Acellular Pertussis, Diphtheria, Tetanus
Conditions
Keywords
dTpa, Boostrix
Brief summary
The purpose of the study is to compare the immunogenicity and safety of a booster dose of BoostrixTM administered in a new syringe presentation to that of BoostrixTM administered in the previous syringe presentation in healthy adolescents aged 10-15 years.
Detailed description
The protocol has been updated following Protocol amendment 1 date 03 August 2011 leading to the update of the exclusion criteria to allow subjects in Mexico to receive the flu vaccine in accordance with the local standard of care. The protocol has been updated following Protocol amendment 2 dated 14 December 2011 due to the recruitment constraints as a result of the DT/dTpa vaccination campaign in the countries. The inclusion and exclusion criteria were amended to allow the participation of those who have already received the 6th dose of the diphtheria, tetanus and/or pertussis containing vaccine.
Interventions
BIOLOGICALBoostrix TM (new syringe presentation)
Single dose, intramuscular administration in a new syringe presentation
BIOLOGICALBoostrix TM (previous syringe presentation)
Single dose, intramuscular administration in previous syringe presentation
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
10 Years to 15 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject's parent(s)/Legally Acceptable Representative(s) and subjects who the investigator believes can and are willing to comply with the requirements of the protocol. * A male or female between 10 and 15 years of age at the time of booster vaccination. * Prior to protocol amendment 2, subjects who have previously received 5 doses of diphtheria-tetanus-pertussis vaccine (whole cell/acellular \[w/a\]) as part of primary and booster vaccination, in line with local recommendations. * After protocol amendment 2, subjects who have previously received 6 doses of either DT(P) (w/a)/ dTpa vaccine as part of primary and booster vaccination, in line with local recommendations. * Healthy subjects as determined by the investigator based on medical history and clinical examination before entering into the study. * Written informed consent to be obtained before study entry from the parent(s)/ Legally Acceptable Representative(s) of the subject. * Written informed assent to be obtained from the subject in addition to the informed consent signed by the parent(s)/ Legally Acceptable Representative(s), if required by local regulations. * Female subjects of non-childbearing potential may be enrolled in the study. * Female subjects of childbearing potential may be enrolled in the study, if the subject: * has a negative pregnancy test on the day of vaccination, * if sexually active, has practiced adequate contraception for 30 days prior to vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after booster vaccination.
Exclusion criteria
* Child in care. * Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose. * Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the booster dose of vaccine - with the exception of influenza vaccine which is allowed up to 7 days before the study vaccine dose, or planned in the period ≥ 7 days after the study vaccine dose. * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. * A history of previous or intercurrent diphtheria, tetanus or pertussis disease. * A history of vaccination against these diseases since the 5th or the 6th dose of DT(P)/dT(pa). For subjects who have received the 6th dose of the diphtheria, tetanus and/or pertussis containing vaccine, the interval between the last DT(P)/dT(pa) vaccination and the administration of the study vaccine should be at least 18 months. * Occurrence of any of the following adverse event after a previous administration of a Boostrix vaccine : * known hypersensitivity to any component of the vaccine, or have shown signs of hypersensitivity after previous administration of diphtheria, tetanus or pertussis vaccines, * encephalopathy of unknown aetiology occurring within 7 days following previous vaccination with pertussis-containing vaccine, * transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. * Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period. * Acute disease and/or fever at the time of enrolment. * Pregnant or lactating female. * Female planning to become pregnant or planning to discontinue contraceptive precautions, if applicable.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | At Month 1 | Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL). |
| Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibody Concentrations | At Month 1 | Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter(EL.U/mL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seropositive Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations) | At Day 0 (PRE) vaccine and at Month 1 (POST) | A seroprotected subject was defined as a subject whose antibody concentration was greater than or equal to (≥) 5 Enzyme Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL). |
| Number of Subjects With Booster Response to Diphtheria (D) and Tetanus (T) Antibodies | At Month 1 | Booster response to the diphtheria and tetanus antigens, was defined as: for initially seronegative subjects (pre-vaccination concentration \<0.1 IU/mL): antibody concentrations at least 4 times the cut-off (post-vaccination concentration ≥ 0.4 IU/mL); for initially seropositive subjects (pre-vaccination concentration ≥ 0.1 IU/mL): an increase in antibody concentrations of at least 4 times the pre-vaccination concentration. |
| Number of Subjects With a Booster Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN) Antigens. | At Month 1 | Booster response to the PT, FHA and PRN antigens, was defined as: for initially seronegative subjects: antibody concentrations at least 4 times the cut-off (post-vaccination concentration ≥ 20 EL.U/mL); 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 4 times the pre-vaccination concentration; and for initially seropositive subjects with pre-vaccination concentration ≥ 20 EL.U/mL: an increase in antibody concentrations of at least 2 times the pre-vaccination concentration. |
| Number of Seropositive Subjects Against Diphtheria (D) and Tetanus (T) Antigens | At Day 0 (PRE) and at Month 1 (POST) | A seroprotected subject was defined as a subject whose antibody concentration was greater than or equal to (≥) 0.1. international units per milliliter (IU/mL), as assessed by the Enzyme Linked Immunosorbent Assay (ELISA). |
| Number of Subjects With Unsolicited Adverse Events (AEs) | Within 31 days (Days 0-30) post | 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. |
| Number of Subjects With Any Solicited General Symptoms | Within 4 days (Days 0-3) post vaccination period | Assessed solicited general symptoms were fatigue, temperature \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], headache and gastrointestinal symptoms. Gastrointestinal symptoms included Nausea, Vomiting, Diarrhea and or Abdominal pain. Any = occurrence of the symptom regardless of intensity grade. |
| Number of Subjects With Serious Adverse Events (SAEs) | During the entire study period (Day 0 - Month 1) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Number of Subjects With Any Solicited Local Symptoms | Within 4 days (Days 0-3) post vaccination period | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. |
| Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens | At Day 0 (PRE) vaccine and at Month 1 (POST) | A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to ( ≥) 1 international units per milliliter (IU/mL). |
Countries
Chile, Mexico
Participant flow
Pre-assignment details
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Participants by arm
| Arm | Count |
|---|---|
| Boostrix New Group Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0. | 335 |
| Boostrix Prev Group Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0. | 336 |
| Total | 671 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 6 |
| Overall Study | Withdrawal by Subject | 3 | 1 |
Baseline characteristics
| Characteristic | Boostrix New Group | Boostrix Prev Group | Total |
|---|---|---|---|
| Age, Continuous | 11.9 Years STANDARD_DEVIATION 1.59 | 11.9 Years STANDARD_DEVIATION 1.61 | 11.9 Years STANDARD_DEVIATION 1.6 |
| Sex: Female, Male Female | 179 Participants | 178 Participants | 357 Participants |
| Sex: Female, Male Male | 156 Participants | 158 Participants | 314 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 263 / 335 | 279 / 336 |
| serious Total, serious adverse events | 1 / 335 | 0 / 336 |
Outcome results
Primary
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 Month 1
Population: The analysis was performed on the According To Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Boostrix New Group | Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | Anti-D | 6.784 IU/mL |
| Boostrix New Group | Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | Anti-T | 18.937 IU/mL |
| Boostrix Prev Group | Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | Anti-D | 6.493 IU/mL |
| Boostrix Prev Group | Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | Anti-T | 18.515 IU/mL |
Comparison: Analysis was performed to demonstrate that Boostrix administered using the new syringe presentation was non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to diphteria vaccine antigens, one month after booster vaccination.95% CI: [0.85, 1.09]ANCOVA
Comparison: Analysis was performed to demonstrate that Boostrix administered using the new syringe presentation was non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to tetanus vaccine antigens, one month after booster vaccination.95% CI: [0.86, 1.1]ANCOVA
Primary
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 Day 0
Population: The analysis was performed on the According To Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Boostrix New Group | Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | Anti-D | 0.472 IU/mL |
| Boostrix New Group | Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | Anti-T | 0.956 IU/mL |
| Boostrix Prev Group | Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | Anti-D | 0.456 IU/mL |
| Boostrix Prev Group | Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | Anti-T | 0.899 IU/mL |
Primary
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter(EL.U/mL)
Time frame: At Month 1
Population: The analysis was performed on the According To Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Boostrix New Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PT | 140.2 EL.U/mL |
| Boostrix New Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-FHA | 1080.2 EL.U/mL |
| Boostrix New Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PRN | 652.4 EL.U/mL |
| Boostrix Prev Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PT | 125.9 EL.U/mL |
| Boostrix Prev Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-FHA | 1013.7 EL.U/mL |
| Boostrix Prev Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PRN | 619.2 EL.U/mL |
Comparison: Analysis was performed to demonstrate that Boostrix administered using the new syringe presentation was non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to pertussis toxoid vaccine antigens, one month after booster vaccination.95% CI: [0.82, 1.04]ANCOVA
Comparison: Analysis was performed to demonstrate that Boostrix administered using the new syringe presentation was non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to filamentous haemagglutinin vaccine antigens, one month after booster vaccination.95% CI: [0.83, 1.03]
Comparison: Analysis was performed to demonstrate that Boostrix administered using the new syringe presentation was non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to pertactin vaccine antigens, one month after booster vaccination.95% CI: [0.85, 1.13]
Primary
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), 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
Population: The analysis was performed on the According To Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Boostrix New Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PT PRE | 7.5 EL.U/mL |
| Boostrix New Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-FHA PRE | 48.9 EL.U/mL |
| Boostrix New Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PRN PRE | 14 EL.U/mL |
| Boostrix Prev Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PT PRE | 7.2 EL.U/mL |
| Boostrix Prev Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-FHA PRE | 49.4 EL.U/mL |
| Boostrix Prev Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PRN PRE | 13.4 EL.U/mL |
Secondary
Number of Seropositive Subjects Against Diphtheria (D) and Tetanus (T) Antigens
A seroprotected subject was defined as a subject whose antibody concentration was greater than or equal to (≥) 0.1. international units per milliliter (IU/mL), as assessed by the Enzyme Linked Immunosorbent Assay (ELISA).
Time frame: At Day 0 (PRE) and at Month 1 (POST)
Population: The analysis was performed on the According To Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix New Group | Number of Seropositive Subjects Against Diphtheria (D) and Tetanus (T) Antigens | Anti-D PRE | 284 Participants |
| Boostrix New Group | Number of Seropositive Subjects Against Diphtheria (D) and Tetanus (T) Antigens | Anti-D POST | 320 Participants |
| Boostrix New Group | Number of Seropositive Subjects Against Diphtheria (D) and Tetanus (T) Antigens | Anti-T PRE | 311 Participants |
| Boostrix New Group | Number of Seropositive Subjects Against Diphtheria (D) and Tetanus (T) Antigens | Anti-T POST | 321 Participants |
| Boostrix Prev Group | Number of Seropositive Subjects Against Diphtheria (D) and Tetanus (T) Antigens | Anti-T POST | 319 Participants |
| Boostrix Prev Group | Number of Seropositive Subjects Against Diphtheria (D) and Tetanus (T) Antigens | Anti-D PRE | 286 Participants |
| Boostrix Prev Group | Number of Seropositive Subjects Against Diphtheria (D) and Tetanus (T) Antigens | Anti-T PRE | 314 Participants |
| Boostrix Prev Group | Number of Seropositive Subjects Against Diphtheria (D) and Tetanus (T) Antigens | Anti-D POST | 319 Participants |
Secondary
Number of Seropositive Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations)
A seroprotected subject was defined as a subject whose antibody concentration was greater than or equal to (≥) 5 Enzyme Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL).
Time frame: At Day 0 (PRE) vaccine and at Month 1 (POST)
Population: The analysis was performed on the According To Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix New Group | Number of Seropositive Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations) | Anti-PT PRE | 175 Participants |
| Boostrix New Group | Number of Seropositive Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations) | Anti-PT POST | 316 Participants |
| Boostrix New Group | Number of Seropositive Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations) | Anti-FHA PRE | 310 Participants |
| Boostrix New Group | Number of Seropositive Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations) | Anti-FHA POST | 319 Participants |
| Boostrix New Group | Number of Seropositive Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations) | Anti-PRN PRE | 269 Participants |
| Boostrix New Group | Number of Seropositive Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations) | Anti-PRN POST | 321 Participants |
| Boostrix Prev Group | Number of Seropositive Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations) | Anti-PRN PRE | 272 Participants |
| Boostrix Prev Group | Number of Seropositive Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations) | Anti-PT PRE | 175 Participants |
| Boostrix Prev Group | Number of Seropositive Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations) | Anti-FHA POST | 319 Participants |
| Boostrix Prev Group | Number of Seropositive Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations) | Anti-PT POST | 315 Participants |
| Boostrix Prev Group | Number of Seropositive Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations) | Anti-PRN POST | 318 Participants |
| Boostrix Prev Group | Number of Seropositive Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations) | Anti-FHA PRE | 310 Participants |
Secondary
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens
A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to ( ≥) 1 international units per milliliter (IU/mL).
Time frame: At Day 0 (PRE) vaccine and at Month 1 (POST)
Population: The analysis was performed on the According To Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix New Group | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens | Anti-D PRE | 83 Participants |
| Boostrix New Group | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens | Anti-D POST | 315 Participants |
| Boostrix New Group | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens | Anti-T PRE | 151 Participants |
| Boostrix New Group | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens | Anti-T POST | 321 Participants |
| Boostrix Prev Group | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens | Anti-T POST | 319 Participants |
| Boostrix Prev Group | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens | Anti-D PRE | 89 Participants |
| Boostrix Prev Group | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens | Anti-T PRE | 143 Participants |
| Boostrix Prev Group | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens | Anti-D POST | 310 Participants |
Secondary
Number of Subjects With a Booster Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN) Antigens.
Booster response to the PT, FHA and PRN antigens, was defined as: for initially seronegative subjects: antibody concentrations at least 4 times the cut-off (post-vaccination concentration ≥ 20 EL.U/mL); 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 4 times the pre-vaccination concentration; and for initially seropositive subjects with pre-vaccination concentration ≥ 20 EL.U/mL: an increase in antibody concentrations of at least 2 times the pre-vaccination concentration.
Time frame: At Month 1
Population: The analysis was performed on the According To Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix New Group | Number of Subjects With a Booster Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN) Antigens. | Anti-PT | 298 Participants |
| Boostrix New Group | Number of Subjects With a Booster Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN) Antigens. | Anti-FHA | 305 Participants |
| Boostrix New Group | Number of Subjects With a Booster Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN) Antigens. | Anti-PRN | 315 Participants |
| Boostrix Prev Group | Number of Subjects With a Booster Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN) Antigens. | Anti-PT | 295 Participants |
| Boostrix Prev Group | Number of Subjects With a Booster Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN) Antigens. | Anti-FHA | 304 Participants |
| Boostrix Prev Group | Number of Subjects With a Booster Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN) Antigens. | Anti-PRN | 317 Participants |
Secondary
Number of Subjects With Any Solicited General Symptoms
Assessed solicited general symptoms were fatigue, temperature \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], headache and gastrointestinal symptoms. Gastrointestinal symptoms included Nausea, Vomiting, Diarrhea and or Abdominal pain. Any = occurrence of the symptom regardless of intensity grade.
Time frame: Within 4 days (Days 0-3) post vaccination period
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study vaccine and with the symptom sheet filled-in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix New Group | Number of Subjects With Any Solicited General Symptoms | Any Fatigue | 83 Participants |
| Boostrix New Group | Number of Subjects With Any Solicited General Symptoms | Any Gastrointestinal symptoms | 32 Participants |
| Boostrix New Group | Number of Subjects With Any Solicited General Symptoms | Any Headache | 88 Participants |
| Boostrix New Group | Number of Subjects With Any Solicited General Symptoms | Any Temperature | 9 Participants |
| Boostrix Prev Group | Number of Subjects With Any Solicited General Symptoms | Any Temperature | 6 Participants |
| Boostrix Prev Group | Number of Subjects With Any Solicited General Symptoms | Any Fatigue | 86 Participants |
| Boostrix Prev Group | Number of Subjects With Any Solicited General Symptoms | Any Headache | 108 Participants |
| Boostrix Prev Group | Number of Subjects With Any Solicited General Symptoms | Any Gastrointestinal symptoms | 42 Participants |
Secondary
Number of Subjects With Any Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Time frame: Within 4 days (Days 0-3) post vaccination period
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study vaccine and with the symptom sheet filled-in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix New Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain | 237 Participants |
| Boostrix New Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness | 113 Participants |
| Boostrix New Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling | 98 Participants |
| Boostrix Prev Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain | 248 Participants |
| Boostrix Prev Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness | 94 Participants |
| Boostrix Prev Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling | 90 Participants |
Secondary
Number of Subjects With Booster Response to Diphtheria (D) and Tetanus (T) Antibodies
Booster response to the diphtheria and tetanus antigens, was defined as: for initially seronegative subjects (pre-vaccination concentration \<0.1 IU/mL): antibody concentrations at least 4 times the cut-off (post-vaccination concentration ≥ 0.4 IU/mL); for initially seropositive subjects (pre-vaccination concentration ≥ 0.1 IU/mL): an increase in antibody concentrations of at least 4 times the pre-vaccination concentration.
Time frame: At Month 1
Population: The analysis was performed on the According To Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix New Group | Number of Subjects With Booster Response to Diphtheria (D) and Tetanus (T) Antibodies | Anti-D | 257 Participants |
| Boostrix New Group | Number of Subjects With Booster Response to Diphtheria (D) and Tetanus (T) Antibodies | Anti-T | 266 Participants |
| Boostrix Prev Group | Number of Subjects With Booster Response to Diphtheria (D) and Tetanus (T) Antibodies | Anti-D | 252 Participants |
| Boostrix Prev Group | Number of Subjects With Booster Response to Diphtheria (D) and Tetanus (T) Antibodies | Anti-T | 270 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: During the entire study period (Day 0 - Month 1)
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Boostrix New Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
| Boostrix Prev Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
Secondary
Number of Subjects With 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.
Time frame: Within 31 days (Days 0-30) post
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Boostrix New Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 44 Participants |
| Boostrix Prev Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 45 Participants |