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The purpose of the study is to evaluate the immunogenicity, safety and reactogenicity of a dTpa (Boostrixâ„¢ vaccine) booster dose given 10 years after the previous vaccination with dTpa in GSK 263855/029 study. Only subjects who were part of the primary study will be invited to participate in this study.This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate study (see reference).
All subjects will receive a booster dose of the vaccine that they received in their primary study. Subjects who received the investigational vaccine formulation, will receive Boostrixâ„¢ in the present study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Boostrix-REF Group | Experimental | Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrixâ„¢ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrixâ„¢ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrixâ„¢ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm. |
|
| Boostrix-US Group | Experimental | Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrixâ„¢ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrixâ„¢ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrixâ„¢ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm. |
|
| Boostrix-INV Group | Experimental | Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrixâ„¢ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrixâ„¢ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrixâ„¢ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Boostrixâ„¢ | Biological | Intramuscular, single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Seroprotected Subjects Against Diphtheria and Tetanus | A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-diphtheria (anti-D)/anti-tetanus (anti-T) antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL). | At Year 8.5 |
| Concentrations for Anti-D and Anti-T Antibodies. | Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL for all antibodies assessed. | At Year 8.5 |
| Number of Seroprotected Subjects Against Diphtheria and Tetanus. | A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-D/anti-T antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL). | At Year 10 |
| Concentrations for Anti-D and Anti-T Antibodies. | Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL. | At Year 10 |
| Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Haemagglutinin (Anti-FHA) Antibodies. | A seropositive subject for anti-PT/anti-PRN/anti-FHA antibodies was defined as a vaccinated subject who had anti-PT/anti-PRN/anti-FHA antibody concentrations greater than or equal to (≥) 5 Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). | At Year 8.5 |
| Concentrations for Anti-PT, Anti-PRN and Anti-FHA Antibodies. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Any Solicited Local Symptoms. | Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = incidence of a particular symptom regardless of intensity grade. | During the 4-day (Days 0-3) follow-up period after booster vaccination |
| Number of Subjects With Any Solicited General Symptoms. |
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Inclusion Criteria:
Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
Male or female subjects who have received Boostrixâ„¢, Boostrixâ„¢-US formulation or the investigational vaccine formulation in the study 263855/029.
Written informed consent obtained from the subject. Additional criteria to be checked before the booster vaccination.
Healthy subjects as established by medical history and clinical examination.
Female subjects of non-childbearing potential may receive the booster vaccine.
Female subjects of childbearing potential may receive the booster vaccine, if the subject:
Exclusion Criteria:
Exclusion criteria to be checked at study entry:
Previous booster vaccination against diphtheria, tetanus, or pertussis since the dose received in the study 263855/029.
History of diphtheria, tetanus, or laboratory confirmed pertussis disease.
Any confirmed or suspected immunosuppressive or immunodeficiency condition, based on medical history and physical examination.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
Occurrence of any of the following adverse event after a previous administration of a DTP vaccine :
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Additional exclusion criteria to be checked for subjects before the booster vaccination administration:
Use of any investigational or non-registered product other than the study vaccine(s) 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.
Administration of a vaccine not foreseen by the study protocol within 30 days prior to booster vaccination, or planned administration during the active study period.
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.
Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose 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.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Brussels | 1200 | Belgium | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25613716 | Derived | Vandermeulen C, Theeten H, Rathi N, Kuriyakose S, Han HH, Sokal E, Hoppenbrouwers K, Van Damme P. Decennial administration in young adults of a reduced-antigen content diphtheria, tetanus, acellular pertussis vaccine containing two different concentrations of aluminium. Vaccine. 2015 Jun 12;33(26):3026-34. doi: 10.1016/j.vaccine.2014.10.049. Epub 2015 Jan 19. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 113055 | Clinical Study Report | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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At Year 8.5, a total of 180 subjects (out of the 478 planned) were enrolled: 54, 60 and 66 subjects in the Boostrix-REF, Boostrix-US, and Boostrix-INV groups, respectively. At Year 10, a total of 177 subjects (out of the 180 planned) were enrolled: 55, 60 and 62 in the Boostrix-REF, Boostrix-US, and Boostrix-INV groups, respectively.
Subjects consisted of those previously vaccinated & boosted in GSK263855/029 study and contacted for participation in this booster (BST) study. Duration of this study was about 19 months, from Year 8.5 (8.5 years post BST in GSK263855/029 study) to one month post BST in this study (Year 10 [10 years post BST in GSK263855/029 study] + one month).
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| ID | Title | Description |
|---|---|---|
| FG000 | Boostrix-US Group | Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrixâ„¢ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrixâ„¢ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrixâ„¢ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm. |
| FG001 | Boostrix-INV Group | Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrixâ„¢ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrixâ„¢ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrixâ„¢ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm. |
| FG002 | Boostrix-REF Group | Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrixâ„¢ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrixâ„¢ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrixâ„¢ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| At Year 8.5 |
| |||||||||||||
| At Year 10 |
|
At Year 8.5, a total of 180 subjects (out of the 478 planned) were enrolled: 54, 60 and 66 subjects in the Boostrix-REF, Boostrix-US, and Boostrix-INV groups, respectively. At Year 10, a total of 177 subjects (out of the 180 planned) were enrolled: 55, 60 and 62 in the Boostrix-REF, Boostrix-US, and Boostrix-INV groups, respectively.
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| ID | Title | Description |
|---|---|---|
| BG000 | Boostrix-US Group | Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrixâ„¢ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrixâ„¢ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrixâ„¢ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The baseline measure data correspond to Year 8.5. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Seroprotected Subjects Against Diphtheria and Tetanus | A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-diphtheria (anti-D)/anti-tetanus (anti-T) antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL). | The analysis was performed on the According To Protocol cohort for persistence at Year 8.5, which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 8.5. | Posted | Count of Participants | Participants | At Year 8.5 |
|
Serious adverse events (SAEs): Entire study period (From Year 8.5 to one month post Year 10) ; Unsolicited adverse events (AEs): During the 31 days (Day 0 - Day 30) post Year 10 booster vaccination; Solicited symptoms: During the 4 days (Day 0 - Day 3) post Year 10 booster vaccination.
Total numbers of subjects at risk for SAEs are those at time points with highest numbers of subjects enrolled. For unsolicited and solicited AEs they correspond to the numbers of subjects with available results. Numbers at risk are the highest ones, at Year 8.5 for Boostrix-US Group, & Year 10 for the other groups.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Boostrix-US Group | Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrixâ„¢ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrixâ„¢ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrixâ„¢ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment | Unsolicited AE reported among subjects receiving the Booster dose of vaccine administered at Year 10. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D013742 | Tetanus |
| D004165 | Diphtheria |
| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| C505143 | Boostrix |
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|
| Boostrixâ„¢-US formulation | Biological | Intramuscular, single dose |
|
Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL for all antibodies assessed.
| At Year 8.5 |
| Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies. | A seropositive subject for anti-PT/anti-FHA/anti-PRN antibodies was defined as a vaccinated subject who had anti-PT/anti-FHA/anti-PRN antibody concentrations greater than or equal to (≥) 5 Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). | At Year 10 |
| Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies. | Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL. | At Year 10 |
| Number of Seroprotected Subjects Against Diphtheria and Tetanus | A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-D/anti-T antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL). | At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST) |
| Concentrations for Anti-D and Anti-T Antibodies. | Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL for all antibodies assessed. | At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST) |
| Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies. | A seropositive subject for anti-PT/anti-PRN/anti-FHA antibodies was defined as a vaccinated subject who had anti-PT/anti-PRN/anti-FHA antibody concentrations greater than or equal to (≥) 5 ELISA units per milliliter (EL.U/mL). | At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST) |
| Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies. | Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL. | At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST) |
| Number of Booster Responders to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens. | A booster responder to PT/PRN antigens was defined as either a vaccinated subject seronegative at analysis baseline (Year 10) with anti-PT/anti-PRN antibody concentration greater than or equal to (≥) 5 EL.U/mL at one month post Year 10 booster vaccination, or as a vaccinated subject seropositive at analysis baseline (Year 10) and with anti-PT/anti-PRN antibody concentration with at least a 2-fold increase at one month post Year 10 booster vaccination. A seronegative/seropositive subject was defined as a vaccinated subject with anti-PT/anti-PRN antibody concentration ≥/< 5 EL.U/mL. | At 1 month post Year 10 booster vaccination |
Assessed solicited general symptoms were fatigue, gastrointestinal, headache and fever [defined as axillary temperature ≥ 37.5 degrees Celsius (°C)]. Any = incidence of a particular symptom regardless of intensity grade and relationship to vaccination. |
| During the 4-day (Days 0-3) follow-up period after booster vaccination |
| Number of Subjects With Any Unsolicited Adverse Events (AEs). | An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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 unsolicited AE = any unsolicited AE regardless of intensity or relationship to vaccination. | During the 31-day (Days 0-30) follow-up period after booster vaccination |
| Number of Subjects With Any 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, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.. | At Year 8.5 |
| Number of Subjects With Any 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, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. | From Year 8.5 up to study end (one month post Year 10 booster vaccination) |
| Leuven |
| 3000 |
| Belgium |
| GSK Investigational Site | Wilrijk | 2610 | Belgium |
For additional information about this study please refer to the GSK Clinical Study Register |
| 113055 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113055 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113055 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113055 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113055 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NOT COMPLETED |
|
|
| BG001 | Boostrix-INV Group | Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrixâ„¢ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrixâ„¢ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrixâ„¢ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm. |
| BG002 | Boostrix-REF Group | Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrixâ„¢ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrixâ„¢ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrixâ„¢ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm. |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Age, Continuous | The baseline measure data correspond to Year 10. | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | The baseline measure data correspond to Year 8.5. | Count of Participants | Participants |
|
| Sex: Female, Male | The baseline measure data correspond to Year 10. | Count of Participants | Participants |
|
| OG001 | Boostrix-INV Group | Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrixâ„¢ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrixâ„¢ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrixâ„¢ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm. |
| OG002 | Boostrix-REF Group | Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrixâ„¢ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrixâ„¢ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrixâ„¢ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm. |
|
|
| Primary | Concentrations for Anti-D and Anti-T Antibodies. | Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL for all antibodies assessed. | The analysis was performed on the According To Protocol cohort for persistence at Year 8.5 , which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrixâ„¢ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 8.5. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | At Year 8.5 |
|
|
|
| Primary | Number of Seroprotected Subjects Against Diphtheria and Tetanus. | A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-D/anti-T antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL). | The analysis was performed on the According To Protocol cohort for persistence at Year 10, which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 10. | Posted | Count of Participants | Participants | At Year 10 |
|
|
|
| Primary | Concentrations for Anti-D and Anti-T Antibodies. | Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL. | The analysis was performed on the According To Protocol cohort for persistence at Year 10, which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrixâ„¢ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 10. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | At Year 10 |
|
|
|
| Primary | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Haemagglutinin (Anti-FHA) Antibodies. | A seropositive subject for anti-PT/anti-PRN/anti-FHA antibodies was defined as a vaccinated subject who had anti-PT/anti-PRN/anti-FHA antibody concentrations greater than or equal to (≥) 5 Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). | The analysis was performed on the According To Protocol cohort for persistence at Year 8.5 , which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 8.5. | Posted | Count of Participants | Participants | At Year 8.5 |
|
|
|
| Primary | Concentrations for Anti-PT, Anti-PRN and Anti-FHA Antibodies. | Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL for all antibodies assessed. | The analysis was performed on the According To Protocol cohort for persistence at Year 8.5 , which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrixâ„¢ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 8.5. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At Year 8.5 |
|
|
|
| Primary | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies. | A seropositive subject for anti-PT/anti-FHA/anti-PRN antibodies was defined as a vaccinated subject who had anti-PT/anti-FHA/anti-PRN antibody concentrations greater than or equal to (≥) 5 Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). | The analysis was performed on the According To Protocol cohort for persistence at Year 10, which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 10. | Posted | Count of Participants | Participants | At Year 10 |
|
|
|
| Primary | Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies. | Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL. | The analysis was performed on the According To Protocol cohort for persistence at Year 10, which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrixâ„¢ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 10. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At Year 10 |
|
|
|
| Primary | Number of Seroprotected Subjects Against Diphtheria and Tetanus | A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-D/anti-T antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL). | Analysis was done on the According-to-Protocol for immunogenicity at Year 10, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine, any formulation (at least 9.5 years after the dose administered in GSK263855/029 study) and for whom data concerning immunogenicity outcome measures were available. | Posted | Count of Participants | Participants | At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST) |
|
|
|
| Primary | Concentrations for Anti-D and Anti-T Antibodies. | Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL for all antibodies assessed. | Analysis was done on the According-to-Protocol for immunogenicity at Year 10, which included all evaluable subjects who had received the booster dose of Boostrixâ„¢ vaccine, any formulation (at least 9.5 years after the dose administered in GSK263855/029 study) and for whom data concerning immunogenicity outcome measures were available. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST) |
|
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| Primary | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies. | A seropositive subject for anti-PT/anti-PRN/anti-FHA antibodies was defined as a vaccinated subject who had anti-PT/anti-PRN/anti-FHA antibody concentrations greater than or equal to (≥) 5 ELISA units per milliliter (EL.U/mL). | Analysis was done on the According-to-Protocol for immunogenicity at Year 10, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine, any formulation (at least 9.5 years after the dose administered in GSK263855/029 study) and for whom data concerning immunogenicity outcome measures were available. | Posted | Count of Participants | Participants | At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST) |
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| Primary | Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies. | Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL. | Analysis was done on the According-to-Protocol for immunogenicity at Year 10, which included all evaluable subjects who had received the booster dose of Boostrixâ„¢ vaccine, any formulation (at least 9.5 years after the dose administered in GSK263855/029 study) and for whom data concerning immunogenicity outcome measures were available. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST) |
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| Primary | Number of Booster Responders to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens. | A booster responder to PT/PRN antigens was defined as either a vaccinated subject seronegative at analysis baseline (Year 10) with anti-PT/anti-PRN antibody concentration greater than or equal to (≥) 5 EL.U/mL at one month post Year 10 booster vaccination, or as a vaccinated subject seropositive at analysis baseline (Year 10) and with anti-PT/anti-PRN antibody concentration with at least a 2-fold increase at one month post Year 10 booster vaccination. A seronegative/seropositive subject was defined as a vaccinated subject with anti-PT/anti-PRN antibody concentration ≥/< 5 EL.U/mL. | Analysis was done on the According-to-Protocol for immunogenicity at Year 10, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine, any formulation (at least 9.5 years after the dose administered in GSK263855/029 study) and for whom data concerning immunogenicity outcome measures were available. | Posted | Count of Participants | Participants | At 1 month post Year 10 booster vaccination |
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| Secondary | Number of Subjects With Any Solicited Local Symptoms. | Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = incidence of a particular symptom regardless of intensity grade. | Analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of Boostrixâ„¢ vaccine, any formulation, for whom data were available. | Posted | Count of Participants | Participants | During the 4-day (Days 0-3) follow-up period after booster vaccination |
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| Secondary | Number of Subjects With Any Solicited General Symptoms. | Assessed solicited general symptoms were fatigue, gastrointestinal, headache and fever [defined as axillary temperature ≥ 37.5 degrees Celsius (°C)]. Any = incidence of a particular symptom regardless of intensity grade and relationship to vaccination. | Analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of Boostrix™ vaccine, any formulation, for whom data were available. | Posted | Number | subjects | During the 4-day (Days 0-3) follow-up period after booster vaccination |
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| Secondary | Number of Subjects With Any Unsolicited Adverse Events (AEs). | An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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 unsolicited AE = any unsolicited AE regardless of intensity or relationship to vaccination. | Analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of Boostrixâ„¢ vaccine, any formulation, for whom data were available. | Posted | Count of Participants | Participants | During the 31-day (Days 0-30) follow-up period after booster vaccination |
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| Secondary | Number of Subjects With Any 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, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.. | Analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of Boostrixâ„¢ vaccine, any formulation, for whom data were available. | Posted | Count of Participants | Participants | At Year 8.5 |
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| Secondary | Number of Subjects With Any 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, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. | Analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of Boostrixâ„¢ vaccine, any formulation, for whom data were available. | Posted | Count of Participants | Participants | From Year 8.5 up to study end (one month post Year 10 booster vaccination) |
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| 0 |
| 55 |
| 53 |
| 55 |
| EG001 | Boostrix-INV Group | Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrixâ„¢ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrixâ„¢ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrixâ„¢ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm. | 0 | 60 | 58 | 60 |
| EG002 | Boostrix-REF Group | Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrixâ„¢ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrixâ„¢ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrixâ„¢ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm. | 0 | 66 | 58 | 62 |
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| Headache | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment | Unsolicited AE reported among subjects receiving the Booster dose of vaccine administered at Year 10. |
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| Pain | General disorders | MedDRA 15.1 | Systematic Assessment | Solicited local symptom assessed in and reported by subjects receiving the Booster dose of vaccine administered at Year 10. |
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| Redness | General disorders | MedDRA 15.1 | Systematic Assessment | Solicited local symptom assessed in and reported by subjects receiving the Booster dose of vaccine administered at Year 10. |
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| Swelling | General disorders | MedDRA 15.1 | Systematic Assessment | Solicited local symptom assessed in and reported by subjects receiving the Booster dose of vaccine administered at Year 10. |
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| Fatigue | General disorders | MedDRA 15.1 | Systematic Assessment | Solicited general symptom reported by subjects who received Year 10 booster vaccination and with available results. |
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| Gastrointestinal symptoms | General disorders | MedDRA 15.1 | Systematic Assessment | Solicited general symptom reported by subjects who received Year 10 booster vaccination and with available results. |
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| Headache | General disorders | MedDRA 15.1 | Systematic Assessment | Solicited general symptom reported by subjects who received Year 10 booster vaccination and with available results. |
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GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D007239 | Infections |
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| Male |
|
| Male |
|
|
| Title | Measurements |
|---|---|
|
|
|
| Anti-PRN [N=54;59;65] |
|
| Anti-FHA [N=54;59;62] |
|
| Anti-PRN [N=54;59;65] |
|
|
| Anti-FHA [N=54;60;60] |
|
| Anti-PRN [N=54;60;60] |
|
| Anti-FHA [N=54;60;60] |
|
| Title | Measurements |
|---|---|
|
| Anti-T, PRE |
|
| Anti-T, POST |
|
|
| Anti-T, PRE |
|
| Anti-T, POST |
|
|
| Anti-PRN, PRE [N=54;59;59] |
|
| Anti-PRN, POST [N=53;59;60] |
|
| Anti-FHA, PRE [N=54;59;59] |
|
| Anti-FHA, POST [N=53;59;60] |
|
| Anti-PT, POST [N=54;59;60] |
|
| Anti-PRN, PRE [N=54;59;59] |
|
| Anti-PRN, POST [N=53;59;60] |
|
| Anti-FHA, PRE [N=54;59;59] |
|
| Anti-FHA, POST [N=53;59;60] |
|
|
| Booster responses to anti-FHA [N=46;52;50] |
|
| Title | Measurements |
|---|---|
|
| Any Swelling |
|
|
| Any Headache |
|
| Any Fever |
|