Events | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 6 | 4 |
Baseline characteristics
| Characteristic | Boostrix + Menactra Group | Boostrix-Menactra Group | Menactra-Boostrix Group | Total |
|---|---|---|---|---|
| Age, Continuous | 13.5 Years STANDARD_DEVIATION 2.31 | 13.2 Years STANDARD_DEVIATION 2.07 | 13.4 Years STANDARD_DEVIATION 2.27 | 13.37 Years STANDARD_DEVIATION 2.22 |
| Sex: Female, Male Female | 210 Participants | 233 Participants | 223 Participants | 666 Participants |
| Sex: Female, Male Male | 236 Participants | 213 Participants | 226 Participants | 675 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 371 / 446 | 385 / 446 | 358 / 449 |
| serious Total, serious adverse events | 1 / 446 | 0 / 446 | 1 / 449 |
Outcome results
Primary
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
Concentrations were presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Time frame: At Month 1 (post Boostrix vaccination)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity,which included all evaluable subjects with immunogenicity data available \& randomization code not broken who had received at least 1 dose of study vaccine (known administration site) \& had not received a vaccine not specified or forbidden by the protocol
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Boostrix + Menactra Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PT | 63.9 EL.U/mL |
| Boostrix + Menactra Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-FHA | 444.8 EL.U/mL |
| Boostrix + Menactra Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PRN | 253.4 EL.U/mL |
| Boostrix-Menactra Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PT | 74.3 EL.U/mL |
| Boostrix-Menactra Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-FHA | 575.8 EL.U/mL |
| Boostrix-Menactra Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PRN | 366.0 EL.U/mL |
Comparison: Non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to anti-pertussis toxoid (anti-PT) geometric mean antibody concentrations (GMCs) one month after vaccination.95% CI: [0.84, 1.03]
Comparison: Non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to anti-filamentous hemagglutinin (anti-FHA) GMCs one month after vaccination.95% CI: [0.69, 0.84]
Comparison: To demonstrate the non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to anti-pertactin (anti-PRN) GMCs one month after vaccination.95% CI: [0.54, 0.72]
Primary
Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies
Cut-off values assessed were greater than or equal to 1.0 international units per milliliter (IU/mL).
Time frame: At Month 1 (post Boostrix vaccination)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available and (\&) randomization code not broken who had received at least 1 dose of study vaccine (known administration site) \& had not received a vaccine not specified or forbidden by the protocol.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix + Menactra Group | Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | Anti-D | 427 Participants |
| Boostrix + Menactra Group | Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | Anti-T | 425 Participants |
| Boostrix-Menactra Group | Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | Anti-D | 405 Participants |
| Boostrix-Menactra Group | Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | Anti-T | 412 Participants |
Comparison: The non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to the percentage of subjects with anti-diphtheria toxoid (anti-D) antibody concentrations equal to or greater than (≥) 1.0 IU/mL one month after vaccination.95% CI: [0.79, 4.17]
Comparison: Non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared toBoostrix® vaccine administered alone at Month 0 with respect to the percentage of subjects with anti-tetanus toxoid (anti-T) antibody concentrations equal to or greater than (≥) 1.0 IU/mL one month after vaccination.95% CI: [-1.4, 1.48]
Primary
Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies
Booster responses for anti-PT, anti-FHA and anti-PRN antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below the cut-off concentration of 5 EL.U/mL): antibody concentrations at least four times the cut-off (postvaccination concentration ≥ 20 EL.U/mL) one month after vaccination with the Boostrix vaccine; for initially seropositive subjects with pre-vaccination concentration ≥5 EL.U/mL and \< 20 EL.U/mL: an increase in antibody concentrations of at least four times the pre-vaccination concentration, one month after vaccination with the Boostrix vaccine; and for initially seropositive subjects with pre-vaccination concentration ≥ 20 EL.U/mL: an increase in antibody concentrations of at least two times the pre-vaccination concentration one month after vaccination with the Boostrix vaccine.
Time frame: At Month 1 (post Boostrix vaccination)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available \& randomization code not broken who had received at least 1 dose of study vaccine (known administration site) \& had not received a vaccine not specified or forbidden by the protocol.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix + Menactra Group | Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies | Anti-PT, Total | 322 Participants |
| Boostrix + Menactra Group | Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies | Anti-FHA, Total | 385 Participants |
| Boostrix + Menactra Group | Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies | Anti-PRN, Total | 398 Participants |
| Boostrix-Menactra Group | Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies | Anti-PT, Total | 333 Participants |
| Boostrix-Menactra Group | Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies | Anti-FHA, Total | 388 Participants |
| Boostrix-Menactra Group | Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies | Anti-PRN, Total | 394 Participants |
Comparison: Non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to a booster response to PT one month after vaccination.95% CI: [-9.91, 1.15]
Comparison: Non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to a booster response to FHA one month after vaccination.95% CI: [-7.03, 0.15]
Comparison: To demonstrate the non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to a booster response to PRN one month after vaccination.95% CI: [-5.25, -1.25]
Primary
Number of Subjects With Vaccine Responses for Serum Bactericidal Assay Against Neisseria Meningitidis Serogroups A (rSBA-MenA), C (rSBA-MenC), Y (rSBA-MenY) and W-135 (rSBA-MenW-135)
Vaccine responses for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below the cut-off titer of 8): antibody titers at least four times the cut-off (post-vaccination concentration ≥ 32) one month after vaccination with Menactra vaccination; and for initially seropositive subjects (pre-vaccination titer ≥ 8): antibody titers at least four times the pre-vaccination antibody titers, one month after vaccination with Menactra vaccine.
Time frame: One month post Boostrix vaccination ((Month 1 for Boostrix + Menactra Group and Month 2 for Menactra-Boostrix Group)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available \& randomization code not broken who had received at least 1 dose of study vaccine (known administration site) \& had not received a vaccine not specified or forbidden by the protocol.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix + Menactra Group | Number of Subjects With Vaccine Responses for Serum Bactericidal Assay Against Neisseria Meningitidis Serogroups A (rSBA-MenA), C (rSBA-MenC), Y (rSBA-MenY) and W-135 (rSBA-MenW-135) | rSBA-MenA, Total | 329 Participants |
| Boostrix + Menactra Group | Number of Subjects With Vaccine Responses for Serum Bactericidal Assay Against Neisseria Meningitidis Serogroups A (rSBA-MenA), C (rSBA-MenC), Y (rSBA-MenY) and W-135 (rSBA-MenW-135) | rSBA-MenC, Total | 390 Participants |
| Boostrix + Menactra Group | Number of Subjects With Vaccine Responses for Serum Bactericidal Assay Against Neisseria Meningitidis Serogroups A (rSBA-MenA), C (rSBA-MenC), Y (rSBA-MenY) and W-135 (rSBA-MenW-135) | rSBA-MenY, Total | 369 Participants |
| Boostrix + Menactra Group | Number of Subjects With Vaccine Responses for Serum Bactericidal Assay Against Neisseria Meningitidis Serogroups A (rSBA-MenA), C (rSBA-MenC), Y (rSBA-MenY) and W-135 (rSBA-MenW-135) | rSBA-MenW-135, Total | 404 Participants |
| Boostrix-Menactra Group | Number of Subjects With Vaccine Responses for Serum Bactericidal Assay Against Neisseria Meningitidis Serogroups A (rSBA-MenA), C (rSBA-MenC), Y (rSBA-MenY) and W-135 (rSBA-MenW-135) | rSBA-MenW-135, Total | 394 Participants |
| Boostrix-Menactra Group | Number of Subjects With Vaccine Responses for Serum Bactericidal Assay Against Neisseria Meningitidis Serogroups A (rSBA-MenA), C (rSBA-MenC), Y (rSBA-MenY) and W-135 (rSBA-MenW-135) | rSBA-MenA, Total | 328 Participants |
| Boostrix-Menactra Group | Number of Subjects With Vaccine Responses for Serum Bactericidal Assay Against Neisseria Meningitidis Serogroups A (rSBA-MenA), C (rSBA-MenC), Y (rSBA-MenY) and W-135 (rSBA-MenW-135) | rSBA-MenY, Total | 358 Participants |
| Boostrix-Menactra Group | Number of Subjects With Vaccine Responses for Serum Bactericidal Assay Against Neisseria Meningitidis Serogroups A (rSBA-MenA), C (rSBA-MenC), Y (rSBA-MenY) and W-135 (rSBA-MenW-135) | rSBA-MenC, Total | 383 Participants |
Comparison: Non-inferiority of Menactra™ vaccine co-administered with Boostrix® vaccinecompared to Menactra™ vaccine administered alone at Month 0 with respect to a vaccine responseto meningococcal serogroup A one month after vaccination.95% CI: [-4.85, 4.43]
Comparison: Non-inferiority of Menactra™ vaccine co-administered with Boostrix® vaccine compared to Menactra™ vaccine administered alone at Month 0 with respect to a vaccine responseto meningococcal serogroup C one month after vaccination.95% CI: [-1.69, 5.16]
Comparison: Non-inferiority of Menactra™ vaccine co-administered with Boostrix® vaccine compared to Menactra™ vaccine administered alone at Month 0 with respect to a vaccine response to meningococcal serogroup Y one month after vaccination.95% CI: [-2.58, 6.25]
Comparison: Non-inferiority of Menactra™ vaccine co-administered with Boostrix® vaccine compared to Menactra™ vaccine administered alone at Month 0 with respect to a vaccine response to meningococcal serogroup W-135 one month after vaccination95% CI: [0.96, 6.45]
Secondary
Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).
Time frame: At one month POST Menactra vaccination (Month 2 for Boostrix-Menactra Group and Month 1 for Menactra-Boostrix Group)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available \& randomization code not broken who had received at least 1 dose of study vaccine (known administration site) \& had not received a vaccine not specified or forbidden by the protocol.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Boostrix + Menactra Group | Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | Anti-D | 16.5 IU/mL |
| Boostrix + Menactra Group | Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | Anti-T | 10.0 IU/mL |
| Boostrix-Menactra Group | Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | Anti-D | 41.6 IU/mL |
| Boostrix-Menactra Group | Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | Anti-T | 0.9 IU/mL |
Secondary
Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).
Time frame: PRE (Day 0) and one month POST Boostrix vaccination (Month 1 for Boostrix + Menactra Group and Boostrix-Menactra Group/ Month 2 for Menactra-Boostrix Group)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available \& randomization code not broken who had received at least 1 dose of study vaccine (known administration site) \& had not received a vaccine not specified or forbidden by the protocol.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Boostrix + Menactra Group | Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | Anti-D, PRE | 0.5 IU/mL |
| Boostrix + Menactra Group | Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | Anti-T, POST | 9.5 IU/mL |
| Boostrix + Menactra Group | Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | Anti-T, PRE | 1.0 IU/mL |
| Boostrix + Menactra Group | Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | Anti-D, POST | 40.1 IU/mL |
| Boostrix-Menactra Group | Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | Anti-T, PRE | 0.8 IU/mL |
| Boostrix-Menactra Group | Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | Anti-D, POST | 10.2 IU/mL |
| Boostrix-Menactra Group | Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | Anti-T, POST | 12.7 IU/mL |
| Boostrix-Menactra Group | Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | Anti-D, PRE | 0.5 IU/mL |
| Menactra-Boostrix Group | Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | Anti-T, POST | 12.2 IU/mL |
| Menactra-Boostrix Group | Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | Anti-D, PRE | 0.5 IU/mL |
| Menactra-Boostrix Group | Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | Anti-D, POST | 27.3 IU/mL |
| Menactra-Boostrix Group | Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | Anti-T, PRE | 0.9 IU/mL |
Secondary
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL).
Time frame: At Day 0 before (PRE) Boostrix vaccination
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available \& randomization code not broken who had received at least 1 dose of study vaccine (known administration site) \& had not received a vaccine not specified or forbidden by the protocol.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Boostrix + Menactra Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-FHA | 46.5 EL.U/mL |
| Boostrix + Menactra Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PT | 8.6 EL.U/mL |
| Boostrix + Menactra Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PRN | 12.5 EL.U/mL |
| Boostrix-Menactra Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-FHA | 43.8 EL.U/mL |
| Boostrix-Menactra Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PT | 10.0 EL.U/mL |
| Boostrix-Menactra Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PRN | 10.6 EL.U/mL |
| Menactra-Boostrix Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PT | 10.3 EL.U/mL |
| Menactra-Boostrix Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PRN | 12.0 EL.U/mL |
| Menactra-Boostrix Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-FHA | 47.8 EL.U/mL |
Secondary
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL).
Time frame: At Month 2 (one month post Boostrix vaccination)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity,which included all evaluable subjects with immunogenicity data available \& randomization code not broken who had received at least 1 dose of study vaccine (known administration site) \& had not received a vaccine not specified or forbidden by the protocol
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Boostrix + Menactra Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PT | 77.8 EL.U/mL |
| Boostrix + Menactra Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | ANTI-FHA | 653.0 EL.U/mL |
| Boostrix + Menactra Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PRN | 412.5 EL.U/mL |
Secondary
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens
Cut-off values assessed were greater than or equal to 0.1 international units per milliliter (IU/m L).
Time frame: PRE (Day 0) and POST Boostrix vaccination (Month 1 for Boostrix + Menactra Group and Boostrix-Menactra Group/ Month 2 for Menactra-Boostrix Group)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available \& randomization code not broken who had received at least 1 dose of study vaccine (known administration site) \& had not received a vaccine not specified or forbidden by the protocol.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix + Menactra Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens | ANTI-T, POST | 428 Participants |
| Boostrix + Menactra Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens | Anti-T, PRE | 423 Participants |
| Boostrix + Menactra Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens | ANTI-D, POST | 428 Participants |
| Boostrix + Menactra Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens | Anti-D, PRE | 399 Participants |
| Boostrix-Menactra Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens | ANTI-D, POST | 415 Participants |
| Boostrix-Menactra Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens | ANTI-T, POST | 415 Participants |
| Boostrix-Menactra Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens | Anti-D, PRE | 383 Participants |
| Boostrix-Menactra Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens | Anti-T, PRE | 409 Participants |
| Menactra-Boostrix Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens | ANTI-T, POST | 429 Participants |
| Menactra-Boostrix Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens | Anti-T, PRE | 423 Participants |
| Menactra-Boostrix Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens | ANTI-D, POST | 429 Participants |
| Menactra-Boostrix Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens | Anti-D, PRE | 391 Participants |
Secondary
Number of Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibodies
Cut-off values assessed were greater than or equal to 1.0 international units per milliliter (IU/mL).
Time frame: At Day 0 (PRE) before Boostrix vaccination
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available \& randomization code not broken who had received at least 1 dose of study vaccine (known administration site) \& had not received a vaccine not specified or forbidden by the protocol.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix + Menactra Group | Number of Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | ANTI-D, PRE | 109 Participants |
| Boostrix + Menactra Group | Number of Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | ANTI-T, PRE | 201 Participants |
| Boostrix-Menactra Group | Number of Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | ANTI-D, PRE | 93 Participants |
| Boostrix-Menactra Group | Number of Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | ANTI-T, PRE | 181 Participants |
| Menactra-Boostrix Group | Number of Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | ANTI-D, PRE | 120 Participants |
| Menactra-Boostrix Group | Number of Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | ANTI-T, PRE | 195 Participants |
Secondary
Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies
Cut-off values assessed were greater than or equal to 1.0 international units per milliliter (IU/mL).
Time frame: At Month 2 (one month post Boostrix vaccination)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available \& randomization code not broken who had received at least 1 dose of study vaccine (known administration site) \& had not received a vaccine not specified or forbidden by the protocol.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix + Menactra Group | Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | Anti-D | 428 Participants |
| Boostrix + Menactra Group | Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | Anti-T | 426 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = any solicited local symptom irrespective of intensity grade. Grade 3 pain = pain that prevented normal activities. Grade 3 redness/swelling = redness/swelling with diameter ≥ 50 millimeters (mm).
Time frame: Within 4-days (Day 0-3) after each dose and across doses
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix + Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, Any, Dose 1 | 99 Participants |
| Boostrix + Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Grade 3, Dose 1 | 26 Participants |
| Boostrix + Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, Any, Dose 1 | 118 Participants |
| Boostrix + Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, ≥ 50 mm, Dose 1 | 10 Participants |
| Boostrix + Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Any, Dose 1 | 331 Participants |
| Boostrix + Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, ≥ 50 mm, Dose 1 | 8 Participants |
| Boostrix + Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Any, Dose 2 | NA Participants |
| Boostrix + Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Grade 3, Dose 2 | NA Participants |
| Boostrix + Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, Any, Dose 2 | NA Participants |
| Boostrix + Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, ≥ 50 mm, Dose 2 | NA Participants |
| Boostrix + Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, Any, Dose 2 | NA Participants |
| Boostrix + Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, ≥ 50 mm, Dose 2 | NA Participants |
| Boostrix + Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Any, Across doses | 331 Participants |
| Boostrix + Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Grade 3, Across doses | 26 Participants |
| Boostrix + Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, Any, Across doses | 118 Participants |
| Boostrix + Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, ≥ 50 mm, Across doses | 10 Participants |
| Boostrix + Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, Any, Across doses | 99 Participants |
| Boostrix + Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, ≥ 50 mm, Across doses | 8 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, ≥ 50 mm, Across doses | 13 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Any, Dose 1 | 304 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, ≥ 50 mm, Dose 2 | 8 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Any, Across doses | 343 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Grade 3, Dose 1 | 14 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, Any, Across doses | 141 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, ≥ 50 mm, Across doses | 8 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, Any, Dose 1 | 111 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, Any, Dose 2 | 64 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, Any, Across doses | 105 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, ≥ 50 mm, Dose 1 | 1 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, Any, Dose 2 | 85 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Grade 3, Across doses | 26 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, Any, Dose 1 | 78 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Grade 3, Dose 2 | 13 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, ≥ 50 mm, Dose 2 | 9 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, ≥ 50 mm, Dose 1 | 7 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Any, Dose 2 | 260 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, ≥ 50 mm, Dose 1 | 5 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Any, Dose 2 | 211 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Grade 3, Dose 2 | 4 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, Any, Across doses | 119 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, Any, Dose 2 | 79 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, ≥ 50 mm, Across doses | 8 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, ≥ 50 mm, Dose 2 | 2 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, Any, Dose 2 | 53 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, ≥ 50 mm, Across doses | 6 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, ≥ 50 mm, Dose 2 | 3 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Any, Dose 1 | 236 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Grade 3, Dose 1 | 6 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Any, Across doses | 291 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, Any, Dose 1 | 84 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, ≥ 50 mm, Dose 1 | 4 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, Any, Dose 1 | 56 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Grade 3, Across doses | 9 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, Any, Across doses | 84 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were fatigue, fever \[defined as oral temperature equal to or above 37.5 degrees Celsius (°C)\], headache and gastrointestinal symptoms \[gastro sympt\]. Any = any solicited general symptom irrespective of intensity grade or relationship to vaccination. Grade 3 = symptoms that prevented normal activities. Grade 3 Fever = temperature higher than (\>) 39° C. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain.
Time frame: Within 4-days (Days 0-3) after each dose and across doses
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix + Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Any, Across | 150 Participants |
| Boostrix + Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Grade 3, Dose 1 | 12 Participants |
| Boostrix + Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Related, Dose 1 | 120 Participants |
| Boostrix + Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Related, Dose 2 | NA Participants |
| Boostrix + Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Grade 3, Across | 12 Participants |
| Boostrix + Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Grade 3, Dose 2 | NA Participants |
| Boostrix + Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Any, Dose 2 | NA Participants |
| Boostrix + Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastro sympt., Any, Across | 67 Participants |
| Boostrix + Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Any, Dose 2 | NA Participants |
| Boostrix + Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Any, Dose 1 | 23 Participants |
| Boostrix + Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastro sympt., Related, Dose 2 | NA Participants |
| Boostrix + Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Related, Dose 2 | NA Participants |
| Boostrix + Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastro sympt., Grade 3, Across | 4 Participants |
| Boostrix + Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastro sympt., Grade 3, Dose 2 | NA Participants |
| Boostrix + Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Any, Dose 2 | NA Participants |
| Boostrix + Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Grade 3, Dose 2 | NA Participants |
| Boostrix + Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Related, Across | 20 Participants |
| Boostrix + Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastro sympt., Any, Dose 2 | NA Participants |
| Boostrix + Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Related, Dose 2 | NA Participants |
| Boostrix + Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Grade 3, Dose 1 | 2 Participants |
| Boostrix + Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Any, Dose 1 | 150 Participants |
| Boostrix + Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Grade 3, Across | 2 Participants |
| Boostrix + Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Related, Dose 1 | 20 Participants |
| Boostrix + Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Related, Across | 127 Participants |
| Boostrix + Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Any, Across | 23 Participants |
| Boostrix + Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastro sympt., Any, Dose 1 | 67 Participants |
| Boostrix + Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Any, Across | 150 Participants |
| Boostrix + Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Related, Dose 1 | 127 Participants |
| Boostrix + Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastro sympt, Grade 3, Dose 1 | 4 Participants |
| Boostrix + Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Grade 3, Dose 1 | 13 Participants |
| Boostrix + Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Related, Across | 120 Participants |
| Boostrix + Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastro sympt, Related, Dose 1 | 46 Participants |
| Boostrix + Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Grade 3, Dose 2 | NA Participants |
| Boostrix + Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Grade 3, Across | 13 Participants |
| Boostrix + Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Any, Dose 1 | 150 Participants |
| Boostrix + Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastro sympt., Related, Across | 46 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Related, Across | 146 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Any, Dose 2 | 14 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastro sympt., Any, Dose 2 | 46 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Any, Dose 1 | 139 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Grade 3, Dose 1 | 9 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Related, Dose 1 | 113 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Any, Dose 1 | 15 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Grade 3, Dose 1 | 1 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Related, Dose 1 | 8 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastro sympt., Any, Dose 1 | 63 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastro sympt, Grade 3, Dose 1 | 4 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastro sympt, Related, Dose 1 | 41 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Any, Dose 1 | 133 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Grade 3, Dose 1 | 12 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Related, Dose 1 | 104 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Any, Dose 2 | 103 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Grade 3, Dose 2 | 5 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Related, Dose 2 | 83 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Grade 3, Dose 2 | 1 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Related, Dose 2 | 9 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastro sympt., Grade 3, Dose 2 | 1 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastro sympt., Related, Dose 2 | 32 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Any, Dose 2 | 95 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Grade 3, Dose 2 | 2 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Related, Dose 2 | 72 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Any, Across | 175 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Grade 3, Across | 13 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Any, Across | 28 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Grade 3, Across | 2 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Related, Across | 16 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastro sympt., Any, Across | 96 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastro sympt., Grade 3, Across | 5 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastro sympt., Related, Across | 65 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Any, Across | 177 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Grade 3, Across | 13 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Related, Across | 142 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Grade 3, Dose 1 | 5 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Related, Dose 2 | 56 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Any, Dose 1 | 116 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Grade 3, Across | 9 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Any, Across | 160 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastro sympt, Related, Dose 1 | 36 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastro sympt., Related, Across | 54 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Grade 3, Across | 7 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastro sympt, Grade 3, Dose 1 | 2 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastro sympt., Any, Dose 1 | 60 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Related, Across | 128 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Related, Dose 1 | 16 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Any, Dose 1 | 114 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Any, Across | 29 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Grade 3, Dose 1 | 0 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Any, Dose 2 | 10 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Grade 3, Across | 1 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Any, Dose 1 | 21 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Any, Across | 157 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Related, Across | 23 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Related, Dose 2 | 9 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (orally), Grade 3, Dose 2 | 1 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastro sympt., Any, Dose 2 | 34 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Related, Dose 2 | 70 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Related, Dose 1 | 86 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastro sympt., Grade 3, Dose 2 | 3 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Grade 3, Dose 2 | 3 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastro sympt., Any, Across | 80 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastro sympt., Related, Dose 2 | 24 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Any, Dose 2 | 90 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Related, Across | 121 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Any, Dose 2 | 75 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Related, Dose 1 | 85 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastro sympt., Grade 3, Across | 5 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Grade 3, Dose 2 | 2 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Grade 3, Dose 1 | 7 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related 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. Grade 3 AE =An AE which prevented normal, everyday activities. Such an AE, for example, prevented attendance at work/school and necessitated the administration of corrective therapy. Related = AE assessed by the investigator as related to the vaccination.
Time frame: Within the 31-day (Days 0-30) period after each vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix + Menactra Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AEs | 37 Participants |
| Boostrix + Menactra Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AEs | 16 Participants |
| Boostrix + Menactra Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AEs | 124 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AEs | 44 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AEs | 149 Participants |
| Boostrix-Menactra Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AEs | 15 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AEs | 22 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AEs | 155 Participants |
| Menactra-Boostrix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AEs | 29 Participants |
Secondary
Number of Subjects With Booster Responses for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies
Booster responses for anti-D and anti-T antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below the cut-off concentration of 0.1 IU/mL): antibody concentrations at least four times the cut-off (postvaccination concentration ≥ 0.4 IU/mL), one month after vaccination with the Boostrix vaccine; and for initially seropositive subjects (pre-vaccination concentration ≥ 0.1 IU/mL): an increase in antibody concentrations of at least four times the pre-vaccination concentration one month after vaccination with the Boostrix vaccine.
Time frame: At one month POST Boostrix vaccination (Month 1 for Boostrix + Menactra Group and Boostrix-Menactra Group/ Month 2 for Menactra-Boostrix Group)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available \& randomization code not broken who had received at least 1 dose of study vaccine (known administration site) \& had not received a vaccine not specified or forbidden by the protocol.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix + Menactra Group | Number of Subjects With Booster Responses for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | Anti-D, Total | 422 Participants |
| Boostrix + Menactra Group | Number of Subjects With Booster Responses for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | Anti-T, Total | 310 Participants |
| Boostrix-Menactra Group | Number of Subjects With Booster Responses for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | Anti-D, Total | 377 Participants |
| Boostrix-Menactra Group | Number of Subjects With Booster Responses for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | Anti-T, Total | 330 Participants |
| Menactra-Boostrix Group | Number of Subjects With Booster Responses for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | Anti-D, Total | 422 Participants |
| Menactra-Boostrix Group | Number of Subjects With Booster Responses for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | Anti-T, Total | 329 Participants |
Secondary
Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies
Booster responses for anti-PT, anti-FHA and anti-PRN antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below the cut-off concentration of 5 EL.U/mL): antibody concentrations at least four times the cut-off (postvaccination concentration ≥20 EL.U/mL) one month after vaccination with the Boostrix vaccine; for initially seropositive subjects with pre-vaccination concentration ≥5 EL.U/mL and \< 20 EL.U/mL: an increase in antibody concentrations of at least four times the pre-vaccination concentration, one month after vaccination with the Boostrix vaccine; and for initially seropositive subjects with pre-vaccination concentration ≥ 20 EL.U/mL: an increase in antibody concentrations of at least two times the pre-vaccination concentration one month after vaccination with the Boostrix vaccine.
Time frame: At Month 2 (one month post Boostrix vaccination)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available \& randomization code not broken who had received at least 1 dose of study vaccine (known administration site) \& had not received a vaccine not specified or forbidden by the protocol.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix + Menactra Group | Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies | Anti-FHA, Total | 405 Participants |
| Boostrix + Menactra Group | Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies | Anti-PT, Total | 338 Participants |
| Boostrix + Menactra Group | Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies | Anti-PRN, Total | 414 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: Throughout the entire study period (Day 0 - Month 2)
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Boostrix + Menactra Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
| Boostrix-Menactra Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| Menactra-Boostrix Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
Secondary
Number of Subjects With Vaccine Responses for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies
Vaccine responses for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below the cut-off titer of 8): antibody titers at least four times the cut-off (post-vaccination concentration ≥ 32) one month after vaccination with Menactra the vaccine, and for initially seropositive subjects (pre-vaccination titer ≥ 8): antibody titers at least four times the pre-vaccination antibody titers, one month after vaccination with the Menactra vaccine.
Time frame: At Month 2 (one month after vaccination with Menactra vaccine)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available \& randomization code not broken who had received at least 1 dose of study vaccine (known administration site) \& had not received a vaccine not specified or forbidden by the protocol.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix + Menactra Group | Number of Subjects With Vaccine Responses for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies | rSBA-MenA, Total | 300 Participants |
| Boostrix + Menactra Group | Number of Subjects With Vaccine Responses for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies | rSBA-MenC, Total | 351 Participants |
| Boostrix + Menactra Group | Number of Subjects With Vaccine Responses for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies | rSBA-MenY, Total | 325 Participants |
| Boostrix + Menactra Group | Number of Subjects With Vaccine Responses for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies | rSBA-MenW-135, Total | 360 Participants |
Secondary
Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies
Antibody titers are presented as geometric mean titers (GMTs).
Time frame: PRE (Day 0) and one month POST Menactra vaccination (Month 2 for Boostrix + Menactra Group and Boostrix-Menactra Group / Month 1 for Menactra-Boostrix Group)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available \& randomization code not broken who had received at least 1 dose of study vaccine (known administration site) \& had not received a vaccine not specified or forbidden by the protocol.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Boostrix + Menactra Group | Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies | rSBA-MenW-135, POST | 4822.1 Titers |
| Boostrix + Menactra Group | Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies | rSBA-MenA, PRE | 533.4 Titers |
| Boostrix + Menactra Group | Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies | rSBA-MenC, POST | 2760.2 Titers |
| Boostrix + Menactra Group | Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies | rSBA-MenW-135, PRE | 23.7 Titers |
| Boostrix + Menactra Group | Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies | rSBA-MenA, POST | 10406.1 Titers |
| Boostrix + Menactra Group | Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies | rSBA-MenY, PRE | 53.8 Titers |
| Boostrix + Menactra Group | Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies | rSBA-MenC, PRE | 21.0 Titers |
| Boostrix + Menactra Group | Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies | rSBA-MenY, POST | 3244.2 Titers |
| Boostrix-Menactra Group | Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies | rSBA-MenA, POST | 7220.0 Titers |
| Boostrix-Menactra Group | Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies | rSBA-MenY, POST | 1470.7 Titers |
| Boostrix-Menactra Group | Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies | rSBA-MenW-135, PRE | 28.0 Titers |
| Boostrix-Menactra Group | Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies | rSBA-MenA, PRE | 490.8 Titers |
| Boostrix-Menactra Group | Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies | rSBA-MenW-135, POST | 2143.1 Titers |
| Boostrix-Menactra Group | Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies | rSBA-MenC, PRE | 16.4 Titers |
| Boostrix-Menactra Group | Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies | rSBA-MenC, POST | 1137.0 Titers |
| Boostrix-Menactra Group | Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies | rSBA-MenY, PRE | 51.4 Titers |
| Menactra-Boostrix Group | Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies | rSBA-MenW-135, POST | 4154.3 Titers |
| Menactra-Boostrix Group | Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies | rSBA-MenA, PRE | 449.4 Titers |
| Menactra-Boostrix Group | Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies | rSBA-MenA, POST | 9466.3 Titers |
| Menactra-Boostrix Group | Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies | rSBA-MenC, PRE | 18.7 Titers |
| Menactra-Boostrix Group | Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies | rSBA-MenC, POST | 2702.8 Titers |
| Menactra-Boostrix Group | Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies | rSBA-MenY, PRE | 56.2 Titers |
| Menactra-Boostrix Group | Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies | rSBA-MenW-135, PRE | 32.2 Titers |
| Menactra-Boostrix Group | Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies | rSBA-MenY, POST | 3022.8 Titers |