Acellular Pertussis, Tetanus, Diphtheria
Conditions
Keywords
Persistence, immunogenicity
Brief summary
The purpose of this study is to evaluate the persistence of antibodies against all the vaccine antigens 1, 3, 5 and 9 years after an initial vaccination with Tdap, and also to assess immunogenicity and safety of another dose of Boostrix, administered in this study. This protocol posting deals with objectives and outcome measures of the extension phase. The objectives and outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00346073).
Detailed description
Subjects were previously vaccinated with either Boostrix or a control Tdap vaccine (Sanofi Pasteurs' Adacel) in study NCT00346073. Only subjects who were part of the primary study will be invited to participate in this study. All subjects will receive a single dose of Boostrix at Visit 6 (Day 0) and subjects will be observed till Visit 7 (Day 30) for safety in terms of solicited adverse events (during 4 days post vaccination), unsolicited adverse events (during 31 days post vaccination) and serious adverse event (during the trial period). A blood sample will be collected from all subjects before vaccination (Visit 6) and one month after vaccination (Visit 7) for antibodies estimation. This summary has been updated following Protocol amendment 1 dated 09 November 2010, amendment 2 dated 18 February 2014, and amendment 3 dated 10 December 2014. The protocol was amended first due to the following reasons: 1. The maximum window period allowed for the return of subjects for the Year 5 and Year 10 follow-up visits (Visit 5 and Visit 6) was extended from ± 5 weeks to ± 8 weeks. 2. The contact details for reporting of SAEs were clarified. 3. Text pertaining to the reporting of spontaneous abortion was removed from the protocol. 4. The number of attempts to contact subjects who did not return for scheduled persistence visits was clarified. The main purpose of protocol amendment 2 is to evaluate the immunogenicity and safety of Boostrix as a second dose of Tdap vaccine when administered 8 years after an initial dose of Tdap. The Year 10 time point for evaluation of persistence has been cancelled because it is no longer feasible to conduct after a second dose of Tdap vaccine has been administered at Year 8. The purpose of amendment 3 is to add co-primary objective to demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Boostrix group and Adacel group) is non-inferior to the immune response elicited by a first dose of Tdap vaccine (Control group), with respect to booster response against diphtheria, tetanus and pertussis (PT, FHA and PRN) antigens, one month following vaccination according to CBER's input. Accordingly, the study start has been pushed to Year 9 and this is reflected throughout the document.
Interventions
PROCEDURETaking of blood samples
No treatment is planned to be given in this study. Blood samples will be collected at the following time points: 1 year, 3 years, 5 years and 9 years after the dose of vaccination.
BIOLOGICALBoostrix
A single dose of Boostrix was administered in the primary study (NCT00346073). No treatment was given in this study.
BIOLOGICALAdacel
A single dose of Adacel was administered in the primary study (NCT00346073). No treatment was given in this study.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
28 Years to 73 Years
Healthy volunteers
Yes
Inclusion criteria
• Persistence follow-up phase up to Year 9 time point: The following criteria are applicable to subjects who refuse vaccination at Year 8 time point: All subjects who received study vaccination (Boostrix or Adacel) in study NCT00346073 will be considered eligible to participate in this study. Written informed consent must be obtained from the subject prior to each study time point. Vaccination phase at Year 9 applicable for subjects in Boostrix and Adacel groups only: The following criterion is applicable to subjects willing to consent to vaccination at Year 9 time point in the Boostrix and Adacel groups: • All subjects who received study vaccination (Boostrix or Adacel) in study NCT00346073 will be considered eligible to participate in this study. Vaccination phase at Year 9 applicable for subjects in the Control group only: The following criterion is applicable to subjects willing to consent to vaccination at Year 9 time point in the Control group only: • Subjects within the age range of 28-73 years will be considered eligible to participate in this study in the Control group. Vaccination phase at Year 9 applicable for ALL subjects (Control, Boostrix and Adacel groups): The following criteria are applicable to subjects willing to consent to vaccination at Year 9 time point in the Boostrix, Adacel and Control groups: All subjects must satisfy the following criteria at study entry at Year 9 time point: Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits). Written informed consent obtained from the subject for vaccination at Year 9 time point. Healthy subjects as established by medical history and clinical examination before entering into the study. * Female subjects of non-childbearing potential may be enrolled in the study. * Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause. * Female subjects of child bearing 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 for 1 month after completion of the vaccine dose
Exclusion criteria
The following criteria should be checked at the time of Year 9 vaccination time point. If any criteria is applicable, the subject must not be vaccinated in the study: For subjects in Boostrix and Adacel groups: • Administration of Tdap vaccine since the last dose received in the study NCT00346073. For subjects in the Control group: • Administration of Tdap (Boostrix or Adacel) vaccine at any time prior to the administration of Boostrix vaccine in this study. For ALL subjects (Control, Boostrix and Adacel groups): Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period, 31 days (Day 0-30). * Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to Visit 6 (pre-vacc). 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 and ending 30 days after the dose of vaccine, with the exception of inactivated Influenza vaccine which is allowed throughout the study period, 31 days (Day 0-30). \-- 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 vaccine/product. * Hypersensitivity to latex. * History of diphtheria, tetanus or pertussis diseases. * Severe allergic reaction (e.g. anaphylaxis) after previous administration of any tetanus toxoid, diphtheria toxoid, or pertussis-antigen containing vaccines, or any component of Boostrix. * History of any neurological disorders or seizures. * Encephalopathy (e.g. coma, decreased level of consciousness, prolonged seizures) of unknown etiology occurring within seven days following previous vaccination with pertussis-containing vaccine. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * Acute disease and/or fever at the time of enrolment. * Fever is defined as temperature ≥ 100.4°F by any route. The preferred route for recording temperature in this study will be oral. * Subjects with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator. * Administration of immunoglobulins and/or any blood products within three months preceding the dose of study vaccine or planned administration during the study period, 31 days (Day 0-30). Administration of any tetanus or diphtheria containing vaccine or any registered or investigational vaccine utilizing a diphtheria toxoid or tetanus toxoid carrier within 5 years prior to the administration of Boostrix vaccine in this study. * Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. * Pregnant or lactating female. * Female planning to become pregnant or planning to discontinue contraceptive precautions during the 31 day (Day 0-30) follow-up period post-vaccination.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Anti-diphtheria (Anti-D) Antibody Concentrations Greater Than or Equal to (≥) Protocol Specified Cut-off | At year 1 after the vaccination in primary study (NCT00346073) | Anti-D cut-off was defined as ≥ 0.1 International Units per milliliter (IU/mL) determined with Enzyme-linked Immunosorbent Assay (ELISA) |
| Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off | At year 3 after the vaccination in primary study (NCT00346073) | Anti-D cut-off was defined as ≥ 0.1 IU/mL as assessed by ELISA |
| Number of Subjects With Anti-tetanus (Anti-T) Antibody Concentrations ≥ Protocol Specified Cut-off | At year 1 after the vaccination in primary study (NCT00346073) | Anti-T cut-off was defined as ≥ 0.1 IU/mL as assessed by ELISA. |
| Number of Subjects With Anti-T Antibody Concentrations ≥ Protocol Specified Cut-off | At year 3 after the vaccination in primary study (NCT00346073) | Anti-T cut-off was defined as ≥ 0.1 IU/mL as assessed by ELISA. |
| Number of Subjects With Anti-D and Anti-T Concentrations ≥ 0.1 IU/mL and 1 IU/mL | At Year 9, one month after the booster vaccination. | Number of subjects with anti-D and anti-T concentrations ≥ 0.1 IU/mL and 1 IU/mL were tabulated |
| Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | At Year 9, one month before booster vaccination | Anti-PT, anti-FHA and anti-PRN antibody concentrations were measured by ELISA, tabulated as GMCs and expressed in IU/mL. |
| Booster Response to D and T Antigens | At Year 9, one month after the booster vaccination. | A booster response was defined as: for initially seronegative subjects (S-) (pre-vaccination concentration below cut-off: \< 0.1 IU/mL) antibody concentrations at least four times the cut-off (post vaccination concentration ≥ 0.4 IU/mL); for initially seropositive subjects (S+) (pre-vaccination concentration ≥ 0.1 IU/mL): an increase in antibody concentrations of at least four times the pre-vaccination concentration; Total = subjects either seropositive or seronegative. |
| Booster Response to PT, FHA and PRN Antigens | At Year 9, one month after the booster vaccination. | Booster response was defined as: for subjects with pre-vaccination antibody concentration \< 5 EL.U/mL (S-): antibody concentration ≥ 20 EL.U/mL; for subjects with pre-vaccination antibody concentration ≥ 5 EL.U/mL and \< 20 EL.U/mL (S+, \<4\*cut-off): antibody concentration at least four times the pre-vaccination concentration; for subjects with pre-vaccination antibody concentration ≥ 20 EL.U/mL (S+, ≥4\*cut-off): antibody concentration at least two times the pre-vaccination concentration; Total = subjects either seropositive or seronegative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti-PRN Antibody Concentration | At 1, 3, and 5 years after the vaccination in primary study (NCT00346073) | Anti-PRN antibody concentration is expressed as GMC in IU/mL |
| Alternative Booster Response to Anti-D and Anti-T Antigens | At Year 9, one month after booster vaccination | Alternative Booster response to D and T antigens is defined as: - For subjects with pre-booster antibody concentration below 0.1 IU/mL: antibody concentrations at least four times the 0.1IU/ML, one month after vaccination, and - For subjects with pre-booster antibody concentration ≥0.1 IU/mL and \<1.0 IU/mL: antibody concentrations of at least four times the pre-booster antibody concentration, one month after vaccination. - For subjects with pre-booster antibody concentration ≥1.0 IU/mL and \<6.0 IU/mL: antibody concentrations of at least two times the pre-booster antibody concentration, one month after vaccination. - Subjects with pre-booster antibody concentration ≥6.0 IU/mL are not evaluable for booster response. S- = Antibody concentration \< 0.1 IU/mL S+ = Antibody concentration ≥ 0.1 IU/mL Total = subjects either seropositive or seronegative |
| Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens | At Year 9, one month after booster vaccination | Alternative Booster response to PT, FHA and PRN antigens is defined as: - For subjects with pre-booster antibody concentration below the assay cut off: antibody concentrations at least four times the assay cut off one month after vaccination, and - For subjects with pre-booster antibody concentration ≥ assay cut off and \< 60 IU/mL: antibody concentration increase of at least 30 IU/mL from the pre-booster antibody concentration, one month after vaccination. - For subjects with pre-booster antibody concentration ≥ 60 IU/mL : at least 1.5 fold increase of antibody concentration from the pre-booster antibody concentration, one month after vaccination. S- = seronegative subjects (antibody concentration below assay cut off for anti-PT, anti-FHA, anti-PRN) S+ = seropositive subjects (antibody concentration below assay cut off for anti-PT, anti-FHA, anti-PRN) Total = subjects either seropositive or seronegative |
| Seroprotection Status for Anti-D Antibody Concentration | At Year 9, one month before(pre booster) and after the booster vaccination(post booster) | Seroprotection status for anti-D antibody concentration \< 0.1 IU/mL were tested for neutralizing antibodies using a VERO-cell neutralization assay. Seroprotection rate is defined as the percentage of subjects with antibody concentrations greater than or equal (≥) the seroprotection cut-off value defined for that antibody. |
| Number of Subjects With Anti-pertussis Toxoid (PT) Antibody Concentrations Equal to or Above Protocol Specified Cut-off | At 1, 3, and 5 years after the vaccination in primary study (NCT00346073) | The cut-off for anti-PT concentrations was defined as ≥ 5 ELISA units per mililiter (EL.U/mL). |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Year 9 | During the 4-day (Days 0-3) post vaccination period. | The solicited general symptoms assessed were Fatigue, Gastrointestinal symptoms (including nausea, vomiting, diarrhea and abdominal pain), Headache and Fever \[defined as temperature of ≥100.4 degrees Fahrenheit (F) by any route\]. Any = Occurrence of any general symptom regardless of its intensity grade or relationship to vaccination; Grade 3 Symptom = Symptom that prevented normal activity; Grade 3 Fever \> 104.0 degrees F. |
| Number of Subjects With Any Large Injection Site Reaction - Year 9 | During the 4-day (Days 0-3) follow-up period after vaccination. | Large injection site reaction = a swelling with a diameter \> 100 mm, noticeable diffuse swelling or noticeable increase in limb circumference. |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) - Year 9 | During the 31-day (Days 0-30) post-vaccination period. | An unsolicited AE covers any untoward medical oc-currence 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. |
| Number of Subjects With Serious Adverse Events (SAEs) - Year 9 | During the 31-day (Days 0-30) post-vaccination period | 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 With Any and Grade 3 Solicited Local Symptoms - Year 9 | During the 4-day (Days 0-3) post vaccination period. | Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as significant pain at rest that prevented normal everyday activities. Grade 3 redness and swelling was greater than 50 millimeters (mm) |
| Number of Subjects With Anti-PT Antibody Concentrations Equal to or Above Protocol Specified Cut-off | At Year 9, one month before(pre booster) and after the booster vaccination(post booster) | The cut-off for anti-PT concentrations was defined as equal to or greater than 2.693 IU/mL. |
| Number of Subjects With Anti-FHA Antibody Concentrations Equal to or Above Protocol Specified Cut-off | At 1, 3, and 5 years after the vaccination in primary study (NCT00346073) | The cut-off for anti-FHA concentrations was defined as equal to or greater than 5 EL.U/mL. |
| Number of Subjects With Anti-PRN Antibody Concentrations Equal to or Above Protocol Specified Cut-off | At 1, 3, and 5 years after the vaccination in primary study (NCT00346073) | The cut-off for anti-PRN concentrations was defined as equal to or greater than 5 EL.U/mL. |
| Anti-D Antibody Concentration | At 1, 3, and 5 years after the vaccination in primary study (NCT00346073) | Anti-D antibody concentration is expressed as geometric mean concentration (GMC) in IU/mL. |
| Anti-T Antibody Concentration | At 1, 3, and 5 years after the vaccination in primary study (NCT00346073) | Anti-T antibody concentration is expressed as GMC in IU/mL. |
| Anti-PT Antibody Concentration | At 1, 3, and 5 years after the vaccination in primary study (NCT00346073) | Anti-PT antibody concentration is expressed as GMC in EL.U/mL. |
| Anti-FHA Antibody Concentration | At 1, 3, and 5 years after the vaccination in primary study (NCT00346073) | Anti-FHA antibody concentration is expressed as GMC in IU/mL |
Countries
United States
Participant flow
Recruitment details
A total of 1592 participants were enrolled in the study at Year 1 (in the Boostrix and Adacel groups). As per advice from the Centre for Biologics and Research Evaluation (CBER), an additional treatment group acting as control was also added at Year 9, therefore the total number of subjects analyzed was 1592 (Year 1) + 362 (Year 9) = 1954.
Pre-assignment details
Subjects who received a single dose of Boostrix or Adacel vaccines, in the primary study (NCT00346073) were included in this study.
Participants by arm
| Arm | Count |
|---|---|
| Boostrix Group Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine \[Tdap\](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a second dose of Boostrix vaccine \[Tdap\](GSK776423). | 1,069 |
| Adacel Group Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm and in this study at Year 9 received a dose of Boostrix vaccine \[Tdap\](GSK776423). | 523 |
| Control Group Subjects received the first dose of Boostrix vaccine \[Tdap\](GSK776423) in this study at Year 9. | 362 |
| Total | 1,954 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Persistence Year 9 | Lost to Follow-up | 2 | 2 | 3 |
| Persistence Year 9 | Other | 1 | 0 | 2 |
Baseline characteristics
| Characteristic | Boostrix Group | Adacel Group | Control Group | Total |
|---|---|---|---|---|
| Age, Continuous | 41.7 years STANDARD_DEVIATION 13.39 | 42.5 years STANDARD_DEVIATION 13.27 | 52.0 years STANDARD_DEVIATION 13.6 | 42.0 years STANDARD_DEVIATION 13.35 |
| Sex: Female, Male Female | 680 Participants | 357 Participants | 196 Participants | 1233 Participants |
| Sex: Female, Male Male | 389 Participants | 166 Participants | 166 Participants | 721 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 309 | 0 / 138 | 0 / 362 |
| other Total, other adverse events | 213 / 309 | 95 / 138 | 172 / 362 |
| serious Total, serious adverse events | 0 / 309 | 0 / 138 | 1 / 362 |
Outcome results
Primary
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
Anti-PT, anti-FHA and anti-PRN antibody concentrations were measured by ELISA, tabulated as GMCs and expressed in IU/mL.
Time frame: At Year 9, one month before booster vaccination
Population: The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Boostrix Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-FHA | 42.2 IU/mL |
| Boostrix Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PT | 8.2 IU/mL |
| Boostrix Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PRN | 63.8 IU/mL |
| Adacel Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-FHA | 28.4 IU/mL |
| Adacel Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PT | 7.8 IU/mL |
| Adacel Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PRN | 64.7 IU/mL |
| Control Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PT | 5.4 IU/mL |
| Control Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PRN | 17.8 IU/mL |
| Control Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-FHA | 23.6 IU/mL |
Primary
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
Anti-PT, anti-FHA and anti-PRN antibody concentrations were measured by ELISA, tabulated as GMCs and expressed in IU/mL.
Time frame: At Year 9, one month after the booster vaccination
Population: Analysis was performed on the Total Vaccinated Cohort (TVC) at Year 9 which included all subjects with a study vaccine administration dose documented: a safety analysis based on the TVC included all vaccinated subjects, an immunogenicity analysis based on the TVC included all vaccinated subjects for whom immunogenicity results were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Boostrix Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | ANTI-PT | 64.1 IU/mL |
| Boostrix Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | ANTI-FHA | 247.9 IU/mL |
| Boostrix Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | ANTI-PRN | 405.4 IU/mL |
| Adacel Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | ANTI-PT | 70.4 IU/mL |
| Adacel Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | ANTI-FHA | 254.6 IU/mL |
| Adacel Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | ANTI-PRN | 511.8 IU/mL |
Comparison: To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Boostrix Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-PT one month following vaccination97.5% CI: [1.31, 1.79]GMC ratio
Comparison: To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Boostrix Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-FHA one month following vaccination97.5% CI: [4.62, 6.01]GMC ratio
Comparison: To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Boostrix Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-PRN one month following vaccination97.5% CI: [3.07, 4.25]GMC ratio
Comparison: To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Adacel Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-PT one month following vaccination97.5% CI: [1.33, 2.03]GMC ratio
Comparison: To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Adacel Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-FHA one month following vaccination97.5% CI: [4.37, 6.36]GMC ratio
Comparison: To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Adacel Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-PRN one month following vaccination97.5% CI: [3.58, 5.57]GMC ratio
Primary
Booster Response to D and T Antigens
A booster response was defined as: for initially seronegative subjects (S-) (pre-vaccination concentration below cut-off: \< 0.1 IU/mL) antibody concentrations at least four times the cut-off (post vaccination concentration ≥ 0.4 IU/mL); for initially seropositive subjects (S+) (pre-vaccination concentration ≥ 0.1 IU/mL): an increase in antibody concentrations of at least four times the pre-vaccination concentration; Total = subjects either seropositive or seronegative.
Time frame: At Year 9, one month after the booster vaccination.
Population: Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix Group | Booster Response to D and T Antigens | Anti-D, S+ | 153 Participants |
| Boostrix Group | Booster Response to D and T Antigens | Anti-D, Total | 169 Participants |
| Boostrix Group | Booster Response to D and T Antigens | Anti-T, S- | 5 Participants |
| Boostrix Group | Booster Response to D and T Antigens | Anti-T, S+ | 121 Participants |
| Boostrix Group | Booster Response to D and T Antigens | Anti-T, Total | 126 Participants |
| Boostrix Group | Booster Response to D and T Antigens | Anti-D, S- | 16 Participants |
| Adacel Group | Booster Response to D and T Antigens | Anti-D, S+ | 68 Participants |
| Adacel Group | Booster Response to D and T Antigens | Anti-D, S- | 3 Participants |
| Adacel Group | Booster Response to D and T Antigens | Anti-T, Total | 44 Participants |
| Adacel Group | Booster Response to D and T Antigens | Anti-D, Total | 71 Participants |
| Adacel Group | Booster Response to D and T Antigens | Anti-T, S+ | 44 Participants |
| Control Group | Booster Response to D and T Antigens | Anti-T, Total | 157 Participants |
| Control Group | Booster Response to D and T Antigens | Anti-D, Total | 222 Participants |
| Control Group | Booster Response to D and T Antigens | Anti-T, S- | 18 Participants |
| Control Group | Booster Response to D and T Antigens | Anti-T, S+ | 139 Participants |
| Control Group | Booster Response to D and T Antigens | Anti-D, S- | 35 Participants |
| Control Group | Booster Response to D and T Antigens | Anti-D, S+ | 187 Participants |
Comparison: To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against diphtheria antigen, one month following vaccination.97.5% CI: [-14.67, 2.85]
Comparison: To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against tetanus antigen, one month following vaccination.97.5% CI: [-10.63, 7.79]
Comparison: To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against diphtheria antigen, one month following vaccination.97.5% CI: [-20.33, 2.73]
Comparison: To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against tetanus antigen, one month following vaccination.97.5% CI: [-22.98, 0.15]
Primary
Booster Response to PT, FHA and PRN Antigens
Booster response was defined as: for subjects with pre-vaccination antibody concentration \< 5 EL.U/mL (S-): antibody concentration ≥ 20 EL.U/mL; for subjects with pre-vaccination antibody concentration ≥ 5 EL.U/mL and \< 20 EL.U/mL (S+, \<4\*cut-off): antibody concentration at least four times the pre-vaccination concentration; for subjects with pre-vaccination antibody concentration ≥ 20 EL.U/mL (S+, ≥4\*cut-off): antibody concentration at least two times the pre-vaccination concentration; Total = subjects either seropositive or seronegative
Time frame: At Year 9, one month after the booster vaccination.
Population: Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix Group | Booster Response to PT, FHA and PRN Antigens | Anti-FHA, S+, < 4*cut-off | 16 Participants |
| Boostrix Group | Booster Response to PT, FHA and PRN Antigens | Anti-PT, S- | 34 Participants |
| Boostrix Group | Booster Response to PT, FHA and PRN Antigens | Anti-PT, S+, < 4*cut-off | 106 Participants |
| Boostrix Group | Booster Response to PT, FHA and PRN Antigens | Anti-PT, S+, ≥ 4*cut-off | 95 Participants |
| Boostrix Group | Booster Response to PT, FHA and PRN Antigens | Anti-PT, Total | 235 Participants |
| Boostrix Group | Booster Response to PT, FHA and PRN Antigens | Anti-FHA, S+, ≥ 4*cut-off | 216 Participants |
| Boostrix Group | Booster Response to PT, FHA and PRN Antigens | Anti-FHA, Total | 232 Participants |
| Boostrix Group | Booster Response to PT, FHA and PRN Antigens | Anti-PRN, S- | 4 Participants |
| Boostrix Group | Booster Response to PT, FHA and PRN Antigens | Anti-PRN, S+, < 4*cut-off | 27 Participants |
| Boostrix Group | Booster Response to PT, FHA and PRN Antigens | Anti-PRN, S+, ≥ 4*cut-off | 179 Participants |
| Boostrix Group | Booster Response to PT, FHA and PRN Antigens | Anti-PRN, Total | 210 Participants |
| Adacel Group | Booster Response to PT, FHA and PRN Antigens | Anti-PRN, Total | 98 Participants |
| Adacel Group | Booster Response to PT, FHA and PRN Antigens | Anti-PRN, S- | 1 Participants |
| Adacel Group | Booster Response to PT, FHA and PRN Antigens | Anti-FHA, S+, < 4*cut-off | 9 Participants |
| Adacel Group | Booster Response to PT, FHA and PRN Antigens | Anti-FHA, S+, ≥ 4*cut-off | 106 Participants |
| Adacel Group | Booster Response to PT, FHA and PRN Antigens | Anti-FHA, S- | 1 Participants |
| Adacel Group | Booster Response to PT, FHA and PRN Antigens | Anti-PT, S- | 10 Participants |
| Adacel Group | Booster Response to PT, FHA and PRN Antigens | Anti-PRN, S+, ≥ 4*cut-off | 87 Participants |
| Adacel Group | Booster Response to PT, FHA and PRN Antigens | Anti-FHA, Total | 116 Participants |
| Adacel Group | Booster Response to PT, FHA and PRN Antigens | Anti-PT, S+, < 4*cut-off | 53 Participants |
| Adacel Group | Booster Response to PT, FHA and PRN Antigens | Anti-PT, Total | 106 Participants |
| Adacel Group | Booster Response to PT, FHA and PRN Antigens | Anti-PRN, S+, < 4*cut-off | 10 Participants |
| Adacel Group | Booster Response to PT, FHA and PRN Antigens | Anti-PT, S+, ≥ 4*cut-off | 43 Participants |
| Control Group | Booster Response to PT, FHA and PRN Antigens | Anti-PRN, S+, ≥ 4*cut-off | 175 Participants |
| Control Group | Booster Response to PT, FHA and PRN Antigens | Anti-PRN, S+, < 4*cut-off | 75 Participants |
| Control Group | Booster Response to PT, FHA and PRN Antigens | Anti-PT, Total | 292 Participants |
| Control Group | Booster Response to PT, FHA and PRN Antigens | Anti-FHA, S- | 5 Participants |
| Control Group | Booster Response to PT, FHA and PRN Antigens | Anti-FHA, S+, ≥ 4*cut-off | 228 Participants |
| Control Group | Booster Response to PT, FHA and PRN Antigens | Anti-FHA, Total | 303 Participants |
| Control Group | Booster Response to PT, FHA and PRN Antigens | Anti-PT, S+, ≥ 4*cut-off | 97 Participants |
| Control Group | Booster Response to PT, FHA and PRN Antigens | Anti-FHA, S+, < 4*cut-off | 70 Participants |
| Control Group | Booster Response to PT, FHA and PRN Antigens | Anti-PRN, S- | 31 Participants |
| Control Group | Booster Response to PT, FHA and PRN Antigens | Anti-PT, S- | 101 Participants |
| Control Group | Booster Response to PT, FHA and PRN Antigens | Anti-PRN, Total | 281 Participants |
| Control Group | Booster Response to PT, FHA and PRN Antigens | Anti-PT, S+, < 4*cut-off | 94 Participants |
Comparison: To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against PT antigen, one month following vaccination.97.5% CI: [-9.09, 3.08]
Comparison: To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against FHA antigen, one month following vaccination.97.5% CI: [-13.16, -1.4]
Comparison: To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against PRN antigen, one month following vaccination.97.5% CI: [-17.5, -3.38]
Comparison: To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against PT antigen, one month following vaccination.97.5% CI: [-10.03, 5.57]
Comparison: To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against FHA antigen, one month following vaccination.97.5% CI: [-2.38, 8.66]
Comparison: To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against PRN antigen, one month following vaccination.97.5% CI: [-14.53, 3.18]
Primary
Number of Subjects With Anti-D and Anti-T Concentrations ≥ 0.1 IU/mL and 1 IU/mL
Number of subjects with anti-D and anti-T concentrations ≥ 0.1 IU/mL and 1 IU/mL were tabulated
Time frame: At Year 9, one month after the booster vaccination.
Population: Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix Group | Number of Subjects With Anti-D and Anti-T Concentrations ≥ 0.1 IU/mL and 1 IU/mL | Anti-D, ≥ 0.1 IU/ML | 245 Participants |
| Boostrix Group | Number of Subjects With Anti-D and Anti-T Concentrations ≥ 0.1 IU/mL and 1 IU/mL | Anti-T, ≥ 0.1 IU/ML | 263 Participants |
| Boostrix Group | Number of Subjects With Anti-D and Anti-T Concentrations ≥ 0.1 IU/mL and 1 IU/mL | Anti-D, ≥ 1 IU/ML | 114 Participants |
| Boostrix Group | Number of Subjects With Anti-D and Anti-T Concentrations ≥ 0.1 IU/mL and 1 IU/mL | Anti-T, ≥ 1 IU/ML | 211 Participants |
| Adacel Group | Number of Subjects With Anti-D and Anti-T Concentrations ≥ 0.1 IU/mL and 1 IU/mL | Anti-T, ≥ 1 IU/ML | 101 Participants |
| Adacel Group | Number of Subjects With Anti-D and Anti-T Concentrations ≥ 0.1 IU/mL and 1 IU/mL | Anti-D, ≥ 0.1 IU/ML | 113 Participants |
| Adacel Group | Number of Subjects With Anti-D and Anti-T Concentrations ≥ 0.1 IU/mL and 1 IU/mL | Anti-D, ≥ 1 IU/ML | 54 Participants |
| Adacel Group | Number of Subjects With Anti-D and Anti-T Concentrations ≥ 0.1 IU/mL and 1 IU/mL | Anti-T, ≥ 0.1 IU/ML | 120 Participants |
| Control Group | Number of Subjects With Anti-D and Anti-T Concentrations ≥ 0.1 IU/mL and 1 IU/mL | Anti-T, ≥ 1 IU/ML | 231 Participants |
| Control Group | Number of Subjects With Anti-D and Anti-T Concentrations ≥ 0.1 IU/mL and 1 IU/mL | Anti-T, ≥ 0.1 IU/ML | 304 Participants |
| Control Group | Number of Subjects With Anti-D and Anti-T Concentrations ≥ 0.1 IU/mL and 1 IU/mL | Anti-D, ≥ 1 IU/ML | 92 Participants |
| Control Group | Number of Subjects With Anti-D and Anti-T Concentrations ≥ 0.1 IU/mL and 1 IU/mL | Anti-D, ≥ 0.1 IU/ML | 265 Participants |
Comparison: To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group and Control group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to seroprotection rate against diphtheria antigen, one month following vaccination.97.5% CI: [-1.16, 4.17]
Comparison: To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group and Control group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to seroprotection rate against tetanus antigen, one month following vaccination.97.5% CI: [-1.52, 2.07]
Comparison: To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group and Control group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to seroprotection rate against diphtheria antigen, one month following vaccination.97.5% CI: [-3.41, 4.15]
Comparison: To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group and Control group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to seroprotection rate against tetanus antigen, one month following vaccination.97.5% CI: [-3.69, 2.07]
Primary
Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off
Anti-D cut-off was defined as ≥ to 0.1IU/mL as assessed by ELISA.
Time frame: At Year 9, one month before the booster vaccination.
Population: The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Boostrix Group | Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off | 245 Participants |
| Adacel Group | Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off | 113 Participants |
Primary
Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off
Anti-D cut-off was defined as ≥ 0.1IU/mL as assessed by ELISA.
Time frame: At year 5 after the vaccination in primary study (NCT00346073)
Population: The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Boostrix Group | Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off | 735 Participants |
| Adacel Group | Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off | 359 Participants |
Primary
Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off
Anti-D cut-off was defined as ≥ 0.1 IU/mL as assessed by ELISA
Time frame: At year 3 after the vaccination in primary study (NCT00346073)
Population: The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Boostrix Group | Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off | 857 Participants |
| Adacel Group | Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off | 425 Participants |
Primary
Number of Subjects With Anti-diphtheria (Anti-D) Antibody Concentrations Greater Than or Equal to (≥) Protocol Specified Cut-off
Anti-D cut-off was defined as ≥ 0.1 International Units per milliliter (IU/mL) determined with Enzyme-linked Immunosorbent Assay (ELISA)
Time frame: At year 1 after the vaccination in primary study (NCT00346073)
Population: The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Boostrix Group | Number of Subjects With Anti-diphtheria (Anti-D) Antibody Concentrations Greater Than or Equal to (≥) Protocol Specified Cut-off | 967 Participants |
| Adacel Group | Number of Subjects With Anti-diphtheria (Anti-D) Antibody Concentrations Greater Than or Equal to (≥) Protocol Specified Cut-off | 489 Participants |
Primary
Number of Subjects With Anti-T Antibody Concentrations ≥ Protocol Specified Cut-off
Anti-T cut-off was defined as ≥ 0.1 IU/mL as assessed by ELISA.
Time frame: At Year 9, one month before the booster vaccination.
Population: The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Boostrix Group | Number of Subjects With Anti-T Antibody Concentrations ≥ Protocol Specified Cut-off | 263 Participants |
| Adacel Group | Number of Subjects With Anti-T Antibody Concentrations ≥ Protocol Specified Cut-off | 120 Participants |
Primary
Number of Subjects With Anti-T Antibody Concentrations ≥ Protocol Specified Cut-off
Anti-T cut-off was defined as ≥ 0.1 IU/mL as assessed by ELISA.
Time frame: At year 5 after the vaccination in primary study (NCT00346073)
Population: The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Boostrix Group | Number of Subjects With Anti-T Antibody Concentrations ≥ Protocol Specified Cut-off | 772 Participants |
| Adacel Group | Number of Subjects With Anti-T Antibody Concentrations ≥ Protocol Specified Cut-off | 370 Participants |
Primary
Number of Subjects With Anti-T Antibody Concentrations ≥ Protocol Specified Cut-off
Anti-T cut-off was defined as ≥ 0.1 IU/mL as assessed by ELISA.
Time frame: At year 3 after the vaccination in primary study (NCT00346073)
Population: The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Boostrix Group | Number of Subjects With Anti-T Antibody Concentrations ≥ Protocol Specified Cut-off | 899 Participants |
| Adacel Group | Number of Subjects With Anti-T Antibody Concentrations ≥ Protocol Specified Cut-off | 440 Participants |
Primary
Number of Subjects With Anti-tetanus (Anti-T) Antibody Concentrations ≥ Protocol Specified Cut-off
Anti-T cut-off was defined as ≥ 0.1 IU/mL as assessed by ELISA.
Time frame: At year 1 after the vaccination in primary study (NCT00346073)
Population: The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Boostrix Group | Number of Subjects With Anti-tetanus (Anti-T) Antibody Concentrations ≥ Protocol Specified Cut-off | 1000 Participants |
| Adacel Group | Number of Subjects With Anti-tetanus (Anti-T) Antibody Concentrations ≥ Protocol Specified Cut-off | 504 Participants |
Secondary
Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens
Alternative Booster response to PT, FHA and PRN antigens is defined as: - For subjects with pre-booster antibody concentration below the assay cut off: antibody concentrations at least four times the assay cut off one month after vaccination, and - For subjects with pre-booster antibody concentration ≥ assay cut off and \< 60 IU/mL: antibody concentration increase of at least 30 IU/mL from the pre-booster antibody concentration, one month after vaccination. - For subjects with pre-booster antibody concentration ≥ 60 IU/mL : at least 1.5 fold increase of antibody concentration from the pre-booster antibody concentration, one month after vaccination. S- = seronegative subjects (antibody concentration below assay cut off for anti-PT, anti-FHA, anti-PRN) S+ = seropositive subjects (antibody concentration below assay cut off for anti-PT, anti-FHA, anti-PRN) Total = subjects either seropositive or seronegative
Time frame: At Year 9, one month after booster vaccination
Population: Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix Group | Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens | ANTI-PRN, S- | 4 Participants |
| Boostrix Group | Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens | ANTI-PT, ≥ 60 IU/mL | 7 Participants |
| Boostrix Group | Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens | ANTI-PRN, Total | 230 Participants |
| Boostrix Group | Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens | ANTI-PRN, ≥ assay Cut-off and < 60 IU/mL | 115 Participants |
| Boostrix Group | Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens | ANTI-FHA, ≥ 60 IU/mL | 82 Participants |
| Boostrix Group | Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens | ANTI-PRN, ≥ 60 IU/mL | 111 Participants |
| Boostrix Group | Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens | ANTI-FHA, ≥ assay Cut-off and < 60 IU/mL | 171 Participants |
| Boostrix Group | Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens | ANTI-PT, ≥ assay Cut-off and < 60 IU/mL | 169 Participants |
| Boostrix Group | Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens | ANTI-FHA, Total | 253 Participants |
| Boostrix Group | Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens | ANTI-PT, Total | 210 Participants |
| Boostrix Group | Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens | ANTI-PT, S- | 34 Participants |
| Adacel Group | Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens | ANTI-FHA, S- | 1 Participants |
| Adacel Group | Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens | ANTI-FHA, ≥ assay Cut-off and < 60 IU/mL | 91 Participants |
| Adacel Group | Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens | ANTI-FHA, ≥ 60 IU/mL | 27 Participants |
| Adacel Group | Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens | ANTI-FHA, Total | 119 Participants |
| Adacel Group | Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens | ANTI-PRN, S- | 1 Participants |
| Adacel Group | Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens | ANTI-PRN, ≥ assay Cut-off and < 60 IU/mL | 52 Participants |
| Adacel Group | Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens | ANTI-PRN, ≥ 60 IU/mL | 53 Participants |
| Adacel Group | Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens | ANTI-PRN, Total | 106 Participants |
| Adacel Group | Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens | ANTI-PT, S- | 10 Participants |
| Adacel Group | Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens | ANTI-PT, ≥ assay Cut-off and < 60 IU/mL | 83 Participants |
| Adacel Group | Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens | ANTI-PT, ≥ 60 IU/mL | 3 Participants |
| Adacel Group | Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens | ANTI-PT, Total | 96 Participants |
| Control Group | Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens | ANTI-FHA, Total | 310 Participants |
| Control Group | Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens | ANTI-PT, ≥ 60 IU/mL | 10 Participants |
| Control Group | Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens | ANTI-PT, S- | 101 Participants |
| Control Group | Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens | ANTI-FHA, ≥ 60 IU/mL | 64 Participants |
| Control Group | Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens | ANTI-FHA, S- | 5 Participants |
| Control Group | Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens | ANTI-PT, ≥ assay Cut-off and < 60 IU/mL | 166 Participants |
| Control Group | Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens | ANTI-PRN, ≥ assay Cut-off and < 60 IU/mL | 185 Participants |
| Control Group | Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens | ANTI-FHA, ≥ assay Cut-off and < 60 IU/mL | 241 Participants |
| Control Group | Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens | ANTI-PRN, ≥ 60 IU/mL | 62 Participants |
| Control Group | Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens | ANTI-PRN, S- | 31 Participants |
| Control Group | Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens | ANTI-PT, Total | 277 Participants |
| Control Group | Alternative Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Antigens | ANTI-PRN, Total | 278 Participants |
Secondary
Alternative Booster Response to Anti-D and Anti-T Antigens
Alternative Booster response to D and T antigens is defined as: - For subjects with pre-booster antibody concentration below 0.1 IU/mL: antibody concentrations at least four times the 0.1IU/ML, one month after vaccination, and - For subjects with pre-booster antibody concentration ≥0.1 IU/mL and \<1.0 IU/mL: antibody concentrations of at least four times the pre-booster antibody concentration, one month after vaccination. - For subjects with pre-booster antibody concentration ≥1.0 IU/mL and \<6.0 IU/mL: antibody concentrations of at least two times the pre-booster antibody concentration, one month after vaccination. - Subjects with pre-booster antibody concentration ≥6.0 IU/mL are not evaluable for booster response. S- = Antibody concentration \< 0.1 IU/mL S+ = Antibody concentration ≥ 0.1 IU/mL Total = subjects either seropositive or seronegative
Time frame: At Year 9, one month after booster vaccination
Population: Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix Group | Alternative Booster Response to Anti-D and Anti-T Antigens | ANTI-T, S+ (<1 IU/ML) | 46 Participants |
| Boostrix Group | Alternative Booster Response to Anti-D and Anti-T Antigens | ANTI-D, S+ (≥1 IU/ML) | 84 Participants |
| Boostrix Group | Alternative Booster Response to Anti-D and Anti-T Antigens | ANTI-T, S+ (≥1 IU/ML) | 151 Participants |
| Boostrix Group | Alternative Booster Response to Anti-D and Anti-T Antigens | ANTI-T, Total | 202 Participants |
| Boostrix Group | Alternative Booster Response to Anti-D and Anti-T Antigens | ANTI-D, S- | 16 Participants |
| Boostrix Group | Alternative Booster Response to Anti-D and Anti-T Antigens | ANTI-D, S+ (<1 IU/ML) | 103 Participants |
| Boostrix Group | Alternative Booster Response to Anti-D and Anti-T Antigens | ANTI-D, Total | 203 Participants |
| Boostrix Group | Alternative Booster Response to Anti-D and Anti-T Antigens | ANTI-T, S- | 5 Participants |
| Adacel Group | Alternative Booster Response to Anti-D and Anti-T Antigens | ANTI-T, S+ (<1 IU/ML) | 14 Participants |
| Adacel Group | Alternative Booster Response to Anti-D and Anti-T Antigens | ANTI-D, S- | 3 Participants |
| Adacel Group | Alternative Booster Response to Anti-D and Anti-T Antigens | ANTI-T, S+ (≥1 IU/ML) | 74 Participants |
| Adacel Group | Alternative Booster Response to Anti-D and Anti-T Antigens | ANTI-D, S+ (≥1 IU/ML) | 40 Participants |
| Adacel Group | Alternative Booster Response to Anti-D and Anti-T Antigens | ANTI-D, Total | 88 Participants |
| Adacel Group | Alternative Booster Response to Anti-D and Anti-T Antigens | ANTI-T, Total | 88 Participants |
| Adacel Group | Alternative Booster Response to Anti-D and Anti-T Antigens | ANTI-D, S+ (<1 IU/ML) | 45 Participants |
| Control Group | Alternative Booster Response to Anti-D and Anti-T Antigens | ANTI-T, Total | 242 Participants |
| Control Group | Alternative Booster Response to Anti-D and Anti-T Antigens | ANTI-D, S- | 35 Participants |
| Control Group | Alternative Booster Response to Anti-D and Anti-T Antigens | ANTI-D, S+ (<1 IU/ML) | 148 Participants |
| Control Group | Alternative Booster Response to Anti-D and Anti-T Antigens | ANTI-D, S+ (≥1 IU/ML) | 65 Participants |
| Control Group | Alternative Booster Response to Anti-D and Anti-T Antigens | ANTI-D, Total | 248 Participants |
| Control Group | Alternative Booster Response to Anti-D and Anti-T Antigens | ANTI-T, S- | 18 Participants |
| Control Group | Alternative Booster Response to Anti-D and Anti-T Antigens | ANTI-T, S+ (<1 IU/ML) | 65 Participants |
| Control Group | Alternative Booster Response to Anti-D and Anti-T Antigens | ANTI-T, S+ (≥1 IU/ML) | 159 Participants |
Secondary
Anti-D Antibody Concentration
Anti-D antibody concentration is expressed as GMC in IU/mL.
Time frame: At Year 9, one month before(pre booster) and after the booster vaccination(post booster)
Population: Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Boostrix Group | Anti-D Antibody Concentration | Pre-booster | 0.7 IU/mL |
| Boostrix Group | Anti-D Antibody Concentration | Post-booster | 4.1 IU/mL |
| Adacel Group | Anti-D Antibody Concentration | Pre-booster | 0.8 IU/mL |
| Adacel Group | Anti-D Antibody Concentration | Post-booster | 4.7 IU/mL |
| Control Group | Anti-D Antibody Concentration | Pre-booster | 0.4 IU/mL |
| Control Group | Anti-D Antibody Concentration | Post-booster | 4.0 IU/mL |
Secondary
Anti-D Antibody Concentration
Anti-D antibody concentration is expressed as geometric mean concentration (GMC) in IU/mL.
Time frame: At 1, 3, and 5 years after the vaccination in primary study (NCT00346073)
Population: The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Boostrix Group | Anti-D Antibody Concentration | Year 1 | 1.4 IU/mL |
| Boostrix Group | Anti-D Antibody Concentration | Year 3 | 0.9 IU/mL |
| Boostrix Group | Anti-D Antibody Concentration | Year 5 | 0.8 IU/mL |
| Adacel Group | Anti-D Antibody Concentration | Year 1 | 1.4 IU/mL |
| Adacel Group | Anti-D Antibody Concentration | Year 3 | 1.0 IU/mL |
| Adacel Group | Anti-D Antibody Concentration | Year 5 | 0.9 IU/mL |
Secondary
Anti-FHA Antibody Concentration
Anti-FHA antibody concentration was expressed as GMC in IU/mL.
Time frame: At Year 9, one month before(pre booster) and after the booster vaccination(post booster)
Population: Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Boostrix Group | Anti-FHA Antibody Concentration | Pre-booster | 42.2 IU/mL |
| Boostrix Group | Anti-FHA Antibody Concentration | Post-booster | 247.9 IU/mL |
| Adacel Group | Anti-FHA Antibody Concentration | Pre-booster | 28.4 IU/mL |
| Adacel Group | Anti-FHA Antibody Concentration | Post-booster | 254.6 IU/mL |
| Control Group | Anti-FHA Antibody Concentration | Pre-booster | 23.6 IU/mL |
| Control Group | Anti-FHA Antibody Concentration | Post-booster | 373.6 IU/mL |
Secondary
Anti-FHA Antibody Concentration
Anti-FHA antibody concentration is expressed as GMC in IU/mL
Time frame: At 1, 3, and 5 years after the vaccination in primary study (NCT00346073)
Population: The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Boostrix Group | Anti-FHA Antibody Concentration | Year 1 | 190.1 IU/mL |
| Boostrix Group | Anti-FHA Antibody Concentration | Year 3 | 114.1 IU/mL |
| Boostrix Group | Anti-FHA Antibody Concentration | Year 5 | 110.0 IU/mL |
| Adacel Group | Anti-FHA Antibody Concentration | Year 1 | 118.8 IU/mL |
| Adacel Group | Anti-FHA Antibody Concentration | Year 3 | 81.8 IU/mL |
| Adacel Group | Anti-FHA Antibody Concentration | Year 5 | 80.8 IU/mL |
Secondary
Anti-PRN Antibody Concentration
Anti-PRN antibody concentration is expressed as GMC in IU/mL
Time frame: At 1, 3, and 5 years after the vaccination in primary study (NCT00346073)
Population: The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Boostrix Group | Anti-PRN Antibody Concentration | Year 1 | 152.2 IU/mL |
| Boostrix Group | Anti-PRN Antibody Concentration | Year 3 | 82.5 IU/mL |
| Boostrix Group | Anti-PRN Antibody Concentration | Year 5 | 85.3 IU/mL |
| Adacel Group | Anti-PRN Antibody Concentration | Year 1 | 132.5 IU/mL |
| Adacel Group | Anti-PRN Antibody Concentration | Year 3 | 70.6 IU/mL |
| Adacel Group | Anti-PRN Antibody Concentration | Year 5 | 77.4 IU/mL |
Secondary
Anti-PRN Antibody Concentration
Anti-PRN antibody concentration is expressed as GMC in IU/mL.
Time frame: At Year 9, one month before(pre booster) and after the booster vaccination(post booster)
Population: Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Boostrix Group | Anti-PRN Antibody Concentration | Pre-booster | 63.8 IU/mL |
| Boostrix Group | Anti-PRN Antibody Concentration | Post-booster | 405.4 IU/mL |
| Adacel Group | Anti-PRN Antibody Concentration | Pre-booster | 64.7 IU/mL |
| Adacel Group | Anti-PRN Antibody Concentration | Post-booster | 511.8 IU/mL |
| Control Group | Anti-PRN Antibody Concentration | Pre-booster | 17.8 IU/mL |
| Control Group | Anti-PRN Antibody Concentration | Post-booster | 336.4 IU/mL |
Secondary
Anti-PT Antibody Concentration
Anti-PT antibody concentration was expressed as GMC in IU/mL.
Time frame: At Year 9, one month before(pre booster) and after the booster vaccination(post booster)
Population: Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Boostrix Group | Anti-PT Antibody Concentration | Pre-booster | 8.2 IU/mL |
| Boostrix Group | Anti-PT Antibody Concentration | Post-booster | 64.1 IU/mL |
| Adacel Group | Anti-PT Antibody Concentration | Pre-booster | 7.8 IU/mL |
| Adacel Group | Anti-PT Antibody Concentration | Post-booster | 70.4 IU/mL |
| Control Group | Anti-PT Antibody Concentration | Pre-booster | 5.4 IU/mL |
| Control Group | Anti-PT Antibody Concentration | Post-booster | 66.2 IU/mL |
Secondary
Anti-PT Antibody Concentration
Anti-PT antibody concentration is expressed as GMC in EL.U/mL.
Time frame: At 1, 3, and 5 years after the vaccination in primary study (NCT00346073)
Population: The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Boostrix Group | Anti-PT Antibody Concentration | Year 1 | 22.4 IU/mL |
| Boostrix Group | Anti-PT Antibody Concentration | Year 3 | 14.1 IU/mL |
| Boostrix Group | Anti-PT Antibody Concentration | Year 5 | 14.6 IU/mL |
| Adacel Group | Anti-PT Antibody Concentration | Year 1 | 15.6 IU/mL |
| Adacel Group | Anti-PT Antibody Concentration | Year 3 | 10.0 IU/mL |
| Adacel Group | Anti-PT Antibody Concentration | Year 5 | 11.6 IU/mL |
Secondary
Anti-T Antibody Concentration
Anti-T antibody concentration is expressed as GMC in IU/mL.
Time frame: At 1, 3, and 5 years after the vaccination in primary study (NCT00346073)
Population: The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Boostrix Group | Anti-T Antibody Concentration | Year 1 | 3.4 IU/mL |
| Boostrix Group | Anti-T Antibody Concentration | Year 3 | 2.2 IU/mL |
| Boostrix Group | Anti-T Antibody Concentration | Year 5 | 2.0 IU/mL |
| Adacel Group | Anti-T Antibody Concentration | Year 1 | 4.4 IU/mL |
| Adacel Group | Anti-T Antibody Concentration | Year 3 | 2.9 IU/mL |
| Adacel Group | Anti-T Antibody Concentration | Year 5 | 2.5 IU/mL |
Secondary
Anti-T Antibody Concentration
Anti-T antibody concentration is expressed as GMC in IU/mL.
Time frame: At Year 9, one month before(pre booster) and after the booster vaccination(post booster)
Population: Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Boostrix Group | Anti-T Antibody Concentration | Pre-booster | 1.8 IU/mL |
| Boostrix Group | Anti-T Antibody Concentration | Post-booster | 8.4 IU/mL |
| Adacel Group | Anti-T Antibody Concentration | Pre-booster | 2.3 IU/mL |
| Adacel Group | Anti-T Antibody Concentration | Post-booster | 8.6 IU/mL |
| Control Group | Anti-T Antibody Concentration | Pre-booster | 1.5 IU/mL |
| Control Group | Anti-T Antibody Concentration | Post-booster | 8.8 IU/mL |
Secondary
Number of Subjects With Anti-FHA Antibody Concentrations Equal to or Above Protocol Specified Cut-off
The cut-off for anti-FHA concentrations was defined as equal to or greater than 2.046 IU/mL
Time frame: At Year 9, one month before(pre booster) and after the booster vaccination(post booster)
Population: Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix Group | Number of Subjects With Anti-FHA Antibody Concentrations Equal to or Above Protocol Specified Cut-off | Pre-booster | 271 Participants |
| Boostrix Group | Number of Subjects With Anti-FHA Antibody Concentrations Equal to or Above Protocol Specified Cut-off | Post-booster | 271 Participants |
| Adacel Group | Number of Subjects With Anti-FHA Antibody Concentrations Equal to or Above Protocol Specified Cut-off | Pre-booster | 119 Participants |
| Adacel Group | Number of Subjects With Anti-FHA Antibody Concentrations Equal to or Above Protocol Specified Cut-off | Post-booster | 121 Participants |
| Control Group | Number of Subjects With Anti-FHA Antibody Concentrations Equal to or Above Protocol Specified Cut-off | Pre-booster | 322 Participants |
| Control Group | Number of Subjects With Anti-FHA Antibody Concentrations Equal to or Above Protocol Specified Cut-off | Post-booster | 327 Participants |
Secondary
Number of Subjects With Anti-FHA Antibody Concentrations Equal to or Above Protocol Specified Cut-off
The cut-off for anti-FHA concentrations was defined as equal to or greater than 5 EL.U/mL.
Time frame: At 1, 3, and 5 years after the vaccination in primary study (NCT00346073)
Population: The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix Group | Number of Subjects With Anti-FHA Antibody Concentrations Equal to or Above Protocol Specified Cut-off | Year 1 | 1012 Participants |
| Boostrix Group | Number of Subjects With Anti-FHA Antibody Concentrations Equal to or Above Protocol Specified Cut-off | Year 3 | 913 Participants |
| Boostrix Group | Number of Subjects With Anti-FHA Antibody Concentrations Equal to or Above Protocol Specified Cut-off | Year 5 | 788 Participants |
| Adacel Group | Number of Subjects With Anti-FHA Antibody Concentrations Equal to or Above Protocol Specified Cut-off | Year 1 | 501 Participants |
| Adacel Group | Number of Subjects With Anti-FHA Antibody Concentrations Equal to or Above Protocol Specified Cut-off | Year 3 | 437 Participants |
| Adacel Group | Number of Subjects With Anti-FHA Antibody Concentrations Equal to or Above Protocol Specified Cut-off | Year 5 | 368 Participants |
Secondary
Number of Subjects With Anti-pertussis Toxoid (PT) Antibody Concentrations Equal to or Above Protocol Specified Cut-off
The cut-off for anti-PT concentrations was defined as ≥ 5 ELISA units per mililiter (EL.U/mL).
Time frame: At 1, 3, and 5 years after the vaccination in primary study (NCT00346073)
Population: The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix Group | Number of Subjects With Anti-pertussis Toxoid (PT) Antibody Concentrations Equal to or Above Protocol Specified Cut-off | Year 1 | 917 Participants |
| Boostrix Group | Number of Subjects With Anti-pertussis Toxoid (PT) Antibody Concentrations Equal to or Above Protocol Specified Cut-off | Year 3 | 751 Participants |
| Boostrix Group | Number of Subjects With Anti-pertussis Toxoid (PT) Antibody Concentrations Equal to or Above Protocol Specified Cut-off | Year 5 | 670 Participants |
| Adacel Group | Number of Subjects With Anti-pertussis Toxoid (PT) Antibody Concentrations Equal to or Above Protocol Specified Cut-off | Year 1 | 435 Participants |
| Adacel Group | Number of Subjects With Anti-pertussis Toxoid (PT) Antibody Concentrations Equal to or Above Protocol Specified Cut-off | Year 3 | 316 Participants |
| Adacel Group | Number of Subjects With Anti-pertussis Toxoid (PT) Antibody Concentrations Equal to or Above Protocol Specified Cut-off | Year 5 | 285 Participants |
Secondary
Number of Subjects With Anti-PRN Antibody Concentrations Equal to or Above Protocol Specified Cut-off
The cut-off for anti-PRN concentrations was defined as equal to or greater than 2.187 IU/mL.
Time frame: At Year 9, one month before(pre booster) and after the booster vaccination(post booster)
Population: Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix Group | Number of Subjects With Anti-PRN Antibody Concentrations Equal to or Above Protocol Specified Cut-off | Pre-booster | 267 Participants |
| Boostrix Group | Number of Subjects With Anti-PRN Antibody Concentrations Equal to or Above Protocol Specified Cut-off | Post-booster | 271 Participants |
| Adacel Group | Number of Subjects With Anti-PRN Antibody Concentrations Equal to or Above Protocol Specified Cut-off | Pre-booster | 117 Participants |
| Adacel Group | Number of Subjects With Anti-PRN Antibody Concentrations Equal to or Above Protocol Specified Cut-off | Post-booster | 121 Participants |
| Control Group | Number of Subjects With Anti-PRN Antibody Concentrations Equal to or Above Protocol Specified Cut-off | Pre-booster | 284 Participants |
| Control Group | Number of Subjects With Anti-PRN Antibody Concentrations Equal to or Above Protocol Specified Cut-off | Post-booster | 326 Participants |
Secondary
Number of Subjects With Anti-PRN Antibody Concentrations Equal to or Above Protocol Specified Cut-off
The cut-off for anti-PRN concentrations was defined as equal to or greater than 5 EL.U/mL.
Time frame: At 1, 3, and 5 years after the vaccination in primary study (NCT00346073)
Population: The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix Group | Number of Subjects With Anti-PRN Antibody Concentrations Equal to or Above Protocol Specified Cut-off | Year 1 | 971 Participants |
| Boostrix Group | Number of Subjects With Anti-PRN Antibody Concentrations Equal to or Above Protocol Specified Cut-off | Year 3 | 862 Participants |
| Boostrix Group | Number of Subjects With Anti-PRN Antibody Concentrations Equal to or Above Protocol Specified Cut-off | Year 5 | 755 Participants |
| Adacel Group | Number of Subjects With Anti-PRN Antibody Concentrations Equal to or Above Protocol Specified Cut-off | Year 1 | 489 Participants |
| Adacel Group | Number of Subjects With Anti-PRN Antibody Concentrations Equal to or Above Protocol Specified Cut-off | Year 3 | 426 Participants |
| Adacel Group | Number of Subjects With Anti-PRN Antibody Concentrations Equal to or Above Protocol Specified Cut-off | Year 5 | 362 Participants |
Secondary
Number of Subjects With Anti-PT Antibody Concentrations Equal to or Above Protocol Specified Cut-off
The cut-off for anti-PT concentrations was defined as equal to or greater than 2.693 IU/mL.
Time frame: At Year 9, one month before(pre booster) and after the booster vaccination(post booster)
Population: Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix Group | Number of Subjects With Anti-PT Antibody Concentrations Equal to or Above Protocol Specified Cut-off | Pre-booster | 230 Participants |
| Boostrix Group | Number of Subjects With Anti-PT Antibody Concentrations Equal to or Above Protocol Specified Cut-off | Post-booster | 268 Participants |
| Adacel Group | Number of Subjects With Anti-PT Antibody Concentrations Equal to or Above Protocol Specified Cut-off | Pre-booster | 106 Participants |
| Adacel Group | Number of Subjects With Anti-PT Antibody Concentrations Equal to or Above Protocol Specified Cut-off | Post-booster | 120 Participants |
| Control Group | Number of Subjects With Anti-PT Antibody Concentrations Equal to or Above Protocol Specified Cut-off | Pre-booster | 209 Participants |
| Control Group | Number of Subjects With Anti-PT Antibody Concentrations Equal to or Above Protocol Specified Cut-off | Post-booster | 322 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Year 9
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as significant pain at rest that prevented normal everyday activities. Grade 3 redness and swelling was greater than 50 millimeters (mm)
Time frame: During the 4-day (Days 0-3) post vaccination period.
Population: The analysis was performed on the Total Vaccinated cohort at Year 9, which included all subjects with study vaccine administration dose documented, who returned at Year 9 and had their diary cards completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Year 9 | Any Pain | 180 Participants |
| Boostrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Year 9 | Grade 3 Pain | 3 Participants |
| Boostrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Year 9 | Any Redness | 74 Participants |
| Boostrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Year 9 | Grade 3 Redness | 5 Participants |
| Boostrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Year 9 | Any Swelling | 57 Participants |
| Boostrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Year 9 | Grade 3 Swelling | 4 Participants |
| Adacel Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Year 9 | Grade 3 Swelling | 2 Participants |
| Adacel Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Year 9 | Any Pain | 84 Participants |
| Adacel Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Year 9 | Grade 3 Redness | 2 Participants |
| Adacel Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Year 9 | Any Swelling | 26 Participants |
| Adacel Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Year 9 | Grade 3 Pain | 1 Participants |
| Adacel Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Year 9 | Any Redness | 32 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Year 9 | Grade 3 Pain | 4 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Year 9 | Any Redness | 53 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Year 9 | Grade 3 Swelling | 2 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Year 9 | Grade 3 Redness | 0 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Year 9 | Any Pain | 132 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Year 9 | Any Swelling | 41 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Year 9
The solicited general symptoms assessed were Fatigue, Gastrointestinal symptoms (including nausea, vomiting, diarrhea and abdominal pain), Headache and Fever \[defined as temperature of ≥100.4 degrees Fahrenheit (F) by any route\]. Any = Occurrence of any general symptom regardless of its intensity grade or relationship to vaccination; Grade 3 Symptom = Symptom that prevented normal activity; Grade 3 Fever \> 104.0 degrees F.
Time frame: During the 4-day (Days 0-3) post vaccination period.
Population: The analysis was performed on the Total Vaccinated cohort at Year 9, which included all subjects with study vaccine administration dose documented, who returned at Year 9 and had their diary cards completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Year 9 | Any Fatigue | 71 Participants |
| Boostrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Year 9 | Grade 3 Fatigue | 3 Participants |
| Boostrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Year 9 | Any Gastrointestinal symptoms | 27 Participants |
| Boostrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Year 9 | Grade 3 Gastrointestinal symptoms | 0 Participants |
| Boostrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Year 9 | Any Headache | 52 Participants |
| Boostrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Year 9 | Grade 3 Headache | 0 Participants |
| Boostrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Year 9 | Any Fever | 2 Participants |
| Boostrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Year 9 | Grade 3 Fever | 0 Participants |
| Adacel Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Year 9 | Any Gastrointestinal symptoms | 4 Participants |
| Adacel Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Year 9 | Any Fever | 0 Participants |
| Adacel Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Year 9 | Grade 3 Gastrointestinal symptoms | 0 Participants |
| Adacel Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Year 9 | Any Headache | 25 Participants |
| Adacel Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Year 9 | Grade 3 Headache | 1 Participants |
| Adacel Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Year 9 | Any Fatigue | 23 Participants |
| Adacel Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Year 9 | Grade 3 Fatigue | 1 Participants |
| Adacel Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Year 9 | Grade 3 Fever | 0 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Year 9 | Any Gastrointestinal symptoms | 29 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Year 9 | Grade 3 Fatigue | 0 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Year 9 | Any Fatigue | 51 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Year 9 | Grade 3 Gastrointestinal symptoms | 0 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Year 9 | Any Fever | 2 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Year 9 | Grade 3 Headache | 1 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Year 9 | Any Headache | 53 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Year 9 | Grade 3 Fever | 0 Participants |
Secondary
Number of Subjects With Any Large Injection Site Reaction - Year 9
Large injection site reaction = a swelling with a diameter \> 100 mm, noticeable diffuse swelling or noticeable increase in limb circumference.
Time frame: During the 4-day (Days 0-3) follow-up period after vaccination.
Population: The analysis was performed on the Total Vaccinated cohort at Year 9, which included all subjects with study vaccine administration dose documented, who returned at Year 9.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Boostrix Group | Number of Subjects With Any Large Injection Site Reaction - Year 9 | 0 Participants |
| Adacel Group | Number of Subjects With Any Large Injection Site Reaction - Year 9 | 0 Participants |
| Control Group | Number of Subjects With Any Large Injection Site Reaction - Year 9 | 0 Participants |
Secondary
Number of Subjects With Any Unsolicited Adverse Events (AEs) - Year 9
An unsolicited AE covers any untoward medical oc-currence 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.
Time frame: During the 31-day (Days 0-30) post-vaccination period.
Population: The analysis was performed on the Total Vaccinated cohort at Year 9, which included all subjects with study vaccine administration dose documented, who returned at Year 9.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Boostrix Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) - Year 9 | 42 Participants |
| Adacel Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) - Year 9 | 23 Participants |
| Control Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) - Year 9 | 37 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs) - Year 9
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: During the 31-day (Days 0-30) post-vaccination period
Population: The analysis was performed on the Total Vaccinated cohort at Year 9, which included all subjects with study vaccine administration dose documented, who returned at Year 9.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Boostrix Group | Number of Subjects With Serious Adverse Events (SAEs) - Year 9 | 0 Participants |
| Adacel Group | Number of Subjects With Serious Adverse Events (SAEs) - Year 9 | 0 Participants |
| Control Group | Number of Subjects With Serious Adverse Events (SAEs) - Year 9 | 1 Participants |
Secondary
Seroprotection Status for Anti-D Antibody Concentration
Seroprotection status for anti-D antibody concentration \< 0.1 IU/mL were tested for neutralizing antibodies using a VERO-cell neutralization assay. Seroprotection rate is defined as the percentage of subjects with antibody concentrations greater than or equal (≥) the seroprotection cut-off value defined for that antibody.
Time frame: At Year 9, one month before(pre booster) and after the booster vaccination(post booster)
Population: Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Boostrix Group | Seroprotection Status for Anti-D Antibody Concentration | Pre-booster | 8.3 Percentage of subjects |
| Boostrix Group | Seroprotection Status for Anti-D Antibody Concentration | Post-booster | 50.0 Percentage of subjects |
| Adacel Group | Seroprotection Status for Anti-D Antibody Concentration | Pre-booster | 40.0 Percentage of subjects |
| Adacel Group | Seroprotection Status for Anti-D Antibody Concentration | Post-booster | 0.0 Percentage of subjects |
| Control Group | Seroprotection Status for Anti-D Antibody Concentration | Pre-booster | 27.6 Percentage of subjects |
| Control Group | Seroprotection Status for Anti-D Antibody Concentration | Post-booster | 14.3 Percentage of subjects |